510(k) · Cleared
ClearedVitros Immunodiagnostic Products Progesterone Reagent Pack and Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · JIS Calibrator, Primary
Cleared on Sep 27, 2002 as substantially equivalent to K972133 (Johnson & Johnson Clinical Diagnostics, Inc., 1997) after a 24-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Sep 27, 2002
- Review
- 24 days
- Class
- Class II
- Product code
- JIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972133 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK972133 Vitros Immunodiagnostics Products Progesterone Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997
- This deviceK022901 Vitros Immunodiagnostic Products Progesterone Reagent Pack and…Ortho-Clinical Diagnostics · 2002
- Descendant · cites it directly · 0 of its ownK032296 Vitros Immunodiagnostic Products Progestrone Reagent Pack and…Ortho-Clinical Diagnostics, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K032296Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsOrtho-Clinical Diagnostics, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070)… | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K022901 | Vitros Immunodiagnostic Products Progesterone Reagent Pack and Calibrators | Ortho-Clinical Diagnostics | 2002 | — |
| +1 | K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 JIS? 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 |
|---|---|---|---|
| * | K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070), Progesterone…Summary page 3…d) are substantially equivalent to VITROS Immunodiagnostic Products Progesterone Reagent Pack and Calibrators cleared by the FDA (K972133) for in vitro diagnostic use. Table 1 lists the assay characteristics performed using the modified VITROS… | 1997 |
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 |
|---|---|---|---|
| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and Calibrators | 2003 | 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 no recall.
- Of its descendants, K032296 (Ortho-Clinical Diagnostics, Inc., 2003) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JIS devicesJIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIS
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JIS
Too few JIS 510(k)s in any year since 2007 to give a median.
Recalls per year · JIS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIS
1in 2024
MAUDE reports naming product code JIS, 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 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VITROS Progesterone Reagent Pack
For in vitro diagnostic use only.
The Vitros Progesterone Reagent Pack quantitatively measures progesterone concentration in human serum and plasma.
VITROS Progesterone Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of Progesterone in human serum and plasma (EDTA a heparin).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022901 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022901: Vitros Immunodiagnostic Products Progesterone Reagent Pack and Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022901
Report an extraction error
Are you the manufacturer?
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