Cleared Traditional

SUCROSEP LUTEINIZING HORMONE (LH) IRMA (K860308) - FDA 510(k) Clearance

Class I Chemistry device.

K860308 · Boots-Celltech Diagnostics, Inc. · Chemistry device

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Mar 1986

Decision

48d

Days

Class 1

Risk

K860308 is an FDA 510(k) clearance for the SUCROSEP LUTEINIZING HORMONE (LH) IRMA. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Boots-Celltech Diagnostics, Inc. (Berkshire, England, GB). The FDA issued a Cleared decision on March 17, 1986 after a review of 48 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 Boots-Celltech Diagnostics, Inc. devices

Submission Details

510(k) Number	K860308 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 28, 1986
Decision Date	March 17, 1986
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

40d faster than avg

Panel avg: 88d · This submission: 48d

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 K860308.

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 K860308

Boots-Celltech Diagnostics, Inc.

Berkshire, England · GB

JOHN SIMPSON

Regulatory profile

20 submissions 20 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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