# K020138: Stat-Site MHGB Meter, Stat-Site MHGB Meter Card Holder, Stat-Site MHGB Test Cards, Stat-Site MHGB Code Way, Models 90090

- Pathway: 510(k) (Special)
- Applicant: Gds Technology
- Decided: Feb 11, 2002 after 26 days
- Product code: KHG (Whole Blood Hemoglobin Determination)
- Device class: 2
- Regulation: 21 CFR 864.7500
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Stat-Site® M8 System is for in-vitro diagnostic use only. The Stat-Site® M€ Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® M2 meter. Target Population: Stat-Site® M8 is for use with adults, children, and infants. Environment of Use: Physician’s office or other Professional Point of Care setting.

Source page: https://510kreport.com/device/K020138
Methodology: https://510kreport.com/methodology