Cleared Traditional

K081709 - OLYMPUS AFP - ALPHA-FETOPROTEIN

K081709 is an FDA 510(k) clearance for OLYMPUS AFP - ALPHA-FETOPROTEIN, manufactured by Olympus Life Science Research Europa GmbH (Europa). The device is a Class 2 Immunology device with product code LOJ cleared through the Traditional 510(k) pathway after a 272-day FDA review.

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.

FDA 510(k) Submission Details - K081709

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
167d slower than avg
Panel avg: 105d · This submission: 272d
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 K081709.
Elecsys AFP
K220176 · Roche Diagnostics · Sep 2022
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K213626 · Ortho-Clinical Diagnostics · Jun 2022
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
K090236 · Siemens Healthcare Diagnostics · Apr 2009
VIDAS AFP ASSAY
K080017 · bioMerieux, Inc. · Sep 2008
DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600
K071597 · Dade Behring, Inc. · Jun 2008
ST AIA-PACK AFP ENZYME IMMUNOASSAY
K023894 · Tosoh Medics, Inc. · Dec 2002
K081709 · OLYMPUS AFP - ALPHA-FETOPROTEIN
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