510(k) · Cleared

Cleared

Pantex AM/PM Salivary Cortisol Enzyme Immunoassay

K102841510(k) TraditionalCleared May 8, 2012587-day reviewClass II21 CFR 862.1205

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pantex, Div. Bio-Analysis, Inc. · NHG Enzyme Immunoassay, Cortisol, Salivary

Cleared on May 8, 2012 as substantially equivalent to K011323 (Salimetrics, LLC, 2001) after a 587-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: May 8, 2012
Review: 587 days
Class: Class II
Product code: NHG
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011323 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011323 High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Salimetrics, LLC · 2001
This deviceK102841 Pantex AM/PM Salivary Cortisol Enzyme ImmunoassayPantex, Div. Bio-Analysis, Inc. · 2012
Descendant · cites it directly · 0 of its ownK150528 Cortisol Saliva Luminescence ImmunoassayIbl International GmbH · 2015 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K150528Cortisol Saliva Luminescence ImmunoassayIbl International GmbH · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011323	High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102	Salimetrics, LLC	2001	—
0 (this device)	K102841	Pantex AM/PM Salivary Cortisol Enzyme Immunoassay	Pantex, Div. Bio-Analysis, Inc.	2012	—
+1	K150528	Cortisol Saliva Luminescence Immunoassay	Ibl International GmbH	2015	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0

FIG. 1 — Lineage of K102841, 2001–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NHG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K011323	High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102	Salimetrics, LLC	2001	—

Also cleared against K011323: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150528	Cortisol Saliva Luminescence Immunoassay	Ibl International GmbH	2015	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K150528 (Ibl International GmbH, 2015) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K011323.

How does its category compare?

All NHG devices

NHG Enzyme Immunoassay, Cortisol, Salivary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · NHG

1in 2015

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHG

Too few NHG 510(k)s in any year since 2007 to give a median.

Recalls per year · NHG

3in 2025

2007high 3 (2025) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHG

1in 2024

2007high 7 (2016) · low 0 (2007)2025

MAUDE reports naming product code NHG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	2
2012	1	—	0	1
2013	0	—	0	1
2014	0	—	0	1
2015	1	—	0	1
2016	0	—	0	7
2017	0	—	0	1
2018	0	—	0	1
2019	0	—	0	1
2020	0	—	0	0
2021	0	—	0	2
2022	0	—	0	0
2023	0	—	0	1
2024	0	—	0	1
2025	0	—	3	0
2026	0	—	0	—

What is it indicated for?

For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102841 · printed Nov 5, 2026

Cite this page

510(k) Report. “K102841: Pantex AM/PM Salivary Cortisol Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102841

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026