Data / Medical devices / United States / Accriva Diagnostics, Inc.
Accriva Diagnostics, Inc.: FDA-registered device maker in San Diego, CA, United States, 30 510(k) clearances
Accriva Diagnostics, Inc. is registered with the FDA (registration 3002721930) in San Diego, CA, United States. It lists 14 device types. The FDA files 30 510(k) clearances under its listings, the newest dated March 2, 2023. 14 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002721930
- FEI number
- 2250033
- Address
- 6260 Sequence Drive, San Diego, CA, United States, 92121
- Owner or operator
- Accriva Diagnostics, Inc. (10048042)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export
- First device listed
- December 1, 2014
- Registered through
- 2027
- Brand names listed
- 4-QCYO - Whole Blood CO-Oximeter Optical QC Filters, 4-TMPB - Whole Blood CO-Oximeter Temperature Probe, 70068 - EQC, 85047 - WQC, 85053 - Aspirin Test, 85053-10 - Aspirin Test, 85062 - Preventative Maintenance Kit, 85063 - Validation Kit 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 |
|---|---|---|---|---|---|---|
| March 2, 2023 | K223352 | Tenderfoot | FMK | Substantially Equivalent | Accriva Diagnostics, Inc. | accessdata.fda.gov |
| December 29, 2021 | K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 | JPA | Substantially Equivalent | Accriva Diagnostics, Inc. | accessdata.fda.gov |
| November 22, 2019 | K193041 | Hemochron Signature Elite | JPA | Substantially Equivalent | Accriva Diagnostics, Inc. | accessdata.fda.gov |
| July 24, 2015 | K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| July 3, 2013 | K120977 | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC | GGN | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| February 10, 2005 | K050016 | HEMOCHRON SIGNATURE ELITE | JPA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| October 6, 2004 | K042423 | VERIFYNOW-ASPIRIN ASSAY | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| May 16, 2002 | K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| March 28, 2002 | K020798 | HEMOCHRON JR. SIGNATURE + | JPA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| October 16, 2001 | K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| June 6, 2001 | K010193 | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS | KFF | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| December 20, 1999 | K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM | JOZ | Substantially Equivalent | Accumetrics, Inc. | accessdata.fda.gov |
| May 3, 1999 | K983475 | HEMOCHRON RESPONSE | KQG | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| April 13, 1999 | K990449 | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE | JPA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| September 30, 1998 | K972866 | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT | GJS | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| November 20, 1997 | K972831 | HEMOCHRON CITRATE APTT | GFO | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| August 12, 1996 | K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT | JBP | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| November 6, 1995 | K951485 | AVOXIMETER 4000 | JKS | Substantially Equivalent | A-Vox Systems, Inc. | accessdata.fda.gov |
| March 15, 1995 | K944691 | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II | GGN | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| June 30, 1994 | K941007 | CATALOG NO. J-ACT+ & QC-ACT+ | JBP | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| May 18, 1994 | K940432 | MICROCOAGULATION PROTHROMBIN TIME TEST | GJS | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| May 11, 1994 | K940401 | JR. MICROCOAGULATION SYSTEM | JPA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| January 22, 1993 | K923302 | TENDERLETT FINGER | FMK | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| November 4, 1992 | K922075 | AVOXIMETER | DQA | Substantially Equivalent | A-Vox Systems, Inc. | accessdata.fda.gov |
| October 18, 1991 | K913861 | HEMOCHRON(R) KACT | JBP | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| February 26, 1991 | K910105 | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 | GFT | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| November 29, 1990 | K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST | KFF | Substantially Equivalent | Intensive Technology, Inc. | accessdata.fda.gov |
| August 30, 1988 | K882481 | HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II | GGN | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| June 1, 1987 | K870831 | PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA | JPA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
| March 1, 1985 | K850542 | SURGICUTT - BLEEDING TIME DEVICE | JCA | Substantially Equivalent | International Technidyne Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 14, 2026 | 99863 | Not yet classified | Open, Classified | Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103 | Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range high error code, or erroneously high results, which may lead retest, or overestimation of patient's anticoagulation, leading to inadequate anticoagulant therapy, which could result in thrombosis. | accessdata.fda.gov |
| April 30, 2026 | 98979 | Class II | Ongoing | directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2 | Assayed Whole blood control contains labeling with incorrect performance range. | accessdata.fda.gov |
| November 5, 2025 | 97942 | Class II | Ongoing | Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System | Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling. | accessdata.fda.gov |
| October 21, 2025 | 97863 | Class III | Ongoing | VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor | Due to an device without a premarket clearance being incorrectly package and distributed. | accessdata.fda.gov |
| December 2, 2024 | 96011 | Class II | Ongoing | VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 | Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatme | accessdata.fda.gov |
| September 27, 2024 | 95497 | Class II | Completed | AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter. | Values used to calibrate whole blood oximeter instruments were observed to be higher than normal, which may result in incorrect patient results where oxygen levels are higher than actual results, which may lead to patient care mismanagement requiring medical intervention. | accessdata.fda.gov |
| March 30, 2022 | 89936 | Class II | Terminated | The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel | Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage | accessdata.fda.gov |
| April 22, 2016 | 73949 | Class II | Terminated | Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012. | Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result. | accessdata.fda.gov |
| June 20, 2014 | 68659 | Class II | Terminated | Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103. | Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples. | accessdata.fda.gov |
| December 19, 2013 | 67237 | Class II | Terminated | Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin a | ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. | accessdata.fda.gov |
| August 22, 2013 | 66353 | Class II | Terminated | Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820.. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven devi | ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose. | accessdata.fda.gov |
| April 15, 2010 | 55404 | Not yet classified | Terminated | directCHECK Whole Blood Control; for Hemochron J. Microcoagulation Systems. | Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect. | accessdata.fda.gov |
| April 9, 2010 | 55427 | Not yet classified | Terminated | Integrated Data Management System - Version 7.1, 7.2 and 7.3; ITC Corporation, 8 Olsen Place South, Piscataway, NJ 08854 | A tabulation error in the Integrated Data Management Systems (IDMS) data management software that results in incorrect Electronic Quality Control (EQC) Summary Reports: The Operator and the Device Performance Summary Reports. The IDMS software is not used for the clinical management of individual patients. | accessdata.fda.gov |
| January 23, 2006 | 34461 | Not yet classified | Terminated | Tenderlett Adult Lancet, sterile, single use. Red trigger color with incision depth/length of 1.75mm/0.94mm. Manual surgical instrument for general use. | Some packages contained a pin-hole defect that permitted the transmission of dye through the primary packaging. This is a sterile product. | accessdata.fda.gov |
Compare with other makers
- All makers of Activated Whole Blood Clotting Time
- All makers of System, Automated Platelet Aggregation
- All makers of System, Multipurpose For In Vitro Coagulation Studies
- All makers of Plasma, Coagulation Control
- All makers of Activated Partial Thromboplastin
- All makers of Protamine Sulphate
Updated October 30, 2026. 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.