Cleared Traditional

K023544 - GENZYME CONTRAST II HCG URINE/SERUM TEST

K023544 is the FDA 510(k) clearance for GENZYME CONTRAST II HCG URINE/SERUM TEST by Genzyme Corp.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K023544 · Genzyme Corp. · Chemistry device
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Jan 2003
Decision
86d
Days
Class 2
Risk

K023544 is an FDA 510(k) clearance for the GENZYME CONTRAST II HCG URINE/SERUM TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on January 16, 2003 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Genzyme Corp. devices

Submission Details

510(k) Number K023544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2002
Decision Date January 16, 2003
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K023544.
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946 · ACON Laboratories, Inc. · Aug 2004
CLINITEST HCG PREGNANCY TEST
K032563 · Bayer Healthcare, LLC · Dec 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944 · Bayer Corp. · Feb 2003
ACCESS TOTAL BHCG
K023480 · Beckman Coulter, Inc. · Dec 2002
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · Sa Scientific, Inc. · Dec 2002
QUPID PLUS E.R.
K020378 · Stanbio Laboratory · Jun 2002