Cleared Traditional

LUTEINIZING HORMONE (LH-IRMA) RIA KIT (K864144) - FDA 510(k) Clearance

Class I Chemistry device.

K864144 · Immuchem Corp. · Chemistry device

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Nov 1986

Decision

33d

Days

Class 1

Risk

K864144 is an FDA 510(k) clearance for the LUTEINIZING HORMONE (LH-IRMA) RIA KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 33 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 Immuchem Corp. devices

Submission Details

510(k) Number	K864144 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 22, 1986
Decision Date	November 24, 1986
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

55d faster than avg

Panel avg: 88d · This submission: 33d

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 K864144.

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K864144

Immuchem Corp.

Carson, CA · US

BURNS, PHD

Regulatory profile

18 submissions 18 cleared

100% clearance rate · Active in Chemistry

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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