FDA Review Panel · CH

FDA 510(k) Chemistry Devices

About Chemistry Devices

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.

13221
Total
13190
Cleared
88d
Avg days
1976
Since
264 Chemistry devices
176–200 of 264
Cleared Oct 18, 2023
SmartBolus Calculator
K231824 · Insulet Corporation
QRX · Continuous Glucose Monitor Informed Insulin Dose Calculator · 119d
Cleared Oct 05, 2023
Tandem Mobi insulin pump with interoperable technology
K233044 · Tandem Diabetes Care, Inc.
QFG · Alternate Controller Enabled Insulin Infusion Pump · 10d
Cleared Oct 05, 2023
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
K220451 · Randox Laboratories Limited
DJG · Enzyme Immunoassay, Opiates · 595d
Cleared Sep 29, 2023
Stat Profile Prime Plus Analyzer System
K221900 · Nova Biomedical Corporation
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 456d
Cleared Sep 27, 2023
CEDIA Heroin Metabolite (6-AM) Assay
K231007 · Microgenics Corporation
DJG · Enzyme Immunoassay, Opiates · 173d
Cleared Sep 24, 2023
ADVIA Centaur® NT-proBNPII (PBNPII)
K220265 · Siemens Healthcare Diagnostics, Inc.
NBC · Test, Natriuretic Peptide · 601d
Cleared Sep 22, 2023
ALFIS Vitamin D, ALFIS-3 Analyzer
K221817 · Immunostics Inc.,
MRG · System, Test, Vitamin D · 457d
Cleared Sep 18, 2023
Access Myoglobin
K231832 · Beckman Coulter, Inc.
DDR · Myoglobin, Antigen, Antiserum, Control · 88d
Cleared Sep 15, 2023
i-STAT G3+ cartridge with the i-STAT 1 System
K223857 · Abbott Point of Care, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 266d
Cleared Sep 11, 2023
i-STAT G cartridge with the i-STAT 1 System
K223755 · Abbott Point of Care, Inc.
CGA · Glucose Oxidase, Glucose · 270d
Cleared Sep 08, 2023
ISE Electrodes
K230890 · Randox Laboratories, Ltd.
CEM · Electrode, Ion Specific, Potassium · 161d
Cleared Sep 05, 2023
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
K221197 · Ortho-Clinical Diagnostics
CEW · Radioimmunoassay, Parathyroid Hormone · 498d
Cleared Aug 23, 2023
Access Folate Assay
K223590 · Beckman Coulter, Inc.
CGN · Acid, Folic, Radioimmunoassay · 265d
Cleared Aug 10, 2023
ReliOn Premier BLU Blood Glucose Monitoring System
K230625 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 157d
Cleared Jul 28, 2023
Quantisal™ II Oral Fluid Collection Device
K223781 · Immunalysis Corporation
PJD · Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device · 224d
Cleared Jul 28, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K223710 · Abbott Point of Care, Inc.
CGA · Glucose Oxidase, Glucose · 228d
Cleared Jul 25, 2023
A-LYTE® Integrated Multisensor (IMT Na K Cl)
K222438 · Siemens Healthcare Diagnostics, Inc.
JGS · Electrode, Ion Specific, Sodium · 347d
Cleared Jul 21, 2023
Elecsys proBNP II, Elecsys proBNP II STAT
K223637 · Roche Diagnostics
NBC · Test, Natriuretic Peptide · 228d
Cleared Jul 17, 2023
BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes
K213953 · Becton, Dickinson and Company
JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection · 577d
Cleared Jul 13, 2023
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
K222116 · Siemens Healthcare Diagnostics, Inc.
JLW · Radioimmunoassay, Thyroid-stimulating Hormone · 360d
Cleared Jul 10, 2023
Tandem Mobi Insulin Pump with Interoperable Technology
K223213 · Tandem Diabetes Care, Inc.
QFG · Alternate Controller Enabled Insulin Infusion Pump · 266d
Cleared Jun 16, 2023
Healgen URS Test Strips
K231045 · Healgen Scientific, LLC
LJX · Test, Urine Leukocyte · 65d
Cleared Jun 12, 2023
Atellica® CH Diazo Direct Bilirubin (D_DBil)
K223078 · Siemens Healthcare Diagnostics, Inc.
CIG · Diazo Colorimetry, Bilirubin · 255d
Cleared Jun 05, 2023
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
K230937 · Abbott Laboratories
DHA · System, Test, Human Chorionic Gonadotropin · 63d
Cleared May 19, 2023
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series
K230790 · Abbott Laboratories
DHA · System, Test, Human Chorionic Gonadotropin · 58d

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All categories 264 NBW System, Test, Blood Glucose, Over The Counter 20 QFG Alternate Controller Enabled Insulin Infusion Pump 19 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 15 QJI Interoperable Automated Glycemic Controller 15 QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated 11 NBC Test, Natriuretic Peptide 9 MMI Immunoassay Method, Troponin Subunit 9 JKA Tubes, Vials, Systems, Serum Separators, Blood Collection 8 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 7 NDC Calculator, Drug Dose 7 CGA Glucose Oxidase, Glucose 7 JLW Radioimmunoassay, Thyroid-stimulating Hormone 6 QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems 6 DHA System, Test, Human Chorionic Gonadotropin 6 PDJ Hemoglobin A1c Test System 6