510(k) · Cleared
ClearedVitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · CGR Radioimmunoassay, Cortisol
Cleared on Jul 3, 2006 as substantially equivalent to K983990 (Ortho-Clinical Diagnostics, Inc., 1998) after a 130-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jul 3, 2006
- Review
- 130 days
- Class
- Class II
- Product code
- CGR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K854419 (1985). No later device cites it as a predicate yet.
- Root · 2 generations backK854419 TDX CortisolAbbott Laboratories · 1985 · Recalled
- 1 generation backK983990 Vitros Immunodiagnostic Products Cortisol AssayOrtho-Clinical Diagnostics, Inc. · 1998
- This deviceK060480 Vitros Immunodiagnostic Products Cortisol Reagent Pack and…Ortho-Clinical Diagnostics · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854419 | TDX Cortisol | Abbott Laboratories | 1985 | 1 |
| −1 | K983990 | Vitros Immunodiagnostic Products Cortisol Assay | Ortho-Clinical Diagnostics, Inc. | 1998 | — |
| 0 (this device) | K060480 | Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and… | Ortho-Clinical Diagnostics | 2006 | — |
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 |
|---|---|---|---|
| * | K983990 | Vitros Immunodiagnostic Products Cortisol AssaySummary page 2…The VITROS Immunodiagnostic Products Cortisol Assay is substantially equivalent to the VITROS Immunodiagnostic Products Cortisol Assay (K983990-original formulation). The only modifications made to the proposed VITROS Immunodiagnostic Products Cortisol Assay… | 1998 |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
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 measurement of cortisol in human serum, plasma (heparin or EDTA) or urine aids in the assessment of adrenal status.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060480: Vitros Immunodiagnostic Products Cortisol Reagent Pack and Calibrators and Metabolism Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060480
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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