# K972676: Urine Screening Device

- Pathway: 510(k) (Traditional)
- Applicant: Combact Diagnostic Systems, Ltd.
- Decided: Feb 23, 1998 after 222 days
- Product code: JXA (Kit, Screening, Urine)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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 K924218 (1993). 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)
- K924218: Bac-T-Screen, Biomerieux Vitek, Inc. (1993) Summary page 1.

## Indications for use
The Bactis 160US is indicated for rapid urine screening for the purpose of determining the occurrence of bacteriuria. Evidence of bacteriuria is an important factor for clinicians to consider in making a diagnosis of urinary tract infection.

Source page: https://510kreport.com/device/K972676
Methodology: https://510kreport.com/methodology