Cleared Traditional

K904405 - BIOCLONES ELEGANCE FSH ELISA KIT

K904405 is an FDA 510(k) clearance for BIOCLONES ELEGANCE FSH ELISA KIT, manufactured by Bioclone Australia Pty , Ltd.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K904405 · Bioclone Australia Pty , Ltd. · Chemistry device
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Oct 1990
Decision
31d
Days
Class 1
Risk

K904405 is an FDA 510(k) clearance for the BIOCLONES ELEGANCE FSH ELISA KIT. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Bioclone Australia Pty , Ltd. (Washington, US). The FDA issued a Cleared decision on October 26, 1990 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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 Bioclone Australia Pty , Ltd. devices

FDA 510(k) Submission Details - K904405

510(k) Number K904405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1990
Decision Date October 26, 1990
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

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 70
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K904405.
OPUS FSH
K911409 · Pb Diagnostic Systems, Inc. · Apr 1991
AFFINITY FSH TEST SYSTEM
K905592 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
CIBA CORNING ACS FSH IMMUNOASSAY
K904649 · Ciba Corning Diagnostics Corp. · Nov 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050
K901345 · Medix Biotech, Inc. · May 1990
ENZYMUN TEST(R) FSH
K900763 · Boehringer Mannheim Corp. · Mar 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT
K896640 · Medix Biotech, Inc. · Jan 1990