# K200204: Stat Profile Prime Plus Analyzer System

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: Apr 6, 2020 after 69 days
- Product code: GGZ (Oxyhemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K061830 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180186: Stat Profile Prime Plus Analyzer System, Nova Biomedical Corporation (2018) Summary page 4.
- (no number) Nova Stat Profile pHOx Ultra Analyzer System: named in the summary without a submission number

## Indications for use
The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood. Hematocrit (Hct) measurements of the packed red blood cell volume are used to distinguish normal from abnormal states, such as anemia and erythrocytosis. Oxygen Saturation (SO2) measurements are used to assess the oxygenation of the hemoglobin and the adequacy of tissue oxygenation in the evaluation of pulmonary function. Measurements are also used to diagnose and treat cyanosis. Total Hemoglobin (tHb) measurements are used in the evaluation of chronic and acute anemia as well as the oxygen transport capability of the hemoglobin. Oxyhemoglobin (O2Hb) measurements are used to assess pulmonary function in combination with Deoxyhemoglobin and are also used in the diagnosis and treatment of cyanosis. Carboxyhemoglobin (COHb) measurements are used to determine if and to what level carbon monoxide has been inhaled by the patient. High levels of carbon monoxide can lead to tissue anoxia and death. Methemoglobin (MetHb) measurements are used to determine congenital methemoglobinemia or determine the ingestion of nitrates, chlorates, or any other drug or chemical that can cause methemoglobin formation. High levels of methemoglobin can lead to cyanosis and death. Deoxyhemoglobin (HHb) measurements are used to assess pulmonary function in combination with Oxyhemoglobin.

Source page: https://510kreport.com/device/K200204
Methodology: https://510kreport.com/methodology