FDA 510(k) Immunology Devices
FDA 510(k) Immunology Devices - Regulatory Overview
FDA 510(k) immunology devices include diagnostic systems that detect immune responses, antibodies and antigens. The FDA review panel code is IM.
Key categories:
- Immunoassay analyzers - automated platforms for ELISA, CLIA and lateral flow
- Allergy testing systems - specific IgE measurement and skin prick test devices
- Autoimmune diagnostics - ANA, anti-dsDNA, rheumatoid factor assays
- Transplant diagnostics - HLA typing and crossmatch systems
Most devices are Class II under 21 CFR Part 866. Data sourced from FDA 510(k) public files. Updated monthly.
3792
Total
3779
Cleared
232d
Avg (2y)
1976
Since
3122 Immunology devices
Cleared
May 13, 2021
A1AT Genotyping Test
PZH
Serpina1 Variant Detection System
29d
Cleared
Jan 08, 2021
i-STAT TBI Plasma cartridge with the i-STAT Alinity System
QAT
Brain Trauma Assessment Test
192d
Cleared
Dec 23, 2020
Helix Genetic Health Risk App for late-onset Alzheimer’s disease
PTA
Genetic Variant Detection And Health Risk Assessment System
509d
Cleared
Dec 11, 2020
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
KTL
Anti-dna Indirect Immunofluorescent Solid Phase
423d
Cleared
Sep 28, 2020
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit
OYE
Flow Cytometric Reagents And Accessories.
89d
Cleared
Sep 17, 2020
EUROIMMUN Anti-BP230-CF ELISA (IgG)
OEG
Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230
310d
Cleared
Sep 04, 2020
Lumipulse G CA15-3
MOI
System, Test, Immunological, Antigen, Tumor
357d
Cleared
Jun 26, 2020
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
CZP
Iga, Antigen, Antiserum, Control
190d
Cleared
Jun 26, 2020
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus
DHB
System, Test, Radioallergosorbent (rast) Immunological
88d
Cleared
Jun 25, 2020
Yumizen C1200 CRP
DCK
C-reactive Protein, Antigen, Antiserum, And Control
335d
Cleared
May 20, 2020
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
DHR
System, Test, Rheumatoid Factor
236d
Cleared
May 14, 2020
Lumipulse G CA19-9-N
NIG
System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer
28d
Cleared
May 01, 2020
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
DHB
System, Test, Radioallergosorbent (rast) Immunological
87d
Cleared
Apr 13, 2020
ADVIA Centaur CEA Assay
DHX
System, Test, Carcinoembryonic Antigen
76d
Cleared
Apr 06, 2020
ADVIA Centaur CA 125II
LTK
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
70d
Cleared
Mar 16, 2020
Transferrin
DDG
Transferrin, Antigen, Antiserum, Control
382d
Cleared
Mar 06, 2020
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
DBF
Ferritin, Antigen, Antiserum, Control
267d
Cleared
Feb 27, 2020
Elecsys Anti-TSHR
JZO
System, Test, Thyroid Autoantibody
90d
Cleared
Feb 21, 2020
Tina-quant C-Reactive Protein IV
DCN
System, Test, C-reactive Protein
203d
Cleared
Feb 13, 2020
ADVIA Centaur BR
MOI
System, Test, Immunological, Antigen, Tumor
58d
Cleared
Jan 15, 2020
ADVIA Centaur Total IgE (tIgE)
DGC
Ige, Antigen, Antiserum, Control
29d
Cleared
Nov 29, 2019
EliA SymphonyS Immunoassay
LLL
Extractable Antinuclear Antibody, Antigen And Control
255d
Cleared
Nov 22, 2019
ADVIA Centaur CA 15-3 assay
MOI
System, Test, Immunological, Antigen, Tumor
53d
Cleared
Nov 08, 2019
CRP Vario
DCK
C-reactive Protein, Antigen, Antiserum, And Control
94d
Cleared
Nov 05, 2019
A1AT Genotyping Test
PZH
Serpina1 Variant Detection System
32d
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