(338 days)
Not Found
No
The summary describes a standard automated analyzer with sensors and a user interface. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The "smart chip" technology is described for identification and data storage, not for analytical processing using AI/ML.
No
The device measures parameters used in the diagnosis and treatment of conditions, but it does not directly treat or provide therapy to patients. It is a diagnostic tool.
Yes
The ABL90 FLEX measures various biomarkers (pH, blood gases, electrolytes, glucose, lactate, and oximetry) that are explicitly stated to be used in the "diagnosis and treatment of life-threatening," "diagnosis and treatment of disease conditions," and "aid in the diagnosis" of different medical conditions. This purpose aligns directly with the definition of a diagnostic device.
No
The device description clearly outlines hardware components such as sensors, an oximetry module with a spectrometer, an ultrasonic hemolyzer, thermostatic components, and a solution pack for calibration and quality control. It is a physical analyzer, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device measures various analytes (pH, blood gases, electrolytes, glucose, lactate, and oximetry) in heparinized whole blood. These measurements are used in the "diagnosis and treatment of life-threatening acid-base disturbances," "monitoring electrolyte balance in the diagnosis and treatment of disease conditions," and other diagnostic and treatment purposes for various medical conditions.
- Sample Type: The device analyzes "heparinized whole blood," which is a biological specimen taken from the human body.
- Purpose: The measurements provided by the device are used to provide information for the diagnosis, treatment, and monitoring of various diseases and conditions.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, a state of health or disease, or a congenital abnormality.
N/A
Intended Use / Indications for Use
The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in 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.
The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized 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.
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 idiopathion. 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 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)
75CHL, CEM, JGS, JFP, CGZ, CGA, KHP, GHS, GKR, KOI, JIX, JJY
Device Description
The ABL90 FLEX system consists of a modular analyzer Incorporating a user interface module with a large colour touch screen interfacing the analyzer electronic and fluidic modules. The user interface module contains the analyzer CPU and all of the required electronic interfaces for external communication and data storage.
Sensors that measure pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose and lactate are contained in a sensor cassette that connects to the sample inlet. This cassette attaches to the front of the instrument.
An oximetry module measures ctHb, sO2, FO2Hb, FCOHb, FMetHb and FHHb. This module consists of a spectrometer, an ultrasonic hemolyzer and thermostatic components integrated into the instrument.
The system also includes a solution pack for the calibration and automatic quality control of the sensor and oximetry system. The solution pack includes calibration and quality control reagents individually packaged in sealed foil pouches.
The instrument and consumables incorporate "smart chip" technology for unique identification and lot-specific calibration and quality control data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
The following data has been generated for the ABL90 FLEX
A: Method Comparison
B: Precision
C: Linearity/Assay Reportable Range
D: Limit of Quantitation
E: Calibration/Quality Control
F: Analytical Specificity Interferences
G: User Testing
H: Stability
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.
K08370 ABL80 FLEX Co-OX, K050869 Modification to ABL800 FLEX, K041874 ABL800 FLEX, K002290 ABL735 Series, K982928 NPT7, K980135 QUALICHECK5
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
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.
0
510(k) Premarket Notification Submission
RADIOMETER R
""
