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
1576–1600 of 13257
Cleared Mar 01, 2011
RANDOX ECSTASY (MDMA) ASSAY
K092275 · Randox Laboratories, Ltd.
DKZ · Enzyme Immunoassay, Amphetamine · 581d
Cleared Feb 18, 2011
FASTPACK TESTO IMMUNOASSAY
K101388 · Qualigen, Inc.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 277d
Cleared Feb 17, 2011
TECO DIAGNOSTICS UTI DETECTION STRIPS
K100024 · Teco Diagnostics
JMT · Diazo (colorimetric), Nitrite (urinary, Non-quant) · 408d
Cleared Feb 16, 2011
ENZYME II CALIBRATOR
K103836 · Siemens Healthcare Diagnostics, Inc.
JIT · Calibrator, Secondary · 48d
Cleared Feb 15, 2011
AFINION ANALYZER
K110056 · Axis-Shield Poc AS
LCP · Assay, Glycosylated Hemoglobin · 36d
Cleared Feb 14, 2011
DIMENSION VISA HBA1C, MODEL K3105A
K102045 · Siemens Heatlhcare Diagnostics, Inc.
LCP · Assay, Glycosylated Hemoglobin · 208d
Cleared Feb 11, 2011
ROCHE ORAL FLUID COCAINE
K101160 · Roche Diagnostics
DIO · Enzyme Immunoassay, Cocaine And Cocaine Metabolites · 291d
Cleared Feb 11, 2011
THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS
K100144 · Microgenics Corp.
OUF · Everolimus Immunoassay · 388d
Cleared Feb 11, 2011
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
K093867 · Roche Diagnostics
DJG · Enzyme Immunoassay, Opiates · 402d
Cleared Feb 11, 2011
ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
K093745 · Lifescan, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 434d
Cleared Feb 10, 2011
LIFESCAN ONETOUCH SELECT / ULTRA / VITA GLUCOSE CONTROL SOLUTION
K103553 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 69d
Cleared Feb 08, 2011
I-STAT 1 WIRELESS ANALYZER
K103195 · Abbott Point of Care, Inc.
CGA · Glucose Oxidase, Glucose · 102d
Cleared Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
K103403 · Abbott Laboratories
JIX · Calibrator, Multi-analyte Mixture · 77d
Cleared Feb 04, 2011
URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
K101673 · Teco Diagnostics
JIL · Method, Enzymatic, Glucose (urinary, Non-quantitative) · 234d
Cleared Feb 04, 2011
NEOPAC SOFTWARE, 3007 DIGITAL PHOTOMETER/FLUOROMETER MODEL NA, 307 AND 350D
K101392 · Astoria-Pacific, Inc.
KQP · Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase · 262d
Cleared Feb 02, 2011
MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
K103387 · ACON Laboratories, Inc.
JJW · Urinalysis Controls (assayed And Unassayed) · 76d
Cleared Jan 25, 2011
DIMENSION VISA ENZ 2 CAL
K103612 · Siemens Healthcare Diagnostics, Inc.
JIX · Calibrator, Multi-analyte Mixture · 47d
Cleared Jan 25, 2011
FDI GLUCOSE CONTROL SOLUTION FOR FREESTYLE
K103450 · Fujirebio Diagnostics,Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 62d
Cleared Jan 25, 2011
MSC LIPID CONTROL
K103271 · Maine Standards Co.
JJY · Multi-analyte Controls, All Kinds (assayed) · 81d
Cleared Jan 25, 2011
DIATRON PICTUS 400
K101741 · Diatron Group
CGA · Glucose Oxidase, Glucose · 217d
Cleared Jan 25, 2011
ORAL FLUID PHENCYCLIDINE
K093989 · Roche Diagnostics
LCM · Enzyme Immunoassay, Phencyclidine · 397d
Cleared Jan 20, 2011
TQ HBA1C GEN3
K102914 · Roche
LCP · Assay, Glycosylated Hemoglobin · 111d
Cleared Jan 20, 2011
ELECYSYS SHBG
K102814 · Roche Diagnostics
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 114d
Cleared Jan 14, 2011
PROLYTE ELECTROLYTE ANALYZER
K102959 · Diamond Diagnostics, Inc.
JGS · Electrode, Ion Specific, Sodium · 101d
Cleared Jan 14, 2011
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL,
K102432 · Diazyme Laboratories
MRG · System, Test, Vitamin D · 141d

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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 JLW Radioimmunoassay, Thyroid-stimulating Hormone 226 CHH Enzymatic Esterase--oxidase, Cholesterol 226 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 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