JAS Diagnostics/Drew Scientific
Plantation, FL, US
JAS Diagnostics/Drew Scientific appears in FDA device records in Plantation, FL. FDA records list 20 510(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 JAS Diagnostics/Drew Scientific 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.
- Drew Scientific Group PLCrecall
- Jas Diagnostics, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 20 510(k) clearances for JAS Diagnostics/Drew Scientific between 2000 and 2014. The busiest year on record is 2001, with 10. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 2 |
| 2001 | 10 |
| 2002 | 5 |
| 2008 | 2 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK | JJE | Substantially Equivalent | |
| K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA | CHH | Substantially Equivalent | |
| K080618 | DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID | LCP | Substantially Equivalent | |
| K022519 | LDL CHOLESTEROL (AUTOMATED) | JHM | Substantially Equivalent | |
| K021671 | JAS HDL CHOLESTEROL (AUTOMATED) REAGENT | LBS | Substantially Equivalent | |
| K020454 | CHEMISTRY CALIBRATOR | JIT | Substantially Equivalent | |
| K020282 | JAS AMYLASE LIQUID REAGENT | JFJ | Substantially Equivalent | |
| K013912 | CREATINE KINASE (CK-NAC) | CGS | Substantially Equivalent | |
| K013698 | AST (SGOT) | CIT | Substantially Equivalent | |
| K012332 | JAS CARBON DIOXIDE LIQUID REAGENT | KHS | Substantially Equivalent | |
| K012038 | JAS URIC ACID LIQUID REAGENT | KNK | Substantially Equivalent | |
| K011900 | GLUCOSE (HEXOKINASE) | CFR | Substantially Equivalent | |
| K011599 | ALKALINE PHOSPHATASE LIQUID REAGENT | CJE | Substantially Equivalent | |
| K011441 | JAS CALCIUM (ARSENAZO) REAGENT | CJY | Substantially Equivalent | |
| K003835 | JAS MAGNESIUM REAGENT | JGJ | Substantially Equivalent | |
| K003912 | PHOSPHORUS REAGENT | CEO | Substantially Equivalent | |
| K003829 | TOTAL BILIRUBIN | CIG | Substantially Equivalent | |
| K003693 | DIRECT BILIRUBIN | CIG | Substantially Equivalent | |
| K003247 | CREATININE | CGX | Substantially Equivalent | |
| K003327 | ALBUMIN | CIX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1064608 | 3003071743 | JAS Diagnostics/Drew Scientific | 6600 NW 14th Street, Plantation, FL 33313 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- LCPAssay, Glycosylated Hemoglobin
- CJYAzo Dye, Calcium
- CIXBromcresol Green Dye-Binding, Albumin
- KRXCalibrator For Cell Indices
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- KRYCalibrator For Platelet Counting
- KSACalibrator For Red-Cell And White-Cell Counting
- JITCalibrator, Secondary
- JFJCatalytic Methods, Amylase
- JHMColorimetric Method, Lipoproteins
- GKZCounter, Differential Cell
- JCBDetergent
- CIGDiazo Colorimetry, Bilirubin
- GIFDiluent, Blood Cell
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KHSEnzymatic, Carbon-Dioxide
- CFRHexokinase, Glucose
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- JPKMixture, Hematology Quality Control
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JGJPhotometric Method, Magnesium
- GGKProducts, Red-Cell Lysing Products
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2656-2017 | Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent. | May result in elevated platelet backgrounds during routine startup/background checks. | Class II | Terminated | |
| Z-1576-2016 | Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL. | The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check. | Class II | Terminated | |
| Z-0827-2015 | Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum. | Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range. | Class II | Terminated | |
| Z-1873-2014 | Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum. | JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications. | Class II | Terminated | |
| Z-0451-2007 | Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. | System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts. | Terminated | ||
| Z-0450-2007 | Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. | System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts. | Terminated | ||
| Z-0449-2007 | Drew Excell 22 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. | Flags and alerts on the user interface will not automatically transfering to the LIS. | Terminated | ||
| Z-0448-2007 | Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX. | Flags and alerts on the user interface will not automatically transfering to the LIS. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain