Cleared Traditional

K943252 - PRO-STEP LH OVULATION PREDICTION TEST

K943252 is the FDA 510(k) clearance for PRO-STEP LH OVULATION PREDICTION TEST by Disease Detection International, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K943252 · Disease Detection International, Inc. · Chemistry device
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Oct 1994
Decision
111d
Days
Class 1
Risk

K943252 is an FDA 510(k) clearance for the PRO-STEP LH OVULATION PREDICTION TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Disease Detection International, Inc. (Irvine, US). The FDA issued a Cleared decision on October 25, 1994 after a review of 111 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 Disease Detection International, Inc. devices

Submission Details

510(k) Number K943252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date October 25, 1994
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 88d · This submission: 111d
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 69
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K943252.
CONCEIVE OVULATION PREDICTOR
K953063 · Quidel Corp. · Aug 1995
COAT-A-COUNT LH IRMA
K951748 · Diagnostic Products Corp. · May 1995
CHEMILUMINESCENCE LH
K935319 · Nichols Institute Diagnostics · Apr 1995
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · Bio-Rad Laboratories, Inc. · Apr 1994
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · Syva Co. · May 1993