# P920048: Fetal Fibronectin Enzyme Immunoassay Kit (Eik)

- Pathway: PMA
- Applicant: Hologic, Inc.
- Decided: Sep 21, 1995 after 1,066 days
- Product code: LKV (Enzyme Immunoassay, Fetal Fibronectin)
- Device class: 3
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 29, 2017 · Class II · Z-0676-2018: 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: 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: 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 w
- Dec 15, 2009 · Not classified · Z-1660-2011: 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 w
- Dec 15, 2009 · Not classified · Z-1659-2011: 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 w
- Dec 15, 2009 · Not classified · Z-1661-2011: 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 w
- Dec 15, 2009 · Not classified · Z-1662-2011: 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 w
- Dec 15, 2009 · Not classified · Z-1658-2011: 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 w

Source page: https://510kreport.com/device/P920048
Methodology: https://510kreport.com/methodology