# K160402: GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 14, 2016 after 306 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- 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). 36 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 39 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 4.
- K142898: ABL800 FLEX with AQURE connectivity, Radiometer Medical Aps (2015) Summary page 4.

## 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 glucose, lactate and total bilirubin from venous, arterial and capillary heparinized whole blood. These parameters aid in the diagnosis of a patient’s metabolite balance. Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma. Lactate (Lac) measurement is used: • to evaluate the acid-base status of patients suspected of having lactic acidosis; • to monitor tissue hypoxia and strenuous physical exertion; • in the diagnosis of hyperlactatemia. Total bilirubin measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

Source page: https://510kreport.com/device/K160402
Methodology: https://510kreport.com/methodology