Alpha-2-Macroglobulin, Antigen, Antiserum, Control
This is an immunological reagent kit for detecting alpha-2-macroglobulin, the major broad-spectrum protease inhibitor in plasma that neutralizes proteases by steric entrapment, including antigen, antiserum, and control components for standard immunoassay procedures in clinical laboratories. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is DEB, regulated under 21 CFR 866.5620, within the Immunology specialty.
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Basic Information
- Product Code
- DEB
- Device Class
- FDA class 2
- Regulation Number
- 866.5620
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
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 |
|---|---|---|---|---|
| K140664 | HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS | Apr 16, 2014 | Substantially Equivalent | The Binding Site Group , Ltd. |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | Jul 21, 2008 | Substantially Equivalent | Dade Behring, Inc. |
| K053073 | N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN | Mar 28, 2006 | Substantially Equivalent | Dade Behring, Inc. |
| K974564 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT | Feb 17, 1998 | Substantially Equivalent | Beckman Instruments, Inc. |
| K914389 | ALPHA-2 MACROGLOBULIN TEST RID KIT | Dec 20, 1991 | Substantially Equivalent | The Binding Site, Ltd. |
| K896483 | QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK | Dec 01, 1989 | Substantially Equivalent | Kallestad Diag, A Div. of Erbamont, Inc. |
| K850683 | 72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2 | Nov 27, 1985 | Substantially Equivalent | Kent Laboratories, Inc. |
| K851282 | RADIAL IMMUNODIFFUSION PLATES ALPHA-2 MACROGLOBULI | May 24, 1985 | Substantially Equivalent | Cooper Biomedical, Inc. |
| K850603 | SPQ TEST SYSTEM FOR ALPHA(2) MACROGLOBULIN | Mar 05, 1985 | Substantially Equivalent | Applications Lab |
| K812493 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO | Sep 23, 1981 | Substantially Equivalent | Dako Corp. |
| K791340 | HUMAN ALPHA2 MACROGLOBULIN | Aug 16, 1979 | Substantially Equivalent | Beckman Instruments, Inc. |
| K772246 | ALPHA-2-MACROGLOBULIN NEPHEL. ASSAY | Dec 22, 1977 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K771780 | LAS-R TM | Oct 04, 1977 | Substantially Equivalent | Hyland Therapeutic Div., Travenol Laboratories |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.