Cleared Traditional

K862055 - CANWEST OVU-BLUE

K862055 is an FDA 510(k) clearance for CANWEST OVU-BLUE, manufactured by Canwest Medictex, Inc.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K862055 · Canwest Medictex, Inc. · Chemistry device
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Jan 1987
Decision
221d
Days
Class 1
Risk

K862055 is an FDA 510(k) clearance for the CANWEST OVU-BLUE. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Canwest Medictex, Inc. (Vancouver B.C., CA). The FDA issued a Cleared decision on January 6, 1987 after a review of 221 days - an extended review 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 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 Canwest Medictex, Inc. devices

FDA 510(k) Submission Details - K862055

510(k) Number K862055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1986
Decision Date January 06, 1987
Days to Decision 221 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 88d · This submission: 221d
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 K862055.
MICROCHECK LH OVULATION TEST
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K863442 · United Biotech, Inc. · Feb 1987
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K864144 · Immuchem Corp. · Nov 1986
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K863929 · Terumo Medical Corp. · Nov 1986
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
K863679 · Nichols Institute Diagnostics · Oct 1986