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.

13224
Total
13193
Cleared
208d
Avg (2y)
1976
Since
3201 Chemistry devices
1026–1050 of 3201
Cleared Aug 22, 2000
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
K001935 · Beckman Coulter, Inc.
CDZ · Radioimmunoassay, Testosterones And Dihydrotestosterone · 57d
Cleared Aug 21, 2000
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
K002120 · Bio-Rad
JJS · Controls For Blood-gases, (assayed And Unassayed) · 39d
Cleared Aug 07, 2000
LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483
K002196 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 18d
Cleared Aug 04, 2000
HDL CHOLESTEROL PLUS
K000568 · Roche Diagnostics Corp.
LBT · Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl · 164d
Cleared Jul 24, 2000
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
K993706 · Roche Diagnostics Corp.
JMM · Column Chromatography & Color Development, Hydroxyproline · 265d
Cleared Jul 13, 2000
ELECSYS INSULIN CALSET
K001906 · Roche Diagnostics Corp.
JIS · Calibrator, Primary · 21d
Cleared Jun 28, 2000
ELECSYS INSULIN CALCHECK
K001846 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 9d
Cleared Jun 02, 2000
SYNCHRON CONTROL
K001458 · Beckman Coulter, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 23d
Cleared May 25, 2000
LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
K001373 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 24d
Cleared May 18, 2000
THE CARDIAC READER SYSTEM
K000784 · Roche Diagnostics Corp.
MMI · Immunoassay Method, Troponin Subunit · 69d
Cleared May 17, 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB
K000121 · Beckman Coulter, Inc.
DFC · Lipoprotein, Low-density, Antigen, Antiserum, Control · 120d
Cleared Apr 20, 2000
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
K000875 · Bio-Rad
JJY · Multi-analyte Controls, All Kinds (assayed) · 31d
Cleared Apr 18, 2000
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
K000874 · Bio-Rad
JJW · Urinalysis Controls (assayed And Unassayed) · 29d
Cleared Apr 17, 2000
SPIFE CHOLESTEROL PROFILE KIT
K000603 · Helena Laboratories
JHO · Electrophoretic Separation, Lipoproteins · 54d
Cleared Mar 28, 2000
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
K994278 · Beckman Coulter, Inc.
CIN · Electrophoretic Separation, Alkaline Phosphatase Isoenzymes · 99d
Cleared Mar 21, 2000
ELECSYS CORTISOL CALCHECK
K000576 · Roche Diagnostics Corp.
JIX · Calibrator, Multi-analyte Mixture · 28d
Cleared Mar 20, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
K000716 · Beckman Coulter, Inc.
JHX · Fluorometric Method, Cpk Or Isoenzymes · 17d
Cleared Mar 17, 2000
ELECSYS B-CROSSLAPS CALCHECK
K000042 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 71d
Cleared Mar 07, 2000
ELECSYS CORTISOL TEST SYSTEM
K000270 · Roche Diagnostics Corp.
JJY · Multi-analyte Controls, All Kinds (assayed) · 39d
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 10, 2000
SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
K000331 · Beckman Coulter, Inc.
JIS · Calibrator, Primary · 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

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All categories 3201 JJY Multi-analyte Controls, All Kinds (assayed) 124 NBW System, Test, Blood Glucose, Over The Counter 97 JJX Single (specified) Analyte Controls (assayed And Unassayed) 94 JIX Calibrator, Multi-analyte Mixture 73 JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use 72 CIG Diazo Colorimetry, Bilirubin 65 JIT Calibrator, Secondary 62 CGA Glucose Oxidase, Glucose 55 JLW Radioimmunoassay, Thyroid-stimulating Hormone 53 CHH Enzymatic Esterase--oxidase, Cholesterol 51 MMI Immunoassay Method, Troponin Subunit 46 LCX Kit, Test, Pregnancy, Hcg, Over The Counter 44 JHI Visual, Pregnancy Hcg, Prescription Use 44 JIS Calibrator, Primary 41 CGX Alkaline Picrate, Colorimetry, Creatinine 38