(71 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 (cCl¯): 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 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, F MetHb, FHHb and FHbF).
The labelling and the software has been modified to assure that the Operator does not use qlucose results obtained from samples with a pO2 level below 25 mmHg.
This document describes a Special 510(k) submission for a device modification to the ABL90 Flex, specifically related to the suppression of cGlu (glucose) results when pO2 levels are below 25 mmHg.
1. Table of Acceptance Criteria and Reported Device Performance
| Hazard | Acceptance Criteria | Testing Results Summary | Met Acceptance Criteria? |
|---|---|---|---|
| 41/Too low Glucose result in the upper reportable range obtained from samples with low pO2 level | Bias: 25 mmHg when compared to the reference method | The results are valid under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg. | Passed. The acceptance criterion is met under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg. |
| 48/Unacceptable bias on Glucose results obtained from samples with pO2 levels above 25 mmHg | Bias: 25 mmHg when compared to the reference method | The results are valid under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg. | Passed. The acceptance criterion is met under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg. |
| 49/Too low Glucose result in the lower and medium reportable range obtained from samples with low pO2 level | Bias: 25 mmHg when compared to the reference method | The results are valid under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg. | Passed. The acceptance criterion is met under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg. |
Note: The table provided in the input shows specific bias percentages for different cGlu and pO2 levels in a separate "Testing results summary" section. I have extracted the overall "Meet the acceptance criteria or not?" statement for the acceptance table as it represents the final determination.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The interference study involved:
- 5-7 different pO2 levels
- 5 different glucose levels
- 10 analyzers
- 5 tests of each sample on each analyzer
- 3 runs
- Total of 3150 measurements.
- Data Provenance: The study used "fresh heparinized samples." The document does not specify the country of origin of the data, but the submitter is Radiometer Medical ApS, located in Denmark. It is a prospective study as it describes validations and verifications activities, including an "Interference study."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This study does not involve human readers or experts establishing ground truth in the traditional sense of medical image analysis. The ground truth for the glucose measurements is established by a "reference method" as indicated by the acceptance criteria "compared to the reference method." The qualifications of those performing the reference method measurements are not specified.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers with potential disagreements requiring adjudication. The direct comparison is between the device's measurement and a reference method.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an MRMC comparative effectiveness study and does not involve AI assistance for human readers. The modification is a software change to suppress glucose results under certain conditions to ensure accuracy.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study (interference study) was done to evaluate the performance of the device's glucose measurement algorithm under varying pO2 and glucose levels. The software modification itself (suppression of results) is an algorithm-only function.
7. The Type of Ground Truth Used
The ground truth used for evaluating the device's performance was a reference method for glucose measurement. The specific nature of this reference method (e.g., a laboratory gold standard instrument) is not detailed in the provided text.
8. The Sample Size for the Training Set
Not applicable. This document describes a modification to an existing device and its verification, not the development or training of a new algorithm. The term "training set" is usually associated with machine learning models. The study described here is an interference study to validate a device modification.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for a new algorithm.
§ 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.