510(k) · Cleared
ClearedAccuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-Ecah
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neo-Genesis · JLX Radioimmunoassay, 17-Hydroxyprogesterone
Cleared on Mar 13, 2007 as substantially equivalent to K042425 (Wallac OY, 2004) after a 385-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Mar 13, 2007
- Review
- 385 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) | K060452 | Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-Ecah | Neo-Genesis | 2007 | — |
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 5…ogical Characteristics 1x2: Characteristic: Predicate Device: Proposed Device: K 042425; Model B048-112 Neo-Genesis Accuwell Wallac Oy AutoDelfia Neonatal 1… | 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 16 years and passes through 3 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. 2007, this device’s year, is highlighted.
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?
The Accuwell TM 17h-Hydroxyprogesterone EIA Kit is designed for the quantitative measurement of 17a.-Hydroxyprogesterone (17-OHP) concentrations in neonatal blood samples that have been collected onto Whatman 903®specimen collection paper. The results are used to screen newborns for classical congenital adrenal hyperplasia (CAH).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060452 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060452: Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-Ecah.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060452
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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