Arkray Factory USA, Inc.
Miami, FL, US
ARKRAY FACTORY USA, INC. appears in FDA device records in Miami, FL. FDA records list 19 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Arkray Factory USA, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Arkray USA, Inc.510(k), recall
- Hypoguard USA, Inc.510(k), recall
510(k) clearance history
FDA records hold 19 510(k) clearances for Arkray Factory USA, Inc. between 2001 and 2011. The busiest year on record is 2009, with 4. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 4 |
| 2010 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110709 | ARK CARE DIABETES MANAGMENT SYSTEM | NBW | Substantially Equivalent | |
| K093819 | ARKRAY DIABETES DATA MANAGEMENT SOFTWARE (SMBG VIEWER) | NBW | Substantially Equivalent | |
| K092104 | ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K091102 | ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS | CGA | Substantially Equivalent | |
| K090653 | POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K090332 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 46001 | NBW | Substantially Equivalent | |
| K082417 | GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 | CGA | Substantially Equivalent | |
| K073416 | ARKRAY GLUCOCARD 01 BLOOD MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K063771 | GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K063068 | FERRARA BLOOD GLUCOSE MONITORING SYSTEM, MODEL 631100 | NBW | Substantially Equivalent | |
| K053079 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001 | CGA | Substantially Equivalent | |
| K051514 | ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 | NBW | Substantially Equivalent | |
| K041881 | ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 | CGA | Substantially Equivalent | |
| K033851 | DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G) | JIL | Substantially Equivalent | |
| K031388 | MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K024347 | EXPRESS BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K022545 | GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 | NBW | Substantially Equivalent | |
| K020232 | HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | |
| K010973 | DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000 | JIL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1832816 | 1832816 | ARKRAY FACTORY USA, INC. | 8260 NW 27th Street, Miami, FL 33122 US | 2026 | and 22 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LCPAssay, Glycosylated Hemoglobin
- KQOAutomated Urinalysis System
- JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
- JIOBlood, Occult, Colorimetric, In Urine
- JITCalibrator, Secondary
- GKZCounter, Differential Cell
- LKMCounter, Urine Particle
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- NXBDispenser, Solid Medication
- CENDye-Indicator, Ph (Urinary, Non-Quantitative)
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- PPMGeneral Purpose Reagent
- CGAGlucose Oxidase, Glucose
- PDJHemoglobin A1c Test System
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- NSCInjector, Pen
- LDMInstrumentation, High Pressure Liquid Chromatography
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- QRLMultiple Use Blood Lancet For Single Patient Use Only
- FMINeedle, Hypodermic, Single Lumen
- JINNitroprusside, Ketones (Urinary, Non-Quant.)
- PZIPrescription Use Blood Glucose Meter For Near-Patient Testing
- JRERefractometer For Clinical Use
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
- FMFSyringe, Piston
- NBWSystem, Test, Blood Glucose, Over The Counter
- GJSTest, Time, Prothrombin
- LJXTest, Urine Leukocyte
- JJWUrinalysis Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1850-2019 | 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 incorrectly. 3) An item rack is used for subsequent sample measurements. | Class II | Terminated | |
| Z-0631-2016 | arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine. | 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. | Class I | Terminated | |
| Z-0630-2016 | 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. | Class I | Terminated | |
| Z-2634-2010 | 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 with 4pH part number D11400 listed on | Terminated | ||
| Z-0699-2008 | 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. | Terminated | ||
| Z-0458-2008 | 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 Blood Glucose Meter, 10 test Strips, Codeing chip and Control Solution (3mL), Lancing device, 10 Lancets, 3V Lithium Battery, Logbook, User Instruction Manual, Quick Reference Guide) | 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 will function properly and give accurat | Terminated | ||
| Z-0276-04 | Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips | When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings. | Terminated | ||
| Z-0275-04 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain