# K900225: Romcheck Specimen Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Adeza Biomedical
- Decided: Feb 2, 1990 after 16 days
- Product code: LIO (Device, Specimen Collection)
- Device class: 1
- Regulation: 21 CFR 866.2900
- Recalls of this device: 2 (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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jan 8, 2025 · Class II · Z-1095-2025: Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The tran
- 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/K900225
Methodology: https://510kreport.com/methodology