Cleared Traditional

K860090 - ANSWER PLUS AT HOME PREGNANCY TEST

K860090 is an FDA 510(k) clearance for ANSWER PLUS AT HOME PREGNANCY TEST, 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 91-day FDA review.

K860090 · Armkel, LLC · Chemistry device
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Apr 1986
Decision
91d
Days
Class 2
Risk

K860090 is an FDA 510(k) clearance for the ANSWER PLUS AT HOME PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 91 days - within the typical 510(k) review window.

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 - K860090

510(k) Number K860090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1986
Decision Date April 11, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
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 169
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K860090.
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE
K863841 · Hybritech, Inc. · Dec 1986
QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
K862207 · Quidel Corp. · Jun 1986
CLEARBLUE PREGNANCY TESTING KIT
K861168 · Unipath , Ltd. · Apr 1986
ANSWER
K852274 · Armkel, LLC · Jun 1985
ANSWER ONE-DAY
K843238 · Armkel, LLC · Sep 1984
BETA STICK, PREGNANCY TEST
K841415 · Quidel Corp. · Jul 1984