# K081719: Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System

- Pathway: 510(k) (Special)
- Applicant: Stanbio Laboratory
- Decided: Jul 18, 2008 after 30 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) HemoPoint® H2 Hemoglobin Measurement System with microcuvette: named in the summary without a submission number

## Most influential descendants
- K172173: DiaSpect Tm, DiaSpect Tm Cuvettes (2018), 0 descendants of its own
- K110393: Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin Microcuvettes (Modified Curvette W (2011), 0 descendants of its own

## Recalls of this device
- Feb 8, 2018 · Class II · Z-2926-2018: The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.

## 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 Hemocue® 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 InVitro Diagnostic Use Only

Source page: https://510kreport.com/device/K081719
Methodology: https://510kreport.com/methodology