Cleared Traditional

PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (K102841) - FDA 510(k) Clearance

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

K102841 · Pantex, Div. Bio-Analysis, Inc. · Chemistry device
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May 2012
Decision
587d
Days
Class 2
Risk

K102841 is an FDA 510(k) clearance for the PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Cortisol, Salivary (product code NHG), Class II - Special Controls.

Submitted by Pantex, Div. Bio-Analysis, Inc. (Santa Monica, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 587 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Pantex, Div. Bio-Analysis, Inc. devices

Submission Details

510(k) Number K102841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date May 08, 2012
Days to Decision 587 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
499d slower than avg
Panel avg: 88d · This submission: 587d
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.