Cleared Traditional

K843284 - OVUSTICK SELF-TEST

K843284 is an FDA 510(k) clearance for OVUSTICK SELF-TEST, manufactured by Monoclonal Antibodies, Inc.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K843284 · Monoclonal Antibodies, Inc. · Chemistry device
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Dec 1984
Decision
113d
Days
Class 1
Risk

K843284 is an FDA 510(k) clearance for the OVUSTICK SELF-TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Monoclonal Antibodies, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 11, 1984 after a review of 113 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 Monoclonal Antibodies, Inc. devices

FDA 510(k) Submission Details - K843284

510(k) Number K843284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date December 11, 1984
Days to Decision 113 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 88d · This submission: 113d
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 102
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K843284.
LEE-BEAD BETA LH (EIA)
K854838 · Leeco Diagnostics, Inc. · Jan 1986
QUIDEL QUEST OVULATION TEST
K852146 · Quidel Corp. · Jul 1985
AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
K851104 · Amersham Corp. · Apr 1985
LH RIA
K842445 · Syncor Intl. Corp. · Sep 1984
MICROMEDIC LH & FSH RIA KIT
K840188 · Micromedic Systems · Mar 1984
LH QUIK RIA KIT
K840174 · Pacific Biotech, Inc. · Mar 1984