Cleared Traditional

ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 (K091867) - FDA 510(k) Clearance

Class I Chemistry device.

K091867 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
205d
Days
Class 1
Risk

K091867 is an FDA 510(k) clearance for the ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATER.... Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on January 14, 2010 after a review of 205 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics devices

Submission Details

510(k) Number K091867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2009
Decision Date January 14, 2010
Days to Decision 205 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 88d · This submission: 205d
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 37
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K091867.
TESTOSTERONE TEST SYSTEM
K120009 · Abbott Laboratories · Sep 2012
ELECYSYS SHBG
K102814 · Roche Diagnostics · Jan 2011
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · Roche Diagnostics Corp. · Apr 2010
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
K083867 · Beckman Coulter, Inc. · Aug 2009
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