Cleared Traditional

K871241 - ANSWER OVULATION TEST KIT

K871241 is an FDA 510(k) clearance for ANSWER OVULATION TEST KIT, manufactured by Armkel, LLC. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 189-day FDA review.

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

FDA 510(k) Submission Details - K871241

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 88d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

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 101
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K871241.
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
K874032 · Diagnostic Products Corp. · Dec 1987
O.P.T.(TM) OVULATION PREDICTION TEST
K870584 · Warner-Lambert Co. · Nov 1987
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K873668 · Medix Biotech, Inc. · Oct 1987
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
K873186 · Serono Diagnostics, Inc. · Sep 1987
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY
K873052 · American Dade · Sep 1987
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
K872131 · Hybritech, Inc. · Aug 1987