Cleared Traditional

K913938 - OPUS LH TEST SYSTEM

K913938 is the FDA 510(k) clearance for OPUS LH TEST SYSTEM by Pb Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code CEP) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K913938 · Pb Diagnostic Systems, Inc. · Toxicology device
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Nov 1991
Decision
65d
Days
Class 1
Risk

K913938 is an FDA 510(k) clearance for the OPUS(R) LH TEST SYSTEM. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on November 7, 1991 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1485 - the FDA toxicology device 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K913938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1991
Decision Date November 07, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
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 67
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K913938.
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921176 · Vitek Systems, Inc. · Apr 1992
LH GEN III SELF-TEST/CONCEIVE
K920160 · Quidel Corp. · Mar 1992
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT
K920504 · Medix Biotech, Inc. · Mar 1992
CIBA CORNING ACS LH IMMUNOASSAY
K910198 · Ciba Corning Diagnostics Corp. · Feb 1991
MILENIA (TM) LH
K902786 · Diagnostic Products Corp. · Oct 1990
CIBA CORNING MAGIC LITE LH IMMUNOASSAY
K902398 · Ciba Corning Diagnostics Corp. · Jun 1990