Cleared Traditional

K914240 - CLEARVIEW HCG SERUM/URINE PROFESS PREG ...

K914240 is the FDA 510(k) clearance for CLEARVIEW HCG SERUM/URINE PROFESS PREG ... by Unipath , Ltd.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K914240 · Unipath , Ltd. · Chemistry device
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Oct 1991
Decision
51d
Days
Class 2
Risk

K914240 is an FDA 510(k) clearance for the CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF. 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 October 25, 1991 after a review of 51 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 Unipath , Ltd. devices

Submission Details

510(k) Number K914240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1991
Decision Date October 25, 1991
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
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 K914240.
MEDIX BIOTECH HCG ENZYME IMMUNOASSAY TEST KIT
K920253 · Medix Biotech, Inc. · Feb 1992
KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION
K915701 · Eastman Kodak Company · Jan 1992
MEDIX BIOTECH TOTAL HCG ENZY IMMUN TEST KT DIF4011
K914696 · Medix Biotech, Inc. · Nov 1991
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