Cleared Traditional

K010244 - SURE CHECK OVULATION PREDICTOR

K010244 is an FDA 510(k) clearance for SURE CHECK OVULATION PREDICTOR, manufactured by Chembio Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K010244 · Chembio Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
97d
Days
Class 1
Risk

K010244 is an FDA 510(k) clearance for the SURE CHECK OVULATION PREDICTOR. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Chembio Diagnostic Systems, Inc. (Beverly, US). The FDA issued a Cleared decision on May 2, 2001 after a review of 97 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 Chembio Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K010244

510(k) Number K010244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2001
Decision Date May 02, 2001
Days to Decision 97 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
9d slower than avg
Panel avg: 88d · This submission: 97d
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 K010244.
INSTANT-VIEW LH OVULATION PREDICTING TEST
K022829 · Alfa Scientific Designs, Inc. · Nov 2002
CLEARPLANE EASY OVULATION TEST
K013874 · Unipath , Ltd. · Feb 2002
QUIK-CHECK OVULATION PREDICTOR
K012252 · ACON Laboratories, Inc. · Aug 2001
EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)
K991386 · Selfcare, Inc. · May 1999
EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)
K991466 · Selfcare, Inc. · May 1999
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031
K990249 · Phamatech · Mar 1999