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
3125 Immunology devices
Cleared
Feb 01, 2000
3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
55d
Cleared
Jan 18, 2000
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
DEW
Igg, Antigen, Antiserum, Control
61d
Cleared
Jan 18, 2000
RHIGENE ANA ELISA TEST SYSTEM
LJM
Antinuclear Antibody (enzyme-labeled), Antigen, Controls
47d
Cleared
Jan 18, 2000
ACCESS HYBRITECH PSA QC, MODEL 37209
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
36d
Cleared
Jan 14, 2000
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
57d
Cleared
Jan 14, 2000
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
CZP
Iga, Antigen, Antiserum, Control
57d
Cleared
Jan 12, 2000
ENA PROFILE ELISA TEST SYSTEM
LLL
Extractable Antinuclear Antibody, Antigen And Control
61d
Cleared
Jan 11, 2000
MDI RF TEST
DHR
System, Test, Rheumatoid Factor
60d
Cleared
Jan 11, 2000
MDI SS-B TEST ENZYME IMMUNOASSAY FOR THE DETECTION OF AUTOANTIBODIES TO SS-B IN HUMAN SERUM
LLL
Extractable Antinuclear Antibody, Antigen And Control
49d
Cleared
Jan 11, 2000
MDI SM TEST
LLL
Extractable Antinuclear Antibody, Antigen And Control
46d
Cleared
Jan 10, 2000
MDI SM/RNP TEST
LJM
Antinuclear Antibody (enzyme-labeled), Antigen, Controls
75d
Cleared
Jan 10, 2000
MDI SS-A TEST
LJM
Antinuclear Antibody (enzyme-labeled), Antigen, Controls
75d
Cleared
Jan 05, 2000
ACCESS HYBRITECH FREE PSA QC, MODEL 37219
JJX
Single (specified) Analyte Controls (assayed And Unassayed)
103d
Cleared
Jan 05, 2000
VARELISA TPO ANTIBODIES, MODEL 12348/12396
JZO
System, Test, Thyroid Autoantibody
75d
Cleared
Dec 21, 1999
IGM MININEPH ANTISERUM
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
580d
Cleared
Dec 21, 1999
BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
MVM
Autoantibodies, Endomysial(tissue Transglutaminase)
57d
Cleared
Dec 21, 1999
BINDAZYME ANTI-DSDNA EIA KIT
LRM
Anti-dna Antibody (enzyme-labeled), Antigen, Control
57d
Cleared
Dec 20, 1999
C3 MININEPH ANTISERUM
CZW
Complement C3, Antigen, Antiserum, Control
579d
Cleared
Dec 20, 1999
C4 MININEPH ANTISERUM
DBI
Complement C4, Antigen, Antiserum, Control
579d
Cleared
Dec 20, 1999
TURBIDIMETRIC/NEPHELOMETRIC HUMAN COMPLEMEMT REFERENCE PREPARATION
JJY
Multi-analyte Controls, All Kinds (assayed)
567d
Cleared
Dec 20, 1999
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS
CFN
Method, Nephelometric, Immunoglobulins (g, A, M)
553d
Cleared
Dec 09, 1999
QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3
JJY
Multi-analyte Controls, All Kinds (assayed)
100d
Cleared
Dec 09, 1999
QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
JJY
Multi-analyte Controls, All Kinds (assayed)
43d
Cleared
Dec 06, 1999
NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028
JNM
Immunochemical, Transferrin
160d
Cleared
Dec 06, 1999
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
DHR
System, Test, Rheumatoid Factor
63d
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