ABL90 FLEX Analyzer
Section 5. 510(k) Summary
AUG 0 6 20:00
092686
1. Submitter Information
- A. Establishment Registration: 3002807968
- B. Manufacturing Site: Radiometer Medical ApS
- C. Company Address: Akandevej 21, DK-2700 Brønshøi, Denmark
- D. Date Prepared: August 26, 2009
2. Contact Person
- A. Jana S. Hellmann
- B. Phone: (+45) 3827 3389
C. Fax: (+45) 3827 2727
- D. Åkandevej 21, DK-2700 Brønshøj, Denmark
- E. E-mail: jana.hellmann@radiometer.dk
3. Application Correspondent
- A. Lone Rønnemoes Pedersen
- B. Phone: (+45) 3827 3335
C. Fax: (+45) 3827 27227
- D. Address: Åkandevej 21, DK-2700 Brønshøj, Denmark
- E. E-mail: lone.ronnemoes@radiometer.dk
4. Device Identification
- A. Trade/Proprietary Name: ABL90 FLEX
B. Classification: Class II (21CFR § 862.1120)
C. Product Code: 75CHL.
D. Subsequent Codes: CEM, JGS, JFP, CGZ, CGA, KHP, GHS, GKR, KOI, JIX, JJY
5. Device Description
The ABL90 FLEX system consists of a modular analyzer Incorporating a user interface module with a large colour touch screen interfacing the analyzer electronic and fluidic modules. The user interface module contains the analyzer CPU and all of the required electronic interfaces for external communication and data storage.
Sensors that measure pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose and lactate are contained in a sensor cassette that connects to the sample inlet. This cassette attaches to the front of the instrument.
An oximetry module measures ctHb, sO2, FO2Hb, FCOHb, FMetHb and FHHb. This module consists of a spectrometer, an ultrasonic hemolyzer and thermostatic components integrated into the instrument.
The system also includes a solution pack for the calibration and automatic quality control of the sensor and oximetry system. The solution pack includes calibration and quality control reagents individually packaged in sealed foil pouches.
1
ABL90 FLEX Analyzer
The instrument and consumables incorporate "smart chip" technology for unique identification and lot-specific calibration and quality control data.
6. Intended Use
The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in 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.
7. Substantial Equivalence
The ABL90 FLEX is substantially equivalent in features and characteristics to the predicates: the ABL80 FLEX Co-Ox, the ABL800 FLEX, the ABL735, the NPT7 and the QUALICHECK5 .
510(k) Number/Device Manufacturer: K08370 ABL80 FLEX Co-OX, SenDx Medical, Inc. K050869 Modification to ABL800 FLEX, Radiometer Medical ApS K041874 ABL800 FLEX, Radiometer Medical ApS K002290 ABL735 Series, Radiometer Medical A/S K982928 NPT7, Radiometer America Inc. K980135 QUALICHECK5*, Radiometer America Inc.
With the ABL800 FLEX, ABL735 Series and the ABL90 FLEX, the principles of operation are similar for all parameters except pO2: Amperometry: Glucose, Lactate Potentiometry: pH, pCO2, sodium, potassium, calcium, chloride, Spectrophotometry: ctHb, sO2, FO2Hb, FCOHb, FMetHb and FHHb.
With the NPT7 and the ABL90 FLEX, the same optical measurement principle is used for pO2, viz. phosphorescence quenching.
8. Performance Data
The following data has been generated for the ABL90 FLEX
A: Method Comparison
- B. Precision
- C. Linearity/Assay Reportable Range
- D. Limit of Quantitation
- E. Calibration/Quality Control
- F. Analytical Specificity Interferences
- G. User Testing
- H. Stability
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Radiometer Medical APS c/o Martin Gabler Regulatory Affairs Akandevej 21. Bronshoi Denmark DK-2700
JUN 0 2 2011
Re: K092686 Trade/Device Name: ABL90 Flex Regulation Number: 21 CFR 862.1600 Regulation Name: Potassium test system. Regulatory Class: II Product Code: CEM, CGA, CGZ, CHL, GHS, GKR, JFP, JGS, JIX, KQI, JJY, KHP Dated: July 29, 2010 Received: August 2, 2010
Dear Mr. Gabler:
This letter corrects our substantially equivalent letter of August 6, 2010.
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (30) and 5450. 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 Small Manufacturers, International on Consumer Assistance at its toollaboration in the Act Trom the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Enclosure
4
Indication for Use
510(k) Number: K092686
Device Name: ABL90 FLEX
Indication For Use:
The ABL90 FLEX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized 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.
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.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
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 Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092686
5
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 idiopathion. 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 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 (21 CFR Part 801 Subpart D) And/Or
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 Diagnostic Device Evaluation and Safety (OIVD)
Dins
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) is 092686