Cleared Traditional

ELECSYS CORTISOL TEST SYSTEM (K070788) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070788 · Roche Diagnostics · Chemistry device
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Oct 2007
Decision
197d
Days
Class 2
Risk

K070788 is an FDA 510(k) clearance for the ELECSYS CORTISOL TEST SYSTEM. Classified as Enzyme Immunoassay, Cortisol, Salivary (product code NHG), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 5, 2007 after a review of 197 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - 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 K070788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2007
Decision Date October 05, 2007
Days to Decision 197 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
109d slower than avg
Panel avg: 88d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHG Enzyme Immunoassay, Cortisol, Salivary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1205
Definition The Hs Salivary Cortisol Enzyme Immunoassay Kit Is For The Quantitative In Vitro Diagnostic Measurement Of Salivary Cortisol. This Kit May Be Used To Measure Adrenal Cortical Function And As A Screen For Cushing's And Addison's Disease. This Kit Is Not Intended For Use With Serum Or Plasma Samples. The Device's Intended Use Differs From The Description In The Classification Regulation In That It Is For Use With Saliva Samples.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.