Cleared Traditional

K964295 - N-ASSAY TIA TRANSFERRIN TEST KIT

K964295 is the FDA 510(k) clearance for N-ASSAY TIA TRANSFERRIN TEST KIT by Crestat Diagnostics, Inc.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K964295 · Crestat Diagnostics, Inc. · Immunology device
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Jun 1997
Decision
230d
Days
Class 2
Risk

K964295 is an FDA 510(k) clearance for the N-ASSAY TIA TRANSFERRIN TEST KIT. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Murrieta, US). The FDA issued a Cleared decision on June 16, 1997 after a review of 230 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 Crestat Diagnostics, Inc. devices

Submission Details

510(k) Number K964295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1996
Decision Date June 16, 1997
Days to Decision 230 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 104d · This submission: 230d
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 39
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K964295.
TRF
K983167 · Abbott Laboratories · Nov 1998
N ANTISERUM TO HUMAN TRANSFERRIN
K972840 · Behring Diagnostics, Inc. · Oct 1997
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
K971958 · Beckman Instruments, Inc. · Aug 1997
IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT
K963976 · Beckman Instruments, Inc. · Mar 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT
K963427 · Beckman Instruments, Inc. · Oct 1996
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
K933589 · Boehringer Mannheim Corp. · Nov 1993