Cleared Traditional

K031271 - ONE-STEP PREGNANCY TEST

K031271 is an FDA 510(k) clearance for ONE-STEP PREGNANCY TEST, manufactured by Amerisource Pharmacal, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K031271 · Amerisource Pharmacal, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
56d
Days
Class 2
Risk

K031271 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 Amerisource Pharmacal, Inc. (Beverly, US). The FDA issued a Cleared decision on June 17, 2003 after a review of 56 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 Amerisource Pharmacal, Inc. devices

FDA 510(k) Submission Details - K031271

510(k) Number K031271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2003
Decision Date June 17, 2003
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
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 162
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K031271.
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K030258 · Armkel, LLC · Feb 2003
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST
K023699 · Unipath , Ltd. · Nov 2002