(287 days)
Not Found
No
The document describes a standard in vitro diagnostic analyzer and its performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) analyzer used for quantitative measurements of various blood parameters to aid in diagnosis and treatment. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyser..." It further lists various measurements (e.g., pH, blood gases, electrolytes, glucose, lactate, oximetry, neonatal bilirubin) that are performed to "aid in assessing," "used in the diagnosis and treatment of," and "used to monitor" disease conditions, all of which fall under the scope of diagnostic purposes.
No
The device description clearly states that the ABL90 FLEX PLUS consists of an instrument with a sensor cassette and a solution pack, which are hardware components. It is an in vitro diagnostic analyzer that physically measures analytes in blood samples.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyser..."
- Nature of Testing: The device measures various analytes (pH, blood gases, electrolytes, glucose, lactate, oximetry, neonatal bilirubin) in biological samples (heparinized whole blood, heparinized capillary whole blood). This is the core function of an in vitro diagnostic device – testing samples taken from the human body outside of the body.
- Intended Use: The intended use describes how the results are used in the diagnosis and treatment of various disease conditions and for assessing risk (e.g., kernicterus, acid-base disturbances, electrolyte imbalances, diabetes mellitus, carbon monoxide poisoning, anemia). This aligns with the purpose of IVD devices.
- Care Setting: The device is intended for use in a laboratory environment, near patient, or point-of-care setting, which are common locations for IVD testing.
N/A
Intended Use / Indications for Use
The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyser that quantitatively measures, pH, blood qases, electrolytes, glucose, lactate and oximetry in heparinized whole blood, and neonatal bilirubin in heparinized capillary whole blood.
The ABL90 FLEX PLUS 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.
Bilirubin measurements on the ABL90 FLEX PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates.
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): qlucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoqlycemia, 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 oxyhemoqlobin and oxyhemoglobin plus reduced hemoqlobin.
FO2Hb: oxyhemoqlobin as a fraction of total hemoqlobin.
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 hemoqlobin 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, JGS, CGZ, CGA, GHS, GKR, KQI, JIX, JFP, JJY, MQM, KHP
Device Description
The ABL90 FLEX PLUS is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, chloride, glucose, lactate, neonatal bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO-Hb, FCOHb, FMetHb, FHHb and FHbF).
The manufacturer of the ABL90 FLEX PLUS is Radiometer Medical ApS.
The ABL90 FLEX PLUS consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available.
The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test load are available. The solution pack is available in two models differing in the number of tests available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates
Intended User / Care Setting
Intended User: trained technologists, nurses, physicians and therapists.
Care Setting: laboratory environment, near patient or point-of-care setting.
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
Method comparison study:
- Sample size: more than 40 samples (N) per parameter
- Data Source: heparinized, leftover whole blood samples (analyzed 2-3 hours post draw). Samples were spiked. For each parameter, less than 20% of the samples were spiked.
- Annotation protocol: Each sample was analyzed in singlicate.
Imprecision study
- Sample size: Not explicitly stated but 2 runs per day and 2 replicates per run for at least 20 days.
- Data Source: samples were spiked whole blood except for neonatal bilirubin for which samples were aqueous solutions. For FHbF, the sample material was cord blood. Fresh whole blood samples were prepared each test day.
- Annotation protocol: Point-of-care precision studies on ABL90 FLEX PLUS syringe, short probe, and capillary mode were performed at 3 point-of care sites. To eliminate the sample-to-sample imprecision contribution, the total imprecision for all parameters except neonatal bilirubin was calculated as the imprecision of the bias towards a reference value determined for each sample on an ABL90 FLEX reference instrument.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Method comparison study of ABL90 FLEX PLUS Short Probe mode versus ABL90 FLEX syringe mode with inlet clip.
Sample size: more than 40 samples (N) per parameter.
Key Results: Data analysis by linear regression showed: Slopes were between 0.95 and 1.05. Coefficients of determination R2 were >0.97. Intercepts were within acceptance criteria. Pass.
Study Type: Imprecision
Sample size: Not explicitly stated, but 2 runs per day and 2 replicates per run for at least 20 days.
