Cleared Traditional

K964298 - N-ASSAY TIA MULTI V-NL

K964298 is the FDA 510(k) clearance for N-ASSAY TIA MULTI V-NL by Crestat Diagnostics, Inc.. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K964298 · Crestat Diagnostics, Inc. · Immunology device
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Jul 1997
Decision
258d
Days
Class 2
Risk

K964298 is an FDA 510(k) clearance for the N-ASSAY TIA MULTI V-NL. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Crestat Diagnostics, Inc. (Murrieta, US). The FDA issued a Cleared decision on July 14, 1997 after a review of 258 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 K964298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1996
Decision Date July 14, 1997
Days to Decision 258 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
154d slower than avg
Panel avg: 104d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - CZW Complement C3, Antigen, Antiserum, Control

All 33
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K964298.
K-ASSAY C3
K993437 · Kamiya Biomedical Co. · Nov 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991907 · Bayer Corp. · Nov 1999
C3
K983441 · Abbott Laboratories · Nov 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
K964842 · Beckman Instruments, Inc. · Jun 1997
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
K962409 · Olympus America, Inc. · Oct 1996
QUANTEX C3
K962199 · Instrumentation Laboratory CO · Sep 1996