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.

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.

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 labelling and the software has been modified to assure that the Operator does not use qlucose results obtained from samples with a pO2 level below 25 mmHg.

AI/ML Overview

This document describes a Special 510(k) submission for a device modification to the ABL90 Flex, specifically related to the suppression of cGlu (glucose) results when pO2 levels are below 25 mmHg.

1. Table of Acceptance Criteria and Reported Device Performance

Hazard	Acceptance Criteria	Testing Results Summary	Met Acceptance Criteria?
41/Too low Glucose result in the upper reportable range obtained from samples with low pO2 level	Bias: <10% for glucose when pO2 is > 25 mmHg when compared to the reference method	The results are valid under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg.	Passed. The acceptance criterion is met under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg.
48/Unacceptable bias on Glucose results obtained from samples with pO2 levels above 25 mmHg	Bias: <10% for glucose when pO2 is > 25 mmHg when compared to the reference method	The results are valid under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg.	Passed. The acceptance criterion is met under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg.
49/Too low Glucose result in the lower and medium reportable range obtained from samples with low pO2 level	Bias: <10% for glucose when pO2 is > 25 mmHg when compared to the reference method	The results are valid under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg.	Passed. The acceptance criterion is met under the condition that all glucose results are suppressed when the pO2 level of the sample is below 25 mmHg.

Note: The table provided in the input shows specific bias percentages for different cGlu and pO2 levels in a separate "Testing results summary" section. I have extracted the overall "Meet the acceptance criteria or not?" statement for the acceptance table as it represents the final determination.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The interference study involved:
- 5-7 different pO2 levels
- 5 different glucose levels
- 10 analyzers
- 5 tests of each sample on each analyzer
- 3 runs
- Total of 3150 measurements.
Data Provenance: The study used "fresh heparinized samples." The document does not specify the country of origin of the data, but the submitter is Radiometer Medical ApS, located in Denmark. It is a prospective study as it describes validations and verifications activities, including an "Interference study."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This study does not involve human readers or experts establishing ground truth in the traditional sense of medical image analysis. The ground truth for the glucose measurements is established by a "reference method" as indicated by the acceptance criteria "compared to the reference method." The qualifications of those performing the reference method measurements are not specified.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers with potential disagreements requiring adjudication. The direct comparison is between the device's measurement and a reference method.

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

Not applicable. This is not an MRMC comparative effectiveness study and does not involve AI assistance for human readers. The modification is a software change to suppress glucose results under certain conditions to ensure accuracy.

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

Yes, a standalone study (interference study) was done to evaluate the performance of the device's glucose measurement algorithm under varying pO2 and glucose levels. The software modification itself (suppression of results) is an algorithm-only function.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance was a reference method for glucose measurement. The specific nature of this reference method (e.g., a laboratory gold standard instrument) is not detailed in the provided text.

8. The Sample Size for the Training Set

Not applicable. This document describes a modification to an existing device and its verification, not the development or training of a new algorithm. The term "training set" is usually associated with machine learning models. The study described here is an interference study to validate a device modification.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a training set for a new algorithm.

Summary

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Special 510(k): Device Modification to ABL90 Flex - cGlu Suppression

RADIOME

Section 5. 510(k) Summary

1. Administrative

NOV 1 6 2012

Device Information Device Name: ABL90 Flex 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 Classification : Class II Clinical Chemistry Classification Panel:

Submitter
Company Name:	Radiometer Medical ApS
ER Number:	3002807968
Address:	Aakandevej 212700 BroenshoejDenkmark
Phone:	+45 3827 3827
Fax:	+45 3827 2727

2. Description of Device Modification

The labelling and the software has been modified to assure that the Operator does not use qlucose results obtained from samples with a pO2 level below 25 mmHg.

3. Intended Use

4. 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.

Calcium (cCa2+): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

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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 includinq diabetes mellitus and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Total Hemoglobin (ctHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

sO3: 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.

5. Substantial Equivalence

The ABL90 FLEX with the modification described above is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:

510(k) Number/Device Manufacturer:

K120197 ABL90 Flex, Radiometer Medical ApS

Predicate: ABL90 Flex (K120197)
Similarities	Differences
Intended Use	Added caution to manual:
The 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,	Low pO2 levels can influence the linearity ofglucose measurements, and can thereforeresult in falsely low glucose results. Pleasenote that glucose performance is not specifiedwhen the pO2 is less than 25 mmHg (3.33kPa).
near patient or point-of-care setting.	The linearity of the glucose is dependent onthe oxygen tension of the sample. Thisdependence is due to the co-reaction ofglucose and oxygen by the enzyme glucoseoxidase. Low pO2 levels can influence thelinearity of the glucose sensor. The followingtable outlines the glucose linearity as afunction of the pO2.

