Cleared Traditional

K905592 - AFFINITY FSH TEST SYSTEM

K905592 is the FDA 510(k) clearance for AFFINITY FSH TEST SYSTEM by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K905592 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Dec 1990
Decision
14d
Days
Class 1
Risk

K905592 is an FDA 510(k) clearance for the AFFINITY FSH TEST SYSTEM. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 27, 1990 after a review of 14 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K905592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1990
Decision Date December 27, 1990
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
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 54
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K905592.
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921746 · Biomerieux Vitek, Inc. · Jun 1992
FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057
K915208 · Medix Biotech, Inc. · Dec 1991
OPUS FSH
K911409 · Pb Diagnostic Systems, Inc. · Apr 1991
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