Key Results: All within-run and total imprecisions were within the acceptance criteria. Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Method comparison study:
Slopes: between 0.95 and 1.05
R2: >0.97
Intercepts:
pH: ±0.75
pO2: ±11 mmHg
pCO2: ±4.5 mmHg
Cl-: ±11 mM
Na+: ±15 mM
K+: ±0.5 mM
Ca2+: ±0.5 mM
Glucose: ±0.6 mmol/L
Lactate: ±0.4 mmol/L
tHb: ±1.5 g/dL
sO2: ±10%
FO2Hb: ±10%
FCOHb: ±1%
FMetHb: ±1%
FHHb: ±2.4%
FHbF: ±21%
Neonatal bilirubin: ±28 μmol/L
Imprecision:
Capillary mode
pH: Sr (within-run) 0.0028-0.0032, %CV (within-run) 0.04, St (total) 0.0056-0.0067, %CV (total) 0.08-0.09
pCO₂ (mmHg): Sr (within-run) 0.71-1.04, %CV (within-run) 1.70-2.54, St (total) 0.86-1.51, %CV (total) 2.48-3.07
pO₂ (mmHg): Sr (within-run) 0.56-2.45, %CV (within-run) 1.20-1.24, St (total) 1.21-4.82, %CV (total) 2.35-2.69
cCa²⁺ (mmol/L): Sr (within-run) 0.009-0.036, %CV (within-run) 0.74-3.62, St (total) 0.029-0.070, %CV (total) 2.40-5.52
cCl⁻ (mmol/L): Sr (within-run) 0.37-0.43, %CV (within-run) 0.30-0.40, St (total) 1.41-1.83, %CV (total) 1.39-1.69
cK⁺ (mmol/L): Sr (within-run) 0.04-0.05, %CV (within-run) 0.61-1.04, St (total) 0.09-0.12, %CV (total) 1.36-2.50
cNa⁺ (mmol/L): Sr (within-run) 0.36-0.48, %CV (within-run) 0.30-0.34, St (total) 0.90-1.15, %CV (total) 0.75-0.82
cGlu (mmol/L): Sr (within-run) 0.04-0.23, %CV (within-run) 1.52-5.13, St (total) 0.11-0.77, %CV (total) 4.18-14.10
cLac (mmol/L): Sr (within-run) 0.09-0.44, %CV (within-run) 2.73-4.29, St (total) 0.17-1.56, %CV (total) 8.10-9.69
ctHb (g/dL): Sr (within-run) 0.07-0.20, %CV (within-run) 0.93-1.89, St (total) 0.09-0.33, %CV (total) 1.30-2.43
sO₂ (%): Sr (within-run) 0.11-0.30, %CV (within-run) 0.11-0.39, St (total) 0.20-0.61, %CV (total) 0.20-0.80
FCOHb (%): Sr (within-run) 0.04, %CV (within-run) 0.11-1.25, St (total) 0.29-0.32, %CV (total) 0.86-9.06
FMetHb (%): Sr (within-run) 0.11-0.13, %CV (within-run) 1.30-3.24, St (total) 0.29-0.33, %CV (total) 2.90-9.71
FHHb (%): Sr (within-run) 0.26, %CV (within-run) 1.09-3.94, St (total) 0.50-0.60, %CV (total) 2.52-7.58
FO₂Hb (%): Sr (within-run) 0.20-0.30, %CV (within-run) 0.21-0.41, St (total) 0.29-0.67, %CV (total) 0.30-0.91
FHbF (%): Sr (within-run) 2.86-2.89, %CV (within-run) 4.52-6.81, St (total) 7.07-7.08, %CV (total) 11.06-16.83
Neonatal bilirubin (µmol/L): Sr (within-run) 0.92-7.07, %CV (within-run) 1.35-2.56, St (total) 1.77-9.41, %CV (total) 1.80-4.92
Syringe mode
pH: Sr (within-run) 0.0013-0.0023, %CV (within-run) 0.02-0.03, St (total) 0.0045-0.0060, %CV (total) 0.06-0.08
pCO2 (mmHg): Sr (within-run) 0.66-1.15, %CV (within-run) 1.83-2.36, St (total) 0.86-1.83, %CV (total) 2.62-3.07
pO2 (mmHg): Sr (within-run) 0.27-1.82, %CV (within-run) 0.60-1.11, St (total) 0.90-3.54, %CV (total) 1.74-2.00
cCa2+ (mmol/L): Sr (within-run) 0.003-0.009, %CV (within-run) 0.48-0.74, St (total) 0.022-0.042, %CV (total) 2.15-3.79
cCl (mmol/L): Sr (within-run) 0.24-0.42, %CV (within-run) 0.20-0.39, St (total) 1.32-1.82, %CV (total) 1.08-1.69
cK+ (mmol/L): Sr (within-run) 0.03-0.04, %CV (within-run) 0.45-0.83, St (total) 0.08, %CV (total) 1.21-1.67
cNa+ (mmol/L): Sr (within-run) 0.36-0.48, %CV (within-run) 0.24-0.34, St (total) 0.77-0.90, %CV (total) 0.60-0.65
cGlu (mmol/L): Sr (within-run) 0.04-0.18, %CV (within-run) 1.22-5.48, St (total) 0.09-0.64, %CV (total) 4.18-12.33
cLac (mmol/L): Sr (within-run) 0.07-0.51, %CV (within-run) 3.15-3.18, St (total) 0.18-1.94, %CV (total) 8.18-11.98
ctHb (g/dL): Sr (within-run) 0.07-0.14, %CV (within-run) 0.65-1.84, St (total) 0.12-0.20, %CV (total) 0.92-3.16
