# K110393: Ekf- Diagnostic Hemo_Control Hemoglobin Measurement System; Ekf-Diagnostic Hemoglobin Microcuvettes (Modified Curvette W

- Pathway: 510(k) (Special)
- Applicant: Ekf-Diagnostic GmbH
- Decided: Mar 4, 2011 after 21 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
Longest line of descent: 1 generation back to K031898 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031898: Ekf Diagnostic Hemo Control Hemoglobin Measurement System, Ekf Diagnostic GmbH (2003) Summary page 1.
- K081719: Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System, Stanbio Laboratory (2008) Summary page 1.

## Indications for use
The Hemo-Control Hemoglobin Measurement System is indicated for the quantitative determination of hemoglobin in arterial, venous, or capillary blood. The microcuvettes part number 3000-3012-0765 are indicated for use in the Hemo-Control Hemoglobin Measurement System and compatible measurement systems. 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/K110393
Methodology: https://510kreport.com/methodology