Cleared Traditional

K964295 - N-ASSAY TIA TRANSFERRIN TEST KIT

K964295 is an FDA 510(k) clearance for N-ASSAY TIA TRANSFERRIN TEST KIT, manufactured by Crestat Diagnostics, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K964295

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d slower than avg
Panel avg: 105d · This submission: 230d
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 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