# K061496: Sas Legionella Test, Sas Legionella Dipstick Test

- Pathway: 510(k) (Traditional)
- Applicant: Sa Scientific, Ltd.
- Decided: Jun 28, 2007 after 393 days
- Product code: MJH (Legionella, Spp., Elisa)
- Device class: 2
- Regulation: 21 CFR 866.3300
- 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. The FDA summary names its predicate without a number.
- (no number) Binax Now® Legionella Urinary Antigen Test: named in the summary without a submission number

## Indications for use
The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.

Source page: https://510kreport.com/device/K061496
Methodology: https://510kreport.com/methodology