Cleared Traditional

K003064 - TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR...

Also marketed or referenced as:
INTEGRA CATALOG # 2148323

K003064 is the FDA 510(k) clearance for TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR... by Roche Diagnostics Corp.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K003064 · Roche Diagnostics Corp. · Immunology device
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May 2001
Decision
211d
Days
Class 2
Risk

K003064 is an FDA 510(k) clearance for the TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315. 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 May 1, 2001 after a review of 211 days - an extended review 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: 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K003064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2000
Decision Date May 01, 2001
Days to Decision 211 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 104d · This submission: 211d
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 K003064.
TINA-QUANT TRANSFERRIN VER.2
K012371 · Roche Diagnostics Corp. · Sep 2001
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
RANDOX TRANSFERRIN
K002585 · Randox Laboratories, Ltd. · Feb 2001
DIMENSION TRNF FLEX REAGENT CARTRIDGE
K994294 · Dade Behring, Inc. · Feb 2000
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
K993162 · Wako Chemicals USA, Inc. · Nov 1999