Cleared Traditional

LUTEINIZING HORMONE DIRECT RIA KIT 125/I (K811024) - FDA 510(k) Clearance

Class I Chemistry device.

K811024 · Immunalysis Corporation · Chemistry device

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May 1981

Decision

23d

Days

Class 1

Risk

K811024 is an FDA 510(k) clearance for the LUTEINIZING HORMONE DIRECT RIA KIT 125/I. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Immunalysis Corporation (Mchenry, US). The FDA issued a Cleared decision on May 8, 1981 after a review of 23 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 Immunalysis Corporation devices

Submission Details

510(k) Number	K811024 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 15, 1981
Decision Date	May 08, 1981
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

65d faster than avg

Panel avg: 88d · This submission: 23d

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 142

Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K811024.

ELECSYS LH ASSAY

K964694 · Boehringer Mannheim Corp. · Jan 1997

COAT-A-COUNT LH IRMA

K951748 · Diagnostic Products Corp. · May 1995

SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT

K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1994

VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY

K926394 · Syva Co. · May 1993

COBAS CORE LH EIA

K930306 · Roche Diagnostic Systems, Inc. · May 1993

MILENIA (TM) LH

K902786 · Diagnostic Products Corp. · Oct 1990

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 K811024

Immunalysis Corporation

Mchenry, IL · US

Regulatory profile

50 submissions 50 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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