CFF · Immunoelectrophoretic, Immunoglobulins, (G, A, M)
Immunology · 21 CFR 866.5510 · Class 2
Overview
| Product Code | CFF |
|---|---|
| Device Name | Immunoelectrophoretic, Immunoglobulins, (G, A, M) |
| Regulation | 21 CFR 866.5510 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203184 | HYDRASHIFT 2/4 isatuximab | Sebia | Nov 12, 2021 | SESE |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 Tera | Sebia | Nov 1, 2019 | SESE |
| K190851 | HYDRASHIFT 2/4 daratumumab | Sebia | May 2, 2019 | SESE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab Control | Sebia | Jan 11, 2018 | SESE |
| K161928 | CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL | Sebia | Dec 21, 2016 | SESE |
| K143483 | MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING | Sebia | Jan 8, 2015 | SESE |
| K120169 | INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT | Grifols USA, LLC | Aug 24, 2012 | SESE |
| K111369 | THE HELENA V8 IMMUNODISPLACEMENT KIT | Helena Laboratories Uk, Ltd. | Jun 26, 2012 | SESE |
| K103757 | IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT | Grifols | Oct 13, 2011 | SESE |
| K082085 | CAPILLARYS IMMUNOTYPING, MODEL 2100 | Sebia | Apr 17, 2009 | SESE |
| K082388 | MINICAP IMMUNOTYPING, MODEL: 2300 | Sebia | Apr 14, 2009 | SESE |
| K061069 | SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 | Helena Laboratories | Jul 6, 2006 | SESE |
| K033187 | INTERLAB IMMUNOFIXATION TEST(S) | Interlab S.R.L. | Nov 19, 2003 | SESE |
| K033277 | HYDRAGEL CSF ISOFOCUSING KITS | Morax | Nov 4, 2003 | SESE |
| K024162 | SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 | Helena Laboratories | Feb 19, 2003 | SESE |
| K002799 | PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 | Beckman Coulter, Inc. | Oct 5, 2000 | SESE |
| K993323 | K-ASSAY IGM | Kamiya Biomedical Co. | Nov 30, 1999 | SESE |
| K993213 | K-ASSAY IGA | Kamiya Biomedical Co. | Nov 23, 1999 | SESE |
| K990998 | POLYSLIT IFE KIT | Helena Laboratories | Jun 28, 1999 | SESE |
| K981048 | HYDRAGEL 6 CSF KIT | Morax | Oct 7, 1998 | SESE |
Top Applicants
- Sebia — 8 clearances
- Helena Laboratories — 6 clearances
- Morax — 3 clearances
- Kamiya Biomedical Co. — 2 clearances
- The Binding Site, Ltd. — 2 clearances
