DBA · Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Immunology · 21 CFR 866.5250 · Class 2
Overview
| Product Code | DBA |
|---|---|
| Device Name | Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5250 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141100 | OPTILITE C1 INACTIVATOR KIT | The Binding Site Group , Ltd. | Jul 18, 2014 | SESE |
| K122304 | HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS | The Binding Site Group , Ltd. | Apr 15, 2013 | SESE |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dade Behring, Inc. | Dec 21, 2007 | SESE |
| K011780 | K-ASSAY C1-INA | Kamiya Biomedical Co. | Jul 25, 2001 | SESE |
| K003747 | C1-INHIBITOR MICROTITER ASSAY DEVICE | Baxter Healthcare Corp | Mar 19, 2001 | SESE |
| K965024 | N-ASSAY TIA C1-INACTIVATOR TEST KIT | Crestat Diagnostics, Inc. | Jul 14, 1997 | SESE |
| K960257 | N ANTISERUM TO C1 INHIBITOR | Behring Diagnostics, Inc. | Aug 1, 1996 | SESE |
| K951967 | HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT | Kent Laboratories, Inc. | May 30, 1995 | SESE |
| K915431 | COMPLEMENT C1 INACTIVATOR KIT | The Binding Site, Ltd. | Jan 17, 1992 | SESE |
| K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY | Cytotech, Inc. | Jul 23, 1987 | SESE |
| K821898 | ORTHO CLASSICAL PATHWAY COMPL. TEST | Ortho Diagnostic Systems, Inc. | Jul 16, 1982 | SESE |
| K781017 | ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) | Icl Scientific | Aug 14, 1978 | SESE |
| K780335 | LAS-R HUMAN C1 ESTERASE INHIBITOR TEST | Hyland Therapeutic Div., Travenol Laboratories | Mar 22, 1978 | SESE |
Top Applicants
- The Binding Site Group , Ltd. — 2 clearances
- The Binding Site, Ltd. — 1 clearance
- Ortho Diagnostic Systems, Inc. — 1 clearance
- Kent Laboratories, Inc. — 1 clearance
- Kamiya Biomedical Co. — 1 clearance
