Cleared Traditional

K964300 - N-ASSAY TIA MULTI V-NL

K964300 is an FDA 510(k) clearance for N-ASSAY TIA MULTI V-NL, manufactured by Crestat Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DBI cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K964300 · Crestat Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K964300

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 105d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBI Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K964300.
K-ASSAY C4
K993481 · Kamiya Biomedical Co. · Nov 1999
C4
K983356 · Abbott Laboratories · Nov 1998
N-ASSAY TIA C4 TEST KIT
K964297 · Crestat Diagnostics, Inc. · Jul 1997
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