sO2 (%): Sr (within-run) 0.11-0.29, %CV (within-run) 0.11-0.39, St (total) 0.22-0.49, %CV (total) 0.22-0.65
FCOHb (%): Sr (within-run) 0.06-0.08, %CV (within-run) 0.21-1.88, St (total) 0.28-0.32, %CV (total) 0.84-8.75
FMetHb (%): Sr (within-run) 0.08-0.09, %CV (within-run) 0.79-2.65, St (total) 0.23-0.30, %CV (total) 2.97-6.76
FHHb (%): Sr (within-run) 0.17-0.25, %CV (within-run) 1.03-2.54, St (total) 0.40-0.41, %CV (total) 1.69-5.97
FO2Hb (%): Sr (within-run) 0.18-0.32, %CV (within-run) 0.19-0.39, St (total) 0.26-0.59, %CV (total) 0.27-0.82
FHbF (%): Sr (within-run) 2.32-4.56, %CV (within-run) 5.66-7.13, St (total) 6.37-8.76, %CV (total) 13.69-15.54
Neonatal bilirubin (µmol/L): Sr (within-run) 1.19-4.46, %CV (within-run) 0.85-3.31, St (total) 2.12-9.15, %CV (total) 1.74-5.89
Short probe mode
pH: Sr (within-run) 0.001-0.002, %CV (within-run) 0.02-0.03, St (total) 0.005-0.006, %CV (total) 0.06-0.08
pCO2 (mmHg): Sr (within-run) 0.66-1.15, %CV (within-run) 1.83-2.36, St (total) 0.86-1.83, %CV (total) 2.62-3.07
pO2 (mmHg): Sr (within-run) 0.27-1.82, %CV (within-run) 0.60-1.11, St (total) 0.90-3.53, %CV (total) 1.73-2.00
cCa²+ (mmol/L): Sr (within-run) 0.003-0.009, %CV (within-run) 0.48-0.74, St (total) 0.02-0.04, %CV (total) 2.15-3.79
cCl⁻ (mmol/L): Sr (within-run) 0.24-0.42, %CV (within-run) 0.20-0.39, St (total) 1.32-1.82, %CV (total) 1.08-1.69
cK⁺ (mmol/L): Sr (within-run) 0.03-0.04, %CV (within-run) 0.45-0.83, St (total) 0.08, %CV (total) 1.21-1.67
cNa⁺ (mmol/L): Sr (within-run) 0.36-0.48, %CV (within-run) 0.24-0.34, St (total) 0.77-0.90, %CV (total) 0.60-0.65
cGlu (mmol/L): Sr (within-run) 0.04-0.18, %CV (within-run) 1.22-5.48, St (total) 0.09-0.65, %CV (total) 4.18-12.33
cLac (mmol/L): Sr (within-run) 0.07-0.51, %CV (within-run) 3.15-3.18, St (total) 0.18-1.94, %CV (total) 8.18-11.98
ctHb (g/dL): Sr (within-run) 0.07-0.14, %CV (within-run) 0.65-1.84, St (total) 0.12-0.20, %CV (total) 0.92-3.16
sO2 (%): Sr (within-run) 0.11-0.29, %CV (within-run) 0.11-0.39, St (total) 0.22-0.49, %CV (total) 0.22-0.65
FCOHb (%): Sr (within-run) 0.06-0.08, %CV (within-run) 0.21-1.88, St (total) 0.28-0.32, %CV (total) 0.84-8.75
FMetHb (%): Sr (within-run) 0.08-0.09, %CV (within-run) 0.79-2.65, St (total) 0.22-0.30, %CV (total) 2.97-6.47
FHHb (%): Sr (within-run) 0.17-0.25, %CV (within-run) 1.03-2.54, St (total) 0.40-0.41, %CV (total) 1.69-5.97
FO₂Hb (%): Sr (within-run) 0.18-0.28, %CV (within-run) 0.19-0.39, St (total) 0.26-0.59, %CV (total) 0.27-0.82
FHbF (%): Sr (within-run) 2.32-4.56, %CV (within-run) 5.66-7.13, St (total) 6.37-8.76, %CV (total) 13.69-15.54
Neonatal bilirubin (µmol/L): Sr (within-run) 1.19-4.46, %CV (within-run) 0.85-3.31, St (total) 0.14-2.48, %CV (total) 1.95-5.89
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.
Not Found
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).
Not Found
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
RADIOMETER MEDICAL APS SOEREN BØEGESTRAND SENIOR REGULATORY AFFAIRS SPECIALIST AAKANDEVEJ 21 BROENSHOEJ DK-2700, DENMARK
November 4, 2016
Re: K160153
Trade/Device Name: ABL 90 FLEX PLUS Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL, CEM, JGS, CGZ, CGA, KHP, GHS, GKR, KQI, JIX, JJY, MQM, JFP Dated: October 05, 2016 Received: October 07, 2016
Dear Soeren Boegestrand:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160153
Device Name ABL90 FLEX PLUS
Indications for Use (Describe)
The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyser that quantitatively measures, pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood, and neonatal bilirubin in heparinized capillary whole blood.
