Cleared Traditional

K001086 - FREE TESTOSTERONE ENZYME IMMUNOASSAY

K001086 is the FDA 510(k) clearance for FREE TESTOSTERONE ENZYME IMMUNOASSAY by Diagnostic Systems Laboratories, Inc.. It is a Class 1 Immunology device (product code CDZ) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K001086 · Diagnostic Systems Laboratories, Inc. · Immunology device
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May 2000
Decision
44d
Days
Class 1
Risk

K001086 is an FDA 510(k) clearance for the FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on May 18, 2000 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1680 - 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 Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K001086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2000
Decision Date May 18, 2000
Days to Decision 44 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 104d · This submission: 44d
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 K001086.
ST AIA-PACK TESTOSTERONE ASSAY
K023091 · Tosoh Medics, Inc. · Dec 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
K021326 · bioMerieux, Inc. · Jul 2002
ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565
K001935 · Beckman Coulter, Inc. · Aug 2000
ABBOTT ARCHITECT TESTOSTERONE
K983212 · Abbott Laboratories · Nov 1998
ACTIVE TESTOSTERONE EIA (DSL-10-4000)
K971823 · Diagnostic Systems Laboratories, Inc. · Jun 1997
ELECSYS TESTOSTERONE ASSAY
K964889 · Boehringer Mannheim Corp. · Mar 1997