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
11216 Chemistry devices
3051–3075 of 11216
Cleared Nov 20, 2001
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963 · Bayer Corp.
CFR · Hexokinase, Glucose · 151d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
K013249 · Roche Diagnostics Corp.
DER · Alpha-1-lipoprotein, Antigen, Antiserum, Control · 49d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013206 · Roche Diagnostics Corp.
DFC · Lipoprotein, Low-density, Antigen, Antiserum, Control · 52d
Cleared Nov 16, 2001
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS
K013203 · Polymer Technology Systems, Inc.
NBW · System, Test, Blood Glucose, Over The Counter · 52d
Cleared Nov 16, 2001
VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006
K013119 · Maine Standards Co.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 59d
Cleared Nov 16, 2001
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
K013101 · Wiener Laboratories Saic
JFJ · Catalytic Methods, Amylase · 60d
Cleared Nov 16, 2001
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311
K013095 · Wiener Laboratories Saic
CEO · Phosphomolybdate (colorimetric), Inorganic Phosphorus · 60d
Cleared Nov 15, 2001
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
K013278 · Roche Diagnostics Corp.
DEL · Lipoprotein X, Antigen, Antiserum, Control · 45d
Cleared Nov 15, 2001
DIMENSION HAIC ASSAY, MODEL DF105
K011852 · Dade Behring, Inc.
LCP · Assay, Glycosylated Hemoglobin · 156d
Cleared Nov 13, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013207 · Roche Diagnostics Corp.
DFC · Lipoprotein, Low-density, Antigen, Antiserum, Control · 49d
Cleared Nov 13, 2001
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
K013102 · Wiener Laboratories Saic
JMO · Ferrozine (colorimetric) Iron Binding Capacity · 57d
Cleared Nov 13, 2001
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
K013097 · Wiener Laboratories Saic
JIY · Photometric Method, Iron (non-heme) · 57d
Cleared Nov 09, 2001
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K013372 · Unipath , Ltd.
LCX · Kit, Test, Pregnancy, Hcg, Over The Counter · 29d
Cleared Nov 09, 2001
N LP(A) STANDARD SY
K013126 · Dade Behring, Inc.
JIS · Calibrator, Primary · 51d
Cleared Nov 08, 2001
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001
K012326 · Wiener Laboratories Saic
JGJ · Photometric Method, Magnesium · 108d
Cleared Nov 07, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
K012987 · Phoenix Diagnostics, Inc.
JIX · Calibrator, Multi-analyte Mixture · 62d
Cleared Nov 02, 2001
OMNI C ANALYZER
K013373 · Roche Diagnostics Corp.
CEM · Electrode, Ion Specific, Potassium · 22d
Cleared Oct 25, 2001
ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
K013272 · Bayer Corp.
KLS · Enzyme Immunoassay, Theophylline · 24d
Cleared Oct 24, 2001
GLUCOSE CONTROL SOLUTION FOR THERASENSE FREESTYLE
K013147 · Bionostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 34d
Cleared Oct 22, 2001
BIOSCANNER PLUS
K013173 · Polymer Technology Systems, Inc.
CHH · Enzymatic Esterase--oxidase, Cholesterol · 28d
Cleared Oct 18, 2001
N LP(A) CONTROL SY
K013130 · Dade Behring, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 29d
Cleared Oct 16, 2001
MODIFICATION TO SYNCHRON CONTROL
K013235 · Beckman Coulter, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 18d
Cleared Oct 16, 2001
ACCESS UNCONJUGATED ESTRIOL CALIBRATORS
K012900 · Beckman Coulter, Inc.
JIT · Calibrator, Secondary · 48d
Cleared Oct 15, 2001
RAICHEM GLUCOSE UV REAGENT
K012668 · Hemagen Diagnostics, Inc.
CFR · Hexokinase, Glucose · 63d
Cleared Oct 15, 2001
RAICHEM BUN RATE REAGENT
K012649 · Hemagen Diagnostics, Inc.
CDQ · Urease And Glutamic Dehydrogenase, Urea Nitrogen · 63d

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All categories 11216 JJY Multi-analyte Controls, All Kinds (assayed) 491 NBW System, Test, Blood Glucose, Over The Counter 461 JJX Single (specified) Analyte Controls (assayed And Unassayed) 384 CGA Glucose Oxidase, Glucose 299 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