Cleared Traditional

K964257 - IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-A...

K964257 is an FDA 510(k) clearance for IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-A..., manufactured by Beckman Instruments, Inc.. The device is a Class 1 Immunology device with product code LKL cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K964257 · Beckman Instruments, Inc. · Immunology device
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Mar 1997
Decision
150d
Days
Class 1
Risk

K964257 is an FDA 510(k) clearance for the IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT. Classified as Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (product code LKL), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on March 24, 1997 after a review of 150 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K964257

510(k) Number K964257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1996
Decision Date March 24, 1997
Days to Decision 150 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 104d · This submission: 150d
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 K964257.
K-ASSAY ALPHA-1 AG
K993441 · Kamiya Biomedical Co. · Nov 1999
N-ASSAY TIA MULTI V-NL
K964299 · Crestat Diagnostics, Inc. · Jul 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