(254 days)
No
The document describes a blood gas analyzer and its connectivity to a data system. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: The device is an in vitro diagnostic device used to test various parameters in whole blood, expired air, and pleura samples. Its purpose is to provide diagnostic information, not to deliver therapy.
Yes
The device is intended for "In Vitro testing of samples of whole blood" and other bodily fluids for various parameters, and the explanation for each parameter clearly states its use for "diagnose," "monitor," or "assess the risk of" different medical conditions, such as diabetes, hyperbilirubinemia, or renal diseases. This directly indicates its role in diagnosis.
No
The device is described as a stationary, automated system (ABL800 FLEX analyzers) that performs in vitro testing. While the modification involves software integration (AQURE connectivity), the core device is a hardware analyzer, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the ABL800 FLEX analyzers are intended for In Vitro testing of samples of whole blood, expired air, and pleura samples. This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The "Device Description" also reiterates that the system is intended for in vitro testing of samples of whole blood.
- Parameters Measured: The device measures various parameters (pH, pO2, pCO2, electrolytes, glucose, lactate, bilirubin, hemoglobin parameters, creatinine) in these samples, and the descriptions of these parameters clearly indicate their use in diagnosing and monitoring various medical conditions.
Therefore, based on the provided text, the ABL800 FLEX analyzer is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ABL800 FLEX analyzers are intended for In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cC22+, cClu, cLac, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for In vitro testing of samples of expired air for the parameters p02 and for In vitro testing of pleura samples for the pH parameter.
pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood gas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range.
pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.
pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.
Potassium (cK+): the measurements of the concentration of plasma are used to monitor the electrolyte balance.
Sodium (cNa+); the measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.
Calcium (cCa++): the measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.
Chloride (cCl-): the measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.
Glucose (cGlu): The glucose measure the concentration of glucose in plasma. The glucose measurements are used to screen for, diagnose and monitor diabetes, pre-diabetes and hyper and hypoglycemia.
Lactate (cLac): The lactate measure the concentration of lactate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply.
Bilirubin (ctBil): The bilirubin measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia.
Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.
Oxygen Saturation (sO2): sO2 is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO2 allows evaluation of oxygenation.
Fraction of Oxyhemoglobin (FO2Hb): FO2Hb is a measure of the potential oxygen transport capacity; that is the fraction of oxyhemoglobins present (tHb) including dyshemoglobins.
Fraction of Carboxyhemoglobin (FCOHb is the fraction of carboxyhemoglobin. It is incapable of transporting oxygen.
Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.
Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoglobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin.
Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consist of two a-chains and two B-chains, and has a higher oxygen affinity than adult Hb.
Creatinine (cCrea): The creatinine measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Pleural pH: The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be part of a single, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
RADIOMETER MEDICAL APS. LASSE POST MOLLER REGULATORY AFFAIRS SPECIALIST AAKANDEVEJ 21 BROENSHOEJ 2700 DENMARK
Re: K142898
Trade/Device Name: ABL800 FLEX with AQURE connectivity 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, JFP, CGZ, CGA, KHP, CGL, CIG, MQM, KQI, GHS, GKR Dated: May 13, 2015 Received: May 20, 2015
Dear Lasse Moller:
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/ResourcesforYou/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
2
Indications for Use
510(k) Number (if known) K142898
Device Name ABL800 FLEX with AQURE connectivity
Indications for Use (Describe)
The ABL800 FLEX analyzers are intended for In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cC22+, cClu, cLac, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for In vitro testing of samples of expired air for the parameters p02 and for In vitro testing of pleura samples for the pH parameter.
pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood gas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range.
pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.
pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.
Potassium (cK+): the measurements of the concentration of plasma are used to monitor the electrolyte balance.
Sodium (cNa+); the measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.
Calcium (cCa++): the measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.
Chloride (cCl-): the measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.
Glucose (cGlu): The glucose measure the concentration of glucose in plasma. The glucose measurements are used to screen for, diagnose and monitor diabetes, pre-diabetes and hyper and hypoglycemia.
Lactate (cLac): The lactate measure the concentration of lactate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply.
Bilirubin (ctBil): The bilirubin measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia.
Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.
Oxygen Saturation (sO2): sO2 is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO2 allows evaluation of oxygenation.
Fraction of Oxyhemoglobin (FO2Hb): FO2Hb is a measure of the potential oxygen transport capacity; that is the fraction of oxyhemoglobins present (tHb) including dyshemoglobins.
Fraction of Carboxyhemoglobin (FCOHb is the fraction of carboxyhemoglobin. It is incapable of transporting
3
oxygen.
Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.
Fraction of Deoxyhemoglobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoglobin in total hemoglobin. It can bind oxygen then forming oxyhemoglobin.
Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consist of two a-chains and two B-chains, and has a higher oxygen affinity than adult Hb.
Creatinine (cCrea): The creatinine measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Pleural pH: The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the word "RADIOMETER" in a sans-serif font. The letters are a light gray color. To the right of the word is a square containing a circle with the letter "R" inside.
