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.

13257
Total
13225
Cleared
177d
Avg (2y)
1976
Since
13257 Chemistry devices
426–450 of 13257
Cleared Mar 26, 2020
Tina-quant Hemoglobin A1cDx Gen.3
K193053 · Roche Diagnostics Operations (Rdo)
PDJ · Hemoglobin A1c Test System · 146d
Cleared Mar 26, 2020
Aina HbA1c Monitoring System 2
K192987 · Jana Care, Inc.
LCP · Assay, Glycosylated Hemoglobin · 153d
Cleared Mar 20, 2020
Bioland Blood Glucose Monitoring System
K191657 · Bioland Technology, Ltd.
NBW · System, Test, Blood Glucose, Over The Counter · 273d
Cleared Mar 17, 2020
EndoTool IV 1.10
K200443 · Monarch Medical Technologies, LLC
NDC · Calculator, Drug Dose · 22d
Cleared Mar 13, 2020
Stat Profile Prime Plus Analyzer System
K200349 · Nova Biomedical Corporation
CGA · Glucose Oxidase, Glucose · 30d
Cleared Feb 28, 2020
Basal-IQ Technology
K193483 · Tandem Diabetes Care, Inc.
QJS · Interoperable Automated Glycemic Controller, Insulin Suspend · 73d
Cleared Feb 27, 2020
Proov Test
K191462 · Mfb Fertility, Inc.
QKE · Immunoassay, Pregnanediol Glucuronide, Over The Counter · 269d
Cleared Feb 18, 2020
InPen Dose Calculator
K190487 · Companion Medical, Inc.
NDC · Calculator, Drug Dose · 355d
Cleared Feb 14, 2020
OneTouch Verio Reflect Blood Glucose Monitoring System
K193475 · Lifescan Europe GmbH
NBW · System, Test, Blood Glucose, Over The Counter · 60d
Cleared Feb 14, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191360 · Abbott Point of Care, Inc.
JFP · Electrode, Ion Specific, Calcium · 269d
Cleared Feb 07, 2020
NeoBase 2 Non-derivatized MSMS Kit
K193103 · Perkinelmer, Inc.
NQL · System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry · 91d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K191298 · Abbott Point of Care, Inc.
JFL · Ph Rate Measurement, Carbon-dioxide · 269d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183688 · Abbott Point of Care, Inc.
JGS · Electrode, Ion Specific, Sodium · 406d
Cleared Feb 07, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
K183678 · Abbott Point of Care, Inc.
CGA · Glucose Oxidase, Glucose · 406d
Cleared Feb 05, 2020
OptiScanner® 5000 Glucose Monitoring System
K192785 · Optiscan Biomedical Corporation
LZF · Pump, Infusion, Analytical Sampling · 128d
Cleared Jan 29, 2020
Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
K193642 · Dexcom, Inc.
QDK · Integrated Continuous Glucose Monitoring System For Non-intensive Diabetes Management · 30d
Cleared Jan 24, 2020
Stat Profile Prime Plus Analyzer System
K193246 · Nova Biomedical Corporation
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 60d
Cleared Jan 24, 2020
CareSens S Clear BT Blood Glucose Monitoring System
K192859 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 112d
Cleared Jan 17, 2020
CareSens S Fit BT Blood Glucose Monitoring System
K193590 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 25d
Cleared Jan 17, 2020
MAGLUMI 2000 HCG/ß-HCG
K192547 · Shenzhen New Industries Biomedical Engineering Co., Ltd.
DHA · System, Test, Human Chorionic Gonadotropin · 122d
Cleared Jan 14, 2020
Oragene®•Dx
K192920 · DNA Genotek, Inc.
OYJ · Dna Specimen Collection, Saliva · 90d
Cleared Dec 20, 2019
ACTIVE® Free Testosterone RIA
K191350 · Immunotech S.R.O.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 214d
Cleared Dec 19, 2019
Albumin BCP
K193001 · SENTINEL CH. SpA
CJW · Bromcresol Purple Dye-binding, Albumin · 52d
Cleared Dec 13, 2019
ReliOn Premier Classic Blood Glucose Monitoring System
K192220 · I-Sens, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 120d
Not Cleared Dec 13, 2019
Control-IQ Technology
DEN190034 · Tandem Diabetes Care, Inc.
QJI · Interoperable Automated Glycemic Controller · 151d

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All categories 13257 JJY Multi-analyte Controls, All Kinds (assayed) 554 NBW System, Test, Blood Glucose, Over The Counter 513 JJX Single (specified) Analyte Controls (assayed And Unassayed) 409 CGA Glucose Oxidase, Glucose 391 JHI Visual, Pregnancy Hcg, Prescription Use 359 JIX Calibrator, Multi-analyte Mixture 271 CIG Diazo Colorimetry, Bilirubin 234 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 226 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 JIT Calibrator, Secondary 224 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 223 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 199 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 183 JGS Electrode, Ion Specific, Sodium 162