# K952721: Rubascan Card Test

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Dec 20, 1996 after 554 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K832228 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832228: Rubascan Latex Card Test, Bd Becton Dickinson Vacutainer Systems Preanalytic (1983) Summary page 1.

## Indications for use
The RUBAscan ® Card Test is a passive latex agglutination test for the detection and/or quantitation of rubella antibodies in human serum. The test is configured to give qualitative results by testing specimens either undiluted or diluted 1:10 to yield two sensitivity levels for detecting rubella antibodies. The choice of protocol used may be based upon judgments concerning the significance of immune status given by antibody levels in protecting the individual from primary rubella infection. The RUBAscan ® Card Test can also be used to give quantitative results when used to test serial dilutions of the specimen. With properly selected paired specimens, the test can determine recent or active infection.

Source page: https://510kreport.com/device/K952721
Methodology: https://510kreport.com/methodology