Cleared Traditional

ANSWER OVULATION TEST KIT (K871241) - FDA 510(k) Clearance

Class I Chemistry device.

K871241 · Armkel, LLC · Chemistry device
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Oct 1987
Decision
189d
Days
Class 1
Risk

K871241 is an FDA 510(k) clearance for the ANSWER OVULATION TEST KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on October 2, 1987 after a review of 189 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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

Submission Details

510(k) Number K871241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1987
Decision Date October 02, 1987
Days to Decision 189 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 88d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 142
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K871241.
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K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1994
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · Syva Co. · May 1993
COBAS CORE LH EIA
K930306 · Roche Diagnostic Systems, Inc. · May 1993
MILENIA (TM) LH
K902786 · Diagnostic Products Corp. · Oct 1990