510(k) Report

510(k) · Cleared

Cleared

High Sensitivity Cortisol Enzyme Immunoassay

K031348510(k) SpecialCleared Jun 10, 200360-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

Salimetrics, LLC · NHG Enzyme Immunoassay, Cortisol, Salivary

Cleared on Jun 10, 2003 as substantially equivalent to K850141 (Diagnostic Systems Laboratories, Inc., 1985) after a 60-day review. Its family tree reaches back 1 generation to 1985.

Decided
Jun 10, 2003
Review
60 days
Class
Class II
Product code
NHG
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K850141 (1985). No later device cites it as a predicate yet.

K850141 · Active Cortisol DSL 2000-SP · Diagnostic Systems Laboratories, Inc. · 198519851990199520002005
K850141 · Active Cortisol DSL 2000-SP · Diagnostic Systems Laboratories, Inc. · 19850
  1. Root · 1 generation backK850141 Active Cortisol DSL 2000-SPDiagnostic Systems Laboratories, Inc. · 1985
  2. This deviceK031348 High Sensitivity Cortisol Enzyme ImmunoassaySalimetrics, LLC · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K850141Active Cortisol DSL 2000-SPDiagnostic Systems Laboratories, Inc.1985—
0 (this device)K031348High Sensitivity Cortisol Enzyme ImmunoassaySalimetrics, LLC2003—
FIG. 1 — Lineage of K031348, 1985–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

TypeNumberDeviceApplicantDecidedRecalls
*K850141Active Cortisol DSL 2000-SP
Summary page 1
…substantially equivalent to the Diagnostic Systems Laboratory Active Cortisol EIA, which was approved by FDA (K850141) for IVD use.…
Diagnostic Systems Laboratories, Inc.1985—

What descends from it?

No later submission names this one as a predicate yet.

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.

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.

FDA decisions per year · NHG

1in 2015

2007: 12012: 12015: 1
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

2007: 12025: 3
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

2011: 22012: 12013: 12014: 12015: 12016: 72017: 12018: 12019: 12021: 22023: 12024: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—10
20080—00
20090—00
20100—00
20110—02
20121—01
20130—01
20140—01
20151—01
20160—07
20170—01
20180—01
20190—01
20200—00
20210—02
20220—00
20230—01
20240—01
20250—30
20260—0—

What is it indicated for?

Salimetrics HS-Cortisol kit is a competitive immunoassay specifically designed 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.

Saliva cortisol accurately reflects the amount of serum cortisol in the circulation. This kit

is not intended for use with serum or plasma samples.

Indications for use as stated in the FDA summary.

More from Salimetrics, LLC

3 FDA decisions under this applicant name. See the company

  • K051012Progesterone Standard Calibrator, One (1) ML of Progesterone in a Saliva-Like Matrix at a Concentration of…Salimetrics, LLC · 2005
  • K011323High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Salimetrics, LLC · 2001

Recent decisions in NHG

The NHG category page

  • K150528Cortisol Saliva Luminescence ImmunoassayIbl International GmbH · 20151 recall
  • K102841Pantex AM/PM Salivary Cortisol Enzyme ImmunoassayPantex, Div. Bio-Analysis, Inc. · 2012
  • K070788Elecsys Cortisol Test SystemRoche Diagnostics · 2007
  • K051733Enzyme Immunoassay for the Detection of Salivary CortisolDrg Intl., Inc. · 2005
  • K043175Elecsys Cortisol Test System, Addition of Saliva Sample TypeRoche Diagnostics Corp. · 20041 recall

https://510kreport.com/device/K031348 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031348: High Sensitivity Cortisol Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031348

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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