(64 days)
The Osmetech OPTI LION Electrolyte Analyzer is intended to be used for the measurement of pH, sodium, potassium, ionized calcium, and chloride in samples of whole blood, serum, plasma and aqueous controls in either a traditional clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
The OPTI LION Electrolyte Analyzer is a small [4.7 x 14.2 x 9.1 inches, 10 pounds}, microprocessor-based instrument using optical fluorescence for the measurement of pH, sodium, potassium, ionized calcium, and chloride and utilizes a graphical touch screen user interface.
The disposable, single use cassette contains five optical fluorescent sensors placed in a polycarbonate substrate, which is packaged with an insert-able sample probe into a sealed foil pouch which bears a bar-code label with calibration, lot identification, and expiration dating information.
The Osmetech OPTI LION Electrolyte Analyzer is a medical device intended for the measurement of pH, sodium, potassium, ionized calcium, and chloride in whole blood, serum, plasma, and aqueous controls. The following information details the acceptance criteria and the study that proves the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria values for each analyte. Instead, it refers to the "medically allowable errors as defined in CLIA'88 performance standards" as the benchmark for comparison. The study's conclusion is that the device's performance is acceptable against these standards.
Without specific numerical acceptance criteria from the document, we can infer the performance metrics reported as evidence of meeting an unspecified acceptable level based on CLIA'88 standards.
| Analyte | Acceptance Criteria (Implied by CLIA'88 Standards) | Reported Device Performance (Systematic Differences and 95% CIs) |
|---|---|---|
| pH | Systematic differences and 95% CIs |
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.