Cleared Traditional

K021326 - VIDAS TESTOSTERONE (TES)

K021326 is the FDA 510(k) clearance for VIDAS TESTOSTERONE (TES) by bioMerieux, Inc.. It is a Class 1 Chemistry device (product code CDZ) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K021326 · bioMerieux, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
83d
Days
Class 1
Risk

K021326 is an FDA 510(k) clearance for the VIDAS TESTOSTERONE (TES), MODEL 30 418. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on July 18, 2002 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1680 - 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K021326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2002
Decision Date July 18, 2002
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 88d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1680
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 - CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone

All 53
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K021326.
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
K032881 · Diagnostic Products Corp. · Oct 2003
ELECSYS SHBG IMMUNOASSAY
K031717 · Roche Diagnostics Corp. · Aug 2003
ST AIA-PACK TESTOSTERONE ASSAY
K023091 · Tosoh Medics, Inc. · Dec 2002
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
K001935 · Beckman Coulter, Inc. · Aug 2000
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
K001086 · Diagnostic Systems Laboratories, Inc. · May 2000
ABBOTT ARCHITECT TESTOSTERONE
K983212 · Abbott Laboratories · Nov 1998