Cleared Traditional

K811024 - LUTEINIZING HORMONE DIRECT RIA KIT 125/I

K811024 is an FDA 510(k) clearance for LUTEINIZING HORMONE DIRECT RIA KIT 125/I, manufactured by Immunalysis Corporation. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 23-day FDA review.

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

FDA 510(k) Submission Details - K811024

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

65d faster than avg

Panel avg: 88d · This submission: 23d

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 101

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

AMERLEX LH RIA KIT (CODE IM2081)

K820753 · Amersham Corp. · Apr 1982

LUTEINIZING HORMONE KIT

K820357 · Pcl-Ria, Inc. · Mar 1982

SHARIA-LH RIA KIT FOR QUANTITATION HORMO

K813213 · Intl. Immunoassay Laboratories, Inc. · Dec 1981

LEECO LH-QUANT DIAGNOSTIC KIT

K810662 · Leeco Diagnostics, Inc. · Mar 1981

LUTEINIZING HORMONE

K810741 · Pcl-Ria, Inc. · Mar 1981

LUTENIZING HORMONES

K810754 · Pcl-Ria, Inc. · Mar 1981

FDA 510(k) Resources - Chemistry

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

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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 . FDA decision: May 8, 1981. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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