Cleared Traditional

K102814 - ELECYSYS SHBG

K102814 is the FDA 510(k) clearance for ELECYSYS SHBG by Roche Diagnostics. It is a Class 1 Chemistry device (product code CDZ) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K102814 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
114d
Days
Class 1
Risk

K102814 is an FDA 510(k) clearance for the ELECYSYS SHBG. Classified as Radioimmunoassay, Testosterones And Dihydrotestosterone (product code CDZ), Class I - General Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on January 20, 2011 after a review of 114 days - within the typical 510(k) review window.

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.

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Submission Details

510(k) Number K102814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2010
Decision Date January 20, 2011
Days to Decision 114 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
26d slower than avg
Panel avg: 88d · This submission: 114d
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 52
Devices cleared under the same product code (CDZ) and FDA review panel - the closest regulatory comparables to K102814.
ADVIA CENTAUR TESTOSTERONE (TSTO)
K133491 · Siemens Healthcare Diagnostics, Inc. · Feb 2014
LIAISON TESTOSTERONE
K122793 · DiaSorin, Inc. · Jan 2013
TESTOSTERONE TEST SYSTEM
K120009 · Abbott Laboratories · Sep 2012
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · Roche Diagnostics Corp. · Apr 2010
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773
K091867 · Siemens Healthcare Diagnostics · Jan 2010
ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND
K083867 · Beckman Coulter, Inc. · Aug 2009