Cleared Traditional

K911409 - OPUS FSH

K911409 is the FDA 510(k) clearance for OPUS FSH by Pb Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code CGJ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K911409 · Pb Diagnostic Systems, Inc. · Toxicology device
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Apr 1991
Decision
15d
Days
Class 1
Risk

K911409 is an FDA 510(k) clearance for the OPUS FSH. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on April 16, 1991 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1300 - 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 K911409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date April 16, 1991
Days to Decision 15 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 87d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
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 - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 44
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K911409.
COBAS CORE FSH EIA
K930304 · Roche Diagnostic Systems, Inc. · Sep 1993
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921746 · Biomerieux Vitek, Inc. · Jun 1992
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057
K915208 · Medix Biotech, Inc. · Dec 1991
AFFINITY FSH TEST SYSTEM
K905592 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
CIBA CORNING ACS FSH IMMUNOASSAY
K904649 · Ciba Corning Diagnostics Corp. · Nov 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050
K901345 · Medix Biotech, Inc. · May 1990