The ABL90 FLEX PLUS 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.
Bilirubin measurements on the ABL90 FLEX PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates.
pH, pO2 and pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acidbase 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 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 plus reduced hemoglobin.
FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.
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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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Submitter and contact information
| Submitter | |
|---|---|
| Company Name: | Radiometer Medical ApS |
| ER Number: | 3002807968 |
| Address: | Aakandevej 21 |
| 2700 Broenshoej | |
| Denmark | |
| Phone: | +45 3827 3827 |
| Fax: | +45 3827 2727 |
| Contact person: | Soeren Boegestrand |
| E-mail: | soren.bogestrand@radiometer.dk |
Contact Person
| Name: | Soeren Boegestrand |
|---|---|
| Function: | Senior Regulatory Affairs Specialist |
| E-mail: | soren.bogestrand@radiometer.dk |
| Phone: | +45 3827 3852 |
| Fax: | +45 3827 2727 |
| Date prepared | |
|---|---|
| Date: | November 4, 2021 |
2. a. Device Information
| Device Name: | ABL90 FLEX PLUS |
|---|---|
| Common Name: | Blood gases (pCO2, pO2) and blood pH test system. |
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Classification:
| Classification name | CFR Section | Device Class | Product Code |
|---|---|---|---|
| Electrode measurement, blood-gases | |||
| (pCO2, pO2) and blood pH | 862.1120 | II | CHL |
| Potassium test system | 862.1600 | II | CEM |
| Sodium test system | 862.1665 | II | JGS |
| Chloride test system | 862.1170 | II | CGZ |
| Glucose test system | 862.1345 | II | CGA |
| Carboxyhemoglobin assay | 864.7425 | II | GHS |
| Automated hemoglobin system | 864.5620 | II | GKR |
| Fetal hemoglobin assay | 864.7455 | II | KQI |
| Calibrator | 862.1150 | II | JIX |
| Calcium test system | 862.1145 | II | JFP |
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| Quality control material (assayed and
| unassayed) | 862.1660 | I | JJY |
|---|---|---|---|
| Bilirubin (total and unbound) in the | |||
| neonate test system | 862.1113 | I | MQM |
| Lactic acid test system | 862.1450 | I | KHP |
6
2. b. Device Description
Instrument name, manufacturer, models and accessories
The ABL90 FLEX PLUS is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, chloride, glucose, lactate, neonatal bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO-Hb, FCOHb, FMetHb, FHHb and FHbF).
The manufacturer of the ABL90 FLEX PLUS is Radiometer Medical ApS.
The ABL90 FLEX PLUS consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available.
The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test load are available. The solution pack is available in two models differing in the number of tests available.
2. c. Purpose of submission
The purpose of this submission is to seek clearance for a design change to the existing ABL90 FLEX analyzer. The design change will result in the introduction of an additional variant of the ABL90 FLEX analyzer called ABL90 FLEX PLUS. To accommodate this, the ABL90 FLEX analyzer has been changed as outlined below:
- . The inlet module on the ABL90 FLEX PLUS analyzer has been mechanized, the mechanized inlet module is in multiple places in this 510(k) referred to as the AutoInlet. The opening and closing of the inlet is either button activated using the touch screen or in certain cases automatic when appropriate. The mechanized inlet module subsequently calls for the following derived changes listed below.
- Addition of the Short Probe Mode measuring mode on the ABL90 FLEX PLUS. In ABL90 . FLEX, a little plastic clip (ABL90 FLEX Inlet Clip) component to be placed on the ABL90 FLEX inlet when using non-Radiometer samplers is incorporated. The purpose of the inlet clip is to shorten the maximum travel of the inlet into the sampler and thereby reduce the sample volume required. The use of an inlet clip for blood measurements is no longer relevant with the introduction of the Short Probe Mode. On the ABL90 FLEX PLUS, the short probe position has been built directly into the analyzer to replace the use of the inlet clip allowing the user the option of the standard syringe mode or the Short Probe Mode.
- . Modifications to software to support both ABL90 FLEX and ABL90 FLEX PLUS. The modifications in the software relevant to this application are the support of the mechanized inlet module in ABL90 FLEX PLUS (including the Short Probe Mode), as well as the ability to distinquish and detect the type of inlet (manual or mechanized) an analyzer is fitted with.
- Instructions for Use for ABL90 FLEX PLUS have been established. .
Except for the above identified modifications and minor differences in visual appearance the ABL90 FLEX and ABL90 FLEX PLUS analyzers are identical. Both analyzers use the same software version and have the same accessories.
