510(k) · Cleared
ClearedVitros Immunodiagnostic Products Progestrone Reagent Pack and Calibrators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · JIS Calibrator, Primary
Cleared on Aug 13, 2003 as substantially equivalent to K022901 (Ortho-Clinical Diagnostics, 2002) after a 19-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Aug 13, 2003
- Review
- 19 days
- Class
- Class II
- Product code
- JIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972133 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK972133 Vitros Immunodiagnostics Products Progesterone Reagent Pack…Johnson & Johnson Clinical Diagnostics, Inc. · 1997
- 1 generation backK022901 Vitros Immunodiagnostic Products Progesterone Reagent Pack and…Ortho-Clinical Diagnostics · 2002
- This deviceK032296 Vitros Immunodiagnostic Products Progestrone Reagent Pack and…Ortho-Clinical Diagnostics, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (Gem.1070)… | Johnson & Johnson Clinical Diagnostics, Inc. | 1997 | — |
| −1 | K022901 | Vitros Immunodiagnostic Products Progesterone Reagent Pack and Calibrators | Ortho-Clinical Diagnostics | 2002 | — |
| 0 (this device) | K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and Calibrators | Ortho-Clinical Diagnostics, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | K022901 | Vitros Immunodiagnostic Products Progesterone Reagent Pack and CalibratorsSummary page 3…ied) are device substantially equivalent to VITROS Immunodiagnostic Products Progesterone Reagent Pack and Calibrators cleared by the FDA (K022901) for in vitro diagnostic use. Table 1 lists the characteristics of the modified VITROS… | 2002 |
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 6 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
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 or heparin).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032296 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032296: Vitros Immunodiagnostic Products Progestrone Reagent Pack and Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032296
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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