510(k) · Cleared
Recalled · 2006Axsym Follicle Stimulating Hormone (FSH)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Cleared on Jun 21, 1994 after a 211-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.
- Decided
- Jun 21, 1994
- Review
- 211 days
- Class
- Class I
- Product code
- CGJ
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK935612 Axsym Follicle Stimulating Hormone (FSH)Abbott Laboratories · 1994
- Descendant · cites it directly · 1 of its ownK032002 Fertell Female Fertility TestGenosis, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK070484 Quantrx Female Fertility TestQuantrx Biomedical Corporation · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935612 | Axsym Follicle Stimulating Hormone (FSH) | Abbott Laboratories | 1994 | — |
| +1 | K032002 | Fertell Female Fertility Test | Genosis, Inc. | 2003 | — |
| +2 | K070484 | Quantrx Female Fertility Test | Quantrx Biomedical Corporation | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 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 CGJ? 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032002 | Fertell Female Fertility Test | 2003 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2006 | Not classified | Z-0023-2007 | Other | Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032002 (Genosis, Inc., 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CGJ devicesCGJ Radioimmunoassay, Follicle-Stimulating Hormone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGJ
FDA has decided no CGJ device since 2007.
Median 510(k) review, days · CGJ
Too few CGJ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGJ
4in 2025
MAUDE reports naming product code CGJ, 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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 1 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 1 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 1 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K935612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935612: Axsym Follicle Stimulating Hormone (FSH).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935612
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026