# K090093: Stanbio Laboratory Hemopoint H2 DM Hemoglobin Measurement System

- Pathway: 510(k) (Special)
- Applicant: Stanbio Laboratory
- Decided: Jun 10, 2009 after 147 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- 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) HemoPoint® H2 Hemoglobin Measurement System with microcuvette: named in the summary without a submission number

## Indications for use
The HemoPoint ® H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The HemoPoint H2 Microcuvettes are indicated for use in the HemoPoint® H2 DM Hemoglobin Measurement System. The microcuvettes are intended to be used only once and must be disposed of after use as potentially infectious waste. Estimation of hematocrit as a function of Hemoglobin is performed for normal hemoglobin ranges only (120 to 180 g/liter or 12.0 to 18.0 g/deciliter). The estimated hematocrit is not indicative of disease states such as anemia and abnormal values will not be reported. The DM (Data Management) system allows enhanced data management features. For In Vitro Diagnostic Use Only

Source page: https://510kreport.com/device/K090093
Methodology: https://510kreport.com/methodology