Cleared Traditional

K040866 - FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST

K040866 is an FDA 510(k) clearance for FIRST RESPONSE ONE-STEP DIGITAL PREGNAN..., manufactured by Armkel, LLC. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K040866 · Armkel, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
200d
Days
Class 2
Risk

K040866 is an FDA 510(k) clearance for the FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Armkel, LLC (Princeton, US). The FDA issued a Cleared decision on October 19, 2004 after a review of 200 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 Armkel, LLC devices

FDA 510(k) Submission Details - K040866

510(k) Number K040866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2004
Decision Date October 19, 2004
Days to Decision 200 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 88d · This submission: 200d
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 168
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K040866.
E.P.T. CERTAINTY PREGNANCY TEST
K050930 · Unipath , Ltd. · May 2005
PROOF POSITIVE ELECTRONIC PREGNANCY TEST
K043231 · Mizuho USA, Inc. · Apr 2005
ONE STEP HCG URINE PREGNANCY TEST
K043443 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2005
FACT PLUS ONE-STEP PREGNANCY TEST KIT
K042280 · Unipath , Ltd. · Sep 2004
ACON SPECTRUM HCG MIDSTREAM PREGNANCY TEST
K042151 · ACON Laboratories, Inc. · Sep 2004
AZOG, INC. HCG ONE-STEP URINE HOME PREGNANCY TEST (DIP STICK, CASSETTE AND MIDSTREAM)
K041748 · Azog, Inc. · Aug 2004