# K973547: Triage Statmeter

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jan 13, 1998 after 117 days
- Product code: KHO (Fluorometer, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
29 later devices descend from it; 4 cite it directly.
0 of 30 devices 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.

## Most influential descendants
- K220046: Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 (2022), 17 descendants of its own
- K231698: AllTest Fentanyl Rapid Test (Urine) (2023), 11 descendants of its own
- K233417: AllTest Fentanyl Urine Test Cassette (2023), 9 descendants of its own
- K080635: Medtoxscan (2009), 9 descendants of its own
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System (2009), 4 descendants of its own

## Indications for use
fluometer for the measurement of fluorescence in various assay systems. General fluorometer.

Source page: https://510kreport.com/device/K973547
Methodology: https://510kreport.com/methodology