Cleared Traditional

BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT (K951538) - FDA 510(k) Clearance

Class I Chemistry device.

K951538 · Syntron Bioresearch, Inc. · Chemistry device
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Jul 1995
Decision
99d
Days
Class 1
Risk

K951538 is an FDA 510(k) clearance for the BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Syntron Bioresearch, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 99 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 Syntron Bioresearch, Inc. devices

Submission Details

510(k) Number K951538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1995
Decision Date July 11, 1995
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
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 K951538.
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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