Cleared Traditional

K964300 - N-ASSAY TIA MULTI V-NL

K964300 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 DBI) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K964300 · Crestat Diagnostics, Inc. · Immunology device
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Jul 1997
Decision
258d
Days
Class 2
Risk

K964300 is an FDA 510(k) clearance for the N-ASSAY TIA MULTI V-NL. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), 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 K964300 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 DBI Complement C4, 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 - DBI Complement C4, Antigen, Antiserum, Control

All 24
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K964300.
C4 MININEPH ANTISERUM
K981785 · The Binding Site, Ltd. · Dec 1999
K-ASSAY C4
K993481 · Kamiya Biomedical Co. · Nov 1999
C4
K983356 · Abbott Laboratories · Nov 1998
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
K962582 · Olympus America, Inc. · Oct 1996
QUANTEX C4
K962198 · Instrumentation Laboratory CO · Sep 1996
IL TEST COMPLEMENT 4
K920010 · Instrumentation Laboratory CO · Mar 1992