Cleared Abbreviated

K022829 - INSTANT-VIEW LH OVULATION PREDICTING TEST

K022829 is the FDA 510(k) clearance for INSTANT-VIEW LH OVULATION PREDICTING TEST by Alfa Scientific Designs, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Abbreviated 510(k) pathway after a 71-day FDA review.

K022829 · Alfa Scientific Designs, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Nov 2002
Decision
71d
Days
Class 1
Risk

K022829 is an FDA 510(k) clearance for the INSTANT-VIEW LH OVULATION PREDICTING TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on November 5, 2002 after a review of 71 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Alfa Scientific Designs, Inc. devices

Submission Details

510(k) Number K022829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2002
Decision Date November 05, 2002
Days to Decision 71 days
Submission Type Abbreviated
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
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Standards-based clearance path.

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 67
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K022829.
CLEARPLANE EASY OVULATION TEST
K013874 · Unipath , Ltd. · Feb 2002
QUIK-CHECK OVULATION PREDICTOR
K012252 · ACON Laboratories, Inc. · Aug 2001
OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031
K990249 · Phamatech · Mar 1999
CLEARPLAN EASY OVULATION TEST
K981271 · Unipath , Ltd. · Jun 1998
TBD* ONE-STEP OVULATION PREDICTOR TEST
K973310 · Armkel, LLC · Oct 1997
ELECSYS LH ASSAY
K964694 · Boehringer Mannheim Corp. · Jan 1997