(190 days)
Not Found
No
The document describes a standard automated blood gas analyzer and data management software. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device measures various parameters in blood for diagnosis and treatment monitoring, but it does not directly administer treatment or therapeutic interventions. It is an in vitro diagnostic device used to provide data for medical decisions.
Yes
The device measures various blood parameters (pH, blood gases, electrolytes, glucose, lactate, and oximetry) that are explicitly stated as being "used in the diagnosis and treatment" of specific diseases and conditions.
No
The device description clearly states that the ABL90 FLEX is a "portable, automated system" that measures various parameters in whole blood. While the modification involves "Data Management software called AQURE system," this software is described as enabling display, data reception, transfer, and initiation of device actions, implying it interacts with and manages data from the physical ABL90 FLEX analyzer, which is a hardware device. The summary does not indicate that the software itself performs the diagnostic measurements or functions independently of the hardware.
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 analyzer measures various parameters in heparinised whole blood. This indicates that the device is used to test samples taken from the human body.
- Device Description: The "Device Description" further clarifies that the system is intended for in vitro testing of samples of whole blood. "In vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Purpose of Measurements: The indications for use clearly state that the measurements are used in the diagnosis and treatment of various disease conditions and disorders. This is a key characteristic of IVD devices, which are used to provide information for diagnostic purposes.
Therefore, based on the provided text, the ABL90 FLEX analyzer 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.
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.
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, JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX
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, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).
The modification consists of Data Management software called AQURE system. The software enables display of test results, receivable of data from connected devices at the point-of-care or laboratory, transfer of test results to the HIS/LIS and initiation of device actions.
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
Not Found
Intended User / Care Setting
trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance characteristics are affected by the change. The performance data submitted in the original submission (K092686) still apply.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K092686 ABL90 FLEX SERIES, Radiometer Medical ApS, K120197 ABL90 FLEX, Radiometer Medical ApS, K122729 ABL90 FLEX, Radiometer Medical ApS
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 word "RADIOMETER" in bold, black, sans-serif font. To the right of the word is a registered trademark symbol. The symbol is a circle with the letter "R" inside of it.
K13014Y
Section 5. 510(k) Summary
JUL 3 1 2013
1. Administrative
Device Information
ABL90 Flex Device Name: 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 Class II Classification : Clinical Chemistry Classification Panel:
Submitter
| Company Name: | Radiometer Medical ApS |
|---|---|
| ER Number: | 3002807968 |
| Address: | Aakandevej 21 |
| 2700 Broenshoej | |
| Denmark | |
| 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, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).
The modification consists of Data Management software called AQURE system. The software enables display of test results, receivable of data from connected devices at the point-of-care or laboratory, transfer of test results to the HIS/LIS and initiation of device actions.
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. Substantial Equivalence
The ABL90 FLEX with AQURE is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:
510(k) Number/Device Manufacturer: K092686 ABL90 FLEX SERIES, Radiometer Medical ApS K120197 ABL90 FLEX, Radiometer Medical ApS K122729 ABL90 FLEX, Radiometer Medical ApS
1
Image /page/1/Picture/0 description: The image shows the word "RADIOMETER" in all caps, followed by the registered trademark symbol. The text is in a bold, sans-serif font. The registered trademark symbol is a capital R inside of a circle, which is then surrounded by a square.
| Similarities | ||
|---|---|---|
| Issue | SE Device | Predicate Device (K092686, K120197 and |
| K122729) | ||
| Intended Use | Same | 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, near | ||
| patient or point-of-care setting. | ||
| Blood Gas | ||
| Measurement | Same | pH, pO2, pCO2 by potentiometry |
| Electrolyte | ||
| Measurement | Same | cK+, cNa+, cCa2+, cCl- by potentiometry |
| Metabolite | ||
| Measurement | Same | cGlu, cLac by amperometry |
| Oximetry | ||
| Measurement | Same | ctHb, sO2, FO2Hb, FHHb, FCOHb, FMetHb, FHbF by |
| spectrophotometry | ||
| Performance | ||
| Characteristics | Same | Identical Performance Characteristics |
| Calibration | Same | Two-Point liquid calibration |
| User Interface | Same | Menu driven touch screen |
| Software operating | ||
| system | Same | Microsoft XPE |
| Sample Introduction | Same | Aspiration |
| Dimensions (height x | ||
| width x depth) | Same | 17.7 × 9.8 × 11.4 in |
| Weight | Same | 11.1 kg |
| Ethernet | Same | 1 × RJ45 connector, |
| 100Base-Tx Fast Ethernet | ||
| USB | Same | Three connectors for USB port |
| Software version | Same | Software version 2.8 (K122729) |
2
Image /page/2/Picture/0 description: The image shows the word "RADIOMETER" in all caps, followed by a circled letter R. The text is in a bold, sans-serif font. The circled R is a registered trademark symbol.
| Differences | ||
|---|---|---|
| Issue | SE Device | Predicate Device |
| (K092686) | ||
| AQURE system | Send Operator data (new, changed) to ABL90 Flex Analyzer | Local Operator Administration at the analyzer |
| Data management software. The software functionalities are: | ||
| Remote display of test results Receivable of data from connected devices at the point-of-care or laboratory Transfer of test results to the HIS/LIS | Analyzer functionalities are: | |
| Local display of test results Direct transfer of test results to the HIS/LIS | ||
| SE Device | Predicate Device | |
| (K120197) | ||
| Initiation of device actions, see section 12.02 Device actions for ABL90 FLEX analyzers | Remote access to the analyser by the Netop host/client OTS software supporting the following functions: | |
| Perform calibrations, Perform replacements, Perform QC measurements, Edit data in the log files, and Approve patient results. |
5, Performance Data
ම . I enformance characteristics are affected by the change. The performance data submitted in the original submission (K092686) still apply.
6. Conclusion
The ABLOG FLEX with AQURE described above is substantially equivalent in Intended Use, fundamental scientific technology, and characteristics to the predicate ABL90 Flex (K092686, K120197 and K122729). For the implementation of the change design control principles (risk management, verification and validation) have been applied which indicated that the change is of no impact to the performance of the device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or lines extending from it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2013
Radiometer Medical ApS C/O Gitte Juel Friis Aakandevej 21 2700 Broenshoej DENMARK
Re: K130144 Trade/Device Name: ABL90 Flex Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX Dated: June 27, 2013 Received: July 1, 2013
Dear Gitte Juel Friis:
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 Amendmounts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or 10 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, l'usting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not mislering.
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 Part 801); 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.
4
Page 2-Mr. Gitte Juel Friis
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.lda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Courtney H. Lias, Ph.D.
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
5
Indications for Use
510(k) Number (if known): K130144
Device Name: ABL90 Flex Analyzer
Indications for Use:
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-ofcare setting. These tests are only performed under a physician's order.
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.
Chloride (cCI-): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.
| Prescription Use _____________________________________________________________________________________________________________________________________________________________ | And/Or | Over the Counter Use _________________________________________________________________________________________________________________________________________________________ |
|---|---|---|
| (21 CFR Part 801 Subpart D) | (21 CFR Part 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles -S 2013.07.31 13:24:35 -04′00″
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)k130144_________________________________________________________________________________________________________________________________________________________
6
Indications for Use
510(k) Number (if known): K130144
Device Name: ABL90 Flex Analyzer
Indications for Use:
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.
Prescription Use _ X And/Or (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Denise Johnson-lyles -S 2013.07.31 13:25:01 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) __k130144 _____________________________________________________________________________________________________________________________________________________________