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
191d
Avg (2y)
1976
Since
11168 Chemistry devices
Cleared
Jun 30, 2022
Cholesterol2
CHH
Enzymatic Esterase--oxidase, Cholesterol
568d
Cleared
Jun 16, 2022
FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
787d
Cleared
Jun 10, 2022
Elecsys AMH
PQO
Anti-müllerian Hormone Test System
534d
Cleared
May 31, 2022
Urea Nitrogen2
CDQ
Urease And Glutamic Dehydrogenase, Urea Nitrogen
524d
Cleared
May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
QLG
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
157d
Cleared
May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
QLG
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
322d
Cleared
May 26, 2022
Amylase2
JFJ
Catalytic Methods, Amylase
449d
Cleared
May 23, 2022
Assure Titanium Blood Glucose Monitoring System
PZI
Prescription Use Blood Glucose Meter For Near-patient Testing
788d
Cleared
May 19, 2022
Alinity i STAT High Sensitivity Troponin-I
MMI
Immunoassay Method, Troponin Subunit
625d
Cleared
May 06, 2022
Elecsys Testosterone II
CDZ
Radioimmunoassay, Testosterones And Dihydrotestosterone
338d
Cleared
May 06, 2022
IWL2020 Blood Glucose Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
501d
Cleared
Apr 06, 2022
Extended Reservoir
LZG
Pump, Infusion, Insulin
392d
Cleared
Apr 06, 2022
MTM301 Blood Glucose and Ketone Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
582d
Cleared
Apr 05, 2022
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
120d
Cleared
Mar 31, 2022
Elecsys proBNP II, Elecsys proBNP II STAT
NBC
Test, Natriuretic Peptide
399d
Cleared
Mar 29, 2022
GAL-1A Plus Blood Glucose Monitoring System
NBW
System, Test, Blood Glucose, Over The Counter
106d
Cleared
Mar 22, 2022
Creatinine2
CGX
Alkaline Picrate, Colorimetry, Creatinine
399d
Cleared
Mar 18, 2022
Albumin BCP2
CJW
Bromcresol Purple Dye-binding, Albumin
471d
Cleared
Mar 10, 2022
GLP systems Track
JGS
Electrode, Ion Specific, Sodium
132d
Cleared
Mar 10, 2022
One Step Pregnancy Test
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
398d
Cleared
Feb 26, 2022
CardioChek Plus Test System
NBW
System, Test, Blood Glucose, Over The Counter
810d
Cleared
Feb 18, 2022
SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream
LCX
Kit, Test, Pregnancy, Hcg, Over The Counter
197d
Cleared
Feb 15, 2022
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
QFG
Alternate Controller Enabled Insulin Infusion Pump
469d
Cleared
Jan 31, 2022
Alltest Pregnancy Rapid Combo Test Cassette
JHI
Visual, Pregnancy Hcg, Prescription Use
451d
Cleared
Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
JHX
Fluorometric Method, Cpk Or Isoenzymes
158d
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