Cleared Traditional

K043385 - OSOM HCG COMBO TEST

K043385 is an FDA 510(k) clearance for OSOM HCG COMBO TEST, manufactured by Genzyme Diagnostics. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K043385 · Genzyme Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
124d
Days
Class 2
Risk

K043385 is an FDA 510(k) clearance for the OSOM HCG COMBO TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Genzyme Diagnostics (San Diego, US). The FDA issued a Cleared decision on April 12, 2005 after a review of 124 days - within the typical 510(k) review window.

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 Genzyme Diagnostics devices

FDA 510(k) Submission Details - K043385

510(k) Number K043385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2004
Decision Date April 12, 2005
Days to Decision 124 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 88d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 280
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K043385.
HOME PREGNANCY TEST
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CLINITEST HCG PREGNANCY TEST
K032563 · Bayer Healthcare, LLC · Dec 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944 · Bayer Corp. · Feb 2003