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
226–250 of 264
Cleared Aug 19, 2022
SmartAdjust(TM) technology
K220394 · Insulet Corporation
QJI · Interoperable Automated Glycemic Controller · 189d
Cleared Jul 29, 2022
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System
K221259 · Dexcom, Inc.
QBJ · Integrated Continuous Glucose Monitoring System, Factory Calibrated · 88d
Cleared Jun 16, 2022
FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
K201037 · Taidoc Technology Corporation
NBW · System, Test, Blood Glucose, Over The Counter · 787d
Cleared Jun 10, 2022
Elecsys AMH
K203757 · Roche Diagnostics
PQO · Anti-müllerian Hormone Test System · 534d
Cleared May 26, 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K213996 · Abbott Diabetes Care, Inc.
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
K212132 · Abbott Diabetes Care, Inc.
QLG · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems · 322d
Cleared May 06, 2022
Elecsys Testosterone II
K211685 · Roche Diagnostics
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 338d
Cleared Apr 06, 2022
MTM301 Blood Glucose and Ketone Monitoring System
K202534 · Apex BioTechnology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 582d
Cleared Mar 31, 2022
Elecsys proBNP II, Elecsys proBNP II STAT
K210546 · Roche Diagnostics
NBC · Test, Natriuretic Peptide · 399d
Cleared Mar 29, 2022
GAL-1A Plus Blood Glucose Monitoring System
K213887 · Apex BioTechnology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 106d
Cleared Mar 10, 2022
GLP systems Track
K213486 · Abbott Laboratories
JGS · Electrode, Ion Specific, Sodium · 132d
Cleared Feb 15, 2022
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
K203234 · Tandem Diabetes Care, Inc.
QFG · Alternate Controller Enabled Insulin Infusion Pump · 469d
Cleared Jan 28, 2022
VITROS Immunodiagnostic Products CK-MB Reagent Pack
K212648 · Ortho-Clinical Diagnostics
JHX · Fluorometric Method, Cpk Or Isoenzymes · 158d
Cleared Jan 27, 2022
SmartAdjust technology
K203774 · Insulet Corporation
QJI · Interoperable Automated Glycemic Controller · 400d
Cleared Jan 27, 2022
Omnipod 5 SmartBolus Calculator
K203772 · Insulet Corporation
QRX · Continuous Glucose Monitor Informed Insulin Dose Calculator · 400d
Cleared Jan 27, 2022
Omnipod 5 ACE Pump (Pod)
K203768 · Insulet Corporation
QFG · Alternate Controller Enabled Insulin Infusion Pump · 400d
Cleared Nov 24, 2021
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · Siemens Healthcare Diagnostics, Inc.
JFY · Enzymatic Method, Creatinine · 131d
Cleared Nov 22, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K210943 · Abbott Diabetes Care, Inc.
QLG · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems · 237d
Cleared Nov 08, 2021
ST AIA-PACK BNP Assay
K211199 · Tosoh Bioscience, Inc.
NBC · Test, Natriuretic Peptide · 200d
Cleared Oct 20, 2021
Piccolo Potassium Test System
K200865 · Abaxis, Inc.
MZV · Test, System, Potassium, Enzymatic Method · 567d
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 21, 2021
Elecsys Troponin T Gen 5
K201441 · Roche Diagnostics
MMI · Immunoassay Method, Troponin Subunit · 477d
Cleared Sep 15, 2021
GlucoSure HT Plus Blood Glucose Monitoring System
K202885 · Apex BioTechnology Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 352d

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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 NDC Calculator, Drug Dose 7 CGA Glucose Oxidase, Glucose 7 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 7 DHA System, Test, Human Chorionic Gonadotropin 6 PDJ Hemoglobin A1c Test System 6 JLW Radioimmunoassay, Thyroid-stimulating Hormone 6 QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems 6