Cleared Traditional

K150528 - Cortisol Saliva Luminescence Immunoassay (FDA 510(k) Clearance)

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

K150528 · Ibl International GmbH · Chemistry device
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Optimized for regulatory review, auditing and printing
Nov 2015
Decision
268d
Days
Class 2
Risk

K150528 is an FDA 510(k) clearance for the Cortisol Saliva Luminescence Immunoassay. Classified as Enzyme Immunoassay, Cortisol, Salivary (product code NHG), Class II - Special Controls.

Submitted by Ibl International GmbH (Hamburg, DE). The FDA issued a Cleared decision on November 25, 2015 after a review of 268 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 K150528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2015
Decision Date November 25, 2015
Days to Decision 268 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
180d slower than avg
Panel avg: 88d · This submission: 268d
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.