Cleared Traditional

IMMUNOCORP LH IRMA COATED TUBE (K903052) - FDA 510(k) Clearance

Class I Chemistry device.

K903052 · Immunocorp Sciences, Inc. · Chemistry device
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Aug 1990
Decision
49d
Days
Class 1
Risk

K903052 is an FDA 510(k) clearance for the IMMUNOCORP LH IRMA COATED TUBE. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Immunocorp Sciences, Inc. (Montreal (Quebec), CA). The FDA issued a Cleared decision on August 29, 1990 after a review of 49 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 Immunocorp Sciences, Inc. devices

Submission Details

510(k) Number K903052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1990
Decision Date August 29, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 16
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K903052.
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
ENZYMUN TEST(R) LH
K900779 · Boehringer Mannheim Corp. · Apr 1990
LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST
K894279 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
ABBOTT OVULATION PREDICTOR TEST
K890510 · Abbott Laboratories · Mar 1989