Cleared Traditional

K924673 - CLEARVIEW HCG

K924673 is the FDA 510(k) clearance for CLEARVIEW HCG by Unipath , Ltd.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K924673 · Unipath , Ltd. · Chemistry device
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May 1993
Decision
237d
Days
Class 2
Risk

K924673 is an FDA 510(k) clearance for the CLEARVIEW HCG. 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 11, 1993 after a review of 237 days - an extended review 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: 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 K924673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1992
Decision Date May 11, 1993
Days to Decision 237 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 88d · This submission: 237d
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 K924673.
OPUS(R) TOTAL B-HCG TEST SYSTEM
K932279 · Pb Diagnostic Systems, Inc. · Jul 1993
QUICKVUE ONE-STEP HCG COMBO
K932042 · Quidel Corp. · Jun 1993
SAS PREGNANCY STRIP
K931302 · Sa Scientific, Inc. · Jun 1993
CIBA CORNING ACS HCG IMMUNOASSAY
K925277 · Ciba Corning Diagnostics Corp. · Mar 1993
VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
K926342 · Syva Co. · Feb 1993
ACCESS TOTAL BHCG ASSAY
K926198 · Bio-Rad Laboratories, Inc. · Feb 1993