Cleared Traditional

K080094 - OLYMPUS TOTAL BHCG TEST SYSTEN

K080094 is an FDA 510(k) clearance for OLYMPUS TOTAL BHCG TEST SYSTEN, manufactured by Olympus Life Science Research Europa GmbH (Europa). The device is a Class 2 Chemistry device with product code DHA cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K080094 · Olympus Life Science Research Europa GmbH (Europa) · Chemistry device
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Sep 2008
Decision
233d
Days
Class 2
Risk

K080094 is an FDA 510(k) clearance for the OLYMPUS TOTAL BHCG TEST SYSTEN. Classified as System, Test, Human Chorionic Gonadotropin (product code DHA), Class II - Special Controls.

Submitted by Olympus Life Science Research Europa GmbH (Europa) (Irving, US). The FDA issued a Cleared decision on September 3, 2008 after a review of 233 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Life Science Research Europa GmbH (Europa) devices

FDA 510(k) Submission Details - K080094

510(k) Number K080094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2008
Decision Date September 03, 2008
Days to Decision 233 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 88d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHA Device Classification - Class 2, Special Controls

Product Code DHA System, Test, Human Chorionic Gonadotropin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 Chemistry devices follow this clearance model.

Regulatory Peers - DHA System, Test, Human Chorionic Gonadotropin

All 51
Devices cleared under the same product code (DHA) and FDA review panel - the closest regulatory comparables to K080094.
ACCESS TOTAL BHCG (5TH IS)
K130020 · Beckman Coulter, Inc. · Oct 2013
LIAISON XL HCG
K131037 · DiaSorin, Inc. · Sep 2013
ONE STEP HCG URINE/SERUM TEST
K072500 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2009
VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS
K063720 · Ortho-Clinical Diagnostics · Apr 2007
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632
K063754 · Dade Behring, Inc. · Feb 2007
STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
K060548 · Dade Behring, Inc. · Apr 2006