Cleared Traditional

K041273 - ONE-STEP PREGNANCY TEST

K041273 is an FDA 510(k) clearance for ONE-STEP PREGNANCY TEST, manufactured by W.H.P.M., Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K041273 · W.H.P.M., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
8d
Days
Class 2
Risk

K041273 is an FDA 510(k) clearance for the ONE-STEP PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on May 20, 2004 after a review of 8 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 W.H.P.M., Inc. devices

FDA 510(k) Submission Details - K041273

510(k) Number K041273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2004
Decision Date May 20, 2004
Days to Decision 8 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
80d faster than avg
Panel avg: 88d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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 - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 126
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K041273.
FACT PLUS ONE-STEP PREGNANCY TEST KIT
K042280 · Unipath , Ltd. · Sep 2004
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
K042151 · ACON Laboratories, Inc. · Sep 2004
CLEARBLUE EASY EASY READ PREGNANCY TEST
K041404 · Unipath , Ltd. · Jun 2004
MODIFICATION TO E.P.T. PREGNANCY TEST
K040329 · Unipath , Ltd. · Mar 2004
CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST
K040341 · Unipath , Ltd. · Mar 2004
E.P.T. PREGNANCY TEST
K033658 · Unipath , Ltd. · Jan 2004