Cleared Traditional

K972462 - AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K972462 is an FDA 510(k) clearance for AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM, manufactured by Bayer Corp.. The device is a Class 2 Immunology device with product code LOJ cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K972462 · Bayer Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
83d
Days
Class 2
Risk

K972462 is an FDA 510(k) clearance for the AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM. Classified as Kit, Test,alpha-fetoprotein For Testicular Cancer (product code LOJ), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on September 22, 1997 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K972462

510(k) Number K972462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1997
Decision Date September 22, 1997
Days to Decision 83 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
22d faster than avg
Panel avg: 105d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LOJ Device Classification - Class 2, Special Controls

Product Code LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - LOJ Kit, Test,alpha-fetoprotein For Testicular Cancer

All 16
Devices cleared under the same product code (LOJ) and FDA review panel - the closest regulatory comparables to K972462.
ELECSYS AFP
K981282 · Roche Diagnostics GmbH · May 1998
ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
K981354 · Beckman Instruments, Inc. · May 1998
ELECSYS AFP
K973351 · Boehringer Mannheim Corp. · Nov 1997
TERRAN ONE BIOMECHANICAL ANALYSIS SYSTEMS
K851891 · Richard Scott Elliott · Jul 1985
K972462 · AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
Download PDF FDA Summary Bayer Corp.