Cleared Traditional

K964299 - N-ASSAY TIA MULTI V-NL

K964299 is the FDA 510(k) clearance for N-ASSAY TIA MULTI V-NL by Crestat Diagnostics, Inc.. It is a Class 1 Immunology device (product code LKL) cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K964299 · Crestat Diagnostics, Inc. · Immunology device
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Jul 1997
Decision
258d
Days
Class 1
Risk

K964299 is an FDA 510(k) clearance for the N-ASSAY TIA MULTI V-NL. Classified as Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (product code LKL), Class I - General 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 866.5420 - 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 K964299 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.

Device Classification

Product Code LKL Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5420
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LKL Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control

All 7
Devices cleared under the same product code (LKL) and FDA review panel - the closest regulatory comparables to K964299.
K-ASSAY ALPHA-1 AG
K993441 · Kamiya Biomedical Co. · Nov 1999
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT
K964257 · Beckman Instruments, Inc. · Mar 1997
AL-ACID GLYCOPROTEIN RID KIT
K922417 · The Binding Site, Ltd. · Aug 1992
RAICHEM (TM) SPIA (TM) - ACID GLYCOPROTEIN REAGENT
K904175 · Reagents Applications, Inc. · Nov 1990
TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN
K884217 · Technicon Instruments Corp. · Nov 1988
ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID)
K873868 · Unipath , Ltd. · Oct 1987