7
3. Intended Use/Indications for use
The ABL90 FLEX PLUS analyzer is an in vitro diagnostic, portable, automated analyser that quantitatively measures, pH, blood qases, electrolytes, glucose, lactate and oximetry in heparinized whole blood, and neonatal bilirubin in heparinized capillary whole blood.
The ABL90 FLEX PLUS 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.
Bilirubin measurements on the ABL90 FLEX PLUS analyzer are intended to aid in assessing the risk of kernicterus in neonates.
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): qlucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoqlycemia, 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 oxyhemoqlobin and oxyhemoglobin plus reduced hemoqlobin.
FO2Hb: oxyhemoqlobin as a fraction of total hemoqlobin.
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 hemoqlobin as a fraction of total hemoglobin.
Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.
8
4. Predicate device: ABL90 FLEX (K132691) Substantial Equivalence
The ABL90 FLEX PLUS analyzer is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate devices:
Predicate Device: 510(k) Number, Name, Device Manufacturer:
K132691, ABL90 FLEX, Radiometer Medical ApS K131988, ABL90 FLEX, Radiometer Medical ApS
| Similarities | ||
|---|---|---|
| Issue | SE Device | Predicate Devices (K132691, K131988) |
| Parameters | Same | pH, pO2, pCO2, sodium, potassium, calcium, chloride, glucose, lactate, sO2, FO2Hb, FCOHb, FMetHb, FHHB, FHbF, neonatal bilirubin. |
| Measuring method | Same | Potentiometry, Amperometry, Optical pO2 ,Spectrophotometry |
| Calibration Method | Same | Two-point liquid calibration |
| Intended Use | Same | The ABL90 FLEX analyzer is an in vitro diagnostic, portable, automated analyser that quantitatively measures, pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood, and neonatal bilirubin in heparinized capillary 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. | ||
| Bilirubin measurements on the ABL90 FLEX analyzer are intended to aid in assessing the risk of kernicterus in neonates. | ||
| Intended use site | Same | Laboratory and point-of-care. |
| Differences | ||
|---|---|---|
| Issue | SE Device | Predicate Devices (K132691, K131988) |
| Inlet | Mechanized inlet | Manual inlet |
| Short probe mode | Yes | No |
9
5. Performance Characteristics
No performance data are affected by the change. The existing performance data still apply.
Verification of the ABL90 FLEX PLUS showed that the precision performance of all three modes of the ABL90 FLEX PLUS is equivalent to the precision performance of ABL90 FLEX for the 17 parameters available on the analyzers: pH, pCO2, pO2, cCa2+, cCli, cK*, cGlu, cLac, ctHb, sO3, FO3Hb, FHHb, FMetHb, FCOHb, FHbF, and neonatal bilirubin.
The existing clinical precision performance claims in the manual for ABL90 FLEX are also applicable to ABL90 FLEX PLUS.
Verification of the ABL90 FLEX PLUS Short Probe mode showed that measurements performed with ABL90 FLEX PLUS in Short Probe mode are equivalent to measurements performed with ABL90 FLEX in syringe mode with inlet clip for the 17 parameters available on the analyzers: pH, pCO₂, pO₂, cCa²†, cCl˙, cK†, cNa†, cGlu, cLac, ctHb, sO₂, FO₂Hb, FHHb, FMetHb, FCOHb, FHbF, and neonatal bilirubin.
The existing clinical method comparison claims in the manual for ABL90 FLEX syringe mode are applicable to ABL90 FLEX PLUS Short Probe mode.
10
6. Summary of Design Control activities
Risk Assessment:
We conducted an FMEA risk analysis and mitigated all identified hazards to As Low As Reasonably Practicable (ALARP) per ISO 14971, and verified mitigations by using test protocols. Results met predefined acceptance criteria
Performance testing:
| Issue | Acceptance
criteria | Verification
method | Result and Pass/Fail | Comments |
|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Method
comparison of
ABL90 FLEX
PLUS Short
Probe mode
versus ABL90
FLEX syringe
mode with inlet
clip | Data analysis by linear
regression must result in:
Slope between 0.95
and 1.05 Coefficient of
determination
R2>0.97 Intercepts: pH:
±0.75
pO2:
±11 mmHg
pCO2:
±4.5 mmHg
Cl-:
±11 mM
Na+:
±15 mM
K+:
±0.5 mM
Ca2+:
±0.5 mM
Glucose: ±0.6 mmol/L
Lactate: ±0.4 mmol/L
tHb:
±1.5 g/dL
sO2:
±10%
FO2Hb:
±10%
FCOHb:
±1%
FMetHb:
±1%
FHHb:
±2.4%
FHbF:
±21%
Neonatal
bilirubin: ±28 μmol/L | In-house method comparison
study of ABL90 FLEX PLUS
Short Probe mode versus
ABL90 FLEX syringe mode with
inlet clip with more than 40
samples (N) per parameter
spanning the measuring range.
