Product Code: DEM
FDA class 2
21 CFR 866.5130
Alpha-1-Antitrypsin, Antigen, Antiserum, Control
Immunology
This is an immunological reagent kit for detecting alpha-1-antitrypsin, a critical serine protease inhibitor produced by the liver that protects pulmonary tissue from enzymatic degradation, including antigen, antiserum, and control components for clinical laboratory immunoassay testing. Measurement is used to diagnose alpha-1-antitrypsin deficiency, which predisposes to early-onset emphysema and hepatic cirrhosis. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DEM, regulated under 21 CFR 866.5130, within the Immunology specialty.
510(k)s
30
FEI Numbers
23
Registration Numbers
23
Unique Applicants
23
Years Active
37
Basic Information
- Product Code
- DEM
- Device Class
- FDA class 2
- Regulation Number
- 866.5130
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 30 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K123256 | HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS | Jul 03, 2013 | Substantially Equivalent | THE BINDING SITE GROUP, LTD. |
| K063610 | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH | Jan 11, 2007 | Substantially Equivalent | DADE BEHRING, INC. |
| K053072 | N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN | Mar 28, 2006 | Substantially Equivalent | DADE BEHRING, INC. |
| K052819 | VITROS CHEMISTRY PRODUCTS AAT REAGENT, CALIBRATOR KIT 99 AND AAT PERFORMANCE VERIFIERS I, II AND III | Dec 23, 2005 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K050596 | QUANTIA A1-AT | May 13, 2005 | Substantially Equivalent | BIOKIT S.A. |
| K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | Sep 04, 2003 | Substantially Equivalent | BAYER DIAGNOSTICS CORP. |
| K011663 | MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS | Jul 30, 2001 | Substantially Equivalent | THE BINDING SITE, LTD. |
| K010978 | TINA-QUANT ALPHA-1 ANTITRYPSIN | May 18, 2001 | Substantially Equivalent | ROCHDIAG |
| K993444 | K-ASSAY ALPHA-1 AT | Nov 24, 1999 | Substantially Equivalent | KAMIYA BIOMEDICAL CO. |
| K972640 | TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY | Jan 09, 1998 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K973392 | CHEMMATE LAMBDA | Oct 03, 1997 | Substantially Equivalent | VENTANA MEDICAL SYSTEMS, INC. |
| K973391 | CHEMMATE KAPPA | Oct 03, 1997 | Substantially Equivalent | VENTANA MEDICAL SYSTEMS, INC. |
| K973390 | CHEMMATE L26 (CD20) | Oct 03, 1997 | Substantially Equivalent | VENTANA MEDICAL SYSTEMS, INC. |
| K973389 | CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING | Oct 03, 1997 | Substantially Equivalent | VENTANA MEDICAL SYSTEMS, INC. |
| K965100 | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT | Jul 14, 1997 | Substantially Equivalent | CRESTAT DIAGNOSTICS, INC. |
| K964766 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) | Apr 25, 1997 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K931979 | VENTANA NEGATIVE CONTROL REAGENT | Mar 30, 1994 | Substantially Equivalent | VENTANA MEDICAL SYSTEMS, INC. |
| K920005 | IL TEST ALPHA-1-ANTITRYPSIN (AAT) | Jul 29, 1992 | Substantially Equivalent | INSTRUMENTATION LABORATORY CO. |
| K913666 | ALPHA-1-ANTITRYPSIN IMMUNOLOGICAL NL TEST KIT | Dec 09, 1991 | Substantially Equivalent | THE BINDING SITE, LTD. |
| K890415 | SPQ(TM) ANTIBODY REAGENT SET II FOR AAT | Feb 17, 1989 | Substantially Equivalent | ATLANTIC ANTIBODIES |
| K882446 | ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM | Jul 08, 1988 | Substantially Equivalent | TECHNICON INSTRUMENTS CORP. |
| K875283 | QM2/QM300 CONTROL B PACK | Feb 10, 1988 | Substantially Equivalent | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. |
| K875281 | QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK | Feb 10, 1988 | Substantially Equivalent | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. |
| K850587 | SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN | Mar 14, 1985 | Substantially Equivalent | APPLICATIONS LAB |
| K801669 | J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO | Sep 16, 1980 | Substantially Equivalent | J.T. BAKER CHEMICAL CO. |
| K791605 | GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN | Sep 04, 1979 | Substantially Equivalent | PROTOS LABORATORIES |
| K781408 | RID SYSTEM-(ACP) TEST | Aug 21, 1978 | Substantially Equivalent | ICL SCIENTIFIC |
| K772080 | RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT | Feb 03, 1978 | Substantially Equivalent | GELMAN INSTRUMENT CO. |
| K760916 | LAS-R HUMAN ALPHA, ANTITRYPSIN TEST | Nov 16, 1976 | Substantially Equivalent | HYLAND THERAPEUTIC DIV., TRAVENOL LABORATORIES |
| K760034 | TEST, STREP, LATEX SLIDE | Aug 11, 1976 | Substantially Equivalent | GAMMA BIOLOGICALS, INC. |
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.