Data / Medical devices / United States / Helena Laboratories, Corp.
Helena Laboratories, Corp.: FDA-registered device maker in Beaumont, TX, United States, 79 510(k) clearances
Helena Laboratories, Corp. is registered with the FDA (registration 1618982) in Beaumont, TX, United States. It lists 47 device types. The FDA files 79 510(k) clearances under its listings, the newest dated October 13, 2022. 14 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1618982
- Address
- 1530 Lindbergh Dr, Beaumont, TX, United States, 77707
- Owner or operator
- HELENA LABORATORIES, CORP. (1618982)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- December 31, 1982
- Registered through
- 2026
- Brand names listed
- 0-Dianisidine Stain, 0-Tolidine, 10-100 µLVariable Volume Pipette with Tip Ejector, 1000 Staining Set, 35uL Micropipette, AA2 Hemoglobin Control, ADP Reagent, AFSA2 Hemo Control and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 13, 2022 | K213396 | SPIFE A1AT kit | OBZ | Substantially Equivalent | Helena Laboratories, Corp. | accessdata.fda.gov |
| April 19, 2022 | K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control | GKA | Substantially Equivalent | Helena Laboratories, Corp. | accessdata.fda.gov |
| October 7, 2013 | K131479 | V8 SP NORMAL CONTROL, ABNORMAL CONTROL | JJY | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 15, 2010 | K100103 | SPECIALTY ASSAYED CONTROL-2 | GGC | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| June 21, 2007 | K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | KHE | Substantially Equivalent | Alfa Scientific Designs, Inc. | accessdata.fda.gov |
| February 23, 2007 | K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | GHR | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| July 6, 2006 | K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 | CFF | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| May 10, 2006 | K061014 | ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP | JPA | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| May 24, 2004 | K040296 | PHOSPHOPLASTIN RL | GJS | Substantially Equivalent | R2 Diagnostics, Inc. | accessdata.fda.gov |
| February 19, 2003 | K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | CFF | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| February 14, 2003 | K023761 | PLATELETWORKS, MODELS PW-A, PW-C | JOZ | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| October 11, 2002 | K022757 | SPIFE CK KIT, MODEL 3332, 3333 | JHY | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| May 6, 2002 | K020625 | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 | CIN | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| March 29, 2002 | K020467 | SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 | CFE | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 21, 2001 | K013466 | SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343 | JHO | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| November 27, 2000 | K003359 | COLOSCREEN-ES | KHE | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| April 17, 2000 | K000603 | SPIFE CHOLESTEROL PROFILE KIT | JHO | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| September 21, 1999 | K992199 | ACID HEMOGLOBIN KIT | JBD | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 22, 1998 | K983914 | REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT | GGP | Substantially Equivalent | Corgenix, Inc. | accessdata.fda.gov |
| December 17, 1998 | K982426 | SPIFE ALKALINE HEMOGLOBIN | JBD | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 11, 1998 | K983649 | MAX-ACT | JBP | Substantially Equivalent | Array Medical, Inc. | accessdata.fda.gov |
| January 2, 1998 | K973040 | SPIFE IFE-6 | CFF | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| October 27, 1997 | K972274 | SPIFE | CEF | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| October 6, 1997 | K972342 | REAADS PROTEIN C ANTIGEN TEST KIT | GGP | Substantially Equivalent | Reaads Medical Products, Inc. | accessdata.fda.gov |
| August 13, 1997 | K972482 | REAADS PROTEIN S ANTIGEN TEST KIT | GGP | Substantially Equivalent | Reaads Medical Products, Inc. | accessdata.fda.gov |
| August 13, 1997 | K972005 | REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT | GGP | Substantially Equivalent | Reaads Medical Products, Inc. | accessdata.fda.gov |
| March 6, 1997 | K964609 | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE | JBP | Substantially Equivalent | Array Medical, Inc. | accessdata.fda.gov |
| March 30, 1995 | K950590 | REP CHOLESTEROL PROFILE CONTROL | JJX | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| October 7, 1994 | K941737 | SPECIALTY ASSAYED CONTROL-1 | GIZ | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| September 14, 1994 | K941860 | SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.) | GGN | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| April 27, 1993 | K931247 | TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 | DAH | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| February 12, 1993 | K926222 | OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 | JPA | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 18, 1992 | K924915 | SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 | JJY | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| September 23, 1992 | K921578 | TITAN GEL ALKALINE PHOSPHATASE (HR) | CIN | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| June 19, 1992 | K920927 | KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 | JJY | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| May 7, 1992 | K920926 | KEMTROL SERUM CONTROL-ABNORMAL | JJY | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| May 1, 1992 | K920147 | THROMBIN CLOTTING TIME REAGENT | GJA | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| February 14, 1992 | K915418 | ELLAGIC ACID APTT REAGENT | GFO | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| August 22, 1991 | K912774 | ARACHIDONIC ACID | JBX | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| July 3, 1991 | K911075 | COLOSCREEN | KHE | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| May 20, 1991 | K910800 | ADP REAGENT | GHR | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| May 20, 1991 | K910706 | COLLAGEN REAGENT CAT. NO. 5368 | GHR | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| May 20, 1991 | K910680 | EPINEPHRINE REAGENT, CAT. NO. 5367 | GHR | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| February 11, 1991 | K905673 | AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 | GGN | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| January 18, 1991 | K904247 | FREE PROTEIN S REAGENT CAT. NO. 5363 | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| January 3, 1991 | K905149 | TITAN GEL | DAH | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| February 5, 1990 | K897136 | PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357 | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| November 17, 1989 | K893038 | PROTOFLUOR Z | JKJ | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| October 25, 1989 | K895528 | GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 | JJX | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| April 12, 1989 | K891683 | TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER | CZN | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| March 22, 1989 | K891188 | TITAN GEL IFE TRIVALENT ANTISERUM | CFQ | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| September 30, 1988 | K882799 | HELENA COLOCARE | KHE | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| August 12, 1987 | K872834 | TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 | CZJ | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| June 1, 1987 | K870890 | ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT | CIN | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| April 29, 1987 | K871498 | TITAN GEL IMMUNOFIX CONTROLS | DFT | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| May 2, 1984 | K841020 | FIBRINOGEN ASSAY KIT | KQJ | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| April 5, 1984 | K840329 | RISTOCETIN COFACTOR ASSAY | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| January 4, 1984 | K833639 | TITANGEL HIGH RESOLUTION CONTROL | JJY | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 16, 1983 | K834031 | FACTOR II DEFICIENT SUBSTRATE PLASMA | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| October 20, 1983 | K832428 | PLATELET AGGREGATION REAGENT SET | GHR | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| July 7, 1983 | K831603 | TITAN GE/IEPLATE | JZR | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 28, 1982 | K823267 | FACTOR VIII RELATED ANTIGEN ROCKET EID | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| August 16, 1982 | K821982 | TITAN GEL SERUM CONTROL | JJY | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| July 22, 1982 | K821981 | TITAN GEL CPK/LDH ISOENZYME CONTROL | JJT | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| November 12, 1980 | K802232 | AB-TROL COAGULATION CONTROL | GGW | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| April 29, 1980 | K800856 | A,FDA2 LYOPHILIZED HEMO CONTROL | JBD | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| April 29, 1980 | K800855 | A,FSC LYOPHILIZED HEMO CONTROL | JBD | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| April 29, 1980 | K800854 | A,A2 LYOPHILIZED HEMO CONTROL | JBD | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| April 29, 1980 | K800853 | A,SA2 LYOPHILIZED HEMO CONTROL | JBD | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| March 25, 1980 | K800432 | HELENA RISTOCETIN | JOZ | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| January 24, 1980 | K792656 | HELENA FACTOR XII DEFICIENT | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 31, 1979 | K792511 | HELENA FACTOR VII DEFICIENT SUB. PLASMA | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 31, 1979 | K792508 | HELENA FACTOR X DEFICIENT SUBSTRATE | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 31, 1979 | K792507 | HELENA FACTOR V DEFICIENT SUBSTRATE | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 31, 1979 | K792476 | HELENA FACTOR XI DEFICIENT SUBSTRATE | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 31, 1979 | K792475 | HELENA FACTOR IX DEFICIENT SUBSTRATE | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 4, 1979 | K792335 | HELENA FACTOR VIII DEFICIENT SUB. PLASMA | GGP | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| December 4, 1979 | K792310 | NORM-TROL | JPA | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
| October 30, 1979 | K792024 | LIPOTROL | JJY | Substantially Equivalent | Helena Laboratories | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 2, 2023 | 92297 | Class II | Ongoing | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics | Packaging for a serrated blade applicator kit (12 Sample) may contain a serrated blade applicator (18 sample). This results in a characteristic pattern of missed or light samples on the gel, leading to incorrect or no result, or delay in result. | accessdata.fda.gov |
| April 6, 2022 | 90060 | Class II | Ongoing | V8 Immunodisplacement Kit REF 1803 | Due to microbial growth causing interference with interpretation. | accessdata.fda.gov |
| January 5, 2021 | 87151 | Class II | Terminated | Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, | Intermittent potential for shorter than expected clot times. | accessdata.fda.gov |
| November 9, 2020 | 86774 | Class II | Ongoing | K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM. | Due to complaints received associated with cracked/split test tube caps. | accessdata.fda.gov |
| August 8, 2018 | 83088 | Class II | Ongoing | ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. | The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly. | accessdata.fda.gov |
| May 23, 2018 | 83930 | Class III | Ongoing | Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epine | Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth. | accessdata.fda.gov |
| February 27, 2018 | 83925 | Class III | Ongoing | SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems | Lots of gel kits contained a newer revision of the Customer Procedures instructions than intended. The incorrect inserts refer to updated parameters associated with new electrodes -- which have not yet been made available to users. | accessdata.fda.gov |
| December 7, 2017 | 83629 | Class II | Terminated | Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX. | Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay. | accessdata.fda.gov |
| July 21, 2017 | 83622 | Class II | Terminated | SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. | The plates do not have wells punched for the controls in the patient 1 area. | accessdata.fda.gov |
| April 4, 2017 | 81024 | Class II | Terminated | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL P | Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as Protein S conjugate. | accessdata.fda.gov |
| February 24, 2017 | 81378 | Class II | Terminated | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY | Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected. | accessdata.fda.gov |
| November 7, 2016 | 81303 | Class III | Terminated | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase | Due to a customer experiencing complaints on bone fraction of assay not being in range. The complaint: ~12% lower enzyme activity was noted. | accessdata.fda.gov |
| October 14, 2016 | 81383 | Class II | Terminated | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL | Due to customer-experienced complaints on narrow assay range compared to prior lots and the user being out of assay range. | accessdata.fda.gov |
| April 20, 2016 | 81356 | Class II | Terminated | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used | Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected | accessdata.fda.gov |
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Updated June 16, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.