Each sample was analyzed in
singlicate. For each parameter,
less than 20% of the samples
were spiked.
Samples were heparinized,
leftover whole blood samples
(analyzed 2-3 hours post
draw). | Data analysis by linear
regression showed:
Slopes were
between 0.95 and
1.05. Coefficients of
determination R2
were >0.97. Intercepts were
within acceptance
criteria. Pass. | Existing method
comparison
claims for ABL90
FLEX syringe
mode apply to
ABL90 FLEX
PLUS Short
Probe mode. |
| Issue | Acceptance
criteria | Verification
method | Result and Pass/Fail | Comments |
| Imprecision | The same or better
clinical precision than
originally determined for
ABL90 FLEX (K092686
and K132691).
The within-run ( $S_r$ ) and
total imprecision ( $S_T$ )
pooled across sites must
be the same or better
than originally determined
for ABL90 FLEX (K092686
and K132691) at a 95%
confidence level using a
Chi-square test.
The acceptance criteria
have been itemized in the
below table. | Point-of-care precision studies
on ABL90 FLEX PLUS syringe,
short probe, and capillary
mode were performed at 3
point-of care sites over at least
20 days, with 2 runs per day
and 2 replicates per run.
Samples were spiked whole
blood except for neonatal
bilirubin for which samples
were aqueous solutions. For
FHbF, the sample material was
cord blood.
Fresh whole blood samples
were prepared each test day.
To eliminate the sample-to-
sample imprecision
contribution, the total
imprecision for all parameters
except neonatal bilirubin was
calculated as the imprecision of
the bias towards a reference
value determined for each
sample on an ABL90 FLEX
reference instrument. | All within-run and total
imprecisions were
within the acceptance
criteria.
Pass | Existing clinical
precision claims
for ABL90 FLEX
apply to ABL90
FLEX PLUS. |
11
12
Imprecision acceptance criteria
| Analyte | Level | Sr (within-run) | %CV (within-run) | St (total) | %CV (total) |
|---|---|---|---|---|---|
| Capillary mode | |||||
| 7.27 | 0.0030 | 0.04 | 0.0056 | 0.08 | |
| pH | 7.38 | 0.0028 | 0.04 | 0.0065 | 0.09 |
| 7.47 | 0.0032 | 0.04 | 0.0067 | 0.09 | |
| 28 | 0.71 | 2.54 | 0.86 | 3.07 | |
| pCO₂ (mmHg) | 42 | 0.76 | 1.81 | 1.13 | 2.69 |
| 61 | 1.04 | 1.70 | 1.51 | 2.48 | |
| 45 | 0.56 | 1.24 | 1.21 | 2.69 | |
| pO₂ (mmHg) | 77 | 0.94 | 1.22 | 1.86 | 2.42 |
| 205 | 2.45 | 1.20 | 4.82 | 2.35 | |
| 0.58 | 0.021 | 3.62 | 0.032 | 5.52 | |
| cCa²⁺ (mmol/L) | 1.21 | 0.009 | 0.74 | 0.029 | 2.40 |
| 1.89 | 0.036 | 1.90 | 0.070 | 3.70 | |
| 94 | 0.38 | 0.40 | 1.41 | 1.50 | |
| cCl⁻ (mmol/L) | 108 | 0.43 | 0.40 | 1.83 | 1.69 |
| 122 | 0.37 | 0.30 | 1.69 | 1.39 | |
| 4.8 | 0.05 | 1.04 | 0.12 | 2.50 | |
| cK⁺ (mmol/L) | 6.6 | 0.04 | 0.61 | 0.09 | 1.36 |
| 120 | 0.36 | 0.30 | 0.90 | 0.75 | |
