(71 days)
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No
The document describes a standard automated blood gas analyzer and its performance studies. There is no mention of AI or ML in the intended use, device description, or performance studies. The modification mentioned is a simple rule-based suppression of glucose results based on a pO2 threshold, which is not indicative of AI/ML.
No.
The device is an analyzer that measures various parameters in blood for diagnostic purposes; it does not provide therapy or treatment.
Yes
The device measures several parameters (pH, blood gases, electrolytes, glucose, lactate, and oximetry) in whole blood, and the intended use states that these measurements are "used in the diagnosis and treatment of life-threatening acid-base disturbances" and various other disease conditions. This directly points to its role in diagnosis.
No
The device description clearly states it is a "portable, automated system intended for in vitro testing of samples of whole blood" and measures various parameters using physical samples. While it has software, it is integrated into a hardware analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device "measures pH, blood gases, electrolytes, glucose, lactate, and oximetry in heparinised whole blood." These are all measurements performed on biological samples in vitro (outside the body) to provide information for the diagnosis and treatment of various medical conditions.
- Device Description: The device description confirms it is "intended for in vitro testing of samples of whole blood".
- Parameters Measured: The list of parameters measured (pH, blood gases, electrolytes, glucose, lactate, and oximetry) are all common diagnostic tests performed on blood samples.
- Clinical Significance: The intended use section details the clinical significance of each parameter, linking the measurements to the diagnosis and treatment of specific diseases and conditions.
Therefore, based on the provided information, the ABL90 FLEX analyzer clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CHL, CEM, CGA, CGZ, GHS, GKR, JFP, JGS, JIX, KQI, KHP, JJY
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Interference study at different pO2 levels and at different glucose levels covering the reportable range of the analyser using fresh heparinized samples.
Bias: 25 mmHg when compared to the reference method.
30 days, 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bias, Percent Bias
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Special 510(k): Device Modification to ABL90 Flex - cGlu Suppression
RADIOME
Section 5. 510(k) Summary
1. Administrative
NOV 1 6 2012
Device Information Device Name: ABL90 Flex Blood gases and blood pH test system Common Name: CHL (JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX) Product Code: Registration Number: 21 CFR 862.1120 Classification : Class II Clinical Chemistry Classification Panel:
| Submitter | |
|---|---|
| Company Name: | Radiometer Medical ApS |
| ER Number: | 3002807968 |
| Address: | Aakandevej 21 |
| 2700 Broenshoej | |
| Denkmark | |
| Phone: | +45 3827 3827 |
| Fax: | +45 3827 2727 |
2. Description of Device Modification
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.
3. Intended Use
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.
4. Indications for use
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.
1
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 includinq 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.
sO3: 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.
5. Substantial Equivalence
The ABL90 FLEX with the modification described above is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:
510(k) Number/Device Manufacturer:
K120197 ABL90 Flex, Radiometer Medical ApS
| Predicate: ABL90 Flex (K120197) | |
|---|---|
| Similarities | Differences |
| Intended Use | Added caution to manual: |
| The ABL90 FLEX is a portable, automated | |
| analyzer that measures pH, blood gases, | |
| electrolytes, glucose, lactate and oximetry in | |
| heparinised whole blood. The ABL90 FLEX is | |
| intended for use by trained technologists, | |
| nurses, physicians and therapists. It is | |
| intended for use in a laboratory environment, | Low pO2 levels can influence the linearity of |
| glucose measurements, and can therefore | |
| result in falsely low glucose results. Please | |
| note that glucose performance is not specified | |
| when the pO2 is less than 25 mmHg (3.33 | |
| kPa). | |
| near patient or point-of-care setting. | The linearity of the glucose is dependent on |
| the oxygen tension of the sample. This | |
| dependence is due to the co-reaction of | |
| glucose and oxygen by the enzyme glucose | |
| oxidase. Low pO2 levels can influence the | |
| linearity of the glucose sensor. The following | |
| table outlines the glucose linearity as a | |
| function of the pO2. |
2
| Similarities | Differences | ||||
|---|---|---|---|---|---|
| Blood Gas Measurement | |||||
| pH, pO2, pCO2 by potentiometry | Added information to manual: | ||||
| Impact of the pO2 level on Glucose | |||||
| linearity and specifications of the ABL90 | |||||
| FLEX analyzer | |||||
| If the pO2 level in a sample is: Then cGlu linearity specifications only apply to cGlu values between: 25 | |||||
| mmHg when | |||||
| compared to the | |||||
| reference | |||||
| method | 30 days | ||||
| 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 | Passed | ||||
| The acceptance | |||||
| criterion is met | |||||
| under the | |||||
| condition that | |||||
| all glucose | |||||
| results are | |||||
| suppressed | |||||
| when the pO₂ | |||||
| level of the | |||||
| 48/Unacceptable bias | |||||
| on Glucose results | |||||
| obtained from | The results are valid under the |
. .
3
. . . .
:
:
| # / Hazard | Validations and
Verifications
activities
descriptions | Pre-
determined
Acceptance
criteria | Testing results summary | Meet the
acceptance
criteria or
not? |
|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| samples with pO2
levels above 25
mmHg | | | condition that all glucose results are
suppressed when the pO2 level of the
sample is below 25 mmHg all
acceptance criteria are met:
Bias