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
11207 Chemistry devices
Cleared
Dec 29, 2004
PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
JXM
Enzyme Immunoassay, Benzodiazepine
43d
Cleared
Dec 27, 2004
MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
KHS
Enzymatic, Carbon-dioxide
118d
Cleared
Dec 23, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
CGN
Acid, Folic, Radioimmunoassay
21d
Cleared
Dec 23, 2004
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279
CGS
Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
35d
Not Cleared
Dec 23, 2004
AMPLICHIP CYP450 TEST, MODEL 04381866190
NTI
Drug Metabolizing Enzyme Genotyping Systems
3d
Cleared
Dec 22, 2004
ASCENSIA ELITE DIABETES CARE SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
21d
Cleared
Dec 22, 2004
ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
37d
Cleared
Dec 22, 2004
QUANTEX MYOGLOBIN
DDR
Myoglobin, Antigen, Antiserum, Control
54d
Cleared
Dec 17, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
15d
Cleared
Dec 17, 2004
NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY
DHA
System, Test, Human Chorionic Gonadotropin
79d
Cleared
Dec 17, 2004
BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
MMI
Immunoassay Method, Troponin Subunit
185d
Cleared
Dec 09, 2004
LIQUID STABLE HBA1C CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
31d
Cleared
Dec 09, 2004
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23
JIT
Calibrator, Secondary
56d
Cleared
Dec 09, 2004
NICHOLS ADVANTAGE CORTISOL
CGR
Radioimmunoassay, Cortisol
71d
Cleared
Dec 09, 2004
AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET
JJY
Multi-analyte Controls, All Kinds (assayed)
105d
Cleared
Dec 07, 2004
TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
67d
Cleared
Dec 03, 2004
OLYMPUS LACTATE, OSR6193
JIT
Calibrator, Secondary
91d
Cleared
Dec 01, 2004
GAMMA-B 1,25-DIHYDROXY VITAMIN D
MRG
System, Test, Vitamin D
76d
Cleared
Dec 01, 2004
VITROS CHEMISTRY PRODUCTS VALP REAGENT
LEG
Enzyme Immunoassay, Valproic Acid
79d
Cleared
Nov 24, 2004
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
NHG
Enzyme Immunoassay, Cortisol, Salivary
8d
Cleared
Nov 24, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
DIF
Drug Mixture Control Materials
37d
Cleared
Nov 24, 2004
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
CHH
Enzymatic Esterase--oxidase, Cholesterol
76d
Cleared
Nov 24, 2004
IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)
DJG
Enzyme Immunoassay, Opiates
148d
Cleared
Nov 24, 2004
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
CGA
Glucose Oxidase, Glucose
180d
Cleared
Nov 23, 2004
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
127d
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