| cNa⁺ (mmol/L) | 141 | 0.48 | 0.34 | 1.15 | 0.82 |
| 151 | 0.48 | 0.32 | 1.15 | 0.76 | |
| 0.78 | 0.04 | 5.13 | 0.11 | 14.10 | |
| cGlu (mmol/L) | 5.5 | 0.09 | 1.64 | 0.23 | 4.18 |
| 15.1 | 0.23 | 1.52 | 0.77 | 5.10 | |
| 2.1 | 0.09 | 4.29 | 0.17 | 8.10 | |
| cLac (mmol/L) | 16.1 | 0.44 | 2.73 | 1.56 | 9.69 |
| 3.7 | 0.07 | 1.89 | 0.09 | 2.43 | |
| ctHb (g/dL) | 15 | 0.15 | 1.00 | 0.33 | 2.20 |
| 21.6 | 0.20 | 0.93 | 0.28 | 1.30 | |
| 76 | 0.30 | 0.39 | 0.61 | 0.80 | |
| sO₂ (%) | 93 | 0.20 | 0.22 | 0.45 | 0.48 |
| 100 | 0.11 | 0.11 | 0.20 | 0.20 | |
| 3.2 | 0.04 | 1.25 | 0.29 | 9.06 | |
| FCOHb (%) | 37.3 | 0.04 | 0.11 | 0.32 | 0.86 |
| 3.4 | 0.11 | 3.24 | 0.33 | 9.71 | |
| FMetHb (%) | 10.0 | 0.13 | 1.30 | 0.29 | 2.90 |
| 6.6 | 0.26 | 3.94 | 0.50 | 7.58 | |
| FHHb (%) | 23.8 | 0.26 | 1.09 | 0.60 | 2.52 |
| FO₂Hb (%) | 74 | 0.30 | 0.41 | 0.67 | 0.91 |
| 89 | 0.28 | 0.31 | 0.44 | 0.49 | |
| 97 | 0.20 | 0.21 | 0.29 | 0.30 | |
| FHbF (%) | 42 | 2.86 | 6.81 | 7.07 | 16.83 |
| 64 | 2.89 | 4.52 | 7.08 | 11.06 | |
| 36 | 0.92 | 2.56 | 1.77 | 4.92 | |
| Neonatal bilirubin | |||||
| (µmol/L) | 127 | 1.85 | 1.46 | 2.55 | 2.01 |
| 523 | 7.07 | 1.35 | 9.41 | 1.80 | |
| Analyte | Level | Sr (within-run) | %CV (within-run) | ST (total) | %CV (total) |
| Syringe mode | |||||
| pH | 7.27 | 0.0023 | 0.03 | 0.0047 | 0.06 |
| 7.37 | 0.0015 | 0.02 | 0.0045 | 0.06 | |
| 7.47 | 0.0013 | 0.02 | 0.0060 | 0.08 | |
| pCO2 (mmHg) | 28 | 0.66 | 2.36 | 0.86 | 3.07 |
| 42 | 0.77 | 1.83 | 1.10 | 2.62 | |
| 60 | 1.15 | 1.92 | 1.83 | 3.05 | |
| pO2 (mmHg) | 45 | 0.27 | 0.60 | 0.90 | 2.00 |
| 76 | 0.84 | 1.11 | 1.43 | 1.88 | |
| 204 | 1.82 | 0.89 | 3.54 | 1.74 | |
| cCa2+ (mmol/L) | 0.58 | 0.003 | 0.52 | 0.022 | 3.79 |
| 1.21 | 0.009 | 0.74 | 0.026 | 2.15 | |
| 1.89 | 0.009 | 0.48 | 0.042 | 2.22 | |
| cCl (mmol/L) | 94 | 0.25 | 0.27 | 1.38 | 1.47 |
| 108 | 0.42 | 0.39 | 1.82 | 1.69 | |
| 122 | 0.24 | 0.20 | 1.32 | 1.08 | |
| cK+ (mmol/L) | 4.8 | 0.04 | 0.83 | 0.08 | 1.67 |
| 6.6 | 0.03 | 0.45 | 0.08 | 1.21 | |
| 119 | 0.36 | 0.30 | 0.77 | 0.65 | |
| cNa+ (mmol/L) | 141 | 0.48 | 0.34 | 0.90 | 0.64 |
| 151 | 0.36 | 0.24 | 0.90 | 0.60 | |
| 0.73 | 0.04 | 5.48 | 0.09 | 12.33 | |
| cGlu (mmol/L) | 5.5 | 0.05 | 0.91 | 0.23 | 4.18 |
| 14.7 | 0.18 | 1.22 | 0.64 | 4.35 | |
| 2.2 | 0.07 | 3.18 | 0.18 | 8.18 | |
| cLac (mmol/L) | 16.2 | 0.51 | 3.15 | 1.94 | 11.98 |
| 3.8 | 0.07 | 1.84 | 0.12 | 3.16 | |
| ctHb (g/dL) | 15 | 0.11 | 0.73 | 0.17 | 1.13 |
| 21.7 | 0.14 | 0.65 | 0.20 | 0.92 | |
| 75 | 0.29 | 0.39 | 0.49 | 0.65 | |
| sO2 (%) | 93 | 0.17 | 0.18 | 0.44 | 0.47 |
| 100 | 0.11 | 0.11 | 0.22 | 0.22 | |
| 3.2 | 0.06 | 1.88 | 0.28 | 8.75 | |
| FCOHb (%) | 38.0 | 0.08 | 0.21 | 0.32 | 0.84 |
| 3.4 | 0.09 | 2.65 | 0.23 | 6.76 | |
