510(k) · Cleared
ClearedVitros Immunodiagnostic Products Cortisol Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · CGR Radioimmunoassay, Cortisol
Cleared on Dec 29, 1998 as substantially equivalent to K854419 (Abbott Laboratories, 1985) after a 50-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.
- Decided
- Dec 29, 1998
- Review
- 50 days
- Class
- Class II
- Product code
- CGR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K854419 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK854419 TDX CortisolAbbott Laboratories · 1985 · Recalled
- This deviceK983990 Vitros Immunodiagnostic Products Cortisol AssayOrtho-Clinical Diagnostics, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK060480 Vitros Immunodiagnostic Products Cortisol Reagent Pack and…Ortho-Clinical Diagnostics · 2006
Most influential descendants
Showing 1 of 1 · See all- K060480Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism…Ortho-Clinical Diagnostics · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854419 | TDX Cortisol | Abbott Laboratories | 1985 | 1 |
| 0 (this device) | K983990 | Vitros Immunodiagnostic Products Cortisol Assay | Ortho-Clinical Diagnostics, Inc. | 1998 | — |
| +1 | K060480 | Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and… | Ortho-Clinical Diagnostics | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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 7.3 · 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 |
|---|---|---|---|
| * | K854419 | TDX CortisolSummary page 2…dicate Device The VITROS Immunodiagnostic Products Cortisol assay is substantially equivalent to Abbott TDx Cortisol assay (predicate device), which was approved by FDA (K854419) for IVD use. s The relationship between the VITROS Cortisol assay and the predicate device, determined by Deming’s Regression,… | 1985 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060480 | Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism… | 2006 | 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 a recall.
- Of its descendants, K060480 (Ortho-Clinical Diagnostics, 2006) has gone furthest, with 0 descendants of its own.
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?
For in vitro .quantitative measurement of cortisol in human
serum, plasma (EDTA or heparin) or urine.
For in vitro use in monitoring the performance of the VITROS
Immunodiagnostic System when used for the measurement of
cortisol in human serum, plasma (EDTA or heparin) or urine.
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/K983990 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983990: Vitros Immunodiagnostic Products Cortisol Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983990
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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