Cleared Traditional

IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I (K843930) - FDA 510(k) Clearance

Class I Immunology device.

K843930 · Euro-Diagnostics BV · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
25d
Days
Class 1
Risk

K843930 is an FDA 510(k) clearance for the IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Euro-Diagnostics BV (Old Greenwich, US). The FDA issued a Cleared decision on October 30, 1984 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1300 - the FDA immunology 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 Euro-Diagnostics BV devices

Submission Details

510(k) Number K843930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1984
Decision Date October 30, 1984
Days to Decision 25 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 104d · This submission: 25d
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 87
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K843930.
ELECSYS FSH ASSAY
K964693 · Boehringer Mannheim Corp. · Dec 1996
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612 · Abbott Laboratories · Jun 1994
COBAS CORE FSH EIA
K930304 · Roche Diagnostic Systems, Inc. · Sep 1993
AFFINITY FSH TEST SYSTEM
K905592 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
ENZYMUN TEST(R) FSH
K900763 · Boehringer Mannheim Corp. · Mar 1990
MILENIA(TM) FSH (MKFS1,5)
K895005 · Diagnostic Products Corp. · Oct 1989