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.
13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
Cleared
Jun 28, 2005
HBA1C ENZYMATIC ASSAY
LCP
Assay, Glycosylated Hemoglobin
153d
Cleared
Jun 27, 2005
FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
119d
Cleared
Jun 24, 2005
MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
DKB
Calibrators, Drug Mixture
57d
Cleared
Jun 17, 2005
SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
CIG
Diazo Colorimetry, Bilirubin
16d
Cleared
Jun 17, 2005
ELECSYS RBC FOLATE HEMOLYZED REAGENT
CGN
Acid, Folic, Radioimmunoassay
30d
Cleared
Jun 15, 2005
DIADEXUS PLAC TEST
NOE
Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2
105d
Cleared
Jun 15, 2005
ADVIA IMS LITHIUM ASSAY
NDW
Assay, Porphyrin, Spectrophotometry, Lithium
121d
Cleared
Jun 13, 2005
INVIEW
LCP
Assay, Glycosylated Hemoglobin
24d
Cleared
Jun 13, 2005
SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT
JXM
Enzyme Immunoassay, Benzodiazepine
25d
Cleared
Jun 13, 2005
ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
NBC
Test, Natriuretic Peptide
28d
Cleared
Jun 13, 2005
OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS
DJG
Enzyme Immunoassay, Opiates
88d
Cleared
Jun 08, 2005
ON TRAK TESTCARD
DKZ
Enzyme Immunoassay, Amphetamine
26d
Cleared
Jun 08, 2005
ON CALL MULTI-DRUG HOME TEST CUP
LDJ
Enzyme Immunoassay, Cannabinoids
63d
Cleared
Jun 06, 2005
SPOTCHEM II LDH TEST
CFH
Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase
70d
Cleared
Jun 06, 2005
DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511
DCN
System, Test, C-reactive Protein
80d
Cleared
Jun 02, 2005
EZ SMART
NBW
System, Test, Blood Glucose, Over The Counter
181d
Cleared
Jun 01, 2005
NICHOLS ADVANTAGE ALDOSTERONE ASSAY
CJM
Radioimmunoassay, Aldosterone
65d
Cleared
May 27, 2005
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
NBW
System, Test, Blood Glucose, Over The Counter
15d
Cleared
May 26, 2005
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
LBS
Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
78d
Cleared
May 23, 2005
ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
104d
Cleared
May 20, 2005
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
CKG
Radioimmunoassay, Acth
59d
Cleared
May 20, 2005
ACON +/- MIDSTREAM PREGNANCY TEST
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
79d
Cleared
May 20, 2005
ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
CGA
Glucose Oxidase, Glucose
183d
Cleared
May 16, 2005
IRMA TRUPOINT CREATININE CONTROL KIT
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
27d
Cleared
May 16, 2005
IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
JHI
Visual, Pregnancy Hcg, Prescription Use
56d
Looking for a specific chemistry device? Search by device name, K-number or manufacturer.
Search all Chemistry 510(k) devices