# K151978: EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Jul 15, 2016 after 364 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943754 (1994). 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)
- K002738: Bayer Rapidpoint 400 System, Bayer Corp. (2000) Summary page 9.
- K943754: Blood Gads, Electrolyte, Glucose, Latate and Bun Quality Control Product, Bionostics, Inc. (1994) Summary page 9.
- K955630: Rna Medical Hemat Control, Bionostics, Inc. (1996) Summary page 9.

## Indications for use
The i15 Blood Gas and Chemistry Analysis System (including Blood Gas and Chemistry Analyzer, Calibrant Fluid Pack, Test Cartridge) is a portable, automated system that measures pH and blood gases (pCO2, pO2), electrolytes (Na+, K+, Ca++, Cl−) and hematocrit in arterial and venous whole blood samples with lithium heparin or calcium balanced heparin. The system is intended for in-vitro diagnostic use only by trained health care professionals in a laboratory environment, near patient or point-of-care settings. pH, pCO2, pO2: 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 and/or oxygenation disturbances. Hct: Whole blood measurements of the packed 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 blood 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. Ca++: 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). The EDAN i15 Calibrant Fluid Pack is intended for the calibration of pH, pO2, pCO2, Na+, K+, Ca++, Cl−, and Hct as part of the EDAN i15 Blood Gas and Chemistry Analysis System. The EDAN i15 Blood Gas and Electrolyte Controls are external multi-analyte quality control material intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Electrolyte Analyze, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of pH, blood gases (pCO2 pO2), and electrolytes (Na+, K+, Ca++, and Cl−). The EDAN i15 Hematocrit Controls are intended to be used for the verification of correct operation and measurement of the EDAN i15 Blood Gas and Chemistry Analysis System, together with i15 Calibrant Fluid Pack and i15 Test Cartridge for the analysis of hematocrit.

Source page: https://510kreport.com/device/K151978
Methodology: https://510kreport.com/methodology