Cleared Traditional

K870584 - O.P.T.(TM) OVULATION PREDICTION TEST

K870584 is an FDA 510(k) clearance for O.P.T.(TM) OVULATION PREDICTION TEST, manufactured by Warner-Lambert Co.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K870584 · Warner-Lambert Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
287d
Days
Class 1
Risk

K870584 is an FDA 510(k) clearance for the O.P.T.(TM) OVULATION PREDICTION TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Warner-Lambert Co. (Morris Plains, US). The FDA issued a Cleared decision on November 25, 1987 after a review of 287 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 Warner-Lambert Co. devices

FDA 510(k) Submission Details - K870584

510(k) Number K870584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1987
Decision Date November 25, 1987
Days to Decision 287 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
199d slower than avg
Panel avg: 88d · This submission: 287d
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 K870584.
ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY
K881124 · Nichols Institute Diagnostics · Apr 1988
FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301
K874624 · Cyberfluor, Inc. · Jan 1988
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
K874032 · Diagnostic Products Corp. · Dec 1987
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K873668 · Medix Biotech, Inc. · Oct 1987
ANSWER OVULATION TEST KIT
K871241 · Armkel, LLC · Oct 1987
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
K873186 · Serono Diagnostics, Inc. · Sep 1987