510(k) · Cleared
ClearedNichols Advantage Chemiluminescence Cortisol Immunoassay, Model 62-7005
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nichols Institute Diagnostics · CGR Radioimmunoassay, Cortisol
Cleared on Feb 5, 1999 as substantially equivalent to K962208 (Nichols Institute Diagnostics, 1997) after a 46-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 5, 1999
- Review
- 46 days
- Class
- Class II
- Product code
- CGR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K962208 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK962208 Nichols Advantage Chemiluminescence Cortisol KitNichols Institute Diagnostics · 1997
- This deviceK984520 Nichols Advantage Chemiluminescence Cortisol Immunoassay, Model…Nichols Institute Diagnostics · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K962208 | Nichols Advantage Chemiluminescence Cortisol Kit | Nichols Institute Diagnostics | 1997 | — |
| 0 (this device) | K984520 | Nichols Advantage Chemiluminescence Cortisol Immunoassay, Model 62-7005 | Nichols Institute Diagnostics | 1999 | — |
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 CGR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CGR device
- #1 K242190 Access Cortisol; DxC 500i Clinical Analyzerscore 7.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K962208 | Nichols Advantage Chemiluminescence Cortisol KitSummary page 1…diagnosis and treatment of disorders of the adrenal gland. SUBSTANTIAL EQUIVALENECE The Assay is identical to the Nichols Advantage® Chemiluminescence Cortisol Assay (K962208 cleared 4/8/97) in its intended use; the use of human serum and EDTA plasma with the added intended use of urine, and sensitivity… | 1997 |
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 CGR devicesCGR Radioimmunoassay, Cortisol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CGR
113in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGR
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGR
1in 2018
MAUDE reports naming product code CGR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 3 | 113 | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 1 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Nichols Advantage® Chemiluminescence Cortisol Inmunoassay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of cortisol concentration in human serum, EDTA plasma, and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
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/K984520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984520: Nichols Advantage Chemiluminescence Cortisol Immunoassay, Model 62-7005.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984520
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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