# K160415: GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 14, 2016 after 306 days
- Product code: GKF (Instrument, Hematocrit, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K801848 (1980). 24 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133407: Gem Premier 4000, Instrumentation Laboratory CO (2014) Summary page 5.

## Most influential descendants
- K203790: GEM Premier 5000 (2021), 1 descendant of its own
- K223608: GEM Premier 7000 with IQM3 (2023), 0 descendants of its own

## Indications for use
The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O2Hb, COHb, MetHb, HHb, sO2 from venous, arterial and capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient’s oxygen delivery capacity. • Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells). • Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia. • COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning. • MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia. • HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygenation status. • O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygenation status. • sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygenation status.

Source page: https://510kreport.com/device/K160415
Methodology: https://510kreport.com/methodology