Cleared Traditional

K983212 - ABBOTT ARCHITECT TESTOSTERONE

K983212 is an FDA 510(k) clearance for ABBOTT ARCHITECT TESTOSTERONE, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K983212 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
65d
Days
Class 1
Risk

K983212 is an FDA 510(k) clearance for the ABBOTT ARCHITECT TESTOSTERONE. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 65 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K983212

510(k) Number K983212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1998
Decision Date November 18, 1998
Days to Decision 65 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
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

CDZ Device Classification - Class 1, General Controls

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 56
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K983212.
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
FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
K001086 · Diagnostic Systems Laboratories, Inc. · May 2000
ACTIVE TESTOSTERONE EIA (DSL-10-4000)
K971823 · Diagnostic Systems Laboratories, Inc. · Jun 1997
ELECSYS TESTOSTERONE ASSAY
K964889 · Boehringer Mannheim Corp. · Mar 1997
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K963080 · Bayer Corp. · Sep 1996