510(k) · Cleared
ClearedHigh Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salimetrics, LLC · NHG Enzyme Immunoassay, Cortisol, Salivary
Cleared on Dec 17, 2001 after a 230-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 17, 2001
- Review
- 230 days
- Class
- Class II
- Product code
- NHG
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK011323 High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Salimetrics, LLC · 2001
- Descendant · cites it directly · 3 of its ownK043175 Elecsys Cortisol Test System, Addition of Saliva Sample TypeRoche Diagnostics Corp. · 2004 · Recalled
- Descendant · 2 generations on · 2 of its ownK070788 Elecsys Cortisol Test SystemRoche Diagnostics · 2007
- Descendant · 3 generations on · 1 of its ownK152227 Elecsys Cortisol II, Cortisol II CalSetRoche Diagnostics · 2016
- Descendant · cites it directly · 1 of its ownK102841 Pantex AM/PM Salivary Cortisol Enzyme ImmunoassayPantex, Div. Bio-Analysis, Inc. · 2012
- Descendant · 4 generations on · 0 of its ownK202136 IDS CortisolImmunodiagnostic Systems, Ltd. · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K043175Elecsys Cortisol Test System, Addition of Saliva Sample TypeRoche Diagnostics Corp. · 2004 · cites it directly3descendants
- K070788Elecsys Cortisol Test SystemRoche Diagnostics · 2007 · 2 generations on2descendants
- K152227Elecsys Cortisol II, Cortisol II CalSetRoche Diagnostics · 2016 · 3 generations on1descendant
- K102841Pantex AM/PM Salivary Cortisol Enzyme ImmunoassayPantex, Div. Bio-Analysis, Inc. · 2012 · cites it directly1descendant
- K202136IDS CortisolImmunodiagnostic Systems, Ltd. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011323 | High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 | Salimetrics, LLC | 2001 | — |
| +1 | K043175 | Elecsys Cortisol Test System, Addition of Saliva Sample Type | Roche Diagnostics Corp. | 2004 | 1 |
| +2 | K070788 | Elecsys Cortisol Test System | Roche Diagnostics | 2007 | — |
| +3 | K152227 | Elecsys Cortisol II, Cortisol II CalSet | Roche Diagnostics | 2016 | — |
| +1 | K102841 | Pantex AM/PM Salivary Cortisol Enzyme Immunoassay | Pantex, Div. Bio-Analysis, Inc. | 2012 | — |
| +4 | K202136 | IDS Cortisol | Immunodiagnostic Systems, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K043175 (Roche Diagnostics Corp., 2004) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NHG devicesNHG Enzyme Immunoassay, Cortisol, Salivary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NHG
1in 2015
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHG
1in 2024
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 | — |
https://510kreport.com/device/K011323 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011323: High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011323
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026