Cleared Traditional

K010978 - TINA-QUANT ALPHA-1 ANTITRYPSIN

K010978 is an FDA 510(k) clearance for TINA-QUANT ALPHA-1 ANTITRYPSIN, manufactured by Rochdiag. The device is a Class 2 Immunology device with product code DEM cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K010978 · Rochdiag · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
66d
Days
Class 2
Risk

K010978 is an FDA 510(k) clearance for the TINA-QUANT ALPHA-1 ANTITRYPSIN. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Rochdiag (Indianapolis, US). The FDA issued a Cleared decision on May 18, 2001 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rochdiag devices

FDA 510(k) Submission Details - K010978

510(k) Number K010978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2001
Decision Date May 18, 2001
Days to Decision 66 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 105d · This submission: 66d
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 26
Devices cleared under the same product code (DEM) and FDA review panel - the closest regulatory comparables to K010978.
QUANTIA A1-AT
K050596 · Biokit, S.A. · May 2005
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
TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY
K972640 · Boehringer Mannheim Corp. · Jan 1998
CHEMMATE UCHL1 (CD45RO) PREDILUTED ANTIBODY FOR IMMUNOHISTOCHEMICAL STAINING
K973389 · Ventana Medical Systems, Inc. · Oct 1997