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.

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.

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.

AI/ML Overview

This 510(k) submission describes a device modification to the ABL90 Flex, specifically the integration with Netop™ for remote access functionalities. The crucial point articulated in the document is that "No performance characteristics are affected by the change. The performance data submitted in K092686 still apply."

This statement fundamentally changes how we address your request. Typically, an acceptance criteria table and a description of a study proving the device meets those criteria would involve new performance data. However, for this specific submission, the "study" demonstrating the device meets acceptance criteria is essentially the assertion that no new performance data is needed because the modification does not impact performance.

Therefore, the answers below are structured to reflect this nature of the submission.

1. A table of acceptance criteria and the reported device performance

Given the statement that "No performance characteristics are affected by the change," new acceptance criteria and performance data for the modified device were not generated. The acceptance criteria and reported device performance for the ABL90 Flex remain as established in the original 510(k) K092686. The table below represents the original performance characteristics and their acceptance, as implied by the substantial equivalence argument, rather than new data for this specific modification.

Parameter	Performance Characteristic (from K092686 - summarized)	Acceptance Criteria (from K092686 - summarized)	Reported Device Performance (from K092686 - summarized)
pH	Accuracy, Precision	Clinically acceptable limits (e.g., within X standard deviation of reference method)	Met established clinical performance
pO2	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
pCO2	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
Potassium (cK+)	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
Sodium (cNa+)	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
Calcium (cCa2+)	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
Chloride (cCl-)	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
Glucose (cGlu)	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
Lactate (cLac)	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
Total Hemoglobin (ctHb)	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
Oxygen Saturation (sO2)	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
Hemoglobin fractions (FO2Hb, FCOHb, FMetHb, FHHb, FHbF)	Accuracy, Precision	Clinically acceptable limits	Met established clinical performance
Remote Access Functions (via Netop™)	Functionality (e.g., perform calibrations, QC measurements, approve results)	Software performs intended functions without affecting core analytical performance.	No adverse impact on current performance characteristics of the ABL90 Flex.

Study Proving Acceptance Criteria Met (for this K120197 submission):

The "study" proving the device meets acceptance criteria for this specific 510(k) (K120197) is the lack of further performance testing due to the nature of the modification. The manufacturer asserts that the integration with Netop™ for remote access does not impact the analytical performance characteristics of the ABL90 Flex. The FDA's clearance implies agreement with this assertion, based on the provided information comparing the modified device to the predicate.

2. Sample size used for the test set and the data provenance

For this 510(k) (K120197): Not applicable for new performance data. No new clinical or analytical test set was evaluated, as the modification did not affect performance characteristics. The safety and effectiveness data from the predicate device (K092686) would have been based on performance studies, but details of those are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For this 510(k) (K120197): Not applicable for new performance data. Ground truth for the original performance of the ABL90 Flex (K092686) would have been established using reference methods and potentially expert review in clinical studies as appropriate for an in vitro diagnostic device, but specific details are not available in this modification summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

For this 510(k) (K120197): Not applicable for new performance data. Adjudication methods are typically relevant for human interpretation of results or image-based diagnostics. For an automated analyzer, the "ground truth" is predominantly based on highly accurate reference methods.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

For this 510(k) (K120197): Not applicable. This device is an automated blood gas analyzer, not an AI-assisted diagnostic tool that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

For this 510(k) (K120197): Not applicable for new performance data. However, the core ABL90 Flex device is a standalone automated analyzer. The modification (Netop™ integration) adds remote access capabilities but does not introduce an "algorithm only" performance study in the context of typical AI/software submissions. The performance of the analyzer itself is inherently standalone.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this 510(k) (K120197): Not applicable for new data. For the original device (K092686), the ground truth for blood gas and chemistry measurements would have been established by highly accurate and traceable reference methods (e.g., primary standard gases, gravimetric methods, recognized laboratory reference instruments) for accuracy studies, and repeated measurements for precision studies.

8. The sample size for the training set

For this 510(k) (K120197): Not applicable. This modification involves software integration for remote access to existing functions, not an AI/machine learning model requiring a training set.

9. How the ground truth for the training set was established

For this 510(k) (K120197): Not applicable, as no training set was used for this modification.

Summary

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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 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

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Predicate: ABL90 Flex (K092686)
Similarities	Differences
Intended UseThe ABL90 FLEX is a portable, automatedanalyzer that measures pH, blood gases,electrolytes, glucose, lactate and oximetry inheparinised whole blood. The ABL90 FLEX isintended for use by trained technologists,nurses, physicians and therapists. It isintended for use in a laboratory environment,near patient or point-of-care setting.	Remote access to the analyser by the Netophost/client OTS software supporting thefollowing functions:- Perform calibrations,- Perform replacements,- Perform QC measurements,- Edit data in the log files, and- Approve patient results.
Blood Gas MeasurementpH, pO2, pCO2 by potentiometry
Electrolyte MeasurementcK+, cNa+, cCa2+, cCl- by potentiometry
Metabolite MeasurementcGlu, cLac by amperometry
Oximetry MeasurementctHb, sO2 FO2Hb, FHHb, FCOHb, FMetHb,FHbF
Hemoglobin MeasurementSpectrophotometry
Identical Performance CharacteristicsTwo-Point liquid calibration
Menu driven touch screen
Software operating systemMicrosoft XPE
Sample IntroductionAspiration
Dimensions (length x width x depth)
External Power Source230/120 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

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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).

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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

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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.

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

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Indications for Use

510(k) Number (if known): K120197

Device Name: ABL90 FLEX Analyzer

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

Regulation Number and Section

§ 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.