Cleared Traditional

K951538 - BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT

K951538 is an FDA 510(k) clearance for BESURE ONE-=STEP HOME OVULATION PREDICT..., manufactured by Syntron Bioresearch, Inc.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K951538 · Syntron Bioresearch, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K951538

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
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 K951538.
ACTIVE LH IRMA
K961109 · Diagnostic Systems Laboratories, Inc. · Apr 1996
FIRST RESPONSE OVULATION PREDICTOR TEST
K953581 · Armkel, LLC · Oct 1995
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
PRO-STEP LH OVULATION PREDICTION TEST
K943252 · Disease Detection International, Inc. · Oct 1994