(152 days)
The ABL90 FLEX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood. The ABL90 FLEX analyzer 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 (cClu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)
Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
sO2: 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.
Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.
The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF).
The change consists of an update to the Intralipid correction algorithm for Oxi parameters. The purpose of this update is to improve the suppression of Intralipid interference.
Here's a breakdown of the acceptance criteria and the study details for the ABL90 Flex with the improved Intralipid correction algorithm, extracted from the provided text:
Acceptance Criteria and Reported Device Performance
| Issue | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Interference | Clinically relevant interferences must be known and specified in the labeling. | Interferences have been determined and specified in the Reference Manual. (Pass) |
| Method Comparison (overall) | Method comparison claims must be unchanged, i.e., 95% confidence intervals for the new algorithm must contain part of the predicted bias intervals for the old algorithm at the medical decision points as per EP9-A2. | 95% confidence intervals for the new algorithm contain part of the predicted bias intervals for the old algorithm at the medical decision points. (Pass) |
| Method Comparison (Specifics per parameter) | Slope: 0.9-1.1; Intercept: 0.975 (for ctHb, SO2, FCOHb, FMetHb, FO2Hb, FHHb); >0.85 (for FHbF) | All parameters met the slope, intercept, and r criteria (reported as 1.00 for slope, -0.10 to 0.28 for intercept, and 1.00 for r, except for FHbF which was 0.87 slope, -4.24% intercept, and 0.89 r). (Pass) |
| LOQ | LoQ claims must be unchanged. | LoQs fulfilled acceptance criteria and were not affected by the change. (Pass) |
| Bias and Imprecision (S₀ and CVₓ) | Claims for bias and imprecision obtained in-house must be unchanged, i.e., less than or equal to values specified in section 7 of the existing Reference Manual. | 0.56% of measurements affected. In no case was the significance level α below 30% (typically >80%). The α acceptance level is ≥5%. This implies equal series mean for current and improved Intralipid algorithm for all the Oxi parameters. Recalculation verified that the acceptance criteria were met. (Pass) |
| Linearity | Linearity claims must be unchanged, i.e., the deviations from linearity must be less than or equal to existing claims. | Recalculation verified that the acceptance criteria were met. (Pass) |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Size: "between 76 and 282 samples per parameter spanning the measuring range."
- Data Provenance: "In-house method comparison study" and "existing performance verification data obtained in-house." This suggests the data was generated internally by Radiometer Medical ApS, likely in Denmark. The data is prospective in nature as it's a verification study against a new algorithm.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: Not explicitly stated. The study references "medical decision points" and "existing claims" but does not detail the involvement or qualifications of experts in establishing the ground truth for these.
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Adjudication Method for the Test Set: Not explicitly stated. Given that the study compared the "new algorithm" against the "previous algorithm" and "existing claims," it implies a comparison to a established reference, but the method of adjudication (e.g., expert consensus) for that reference is not detailed.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The study focuses on the analytical performance of the device's algorithm.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: Yes, this appears to be a standalone (algorithm only) performance study. The focus is on the performance of the "Improved Intralipid correction algorithm for Oxi parameters" and its impact on measurements, without human interaction with the algorithm's output as part of the primary evaluation.
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Type of Ground Truth Used: The ground truth used for performance evaluation was based on the "previous algorithm" (predicate device's algorithm) and "existing claims" for analytical performance (bias, imprecision, linearity, LOQ). This can be categorized as a comparative analytical truth against a previously validated method, rather than a clinical ground truth like pathology or patient outcomes.
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Sample Size for the Training Set: Not explicitly stated. The document describes a "new correction" and an "improved Intralipid correction algorithm," implying development and training, but the sample size used for this training is not provided in this 510(k) summary.
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How the Ground Truth for the Training Set Was Established: Not explicitly stated. The document describes the verification of the new algorithm against the old one and existing claims, but it does not detail how the ground truth was established for the training of the new algorithm itself.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
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.(b)
Classification. Class II.