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.

13237
Total
13205
Cleared
181d
Avg (2y)
1976
Since
11220 Chemistry devices
3301–3325 of 11220
Cleared Mar 02, 2000
UBAS
K993941 · Marukin Diagnostics
KWX · Radioimmunoassay, Conjugated Sulfalithocholic (slcg) Acid, Bile Acids · 104d
Cleared Mar 02, 2000
TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
K000231 · Biosite Incorporated
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 35d
Cleared Feb 29, 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS
K000230 · Biosite Incorporated
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 33d
Cleared Feb 28, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K000318 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 27d
Cleared Feb 23, 2000
ACCU-CHEK ADVANTAGE METER
K000365 · Roche Diagnostics Corp.
CGA · Glucose Oxidase, Glucose · 19d
Cleared Feb 23, 2000
ACCU-CHEK COMPLETE METER
K000364 · Roche Diagnostics Corp.
LFR · Glucose Dehydrogenase, Glucose · 19d
Cleared Feb 18, 2000
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
K000196 · Beckman Coulter, Inc.
DDR · Myoglobin, Antigen, Antiserum, Control · 28d
Cleared Feb 18, 2000
CREATININE-S ASSAY, MODEL 221-30, 221-50, 221-17
K000055 · Diagnostic Chemicals , Ltd.
CGX · Alkaline Picrate, Colorimetry, Creatinine · 42d
Cleared Feb 15, 2000
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K992662 · Bayer Corp.
MSJ · Apolipoproteins · 190d
Cleared Feb 15, 2000
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
K000116 · Consolidated Technologies, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 32d
Not Cleared Feb 15, 2000
WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000
DEN990008 · Wallac, Inc.
NAK · System, Test, Biotinidase · 57d
Cleared Feb 10, 2000
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
K000331 · Beckman Coulter, Inc.
JIS · Calibrator, Primary · 50d
Cleared Feb 08, 2000
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102 · Teco Diagnostics
CFR · Hexokinase, Glucose · 26d
Cleared Feb 04, 2000
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K994438 · Spectrx, Inc.
MQM · Bilirubin (total And Unbound) In The Neonate Test System · 36d
Cleared Feb 03, 2000
ADVANTAGE HCG TEST (URINE/SERUM)
K994227 · Advantage Diagnostics Corp.
JHI · Visual, Pregnancy Hcg, Prescription Use · 50d
Cleared Feb 03, 2000
SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR
K994169 · Beckman Coulter, Inc.
JIS · Calibrator, Primary · 55d
Cleared Feb 03, 2000
SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR
K994168 · Beckman Coulter, Inc.
JIS · Calibrator, Primary · 55d
Cleared Feb 01, 2000
ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
K994346 · Sendx Medical, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 40d
Cleared Feb 01, 2000
IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15
K994035 · Diagnostic Chemicals , Ltd.
JIR · Indicator Method, Protein Or Albumin (urinary, Non-quant.) · 64d
Cleared Jan 28, 2000
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115 · Dade Behring, Inc.
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 53d
Cleared Jan 28, 2000
IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5
K994085 · Diagnostic Products Corp.
DHA · System, Test, Human Chorionic Gonadotropin · 56d
Cleared Jan 27, 2000
GAMBRO DQM 200
K990039 · Gambro Healthcare
LFP · Conductivity Rate, Urea Nitrogen · 386d
Cleared Jan 20, 2000
OLYMPUS CREATINE KINASE REAGENT OSR6179/6279
K994189 · Olympus Diagnostica GmbH
CGS · Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes · 38d
Cleared Jan 20, 2000
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
K994114 · Dade Behring, Inc.
JIS · Calibrator, Primary · 45d
Cleared Jan 20, 2000
SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL
K994005 · Syva Co.
DJR · Enzyme Immunoassay, Methadone · 57d

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All categories 11220 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 463 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 CGA Glucose Oxidase, Glucose 300 JHI Visual, Pregnancy Hcg, Prescription Use 285 JIX Calibrator, Multi-analyte Mixture 248 CIG Diazo Colorimetry, Bilirubin 218 JIT Calibrator, Secondary 199 JLW Radioimmunoassay, Thyroid-stimulating Hormone 188 CHH Enzymatic Esterase--oxidase, Cholesterol 186 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 176 CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph 157 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 153 JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use 147 CGX Alkaline Picrate, Colorimetry, Creatinine 143