Cleared Traditional

CLINITEST HCG PREGNANCY TEST (K032563) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032563 · Bayer Healthcare, LLC · Chemistry device
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Dec 2003
Decision
125d
Days
Class 2
Risk

K032563 is an FDA 510(k) clearance for the CLINITEST HCG PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Medfield, US). The FDA issued a Cleared decision on December 23, 2003 after a review of 125 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.

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Submission Details

510(k) Number K032563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2003
Decision Date December 23, 2003
Days to Decision 125 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
37d slower than avg
Panel avg: 88d · This submission: 125d
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 95
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K032563.
Alltest Pregnancy Rapid Combo Test Cassette
K203272 · Hangzhou AllTest Biotech Co., Ltd. · Jan 2022
Atellica IM Total hCG (ThCG)
K172322 · Siemens Healthcare Diagnostics, Inc. · Mar 2018
SOFIA(R) HCG FIA
K131166 · Quidel Corp. · Aug 2013
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