Cleared Traditional

CANWEST OVU-BLUE (K862055) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

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 16
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K862055.
ABBOTT IMX LH
K884138 · Abbott Laboratories · Nov 1988
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
K874032 · Diagnostic Products Corp. · Dec 1987
DPC COAT-A-COUNT IRMA LH KIT
K863934 · Diagnostic Products Corp. · Feb 1987
QUANTIMUNE HLH RIA
K821346 · Bio-Rad · May 1982
QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM
K810302 · Bio-Rad · Feb 1981
125I LEUTINIZING HORMONE RIA KIT
K791405 · Diagnostic Products Corp. · Sep 1979