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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 358
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K043385.
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
K052694 · Ind Diagnostic, Inc. · Dec 2005
WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
K051841 · W.H.P.M., Inc. · Aug 2005
IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
K050741 · Ind Diagnostic, Inc. · May 2005
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946 · ACON Laboratories, Inc. · Aug 2004
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
K041728 · Immunostics Inc., · Aug 2004
ZAP HCG TEST, MODEL 8001
K033297 · Zbx Corporation · Mar 2004
K043385 · OSOM HCG COMBO TEST
Download PDF FDA Summary Genzyme Diagnostics