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
191d
Avg (2y)
1976
Since
11178 Chemistry devices
Cleared
Mar 03, 2015
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
NBW
System, Test, Blood Glucose, Over The Counter
236d
Cleared
Feb 26, 2015
NIOX VERO Airway Inflammation Monitor
MXA
System, Test, Breath Nitric Oxide
24d
Cleared
Feb 26, 2015
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
LAF
Gas Chromatography, Methamphetamine
31d
Cleared
Feb 26, 2015
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
93d
Cleared
Feb 26, 2015
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
JIT
Calibrator, Secondary
133d
Cleared
Feb 25, 2015
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
65d
Cleared
Feb 19, 2015
ORAGENE DX OGD-500.001
OYJ
Dna Specimen Collection, Saliva
266d
Not Cleared
Feb 19, 2015
23ANDME PERSONAL GENOME SERVICE (HEREINAFTER KNOWN AS PGS)
PKB
Autosomal Recessive Carrier Screening Gene Mutation Detection System
266d
Cleared
Jan 28, 2015
LDLC3 LDL-Cholesterol Gen.3
LBR
Ldl & Vldl Precipitation, Hdl
35d
Cleared
Jan 27, 2015
Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
DJG
Enzyme Immunoassay, Opiates
83d
Cleared
Jan 23, 2015
Audit MicroControls Linearity LQ Cystatin-C
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
37d
Not Cleared
Jan 23, 2015
Dexcom Share Direct Secondary Displays
PJT
Continuous Glucose Monitor Secondary Display
39d
Cleared
Jan 14, 2015
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
35d
Cleared
Jan 13, 2015
CR3 Keyless Split Sample Cup Secobarbital- Methadone
DIS
Enzyme Immunoassay, Barbiturate
29d
Cleared
Jan 09, 2015
BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D
MRG
System, Test, Vitamin D
254d
Cleared
Jan 08, 2015
TIVA
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
90d
Cleared
Jan 07, 2015
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
DCK
C-reactive Protein, Antigen, Antiserum, And Control
198d
Cleared
Dec 23, 2014
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS
OSX
Galectin-3 In Vitro Diagnostic Assay
305d
Cleared
Dec 22, 2014
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine )
JFY
Enzymatic Method, Creatinine
117d
Cleared
Dec 22, 2014
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst
MRG
System, Test, Vitamin D
119d
Cleared
Dec 19, 2014
Elecsys T-Uptake Calset
JIT
Calibrator, Secondary
28d
Cleared
Dec 19, 2014
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.
MRG
System, Test, Vitamin D
116d
Cleared
Dec 19, 2014
IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
MRG
System, Test, Vitamin D
290d
Cleared
Dec 18, 2014
RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
LAF
Gas Chromatography, Methamphetamine
447d
Cleared
Dec 17, 2014
ACCU-CHEK AVIVA EXPERT SYSTEM
LFR
Glucose Dehydrogenase, Glucose
138d
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