OPTI CCA-TS2

K131126 · Opti Medical Systems, Inc. · CHL · Aug 22, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131126
• Device Name: OPTI CCA-TS2
• Applicant: Opti Medical Systems, Inc.
• Product Code: CHL · Clinical Chemistry
• Decision Date: Aug 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1120
• Device Class: Class 2

Indications for Use

The OPTI CCA-TS2 system when used with disposable cassettes containing parameter specific sensors is intended to be used for the measurement of pH, pCO2, pO2, Na +, K +, Ca ++, Cl -, Glucose, BUN (urea), lactate, tHb, and SO2 in samples of whole blood, and pH, Na +, K +, Ca ++, Cl -, Glucose and BUN (urea) in serum and plasma, in a clinical laboratory setting or point of care locations. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-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 (SO2) 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 (Na+) measurements are used in the diagnosis and treatment of aldosteronism (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 (Cl-) 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.

Device Story

OPTI CCA-TS2 is a modified version of the OPTI CCA-TS analyzer; updates electronic hardware to prevent obsolescence; consolidates processors into a single System on a Chip (SoC); updates power supply and battery; modifies software architecture for modularity. Device uses optical fluorescence and reflectance technology to measure parameters in whole blood, serum, or plasma samples aspirated into disposable, bar-coded cassettes. Used in clinical labs or point-of-care settings by healthcare professionals. Analyzer calibrates cassette, introduces sample, and measures parameters at 37°C. Output provides quantitative diagnostic data for blood gases, electrolytes, and metabolites. Updated design includes improved user interface, serial USB connectivity, and enhanced QC features. No changes to sensor chemistry or measurement algorithms. Benefits include continued availability of critical care analysis with modernized, scalable hardware.

Clinical Evidence

Bench testing only. Method comparison studies (n=126 for pH, n=144 for pO2, etc.) demonstrated high correlation (R² > 0.98) between CCA-TS2 and predicate across all parameters. Precision/reproducibility testing (CLSI EP5-A2) performed over 10-20 days using aqueous controls and whole blood samples showed total %CV generally < 5%. Linearity verified across reportable ranges per CLSI EP15-A2. No clinical patient outcome data required.

Technological Characteristics

Optical fluorescence (Na+, K+, Ca++, Cl-, pH, pCO2, pO2, Glucose, Lactate, BUN) and reflectance (tHb, SO2) sensing. Single SoC processor architecture. Connectivity: Serial USB, POCT1-A protocol. Power: 16V, 3.75A; 10.8V Li-ion battery. Dimensions/form factor: Portable analyzer with disposable cassette system. Standards: IEC 61010-1, IEC 62133, IEC 62304, IEC 61326-2-6.

Indications for Use

Indicated for patients requiring measurement of blood gases, electrolytes, and metabolites (pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, BUN, lactate, tHb, SO2) in whole blood, serum, or plasma. Used in clinical labs or point-of-care settings for diagnosis/treatment of acid-base, electrolyte, renal, and metabolic disorders.

Regulatory Classification

Identification

A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k131126

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.