# K191184: ImmuView S pneumoniae and L pneumophila Urinary Antigen Test

- Pathway: 510(k) (Traditional)
- Applicant: Ssi Diagnostica A/S
- Decided: Mar 5, 2020 after 307 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
Longest line of descent: 3 generations back to K934965 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012521: Binax Now Streptococcus Pneumoniae Test, Binax, Inc. (2001) Summary page 4.
- K982238: Binax Now Legionella Urinary Antigen Test Model 852-020 and Binax Now Leg Ionella Urinary Antigen Control Kit Model 8522, Binax, Inc. (1998) Summary page 4.
- K991726: Binax Nowr Streptococcus Pneumoniae Urinary Antigen Test (22 Test Kit),(12 Test Kit), Binax Nowr Streptococcus Pneumoni, Binax, Inc. (1999) Summary page 5.
- K070522: Modification to: Binax Now  Legionella Urinary Antigen Test, #852-000,852-012, Inverness Medical Professional Diagnostics (2007) Summary page 5.

## Indications for use
The ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test is an in vitro, rapid, lateral flow test, also known as a lateral flow immunochromatographic assay, intended for the qualitative detection of Streptococcus pneumoniae and Legionella pneumophila antigens in urine specimens from patients with symptoms of pneumonia. The assay is intended to aid in diagnosis of S. pneumoniae and L. pneumophila serogroup 1 infections. The assay is further intended to aid in the diagnosis of S. pneumoniae infections by detection of S. pneumoniae antigen in cerebrospinal fluid (CSF). Results from the ImmuView S. pneumoniae and L. pneumophila Urinary Antigen Test should be interpreted in conjunction with the patient’s clinical evaluation and other diagnostic methods.

Source page: https://510kreport.com/device/K191184
Methodology: https://510kreport.com/methodology