Cleared Traditional

K023544 - GENZYME CONTRAST II HCG URINE/SERUM TEST

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

K023544 · Genzyme Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K023544

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 89d · This submission: 86d
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 375
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K023544.
EASYCUP
K023823 · Zer Hitech · May 2003
POLY STAT SERUM/URINE HCG TEST
K030430 · Alidex, Inc. · Apr 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
POLY STAT HCG DIPSTICK TEST
K021386 · Alidex, Inc. · Aug 2002
K023544 · GENZYME CONTRAST II HCG URINE/SERUM TEST
Download PDF FDA Summary Genzyme Corp.