Cleared Traditional

OLYMPUS AFP - ALPHA-FETOPROTEIN (K081709) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081709 · Olympus Life Science Research Europa GmbH (Europa) · Immunology device
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Mar 2009
Decision
272d
Days
Class 2
Risk

K081709 is an FDA 510(k) clearance for the OLYMPUS AFP - ALPHA-FETOPROTEIN. Classified as Kit, Test,alpha-fetoprotein For Testicular Cancer (product code LOJ), Class II - Special Controls.

Submitted by Olympus Life Science Research Europa GmbH (Europa) (O'Callaghans Mills, Co. Clare, IE). The FDA issued a Cleared decision on March 16, 2009 after a review of 272 days - an extended review 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: 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 Olympus Life Science Research Europa GmbH (Europa) devices

Submission Details

510(k) Number K081709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date March 16, 2009
Days to Decision 272 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
168d slower than avg
Panel avg: 104d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K081709.
Elecsys AFP
K220176 · Roche Diagnostics · Sep 2022
VITROS AFP
K213626 · Ortho-Clinical Diagnostics · Jun 2022
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
K071597 · Dade Behring, Inc. · Jun 2008
IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2
K983263 · Diagnostic Products Corp. · Dec 1998
ELECSYS AFP
K973351 · Boehringer Mannheim Corp. · Nov 1997