Cleared Special

K031348 - HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY

K031348 is an FDA 510(k) clearance for HIGH SENSITIVITY CORTISOL ENZYME IMMUNO..., manufactured by Salimetrics, LLC. The device is a Class 2 Chemistry device with product code NHG cleared through the Special 510(k) pathway after a 60-day FDA review.

K031348 · Salimetrics, LLC · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
60d
Days
Class 2
Risk

K031348 is an FDA 510(k) clearance for the HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Cortisol, Salivary (product code NHG), Class II - Special Controls.

Submitted by Salimetrics, LLC (State College, US). The FDA issued a Cleared decision on June 10, 2003 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1205 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031348

510(k) Number K031348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2003
Decision Date June 10, 2003
Days to Decision 60 days
Submission Type Special
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
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Modification to existing cleared device.

NHG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NHG Enzyme Immunoassay, Cortisol, Salivary

Devices cleared under the same product code (NHG) and FDA review panel - the closest regulatory comparables to K031348.
ELECSYS CORTISOL TEST SYSTEM
K070788 · Roche Diagnostics · Oct 2007
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL
K051733 · Drg Intl., Inc. · Dec 2005
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
K043175 · Roche Diagnostics Corp. · Nov 2004
HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102
K011323 · Salimetrics, LLC · Dec 2001
K031348 · HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY
Download PDF FDA Summary Salimetrics, LLC