Cleared Traditional

K800106 - LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS

K800106 is the FDA 510(k) clearance for LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS by Radioimmunoassay, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K800106 · Radioimmunoassay, Inc. · Chemistry device

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Feb 1980

Decision

28d

Days

Class 1

Risk

K800106 is an FDA 510(k) clearance for the LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Radioimmunoassay, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 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 Radioimmunoassay, Inc. devices

Submission Details

510(k) Number	K800106 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 16, 1980
Decision Date	February 13, 1980
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 78

Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K800106.

LUTENIZING HORMONES

K810754 · Pcl-Ria, Inc. · Mar 1981

QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM

K810302 · Bio-Rad · Feb 1981

LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT

K803278 · Immuno Nuclear Corp. · Jan 1981

CENTRIA LH RIA

K792350 · Union Carbide Corp. · Jan 1980

125I LEUTINIZING HORMONE RIA KIT

K791405 · Diagnostic Products Corp. · Sep 1979

RIA KIT, LH

K781685 · Amersham Corp. · Oct 1978

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 K800106

Radioimmunoassay, Inc.

Mchenry, IL · US

Regulatory profile

9 submissions 9 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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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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