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
976–1000 of 3201
Cleared Jun 20, 2001
ACCU-CHEK ACTIVE SYSTEM
K011738 · Roche Diagnostics Corp.
NBW · System, Test, Blood Glucose, Over The Counter · 15d
Cleared Jun 18, 2001
PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY
K010553 · Abbott Laboratories
NBW · System, Test, Blood Glucose, Over The Counter · 112d
Cleared Jun 14, 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
K011035 · Dade Behring, Inc.
JIX · Calibrator, Multi-analyte Mixture · 70d
Cleared Jun 08, 2001
SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO
K011465 · Beckman Coulter, Inc.
LDP · Colorimetry, Acetaminophen · 25d
Cleared Jun 07, 2001
DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132
K011033 · Dade Behring, Inc.
JIH · Flame Photometry, Lithium · 63d
Cleared Jun 06, 2001
EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
K011528 · Syva Co.
DLZ · Enzyme Immunoassay, Phenobarbital · 20d
Cleared Jun 05, 2001
ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
K010429 · Beckman Coulter, Inc.
MMI · Immunoassay Method, Troponin Subunit · 112d
Cleared May 29, 2001
SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT
K010597 · Beckman Coulter, Inc.
DCK · C-reactive Protein, Antigen, Antiserum, And Control · 90d
Cleared May 16, 2001
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
K011213 · Beckman Coulter, Inc.
JGS · Electrode, Ion Specific, Sodium · 26d
Cleared May 07, 2001
GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS
K010520 · Instrumentation Laboratory CO
CGA · Glucose Oxidase, Glucose · 74d
Cleared Apr 26, 2001
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS
K004010 · Roche Diagnostics Corp.
LFR · Glucose Dehydrogenase, Glucose · 121d
Cleared Apr 20, 2001
DIMENSION CTNI CALIBRATOR
K010314 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 77d
Cleared Apr 20, 2001
DIMENSION CTNI FLEX REAGENT CARTRIDGE
K010313 · Dade Behring, Inc.
MMI · Immunoassay Method, Troponin Subunit · 77d
Cleared Mar 19, 2001
ACCU-CHEK INFORM METER
K003846 · Roche Diagnostics Corp.
LFR · Glucose Dehydrogenase, Glucose · 97d
Cleared Mar 16, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137
K010206 · Dade Behring, Inc.
KHS · Enzymatic, Carbon-dioxide · 52d
Cleared Mar 15, 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 122d
Cleared Mar 14, 2001
DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND
K010061 · Dade Behring, Inc.
CEM · Electrode, Ion Specific, Potassium · 65d
Cleared Mar 13, 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
K010428 · Beckman Coulter, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 28d
Cleared Mar 13, 2001
N LATEX CYSTATIN C
K003503 · Dade Behring, Inc.
NDY · Test, Cystatin C · 120d
Cleared Mar 07, 2001
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362 · Roche Diagnostics Corp.
LFR · Glucose Dehydrogenase, Glucose · 29d
Cleared Mar 01, 2001
ELECSYS TESTOSTERONE CALSET II
K003411 · Roche Diagnostics Corp.
JIT · Calibrator, Secondary · 119d
Cleared Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · Dade Behring, Inc.
JIT · Calibrator, Secondary · 28d
Cleared Feb 14, 2001
ELECSYS HCG+B CALCHECK
K010237 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 20d
Cleared Feb 14, 2001
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS)
K004002 · Diagnostic Products Corp.
JHX · Fluorometric Method, Cpk Or Isoenzymes · 50d
Cleared Jan 26, 2001
ELECSYS FSH CALSET II
K003409 · Roche Diagnostics Corp.
JIT · Calibrator, Secondary · 85d

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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