Data / Medical devices / United States / Arkray Factory Usa, Inc.
Arkray Factory Usa, Inc.: FDA-registered device maker in Miami, FL, United States, 36 510(k) clearances
Arkray Factory Usa, Inc. is registered with the FDA (registration 1832816) in Miami, FL, United States. It lists 32 device types. The FDA files 36 510(k) clearances under its listings, the newest dated May 3, 2024. 6 recall events name it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1832816
- Address
- 8260 NW 27th Street Suite 403, Miami, FL, United States, 33122
- Owner or operator
- ARKRAY FACTORY USA, Inc. (8030316)
- Roles
- Complaint file establishment
- First device listed
- December 4, 2001
- Registered through
- 2027
- Brand names listed
- ADAMS A1c HA-8180V, AUTION CHECK Plus, AUTION ELEVEN AE-4022 Semi-Automated Urinalysis System, AUTION EYE AI-4510, AUTION EYE Calibrator, AUTION EYE Control Solution, AUTION EYE Sheath Solution, AUTION MAX AX-4030 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 |
|---|---|---|---|---|---|---|
| May 3, 2024 | K232416 | AUTION EYE AI-4510 Urine Particle Analysis System | LKM | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| August 10, 2023 | K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| April 13, 2023 | K193514 | AUTION MAX AX-4060 Urinalysis System | JIL | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| March 2, 2023 | K223453 | Insulin Syringe | FMF | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| November 2, 2022 | K222084 | OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie | FMK | Substantially Equivalent | Asahi Polyslider Co., Ltd. | accessdata.fda.gov |
| October 17, 2022 | K221175 | Multi-Lancet Device 2, ReliOn Premier Lancing Device | QRL | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| August 30, 2022 | K221970 | Lancing device | QRL | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| May 23, 2022 | K200788 | Assure Titanium Blood Glucose Monitoring System | PZI | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| July 21, 2021 | K210059 | Promisemed Insulin Pen Needle | FMI | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| April 22, 2021 | K210065 | Verifine Safety Type Insulin Pen Needle | FMI | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| December 31, 2020 | K202681 | Promisemed Covered Safety Pen Needle | FMI | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| November 24, 2020 | K202682 | Promisemed Triple Safety Pen Needle | FMI | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| December 13, 2019 | K192220 | ReliOn Premier Classic Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| September 5, 2019 | K191853 | Dual-Safety Pen Needle | FMI | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| February 21, 2019 | K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | GJS | Substantially Equivalent | Coagusense, Inc. | accessdata.fda.gov |
| November 1, 2018 | K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| March 21, 2018 | K171982 | DROPLET PEN NEEDLE | FMI | Substantially Equivalent | Htl-Strefa S.A | accessdata.fda.gov |
| October 19, 2017 | K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| June 29, 2017 | K162822 | ADAMS A1c HA-8180V, CALIBRATOR 80 | PDJ | Substantially Equivalent | Arkray Factory, Inc. | accessdata.fda.gov |
| May 11, 2017 | K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle | FMI | Substantially Equivalent | Promisemed Hangzhou Meditech Co., Ltd. | accessdata.fda.gov |
| October 7, 2016 | K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | JIL | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| August 7, 2015 | K151164 | Assure Prism multi Blood Glucose Monitoring System | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| April 10, 2015 | K142262 | AUTION CHECK PLUS | JJW | Substantially Equivalent | Quantimetrix Corp. | accessdata.fda.gov |
| June 30, 2014 | K124021 | ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | Arkray Factory, Inc. | accessdata.fda.gov |
| August 2, 2012 | K111534 | ABACUS 3CP | GKZ | Substantially Equivalent | Diatron U.S., Inc. | accessdata.fda.gov |
| July 10, 2012 | K121133 | CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| June 5, 2012 | K120759 | CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION | CGA | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| May 3, 2012 | K120351 | CARESENS N POP BLOOD GLUCOSE MONITORING SYSTEM CARESENS N POP BLOOD GLUCOSE METER CARESENS N BLOOD GLUCOSE TEST STRIP CA | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| March 27, 2012 | K112755 | ABACUS 5 | GKZ | Substantially Equivalent | Diatron U.S., Inc. | accessdata.fda.gov |
| January 17, 2012 | K113098 | AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III | NBW | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| December 23, 2009 | K093098 | AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM | KQO | Substantially Equivalent | Arkray, Inc. | accessdata.fda.gov |
| November 24, 2009 | K092104 | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | Arkray Factory USA, Inc. | accessdata.fda.gov |
| October 23, 2009 | K091102 | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | CGA | Substantially Equivalent | Arkray Factory USA, Inc. | accessdata.fda.gov |
| February 10, 2009 | K083468 | CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A OR GM5051B OR GM5051C (COLOR) | NBW | Substantially Equivalent | I-Sens, Inc. | accessdata.fda.gov |
| October 21, 2008 | K082417 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | CGA | Substantially Equivalent | Arkray Factory USA, Inc. | 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 3, 2019 | 82737 | Class II | Terminated | AUTION HYBRID AU-4050 | This correction is being initiated due to a software issue which results in the possibility of incorrect patient information being assigned to sample results when the following rare combination of three specific events were to occur: 1) No measurement results are generated due to an error by a urine sediment measurement. 2) The instrument is shutdown incorre | accessdata.fda.gov |
| December 18, 2015 | 72860 | Class I | Terminated | arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples. | One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL. | accessdata.fda.gov |
| March 24, 2010 | 55680 | Not yet classified | Terminated | Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400. | This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four reagents. The Ketone reagent should not be included on the label. The test strips contained in the bottle and all other labeling are correct and properly align | accessdata.fda.gov |
| November 16, 2007 | 45966 | Not yet classified | Terminated | Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard, Minneapolis, MN 55439 USA. Made in Taiwan. | Mislabeling: incorrect control range-The Level 1 control solution range printed on the 50-count test strip bottles is incorrect. The range printed on the bottle is 62-54 when it should be 62-94. | accessdata.fda.gov |
| October 18, 2007 | 45483 | Not yet classified | Terminated | Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc., Minneapolis, MN 55439 USA. (Package Contents -Advance Micro-draw Bloo | Mis-labeled/coded strips : Meter kits from this lot contain mislabeled 10-count test strip vials. The code number printed on the Advance Micro-draw 10-count test strip bottle is incorrect. The code number on the vial is 867 when it should be 687. The 687-labeled code chip contains the correct calibration information for the "867" test strips, so the meter wi | accessdata.fda.gov |
| November 26, 2003 | 27760 | Not yet classified | Terminated | Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles. | When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Blood Glucose, Over The Counter
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- All makers of Glucose Oxidase, Glucose
- All makers of Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- All makers of Dispenser, Solid Medication
- All makers of Automated Urinalysis System
Updated May 3, 2024. 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.