510(k) · Cleared
Recalled · Class II · 2018Cortisol Saliva Luminescence Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ibl International GmbH · NHG Enzyme Immunoassay, Cortisol, Salivary
Cleared on Nov 25, 2015 as substantially equivalent to K102841 (Pantex, Div. Bio-Analysis, Inc., 2012) after a 268-day review. Its family tree reaches back 2 generations to 2001. It has been recalled once.
- Decided
- Nov 25, 2015
- Review
- 268 days
- Class
- Class II
- Product code
- NHG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011323 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK011323 High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102Salimetrics, LLC · 2001
- 1 generation backK102841 Pantex AM/PM Salivary Cortisol Enzyme ImmunoassayPantex, Div. Bio-Analysis, Inc. · 2012
- This deviceK150528 Cortisol Saliva Luminescence ImmunoassayIbl International GmbH · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011323 | High Sensitivity Cortisol Enzyme Immunoassay, Model 1-0101/1-0102 | Salimetrics, LLC | 2001 | — |
| −1 | K102841 | Pantex AM/PM Salivary Cortisol Enzyme Immunoassay | Pantex, Div. Bio-Analysis, Inc. | 2012 | — |
| 0 (this device) | K150528 | Cortisol Saliva Luminescence Immunoassay | Ibl International GmbH | 2015 | — |
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
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 | Decided |
|---|---|---|---|
| * | K102841 | Pantex AM/PM Salivary Cortisol Enzyme ImmunoassaySummary page 5…tisone and hydroxycorticosterone) test system Classification Regulation: 862.1205 Product Code: NHG 6. Predicate Device Pantex INC. AM/PM Salivary cortisol EIA k102841. 7. Device Description Summary and explanation: Cortisol (also known as hydrocortisone, compound F) is the main glucoco… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 12, 2018 | Class II | Z-2923-2018 | Nonconforming Material/Component | Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All NHG devicesNHG Enzyme Immunoassay, Cortisol, Salivary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The IBL International Cortisol Saliva Luminescence Immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders.
The device is not intended for point-of-care settings.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150528: Cortisol Saliva Luminescence Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150528
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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