Cleared Traditional

K862180 - MODIFIED COTROPIN RADIOIMMUNOASSAY KIT

K862180 is the FDA 510(k) clearance for MODIFIED COTROPIN RADIOIMMUNOASSAY KIT by Clinetics Corp.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K862180 · Clinetics Corp. · Chemistry device
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Jul 1986
Decision
28d
Days
Class 1
Risk

K862180 is an FDA 510(k) clearance for the MODIFIED COTROPIN RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Clinetics Corp. (Tustin, US). The FDA issued a Cleared decision on July 7, 1986 after a review of 28 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clinetics Corp. devices

Submission Details

510(k) Number K862180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1986
Decision Date July 07, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 69
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K862180.
ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM
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RIGHT-DAY OVULATION HOME TEST
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RIGHT-DAY URINARY LH (EIA)
K860538 · Leeco Diagnostics, Inc. · Jul 1986
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
K860984 · Hybritech, Inc. · Apr 1986
DELFIA TM HLH KIT
K855173 · Lkb Instruments, Inc. · Feb 1986
LEE-BEAD BETA LH (EIA)
K854838 · Leeco Diagnostics, Inc. · Jan 1986