Cleared Traditional

OVUTIME OVULATION PREDICTOR TEST (K853142) - FDA 510(k) Clearance

Class I Chemistry device.

K853142 · Advanced Care Products · Chemistry device
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Dec 1985
Decision
141d
Days
Class 1
Risk

K853142 is an FDA 510(k) clearance for the OVUTIME OVULATION PREDICTOR TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Advanced Care Products (Raritan, US). The FDA issued a Cleared decision on December 17, 1985 after a review of 141 days - within the typical 510(k) review window.

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 Advanced Care Products devices

Submission Details

510(k) Number K853142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1985
Decision Date December 17, 1985
Days to Decision 141 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 88d · This submission: 141d
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 16
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K853142.
ABBOTT IMX LH
K884138 · Abbott Laboratories · Nov 1988
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
K874032 · Diagnostic Products Corp. · Dec 1987
DPC COAT-A-COUNT IRMA LH KIT
K863934 · Diagnostic Products Corp. · Feb 1987
QUANTIMUNE HLH RIA
K821346 · Bio-Rad · May 1982
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302 · Bio-Rad · Feb 1981
125I LEUTINIZING HORMONE RIA KIT
K791405 · Diagnostic Products Corp. · Sep 1979