FDA Review Panel · CH

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
326–350 of 3201
Cleared Oct 15, 2021
MultiSure GK Link Blood Glucose and Ketone Monitoring System
K201880 · Apex BioTechnology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 465d
Cleared Oct 05, 2021
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System
K201394 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 496d
Cleared Oct 04, 2021
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack
K201312 · Ortho-Clinical Diagnostics
NBC · Test, Natriuretic Peptide · 504d
Cleared Sep 28, 2021
Advisor Pro Platform
K210561 · DreaMed Diabetes, Ltd.
QCC · Insulin Pump Therapy Adjustment Calculator For Healthcare Professionals · 215d
Cleared Sep 21, 2021
Elecsys Troponin T Gen 5
K201441 · Roche Diagnostics
MMI · Immunoassay Method, Troponin Subunit · 477d
Cleared Sep 21, 2021
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
K200898 · Medicon Hellas S.A
CIX · Bromcresol Green Dye-binding, Albumin · 536d
Cleared Sep 15, 2021
GlucoSure HT Plus Blood Glucose Monitoring System
K202885 · Apex BioTechnology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 352d
Cleared Sep 08, 2021
BlueStar Rx
K203434 · Welldoc, Inc.
NDC · Calculator, Drug Dose · 289d
Cleared Sep 01, 2021
Elecsys Vitamin D total III
K210901 · Roche Diagnostics
MRG · System, Test, Vitamin D · 159d
Cleared Sep 01, 2021
EASYMAX Tag Self-Monitoring Blood Glucose System
K201258 · Eps Bio Technology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 478d
Cleared Aug 20, 2021
GEM Premier 5000
K203790 · Instrumentation Laboratory CO
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 235d
Not Cleared Aug 20, 2021
ADVIA Centaur Enhanced Liver Fibrosis (ELF)
DEN190056 · Siemens Healthcare Diagnostics, Inc.
QQB · Prognostic Test For Assessment Of Liver Related Disease Progression · 603d
Cleared Aug 18, 2021
Elecsys HCG STAT
K203227 · Roche Diagnostics
DHA · System, Test, Human Chorionic Gonadotropin · 289d
Cleared Aug 17, 2021
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K203089 · Dexcom, Inc.
QDK · Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management · 308d
Cleared Aug 13, 2021
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K211575 · Insulet Corporation
LZG · Pump, Infusion, Insulin · 84d
Cleared Aug 13, 2021
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K210958 · Abbott Point of Care, Inc.
CGA · Glucose Oxidase, Glucose · 135d
Cleared Aug 13, 2021
Clearblue® Early Digital Pregnancy Test
K200913 · Spd Swiss Precision Diagnostics GmbH
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 494d
Cleared Aug 11, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System
K211102 · Abbott Diabetes Care, Inc.
QLG · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems · 120d
Cleared Aug 11, 2021
CONTOUR® NEXT ONE Blood Glucose Monitoring System
K210687 · Ascensia Diabetes Care
NBW · System, Test, Blood Glucose, Over The Counter · 156d
Cleared Aug 06, 2021
Diazyme PLAC® Test for Lp-PLA2 Activity
K203136 · Diazyme Laboratories, Inc.
NOE · Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 · 290d
Cleared Aug 05, 2021
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
K200904 · Tosoh Bioscience, Inc.
PDJ · Hemoglobin A1c Test System · 486d
Cleared Aug 04, 2021
Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream)
K203246 · Atlas Link Technology Co., Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 273d
Cleared Aug 02, 2021
OPTI® B-Lac Cassette
K200986 · Opti Medical Systems, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 474d
Cleared Jul 30, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K201761 · Abbott Diabetes Care, Inc.
QLG · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems · 396d
Cleared Jul 16, 2021
Medtronic Extended infusion set
K210544 · Unomedical A/S
FPA · Set, Administration, Intravascular · 142d

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All categories 3201 JJY Multi-analyte Controls, All Kinds (assayed) 124 NBW System, Test, Blood Glucose, Over The Counter 97 JJX Single (specified) Analyte Controls (assayed And Unassayed) 94 JIX Calibrator, Multi-analyte Mixture 73 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 72 CIG Diazo Colorimetry, Bilirubin 65 JIT Calibrator, Secondary 62 CGA Glucose Oxidase, Glucose 55 JLW Radioimmunoassay, Thyroid-stimulating Hormone 53 CHH Enzymatic Esterase--oxidase, Cholesterol 51 MMI Immunoassay Method, Troponin Subunit 46 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 44 JHI Visual, Pregnancy Hcg, Prescription Use 44 JIS Calibrator, Primary 41 CGX Alkaline Picrate, Colorimetry, Creatinine 38