510(k) · Cleared
Recalled · 2010Access Progesterone Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · JLS Radioimmunoassay, Progesterone
Cleared on Feb 5, 1996 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.
- Decided
- Feb 5, 1996
- Review
- 46 days
- Class
- Class I
- Product code
- JLS
- Recalls
- 2
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JLS? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2010 | Not classified | Z-2620-2010 | Other | The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed… |
| Dec 6, 2002 | Not classified | Z-0494-03 | Other | Primary tube sampling issue may cause false low results. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JLS devicesJLS Radioimmunoassay, Progesterone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JLS
FDA has decided no JLS device since 2007.
Median 510(k) review, days · JLS
Too few JLS 510(k)s in any year since 2007 to give a median.
Recalls per year · JLS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLS
3in 2025
MAUDE reports naming product code JLS, 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 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 19 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 3 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 1 | 41 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K955769 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955769: Access Progesterone Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955769
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026