Cleared Traditional

K012371 - TINA-QUANT TRANSFERRIN VER.2

K012371 is the FDA 510(k) clearance for TINA-QUANT TRANSFERRIN VER.2 by Roche Diagnostics Corp.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K012371 · Roche Diagnostics Corp. · Immunology device
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Sep 2001
Decision
55d
Days
Class 2
Risk

K012371 is an FDA 510(k) clearance for the TINA-QUANT TRANSFERRIN VER.2. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 19, 2001 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K012371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2001
Decision Date September 19, 2001
Days to Decision 55 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
49d faster than avg
Panel avg: 104d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 - DDG Transferrin, Antigen, Antiserum, Control

All 31
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K012371.
DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
K063322 · Dade Behring, Inc. · Jan 2007
N ANTISERA TO HUMAN TRANSFERRIN
K053075 · Dade Behring, Inc. · Mar 2006
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT
K042477 · Ortho-Clinical Diagnostics, Inc. · Nov 2004
TINA-QUANT TRANSFERRIN VER.2
K012393 · Roche Diagnostics Corp. · Sep 2001
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
K011662 · The Binding Site, Ltd. · Jul 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
K003064 · Roche Diagnostics Corp. · May 2001