Cleared Traditional

IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES (K883747) - FDA 510(k) Clearance

Class I Chemistry device.

K883747 · Diagnostic Products Corp. · Chemistry device
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Nov 1988
Decision
61d
Days
Class 1
Risk

K883747 is an FDA 510(k) clearance for the IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on November 1, 1988 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1625 - 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K883747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1988
Decision Date November 01, 1988
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 88d · This submission: 61d
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 K883747.
ELECSYS PROLACTIN ASSAY
K964748 · Boehringer Mannheim Corp. · Jan 1997
AXSYM PROLACTIN
K935675 · Abbott Laboratories · Jun 1994
VISTA PROLACTIN ASSAY
K926386 · Syva Co. · Mar 1993
IMMULITE PROLACTIN
K925846 · Diagnostic Products Corp. · Mar 1993
AFFINITY PROLACTIN TEST SYSTEM
K902698 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1990
PROLACTIN (LACTOGEN) TEST SYSTEM
K901673 · Baxter Healthcare Corp · Jun 1990