510(k) · Cleared
ClearedModification to: Autodelfia Neonatal 17A-OH-Progesterone L Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallac OY · JLX Radioimmunoassay, 17-Hydroxyprogesterone
Cleared on Jul 11, 2005 as substantially equivalent to K042425 (Wallac OY, 2004) after an 84-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jul 11, 2005
- Review
- 84 days
- Class
- Class I
- Product code
- JLX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K912026 (1991). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912026 | Delfia (R) 17 -OH-Progesteron Kit | Pharmacia Diagnostics, Inc. | 1991 | — |
| −1 | K042425 | Autodelfia Neonatal 17A-OH-Progesterone Kit | Wallac OY | 2004 | — |
| 0 (this device) | K050960 | Modification to: Autodelfia Neonatal 17A-OH-Progesterone L Kit | Wallac OY | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 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? (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 |
|---|---|---|---|
| * | K042425 | Autodelfia Neonatal 17A-OH-Progesterone KitSummary page 1…Class I per 21 CFR § 862.1395 Product Code: JLX Predicate Device: AutoDELFIA® Neonatal 17 a-OH-progesterone kit, K042425 Device Description: The AutoDELFIA Neonatal 17(x-OH-progesterone (17-OHP) assa… | 2004 |
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 14 years and passes through 2 companies; a new generation was cleared every 13.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K042425.
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 | — |
What is it indicated for?
This kit is intended for the quantitative determination of 17 a- OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA automatic immunoassay system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050960 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050960: Modification to: Autodelfia Neonatal 17A-OH-Progesterone L Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050960
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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