Cleared Traditional

K972640 - TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN...

K972640 is an FDA 510(k) clearance for TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN..., manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code DEM cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K972640 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
178d
Days
Class 2
Risk

K972640 is an FDA 510(k) clearance for the TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 178 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5130 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K972640

510(k) Number K972640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1997
Decision Date January 09, 1998
Days to Decision 178 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 104d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEM Device Classification - Class 2, Special Controls

Product Code DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control

All 22
Devices cleared under the same product code (DEM) and FDA review panel - the closest regulatory comparables to K972640.
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
K031857 · Bayer Diagnostics Corp. · Sep 2003
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
K011663 · The Binding Site, Ltd. · Jul 2001
K-ASSAY ALPHA-1 AT
K993444 · Kamiya Biomedical Co. · Nov 1999
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
K973389 · Ventana Medical Systems, Inc. · Oct 1997
CHEMMATE L26 (CD20)
K973390 · Ventana Medical Systems, Inc. · Oct 1997
CHEMMATE KAPPA
K973391 · Ventana Medical Systems, Inc. · Oct 1997