# K031898: Ekf Diagnostic Hemo Control Hemoglobin Measurement System

- Pathway: 510(k) (Traditional)
- Applicant: Ekf Diagnostic GmbH
- Decided: Sep 24, 2003 after 97 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K200909: Hemo Control (optional Add Pack Hemo Control DM) (2020), 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

## 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 3000-3011-050 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 In Vitro Diagnostic Use Only Caution: Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K031898
Methodology: https://510kreport.com/methodology