(56 days)
Not Found
No
The summary describes a standard automated blood gas analyzer and does not mention any AI or ML capabilities.
No
This device is an automated analyzer for measuring various parameters in blood samples, used for diagnosis and monitoring, not for treating conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements performed by the device (e.g., pH, blood gases, electrolytes, glucose, lactate, oximetry) "are used in the diagnosis and treatment of life-threatening acid-base disturbances" and various other disease conditions.
No
The device description clearly states it is a "portable, automated system intended for in vitro testing of samples of whole blood," indicating it is a hardware device that performs physical measurements. While it mentions integration with software for remote access, the core device is 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 device "measures pH, blood gases, electrolytes, glucose, lactate and oximetry in heparinized whole blood." These are all measurements performed on biological samples in vitro (outside the body).
- Device Description: The "Device Description" further clarifies that the system is "intended for in vitro testing of samples of whole blood".
- Purpose of Measurements: The descriptions of what each parameter measurement is used for (e.g., diagnosis and treatment of acid-base disturbances, monitoring electrolyte balance, diagnosis of diabetes mellitus) clearly indicate that the results are used for medical purposes related to a patient's health status, which is a key characteristic of IVDs.
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 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 idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Lactate (cLac): The lactate measurements measure the concentration of lactate in plasma. Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)
Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
FO2Hb: oxyhemoglobin as a fraction of total hemoglobin.
FCOHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
FMetHb: methemoglobin as a fraction of total hemoglobin.
FHHb: reduced hemoglobin as a fraction of total hemoglobin.
Fraction of Fetal Hemoglobin (FHbF): FHbF indicates the amount of fetal hemoglobin. FHbF is seldom used clinically.
Product codes (comma separated list FDA assigned to the subject device)
CHL, CEM, CGA, CGZ, GHS, GKR, JFP, JGS, JIX, KQI, JJY, KHP
Device Description
The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).
The integration with Netop™ allows remote operators to access a specific ABL90 Flex analyser and to execute a number of predefined functions.
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)
No performance characteristics are affected by the change. The performance data submitted in 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
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
Special 510(k): Device Modification to ABL90 Flex
Section 5. 510(k) Summary
120197
MAR 1 9 2012
1. Administrative
Device Information Device Name: Common Name: Product Code: Registration Number: Classification : Classification Panel:
ABL90 Flex Blood gases and blood pH test system CHL (JGS, CEM; JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX) 21 CFR 862.1120 Class II Clinical Chemistry
Submitter . Company Name: ER Number: .
Address:
Phone:
Fax:
Radiometer Medical ApS 3002807968 Aakandevej 21 2700 Broenshoej Denkmark 445 3827 3827 +45 3827 2727
2. Description of Device Modification
The ABL90 FLEX is a portable, automated system intended for in vitro testing of samples of whole blood for the parameters pH, pO2 , pCO2, potassium, sodium, calcium, chloride, glucose, lactate, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, F MetHb, FHHb and FHbF).
The integration with Netop™ allows remote operators to access a specific ABL90 Flex analyser and to execute a number of predefined functions.
3. Intended Use
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.
4. Substantial Equivalence
The ABL90 FLEX with the integration with Netop™ is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:
510(k) Number/Device Manufacturer: K092686 ABL90 Flex, Radiometer Medical ApS
1
| Predicate: ABL90 Flex (K092686) | |
|---|---|
| Similarities | Differences |
| Intended Use | |
| 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. | 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. |
| Blood Gas Measurement
pH, pO2, pCO2 by potentiometry | |
| Electrolyte Measurement
cK+, cNa+, cCa2+, cCl- by potentiometry | |
| Metabolite Measurement
cGlu, cLac by amperometry | |
| Oximetry Measurement
ctHb, sO2 FO2Hb, FHHb, FCOHb, FMetHb,
FHbF | |
| Hemoglobin Measurement
Spectrophotometry | |
| Identical Performance Characteristics
Two-Point liquid calibration | |
| Menu driven touch screen | |
| Software operating system
Microsoft XPE | |
| Sample Introduction
Aspiration | |
| Dimensions (length x width x depth) | |
| External Power Source
230/120 V mains | |
5. Performance Data
No performance characteristics are affected by the change. The performance data submitted in K092686 still apply.
Page 2 of 2
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Radiometer Medical ApS c/o Martin Gabler Aakandevej 21 Denkmark DK-2700
MAR 1 9 2012
K120197 Re:
Trade Name: ABL90 Flex Regulation Number: 21 CFR §862.1120 Regulation Name: Blood Gases and blood pH test system Regulatory Class: Class II Product Codes: CHL, CEM, CGA, CGZ, GHS, GKR, JFP, JGS, JIX, KQI, JJY, KHP Dated: February 28, 2012 Received: March 2, 2012
Dear Mr. Gabler:
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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
Signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K120197
Device Name: ABL90 FLEX Analyzer
Indications 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, p02 and pC02: pH, pC02 and p02 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 (cCT): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.
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)
Rute Chealer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120197
5
Indications for Use
510(k) Number (if known): K120197
Device Name: ABL90 FLEX Analyzer
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.
sO>: 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)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Rute Chaber
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 120197