# K131126: Opti Cca-TS2

- Pathway: 510(k) (Traditional)
- Applicant: Opti Medical Systems, Inc.
- Decided: Aug 22, 2013 after 122 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: 6 generations back to K861087 (1986). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993837: Avl Opti Critical Care Analyzer, Avl Scientific Corp. (1999) Summary page 1.

## Most influential descendants
- K200986: OPTI® B-Lac Cassette (2021), 0 descendants of its own

## Indications for use
The OPTI CCA-TS2 system when used with disposable cassettes containing parameter specific sensors isintended to be used for the measurement of pH, PCO 2, p02, Na, K*, Ca", C-, Glucose, BUN (urea), lactate, tHb, and SO2 in samples of whole blood, and pH, Na+, r%Ca't Ci; Glucose and BUN (urea) in serum and plasma, in a clinical laboratory setting or point of care locations. * Measurements of blood gases KPC2, P02) and blood pH are used in the diagnosis and treatment of life-threatening adid-base disturbances. * Lactate (lactic acid) measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood). * Total hemoglobin (tHb) measurement is used to determine the hemoglobin content of human blood. * Oxygen saturation (S02) measurement is used to determine the oxygen capacity of the hemoglobin. * Potassium (K*) measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. * Calcium (Ca') 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). * Sodium (Nat) measurements are used in the diagnosis and treatment of aldlosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst),adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. * Chloride (C1') measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. * Urea nitrogen (an end-product of nitrogen metabolism) measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. * Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K131126
Methodology: https://510kreport.com/methodology