# K141907: Stat Profile Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat Profile Prime Ampuled Control Abg/CCS, Stat Profile Prime Calibrtor Cartridge CCS/CCS Comp, Nova Linearity Standard Set a

- Pathway: 510(k) (Traditional)
- Applicant: Nova Biomedical Corporation
- Decided: May 29, 2015 after 318 days
- Product code: CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph)
- Device class: 2
- Regulation: 21 CFR 862.1120
- Recalls of this device: 1 (0 Class I)
- 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)
- K131703: Nova Stat Profile Prime CCS Analyzer System, Nova Biomedical Corporation (2014) Summary page 5.

## Recalls of this device
- Jun 19, 2017 · Class II · Z-2732-2017: Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.

## Indications for use
The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of pH, PCO2, PO2, Hct, Na+. K+, Cl-, iCa, Glu (Glucose), and Lac (Lactate) in heparinized whole blood. PC02,P02,pH: Whole blood measurement of certain gases in whole blood,or pH of whole blood,is used in the diagnosis and treatment of life-threatening acid-base disturbances. Hct: Whole blood measurements 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). Na+: Sodium measurement is used in the diagnosis and treatment of aldosteronism,diabetes insipidus, adrenal hypertension, Addison's disease,dehydration,or diseases involving electrolyte imbalance. K+: Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high potassium levels. Cl-: Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. iCa: Calcium measurements are used in the diagnosis and treatment of parathyroid disease,a variety of bone diseases,chronic renal disease and tetany (intermittent muscular contractions or spasms). Glu: Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus,neonatal hypoglycemia,and idiopathic hypoglycemia,and of pancreatic islet cell carcinoma. Lac: Lactate (lactic acid) measurement is used to evaluate the acid-base status of patients suspected of having lactic acidosis. The Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer. The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer. The Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na+, K+, Cl‐, iCa, Glucose and Lactate using the Stat Profile Prime CCS Analyzer. Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration, analytical linearity, estimate test imprecision, and detect systematic analytical deviations that may arise from calibrator cartridge or analytical instrument variation.

Source page: https://510kreport.com/device/K141907
Methodology: https://510kreport.com/methodology