Cleared Special

K002867 - INVERNESS MEDICAL OVULATION PREDICTOR TEST

K002867 is an FDA 510(k) clearance for INVERNESS MEDICAL OVULATION PREDICTOR TEST, manufactured by Selfcare, Inc.. The device is a Class 1 Chemistry device with product code CEP cleared through the Special 510(k) pathway after a 29-day FDA review.

K002867 · Selfcare, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
29d
Days
Class 1
Risk

K002867 is an FDA 510(k) clearance for the INVERNESS MEDICAL OVULATION PREDICTOR TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Selfcare, Inc. (Waltham, US). The FDA issued a Cleared decision on October 12, 2000 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K002867

510(k) Number K002867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2000
Decision Date October 12, 2000
Days to Decision 29 days
Submission Type Special
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
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 125
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K002867.
TCI-31 LIFELONG OVULATION TESTER
K013323 · Tci New York · Dec 2001
QUIK-CHECK OVULATION PREDICTOR
K012252 · ACON Laboratories, Inc. · Aug 2001
SURE CHECK OVULATION PREDICTOR
K010244 · Chembio Diagnostic Systems, Inc. · May 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
K002867 · INVERNESS MEDICAL OVULATION PREDICTOR TEST
Download PDF FDA Summary Selfcare, Inc.