PMA · Approved
Recalled · Class II · 2017Fetal Fibronectin Enzyme Immunoassay Kit (Eik)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · LKV Enzyme Immunoassay, Fetal Fibronectin
Approved on Sep 21, 1995 through premarket approval, which rests on the device’s own clinical evidence after a 1,066-day review. It has been recalled 8 times.
- Decided
- Sep 21, 1995
- Review
- 1,066 days
- Class
- Class III
- Product code
- LKV
- Recalls
- 8
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P920048 has 26 supplements since 1997: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1997 | 1 |
| 1998 | 1 |
| 2001 | 1 |
| 2008 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2020 | 5 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 2 |
| 2026 | 3 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LKV? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
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 |
|---|---|---|---|---|
| Nov 29, 2017 | Class II | Z-0676-2018 | Mixed-up of materials/components | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX. |
| Nov 29, 2017 | Class II | Z-0677-2018 | Mixed-up of materials/components | Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). The products were distributed to customers before FDA approved the change to use the material from SDIX. |
| Dec 15, 2009 | Not classified | Z-1663-2011 | PMA | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation. |
| Dec 15, 2009 | Not classified | Z-1660-2011 | PMA | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation. |
| Dec 15, 2009 | Not classified | Z-1659-2011 | PMA | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation. |
| Dec 15, 2009 | Not classified | Z-1661-2011 | PMA | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation. |
| Dec 15, 2009 | Not classified | Z-1662-2011 | PMA | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation. |
| Dec 15, 2009 | Not classified | Z-1658-2011 | PMA | Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LKV devicesLKV Enzyme Immunoassay, Fetal Fibronectin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKV
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LKV
Too few LKV 510(k)s in any year since 2007 to give a median.
Recalls per year · LKV
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKV
2in 2025
MAUDE reports naming product code LKV, 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 5 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 2 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 5 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 3 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 3 | — | 0 | — |
https://510kreport.com/device/P920048 · printed Nov 6, 2026
Cite this page
510(k) Report. “P920048: Fetal Fibronectin Enzyme Immunoassay Kit (Eik).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P920048
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026