FDA 510(k) Chemistry Devices
FDA 510(k) Chemistry Devices - Regulatory Overview
FDA 510(k) chemistry devices cover in vitro diagnostic (IVD) instruments used in clinical laboratories. The FDA review panel code is CH.
This category includes:
- Clinical chemistry analyzers - glucose, electrolytes, enzymes, proteins
- Point-of-care test systems - rapid diagnostics for hospital and home use
- Reagents and calibrators - consumables used with automated analyzers
- Urinalysis systems - dipstick readers and urine sediment analyzers
Most devices in this panel are Class II (Special Controls) under 21 CFR Part 862. Data sourced from FDA 510(k) public files. Updated monthly.
13237
Total
13205
Cleared
181d
Avg (2y)
1976
Since
11220 Chemistry devices
Cleared
Jan 20, 2000
ACON ONE STEP HOME PREGNANCY TEST STRIP
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
98d
Cleared
Jan 20, 2000
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
CJE
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
10d
Cleared
Jan 14, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
JHX
Fluorometric Method, Cpk Or Isoenzymes
22d
Cleared
Jan 14, 2000
ACCESS OSTASE QC
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
25d
Cleared
Jan 14, 2000
FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
LFR
Glucose Dehydrogenase, Glucose
157d
Cleared
Jan 13, 2000
MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
NAQ
Lipoprotein, High Density, Hdl, Over The Counter
107d
Cleared
Jan 12, 2000
SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR
JIS
Calibrator, Primary
21d
Cleared
Jan 10, 2000
CLINICAL BLOOD GAS MIXTURE
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
62d
Cleared
Jan 10, 2000
ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
138d
Cleared
Jan 03, 2000
URINALYSIS REAGENT STRIPS (10 PARAMETERS)
JMT
Diazo (colorimetric), Nitrite (urinary, Non-quant)
52d
Cleared
Dec 29, 1999
HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
188d
Cleared
Dec 27, 1999
K-ASSAY MULTI-ANALYTE CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
45d
Cleared
Dec 27, 1999
CARESIDE DIRECT BILIRUBIN
CIG
Diazo Colorimetry, Bilirubin
49d
Cleared
Dec 27, 1999
VISUALINE V DRUGS OF ABUSE DIPSTRIP PANEL FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPE
DIO
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
74d
Cleared
Dec 27, 1999
MTM BIOSCANNER K TEST STRIPS, CAT # BSA610
JMK
Acid, Alpha-ketobutyric And Nadh (u.v.), Hydroxybutyric Dehydrogenase
420d
Cleared
Dec 22, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS
JIS
Calibrator, Primary
14d
Cleared
Dec 21, 1999
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
DFC
Lipoprotein, Low-density, Antigen, Antiserum, Control
15d
Cleared
Dec 21, 1999
FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET
LCP
Assay, Glycosylated Hemoglobin
60d
Cleared
Dec 21, 1999
AXIS %CDT TURBIDIMETRIC IMMUNOASSAY
NAO
Test, Carbohydrate Deficient Transferrin
148d
Cleared
Dec 21, 1999
FIRST RESPONSE 1-STEP PREGNANCY
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
172d
Cleared
Dec 21, 1999
QUANTECH TOTAL B-HCG ASSAY
NAL
Test, Immunoassay, Biosensor, Hcg
328d
Cleared
Dec 20, 1999
PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR
CHH
Enzymatic Esterase--oxidase, Cholesterol
206d
Cleared
Dec 16, 1999
AVL OPTI CRITICAL CARE ANALYZER
CGA
Glucose Oxidase, Glucose
34d
Cleared
Dec 16, 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM (INVITRO DIAGNOSTIC SYSTEM WITH 5 ADDITIONAL ASSAYS)
JZG
System, Test, Beta-2-microglobulin Immunological
43d
Cleared
Dec 16, 1999
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
CDD
Radioassay, Vitamin B12
56d
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