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The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

These tests are only performed under a physician's order:

pH, pO2, and pCO2 : pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.

Potassium (cK'): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

Sodium (cNa"): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

Calcium (cCa2+): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Chloride (cCI): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

Glucose (cGlu): 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.

The following six parameters will be introduced with the ABL80 FLEX CO-OX:

Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sOx oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.

FO₂Hb: oxyhemoglobin as a fraction of total hemoglobin.

FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoglobin as a fraction of total hemoglobin.

FHHb: reduced hemoglobin as a fraction of total hemoglobin.

The ABL80 FLEX CO-OX syste:n consists òf a modular analy.cer incorporating a user interface module with a large color touch screen interfacing to analyzer electronic and fluidis modules. The user interface module contains the analyzer CP1J and all of the required electronic interfaces for external communication and data stor:ge.

Sensors that measure pH, pCO2, pO2, cCa2', cCI, cK* cNa* and cGlu are contained in a cassette that also contains the sample inlet. This cassette attaches to the front of the analyzer.

The oximetry module measures ctHb, sO2, FO2Hb, F MetHb and FHHb. This module consists of a spectrometer, an ultrasonic hemolyzer and thermostatic components integrated into the analyzer.

The system also includes a reagent cartridge for the calibration and automatic quality control of the sensor and oximetry system. The calibration and quality control reagents are packaged in sealed foil pouches.

The analyzer and consumables incorporate "smart chip" technology for unique identification and lot specific calibration and quality control data.

The provided document describes the ABL80 FLEX CO-OX system, an automated analyzer for measuring various blood parameters. While it lists "Performance Data" categories, the document does not explicitly state acceptance criteria or present the results of a study demonstrating the device meets specific acceptance criteria.

Instead, the document primarily focuses on:

• Device Description: How the ABL80 FLEX CO-OX system works, including its components and measurement principles.
• Intended Use / Indications for Use: What the device measures and for what clinical purposes, and who should use it.
• Substantial Equivalence: Comparing the ABL80 FLEX CO-OX to predicate devices (ABL80 FLEX and ABL700) and highlighting similarities in operational principles.
• FDA 510(k) Clearance: The formal notification from the FDA approving the device for marketing.

The "PERFORMANCE DATA" section merely lists the types of studies that were performed (Method Comparison, Precision, Linearity, Calibration/Quality Control, Analytical Specificity, User Testing) and states that the ABL700 (a predicate device) was used for some of this data. It does not provide the results of these studies nor does it define what would be considered "acceptable" performance for each category.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study results based solely on the provided text. The document acts as an overview and regulatory clearance, not a detailed performance study report.

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