# K980314: Fetal D Tection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Biopool Intl., Inc.
- Decided: Apr 8, 1998 after 71 days
- Product code: LIM (Test, Screening, For D Positive Fetal Rbc'S)
- Device class: 2
- Regulation: 21 CFR 864.7455
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Fetal D Tection Kit is indicated for use to test blood samples drawn from D negative mothers who have delivered D positive infants. The blood sample should be drawn shortly after all products of conception have been delivered, and then assayed as soon as possible, since RhIg should be administered to the mother within 72 hours of delivery to be effective. Positive result in this qualitative test indicates the need to perform a quantitative test to determine if more than one 300 mg dose of RhIg will adequately protect the mother from being sensitized to the D antigen.

Source page: https://510kreport.com/device/K980314
Methodology: https://510kreport.com/methodology