Cleared Traditional

K913280 - OPUS PROLACTIN TEST SYSTEM

K913280 is the FDA 510(k) clearance for OPUS PROLACTIN TEST SYSTEM by Pb Diagnostic Systems, Inc.. It is a Class 1 Toxicology device (product code CFT) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K913280 · Pb Diagnostic Systems, Inc. · Toxicology device
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Aug 1991
Decision
23d
Days
Class 1
Risk

K913280 is an FDA 510(k) clearance for the OPUS(R) PROLACTIN TEST SYSTEM. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on August 16, 1991 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1625 - 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 K913280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1991
Decision Date August 16, 1991
Days to Decision 23 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
64d faster than avg
Panel avg: 87d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFT Radioimmunoassay, Prolactin (lactogen)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1625
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 - CFT Radioimmunoassay, Prolactin (lactogen)

All 48
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K913280.
AMERLITE PROLACTIN-30 ASSAY
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PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)
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AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
K914135 · Amersham Corp. · Feb 1992
CIBA CORNING ACS PROLACTIN IMMUNOASSAY
K904714 · Ciba Corning Diagnostics Corp. · Nov 1990
AFFINITY PROLACTIN TEST SYSTEM
K902698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
PROLACTIN (LACTOGEN) TEST SYSTEM
K901673 · Baxter Healthcare Corp · Jun 1990