Section 06. 510(k) Summary
June 17, 2015
1. Administrative
Device Information
| Device Name: | ABL800 FLEX with AQURE connectivity |
|---|---|
| Common Name: | Blood gases and blood pH test system |
| Product Code: | CHL (CGZ, CGA, CGL, CEM, CIG, GKR, GHS, JFP, JGS, KHP, KQI, MQM) |
| Registration Number: | 21 CFR 862.1120 |
| Classification: | Class II |
| Classification Panel: | Clinical Chemistry |
Submitter
| Company Name: | Radiometer Medical ApS |
|---|---|
| ER Number: | 3002807968 |
| Address: | Aakandevej 21 |
| 2700 Broenshoej | |
| Denmark | |
| Phone: | +45 3827 3827 |
| Fax: | +45 3827 2727 |
Official Representative
| Name: | Gitte Juel Friis |
|---|---|
| Function: | Director, Regulatory Affairs |
| E-mail: | gitte.friis@radiometer.dk |
| Phone: | +45 3827 3384 |
| Fax: | +45 3827 2727 |
Contact Person
| Name: | Lasse Post Møller |
|---|---|
| Function: | Regulatory Affairs |
| E-mail: | lpm@radiometer.dk |
| Phone: | +45 3827 3436 |
| Fax: | +45 3827 2727 |
2. Description of Device Modification
ABL800 FLEX with AQURE connectivity is a stationary, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions F02Hb, FCOHb, FMetHb, FHHb and FHbF).
The modification consists of integration with the Medical Device Data System (MDDS) called AQURE system. The software enables the initiation of device actions on connected ABL800 series analyzers.
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Image /page/5/Picture/0 description: The image shows the word "RADIOMETER" in gray, block letters. To the right of the word is a gray square containing a circle with the letter "R" inside. The circle is connected to the square by a horizontal line on either side.
3. Intended Use
The ABL800 FLEX analyzers are intended for In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FMetHb, FHHb and FHbF). In addition the ABL800 FLEX is intended for In vitro testing of samples of expired air for the parameters pO2 and pCO2, and for In vitro testing of pleura samples for the pH parameter.
pH: pH is the indispensable measure of acidemia or alkalemia and is therefore an essential part of the pH/blood qas measurement. The normal function of many metabolic processes requires a pH to be within a relatively narrow range.
pO2: The arterial oxygen tension is an indicator of the oxygen uptake in the lungs.
pCO2: pCO2 is a direct reflection of the adequacy of alveolar ventilation in relation to the metabolic rate.
Potassium (cK+): the measurements of the concentration of potassium ions in plasma are used to monitor the electrolyte balance.
Sodium (cNa+): the measurements of the concentration of sodium ions in plasma are used to monitor the electrolyte balance.
Calcium (cCa++): the measurements of the concentration of calcium ions in plasma are used to monitor the electrolyte balance.
Chloride (cCl-): the measurements of the concentration of chloride ions in plasma are used to monitor the electrolyte balance.
Glucose (cGlu): The qlucose measurements measure the concentration of glucose in plasma. The qlucose measurements are used to screen for, diaqnose and monitor diabetes, pre-diabetes and hyper and hypoglycemia.
Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements serve as a marker of critical imbalance between tissue oxygen demand and oxygen supply.
Bilirubin (ctBil): The bilirubin measurements measure the total concentration of bilirubin in plasma. ctBil is used to assess the risk of hyperbilirubinemia.
Total Hemoglobin (ctHb): ctHb is a measure of the potential oxygen-carrying capacity of the blood.
Oxygen Saturation (s02): s02 is the percentage of oxygenated hemoglobin in relation to the amount of hemoglobin capable of carrying oxygen. sO2 allows evaluation of oxygenation.
6
Image /page/6/Picture/0 description: The image shows the word "RADIOMETER" in a sans-serif font. The letters are a light gray color. To the right of the word is a square box with a circle inside of it, and the letter "R" is inside the circle.
Fraction of Oxyhemoglobin (FO2Hb): FO2Hb is a measure of the utilization of the potential oxygen transport capacity; that is the fraction of oxyhemoqlobin in relation to all hemoglobins present (tHb) including dyshemoqlobins.
Fraction of Carboxyhemoglobin (FCOHb): FCOHb is the fraction of carboxyhemoglobin. It is incapable of transporting oxygen.
Fraction of Methemoglobin (FMetHb): FMetHb is the fraction of methemoglobin. It is incapable of transporting oxygen.
Fraction of Deoxyhemoqlobin in Total Hemoglobin (FHHb): FHHb is the fraction of deoxyhemoqlobin in total hemoqlobin. It can bind oxygen then forming oxyhemoqlobin.
Fraction of Fetal Hemoglobin (FHbF): Fetal hemoglobin consist of two a-chains and two ßchains,
and has a higher oxygen affinity than adult Hb.
Creatinine (cCrea): The creatinine measurements measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Pleural pH: The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions. Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of