Cleared Traditional

K983113 - BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT

K983113 is an FDA 510(k) clearance for BESURE PLUS ONE-STEP HOME OVULATION PRE..., 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 75-day FDA review.

K983113 · Syntron Bioresearch, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
75d
Days
Class 1
Risk

K983113 is an FDA 510(k) clearance for the BESURE PLUS 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 November 18, 1998 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Syntron Bioresearch, Inc. devices

FDA 510(k) Submission Details - K983113

510(k) Number K983113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1998
Decision Date November 18, 1998
Days to Decision 75 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
13d faster than avg
Panel avg: 88d · This submission: 75d
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

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