# K032482: Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Stanbio Laboratory
- Decided: Oct 24, 2003 after 73 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) HemoCue B-Hemoglobin System with microcuvette: named in the summary without a submission number

## Most influential descendants
- K122553: Mission Plus HB Hemoglobin Testing System (2013), 0 descendants of its own

## Indications for use
The HemoPoint@H2 Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The microcuvettes part number 3010-100 are indicated for use in the HemoPoint@H2 Hemoglobin Measurement System and the Hernocue@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. For In Vitro Diagnostic Use Only

Source page: https://510kreport.com/device/K032482
Methodology: https://510kreport.com/methodology