Cleared Traditional

K963693 - OVUSIGN - ONE-STEP HOME OVULATION PREDI...

K963693 is an FDA 510(k) clearance for OVUSIGN - ONE-STEP HOME OVULATION PREDI..., manufactured by Princeton BioMeditech Corp.. The device is a Class 1 Toxicology device with product code CEP cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K963693 · Princeton BioMeditech Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
74d
Days
Class 1
Risk

K963693 is an FDA 510(k) clearance for the OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on November 29, 1996 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1485 - the FDA toxicology device 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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K963693

510(k) Number K963693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1996
Decision Date November 29, 1996
Days to Decision 74 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
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: 87d · This submission: 74d
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 85
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K963693.
TBD* ONE-STEP OVULATION PREDICTOR TEST
K973310 · Armkel, LLC · Oct 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
K964982 · Johnson & Johnson Clinical Diagnostics, Inc. · Feb 1997
ELECSYS LH ASSAY
K964694 · Boehringer Mannheim Corp. · Jan 1997
OPUS HLH
K962866 · Behring Diagnostics, Inc. · Aug 1996
ACS LH2 IMMUNOASSAY
K962041 · Ciba Corning Diagnostics Corp. · Jun 1996
ACTIVE LH IRMA
K961109 · Diagnostic Systems Laboratories, Inc. · Apr 1996