510(k) · Cleared
ClearedDelfia (R) 17 -OH-Progesteron Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia Diagnostics, Inc. · JLX Radioimmunoassay, 17-Hydroxyprogesterone
Cleared on Jun 25, 1991 after a 49-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Jun 25, 1991
- Review
- 49 days
- Class
- Class I
- Product code
- JLX
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK912026 Delfia (R) 17 -OH-Progesteron KitPharmacia Diagnostics, Inc. · 1991
- Descendant · cites it directly · 4 of its ownK042425 Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY · 2004
- Descendant · 2 generations on · 1 of its ownK081922 Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY · 2009
- Descendant · 3 generations on · 0 of its ownK100682 GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001UWallac OY · 2010
- Descendant · 2 generations on · 0 of its ownK060452 Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models…Neo-Genesis · 2007
- Descendant · 2 generations on · 0 of its ownK050960 Modification to: Autodelfia Neonatal 17A-OH-Progesterone L KitWallac OY · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K042425Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY · 2004 · cites it directly4descendants
- K081922Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY · 2009 · 2 generations on1descendant
- K100682GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001UWallac OY · 2010 · 3 generations on0descendants
- K060452Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-EcahNeo-Genesis · 2007 · 2 generations on0descendants
- K050960Modification to: Autodelfia Neonatal 17A-OH-Progesterone L KitWallac OY · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912026 | Delfia (R) 17 -OH-Progesteron Kit | Pharmacia Diagnostics, Inc. | 1991 | — |
| +1 | K042425 | Autodelfia Neonatal 17A-OH-Progesterone Kit | Wallac OY | 2004 | — |
| +2 | K081922 | Autodelfia Neonatal 17A-OH-Progesterone Kit | Wallac OY | 2009 | — |
| +3 | K100682 | GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001U | Wallac OY | 2010 | — |
| +2 | K060452 | Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-Ecah | Neo-Genesis | 2007 | — |
| +2 | K050960 | Modification to: Autodelfia Neonatal 17A-OH-Progesterone L Kit | Wallac OY | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
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 JLX? 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K042425 (Wallac OY, 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All JLX devicesJLX Radioimmunoassay, 17-Hydroxyprogesterone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JLX
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · JLX
Too few JLX 510(k)s in any year since 2007 to give a median.
Recalls per year · JLX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JLX
1in 2021
MAUDE reports naming product code JLX, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K912026 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912026: Delfia (R) 17 -OH-Progesteron Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912026
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026