Cleared Traditional

K905741 - CLEARVIEW HCG SERUM/URINE

K905741 is the FDA 510(k) clearance for CLEARVIEW HCG SERUM/URINE by Unipath , Ltd.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K905741 · Unipath , Ltd. · Chemistry device
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May 1991
Decision
142d
Days
Class 2
Risk

K905741 is an FDA 510(k) clearance for the CLEARVIEW HCG SERUM/URINE. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on May 15, 1991 after a review of 142 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 Unipath , Ltd. devices

Submission Details

510(k) Number K905741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1990
Decision Date May 15, 1991
Days to Decision 142 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 88d · This submission: 142d
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 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K905741.
DIRECTIGEN 1-2-3(TM) HCG TEST
K913122 · Quidel Corp. · Aug 1991
IMX HCG
K912534 · Abbott Laboratories · Jul 1991
IMX TOTAL B-HCG
K912535 · Abbott Laboratories · Jul 1991
CIBA CORNING ACS HCG IMMUNOASSAY
K904123 · Ciba Corning Diagnostics Corp. · Oct 1990
ABBOTT TESTPACK PLUS TM HCG-COMBO
K903219 · Abbott Laboratories · Sep 1990
AFFINITY HCG TEST SYSTEM
K902720 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990