Cleared Traditional

K003064 - TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315

Also marketed or referenced as:
INTEGRA CATALOG # 2148323

K003064 is an FDA 510(k) clearance for TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K003064

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
106d slower than avg
Panel avg: 105d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDG Device Classification - Class 2, Special Controls

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 42
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
K-ASSAY TRANSFERRIN
K993537 · Kamiya Biomedical Co. · Nov 1999