Cleared Traditional

K902443 - LUMATAG(TM) LH DIAGNOSTIC KIT

K902443 is an FDA 510(k) clearance for LUMATAG(TM) LH DIAGNOSTIC KIT, manufactured by London Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K902443 · London Diagnostics, Inc. · Chemistry device

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Aug 1990

Decision

62d

Days

Class 1

Risk

K902443 is an FDA 510(k) clearance for the LUMATAG(TM) LH DIAGNOSTIC KIT. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by London Diagnostics, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on August 2, 1990 after a review of 62 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.

FDA 510(k) Submission Details - K902443

510(k) Number	K902443 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 01, 1990
Decision Date	August 02, 1990
Days to Decision	62 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

27d faster than avg

Panel avg: 89d · This submission: 62d

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 142

Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K902443.

BIOCLONES ELEGANCE LH ELISA KIT

K904387 · Bioclone Australia Pty , Ltd. · Nov 1990

MILENIA (TM) LH

K902786 · Diagnostic Products Corp. · Oct 1990

IMMUNOCORP LH IRMA COATED TUBE

K903052 · Immunocorp Sciences, Inc. · Aug 1990

MODIFIED OVUGEN

K902208 · Biogenex Laboratories · Jul 1990

CIBA CORNING MAGIC LITE LH IMMUNOASSAY

K902398 · Ciba Corning Diagnostics Corp. · Jun 1990

ENZYMUN TEST(R) LH

K900779 · Boehringer Mannheim Corp. · Apr 1990

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 K902443

London Diagnostics, Inc.

Eden Prairie, MN · US

RAMAKRISHNAN, PHD

Regulatory profile

12 submissions 12 cleared

100% clearance rate · Active in Chemistry

View all devices by London Diagnostics, Inc. →

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: August 2, 1990. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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