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.
13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3201 Chemistry devices
Cleared
Mar 28, 2005
SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT
JXM
Enzyme Immunoassay, Benzodiazepine
91d
Cleared
Mar 24, 2005
QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
22d
Cleared
Feb 15, 2005
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT
NBC
Test, Natriuretic Peptide
61d
Cleared
Feb 09, 2005
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
CGR
Radioimmunoassay, Cortisol
12d
Cleared
Jan 18, 2005
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
CDT
Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
26d
Cleared
Jan 07, 2005
LIQUID ASSAYED MULTIQUAL CONTROL
JJY
Multi-analyte Controls, All Kinds (assayed)
49d
Cleared
Dec 23, 2004
MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY
CGN
Acid, Folic, Radioimmunoassay
21d
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
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 19, 2004
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
NBC
Test, Natriuretic Peptide
81d
Cleared
Nov 17, 2004
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
LCP
Assay, Glycosylated Hemoglobin
68d
Cleared
Nov 12, 2004
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
CEM
Electrode, Ion Specific, Potassium
80d
Cleared
Nov 02, 2004
LIQUICHEK ELEVATED CRP CONTROL
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
19d
Cleared
Oct 29, 2004
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
NQD
Cardiac C-reactive Protein, Antigen, Antiserum, And Control
46d
Cleared
Oct 07, 2004
LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5
JJY
Multi-analyte Controls, All Kinds (assayed)
41d
Cleared
Sep 30, 2004
ELECSYS FOLATE II CALSET II
JIT
Calibrator, Secondary
16d
Cleared
Sep 16, 2004
MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY
JLW
Radioimmunoassay, Thyroid-stimulating Hormone
23d
Cleared
Sep 16, 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
34d
Cleared
Sep 14, 2004
MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA
JJY
Multi-analyte Controls, All Kinds (assayed)
12d
Cleared
Sep 10, 2004
ABBOTT AXSYM TROPONIN-I ADV
MMI
Immunoassay Method, Troponin Subunit
66d
Cleared
Aug 18, 2004
ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
57d
Cleared
Aug 18, 2004
SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
CEO
Phosphomolybdate (colorimetric), Inorganic Phosphorus
62d
Cleared
Aug 16, 2004
N LATEX CYSTATIN
NDY
Test, Cystatin C
35d
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