Cleared Traditional

K964299 - N-ASSAY TIA MULTI V-NL

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

K964299 · Crestat Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K964299

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
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.

LKL Device Classification - Class 1, General Controls

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