| FMetHb (%) | 10.1 | 0.08 | 0.79 | 0.30 | 2.97 |
| 6.7 | 0.17 | 2.54 | 0.40 | 5.97 | |
| FHHb (%) | 24.3 | 0.25 | 1.03 | 0.41 | 1.69 |
| 72 | 0.28 | 0.39 | 0.59 | 0.82 | |
| FO2Hb (%) | 91 | 0.32 | 0.35 | 0.45 | 0.49 |
| 97 | 0.18 | 0.19 | 0.26 | 0.27 | |
| FHbF (%) | 41 | 2.32 | 5.66 | 6.37 | 15.54 |
| 64 | 4.56 | 7.13 | 8.76 | 13.69 | |
| Neonatal bilirubin | |||||
| (µmol/L) | 36 | 1.19 | 3.31 | 2.12 | 5.89 |
| 127 | 1.35 | 1.06 | 2.48 | 1.95 | |
| 525 | 4.46 | 0.85 | 9.15 | 1.74 | |
| Analyte | Level | Sr (within-run) | %CV (within-run) | ST (total) | %CV (total) |
| Short probe mode | |||||
| pH | 7.27 | 0.002 | 0.03 | 0.005 | 0.06 |
| 7.37 | 0.002 | 0.02 | 0.005 | 0.06 | |
| 7.47 | 0.001 | 0.02 | 0.006 | 0.08 | |
| pCO2 (mmHg) | 28 | 0.66 | 2.36 | 0.86 | 3.07 |
| 42 | 0.77 | 1.83 | 1.10 | 2.62 | |
| 60 | 1.15 | 1.92 | 1.83 | 3.05 | |
| pO2 (mmHg) | 45 | 0.27 | 0.60 | 0.90 | 2.00 |
| 76 | 0.84 | 1.11 | 1.43 | 1.88 | |
| 204 | 1.82 | 0.89 | 3.53 | 1.73 | |
| cCa²+ (mmol/L) | 0.58 | 0.003 | 0.52 | 0.02 | 3.79 |
| 1.21 | 0.009 | 0.74 | 0.03 | 2.15 | |
| 1.89 | 0.009 | 0.48 | 0.04 | 2.22 | |
| cCl⁻ (mmol/L) | 94 | 0.25 | 0.27 | 1.38 | 1.47 |
| 108 | 0.42 | 0.39 | 1.82 | 1.69 | |
| 122 | 0.24 | 0.20 | 1.32 | 1.08 | |
| cK⁺ (mmol/L) | 4.8 | 0.04 | 0.83 | 0.08 | 1.67 |
| 6.6 | 0.03 | 0.45 | 0.08 | 1.21 | |
| cNa⁺ (mmol/L) | 119 | 0.36 | 0.30 | 0.77 | 0.65 |
| 141 | 0.48 | 0.34 | 0.90 | 0.64 | |
| 151 | 0.36 | 0.24 | 0.90 | 0.60 | |
| cGlu (mmol/L) | 0.73 | 0.04 | 5.48 | 0.09 | 12.33 |
| 5.5 | 0.05 | 0.91 | 0.23 | 4.18 | |
| 14.7 | 0.18 | 1.22 | 0.65 | 4.42 | |
| cLac (mmol/L) | 2.2 | 0.07 | 3.18 | 0.18 | 8.18 |
| 16.2 | 0.51 | 3.15 | 1.94 | 11.98 | |
| ctHb (g/dL) | 3.8 | 0.07 | 1.84 | 0.12 | 3.16 |
| 15 | 0.11 | 0.73 | 0.17 | 1.13 | |
| 21.7 | 0.14 | 0.65 | 0.20 | 0.92 | |
| sO2 (%) | 75 | 0.29 | 0.39 | 0.49 | 0.65 |
| 93 | 0.17 | 0.18 | 0.44 | 0.47 | |
| 100 | 0.11 | 0.11 | 0.22 | 0.22 | |
| FCOHb (%) | 3.2 | 0.06 | 1.88 | 0.28 | 8.75 |
| 38.0 | 0.08 | 0.21 | 0.32 | 0.84 | |
| FMetHb (%) | 3.4 | 0.09 | 2.65 | 0.22 | 6.47 |
| 10.1 | 0.08 | 0.79 | 0.30 | 2.97 | |
| FHHb (%) | 6.7 | 0.17 | 2.54 | 0.40 | 5.97 |
| 24.3 | 0.25 | 1.03 | 0.41 | 1.69 | |
| FO₂Hb (%) | 72 | 0.28 | 0.39 | 0.59 | 0.82 |
| 91 | 0.32 | 0.35 | 0.45 | 0.49 | |
| 97 | 0.18 | 0.19 | 0.26 | 0.27 | |
| FHbF (%) | 41 | 2.32 | 5.66 | 6.37 | 15.54 |
| 64 | 4.56 | 7.13 | 8.76 | 13.69 | |
| Neonatal bilirubin | |||||
| (µmol/L) | 36 | 1.19 | 3.31 | 2.12 | 5.89 |
| 127 | 1.35 | 1.06 | 2.48 | 1.95 | |
| 525 | 4.46 | 0.85 | 0.14 | 1.74 |
13
14
15
7. Conclusion
Based on the substantial equivalence comparison and the results of the conducted performance evaluations it has been concluded that the ABL90 FLEX PLUS is as safe and effective as the predicate device.