Cleared Traditional

K013249 - TINA-QUANT APOLIPOPROTEIN VER.2

K013249 is the FDA 510(k) clearance for TINA-QUANT APOLIPOPROTEIN VER.2 by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code DER) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K013249 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
49d
Days
Class 2
Risk

K013249 is an FDA 510(k) clearance for the TINA-QUANT APOLIPOPROTEIN VER.2. Classified as Alpha-1-lipoprotein, Antigen, Antiserum, Control (product code DER), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on November 16, 2001 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5580 - the FDA in vitro diagnostics and chemistry 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K013249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2001
Decision Date November 16, 2001
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DER Alpha-1-lipoprotein, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5580
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 Chemistry devices follow this clearance model.

Regulatory Peers - DER Alpha-1-lipoprotein, Antigen, Antiserum, Control

Devices cleared under the same product code (DER) and FDA review panel - the closest regulatory comparables to K013249.
BAYER ADVIA IMS SYSTEM
K000921 · Bayer Corp. · May 2000
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
K990594 · Roche Diagnostics Corp. · Apr 1999
APOLIPOPROTEIN A1
K983289 · Abbott Laboratories · Jan 1999
ROCHE APOLIPOPROTEIN STANDARD
K910553 · Roche Diagnostic Systems, Inc. · May 1991
VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN
K840830 · Ventrex Laboratories, Inc. · May 1984