Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
This is an immunological reagent kit for detecting complement C1 inhibitor (C1-INH, also known as C1 inactivator), a serine protease inhibitor that regulates activation of the complement and contact-kinin systems, and whose deficiency causes hereditary angioedema. The kit includes antigen, antiserum, and control components for in vitro immunological testing. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DBA, regulated under 21 CFR 866.5250, within the Immunology specialty.
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Basic Information
- Product Code
- DBA
- Device Class
- FDA class 2
- Regulation Number
- 866.5250
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K141100 | OPTILITE C1 INACTIVATOR KIT | Jul 18, 2014 | Substantially Equivalent | The Binding Site Group , Ltd. |
| K122304 | HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS | Apr 15, 2013 | Substantially Equivalent | The Binding Site Group , Ltd. |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dec 21, 2007 | Substantially Equivalent | Dade Behring, Inc. |
| K011780 | K-ASSAY C1-INA | Jul 25, 2001 | Substantially Equivalent | Kamiya Biomedical Co. |
| K003747 | C1-INHIBITOR MICROTITER ASSAY DEVICE | Mar 19, 2001 | Substantially Equivalent | Baxter Healthcare Corp |
| K965024 | N-ASSAY TIA C1-INACTIVATOR TEST KIT | Jul 14, 1997 | Substantially Equivalent | Crestat Diagnostics, Inc. |
| K960257 | N ANTISERUM TO C1 INHIBITOR | Aug 01, 1996 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K951967 | HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT | May 30, 1995 | Substantially Equivalent | Kent Laboratories, Inc. |
| K915431 | COMPLEMENT C1 INACTIVATOR KIT | Jan 17, 1992 | Substantially Equivalent | The Binding Site, Ltd. |
| K872426 | CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY | Jul 23, 1987 | Substantially Equivalent | Cytotech, Inc. |
| K821898 | ORTHO CLASSICAL PATHWAY COMPL. TEST | Jul 16, 1982 | Substantially Equivalent | Ortho Diagnostic Systems, Inc. |
| K781017 | ANTI-HUMAN C1 INHIBITOR SERUM (GOAT) | Aug 14, 1978 | Substantially Equivalent | Icl Scientific |
| K780335 | LAS-R HUMAN C1 ESTERASE INHIBITOR TEST | Mar 22, 1978 | Substantially Equivalent | Hyland Therapeutic Div., Travenol Laboratories |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.