Cleared Traditional

OPUS(R) PROLACTIN TEST SYSTEM (K913280) - FDA 510(k) Clearance

Class I Toxicology device.

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
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 79
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K913280.
ELECSYS PROLACTIN ASSAY
K964748 · Boehringer Mannheim Corp. · Jan 1997
AXSYM PROLACTIN
K935675 · Abbott Laboratories · Jun 1994
COBAS CORE PROLACTIN EIA
K930305 · Roche Diagnostic Systems, Inc. · Aug 1993
VISTA PROLACTIN ASSAY
K926386 · Syva Co. · Mar 1993
IMMULITE PROLACTIN
K925846 · Diagnostic Products Corp. · Mar 1993
AMERLITE PROLACTIN-30 ASSAY
K922170 · Eastman Kodak Company · Sep 1992