Cleared Traditional

K842478 - PROLACTIN IRMA

K842478 is the FDA 510(k) clearance for PROLACTIN IRMA by Euro-Diagnostics BV. It is a Class 1 Chemistry device (product code CFT) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K842478 · Euro-Diagnostics BV · Chemistry device
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Sep 1984
Decision
81d
Days
Class 1
Risk

K842478 is an FDA 510(k) clearance for the PROLACTIN IRMA. Classified as Radioimmunoassay, Prolactin (lactogen) (product code CFT), Class I - General Controls.

Submitted by Euro-Diagnostics BV (Mchenry, US). The FDA issued a Cleared decision on September 14, 1984 after a review of 81 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 Euro-Diagnostics BV devices

Submission Details

510(k) Number K842478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1984
Decision Date September 14, 1984
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 88d · This submission: 81d
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 50
Devices cleared under the same product code (CFT) and FDA review panel - the closest regulatory comparables to K842478.
ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM
K854805 · Nichols Institute Diagnostics · Jan 1986
TERUMO SENSIBEAD EIA HPRL KIT
K854768 · Terumo Medical Corp. · Jan 1986
TANDEM - EPRL
K843804 · Hybritech, Inc. · Nov 1984
PROLACTIN RIABEAD PROLACTIN RADIOIMM
K841118 · Abbott Laboratories · May 1984
COAT-A-COUNT NHS-PROLACTIN KIT AND
K833925 · Diagnostic Products Corp. · Jan 1984
ABBOTT LABORATORIES PROLACTIN EIA
K822759 · Abbott Laboratories · Oct 1982