Cleared Traditional

K031717 - ELECSYS SHBG IMMUNOASSAY

K031717 is an FDA 510(k) clearance for ELECSYS SHBG IMMUNOASSAY, manufactured by Roche Diagnostics Corp.. The device is a Class 1 Chemistry device with product code CDZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K031717 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
63d
Days
Class 1
Risk

K031717 is an FDA 510(k) clearance for the ELECSYS SHBG IMMUNOASSAY. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 5, 2003 after a review of 63 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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K031717

510(k) Number K031717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2003
Decision Date August 05, 2003
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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 66
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K031717.
ARCHITECT SHBG REAGENT KIT, ARCHITECT SHBG CALIBRATOR KIT, AND ARCHITECT SHBG CONTROL KIT WITH MODELS, 8K26-25, 8K26-01
K060818 · Biokit, S.A. · Jan 2007
ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
K041866 · Axis-Shield Diagnostics, Ltd. · Sep 2004
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
K032881 · Diagnostic Products Corp. · Oct 2003
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