Cleared Traditional

K981354 - ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211

K981354 is an FDA 510(k) clearance for ACCESS AFP REAGENTS ON THE ACCESS IMMUN..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code LOJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K981354 · Beckman Instruments, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
May 1998
Decision
17d
Days
Class 2
Risk

K981354 is an FDA 510(k) clearance for the ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211. Classified as Kit, Test,alpha-fetoprotein For Testicular Cancer (product code LOJ), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Chaska, US). The FDA issued a Cleared decision on May 1, 1998 after a review of 17 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.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K981354

510(k) Number K981354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1998
Decision Date May 01, 1998
Days to Decision 17 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
88d faster than avg
Panel avg: 105d · This submission: 17d
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 15
Devices cleared under the same product code (LOJ) and FDA review panel - the closest regulatory comparables to K981354.
VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
K983031 · Ortho-Clinical Diagnostics, Inc. · Dec 1998
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
K983263 · Diagnostic Products Corp. · Dec 1998
ELECSYS AFP
K981282 · Roche Diagnostics GmbH · May 1998
ELECSYS AFP
K973351 · Boehringer Mannheim Corp. · Nov 1997
AFP ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972462 · Bayer Corp. · Sep 1997