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Similarities	Differences
Blood Gas MeasurementpH, pO2, pCO2 by potentiometry	Added information to manual:
	Impact of the pO2 level on Glucoselinearity and specifications of the ABL90FLEX analyzer
	If the pO2 level in a sample is: Then cGlu linearity specifications only apply to cGlu values between: <25 mmHg (3.33 kPa) Linearity not specified.Glu is not usable.
	Software changes:
	- Suppression of glucose results when pO2 < 25 mmHg- Message: "Glu not usable"
Electrolyte MeasurementcK+, cNa+, cCa2+, cCl- by potentiometry
Metabolite MeasurementcGlu, cLac by amperometry
Oximetry MeasurementctHb, sO2 FO2Hb, FHHb, FCOHb, FMetHb, FHbF
Hemoglobin MeasurementSpectrophotometry
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

6. Design Control Activities

The risk associated with a negative bias on glucose results obtained from samples with low pO₂ level was assessed in a risk analysis. An interference study confirmed that this could lead to an unacceptable negative bias of more than 10% on glucose values in the upper reportable range.

# / Hazard	Validations andVerificationsactivitiesdescriptions	Pre-determinedAcceptancecriteria	Testing results summary	Meet theacceptancecriteria ornot?
41/Too low Glucoseresult in the upperreportable rangeobtained fromsamples with lowpO2 level	Interference study atdifferent pO2 levelsand at differentglucose levelscovering thereportable range ofthe analyser usingfresh heparinizedsamples.	Bias: <10% forglucose whenpO₂ is > 25mmHg whencompared to thereferencemethod	30 days5-7 different pO₂ levels5 different glucose levels10 analyzers5 tests of each sample on eachanalyzer3 runsTotal of 3150 measurements	PassedThe acceptancecriterion is metunder thecondition thatall glucoseresults aresuppressedwhen the pO₂level of the
48/Unacceptable biason Glucose resultsobtained from			The results are valid under the

. .

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. . . .

# / Hazard	Validations andVerificationsactivitiesdescriptions	Pre-determinedAcceptancecriteria	Testing results summary	Meet theacceptancecriteria ornot?
samples with pO2levels above 25mmHg			condition that all glucose results aresuppressed when the pO2 level of thesample is below 25 mmHg allacceptance criteria are met:Bias < 10%	sample is below25 mmHg.
49/Too low Glucoseresult in the lowerand mediumreportable rangeobtained fromsamples with lowpO2level

and the comments of the comments of

. . .

100 million in the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the st

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RADIOMET Special 510(k): Device Modification to ABL90 Flex - cGlu Suppression

ਿੰ

	cGlu= 36 mg/dL(2 mmol/L)	cGlu= 108 mg/dL(6 mmol/L)	cGlu= 180 mg/dL(10 mmol/L)	cGlu= 450 mg/dL(25 mmol/L)	cGlu= 720 mg/dL(40 mmol/L)
ave pO₂[mmHg]	BiasABL735[mg/dL] [%]	BiasABL735[mg/dL] [%]	BiasABL735[mg/dL] [%]	BiasABL735[mg/dL] [%]	BiasABL735[mg/dL] [%]
17.9	0.72 2.36	14.9 0.90 0.77	14.8 -7.56 -4.15	16.1 -37.26 -8.30	13.5 -81.0 -11.20
28.4	0.54 1.78	30.5 1.08 0.97	26.4 -3.42 -1.91	27.4 -7.74 -1.79	25.6 -9.36 -1.32
					33.3 -46.8 -6.67
46.8	1.62 4.95	43.0 1.80 1.75	43.8 2.52 1.45	41.6 -0.18 -0.05	44.9 24.8 3.65
62.1	0.54 1.46	55.5 1.44 1.29	60.7 -1.08 -0.63	60.2 1.62 0.36	59.0 29.7 4.43
77.0	0.54 1.43	80.8 1.26 1.27	75.4 -0.72 -0.37	74,7 -0.9 -0.21	76.2 27.0 4.03
					97.6 4.86 0.70

The labeling and the software has been that the Operator does not use glucose results obsined from sample
with a pg. level below 25 mm|g.
The verification and validation acti

The verification and validation activities for the software change have been conducted and it has been concluded that the device is
effective and safe.

Performance Data
The performance data submitted in the original submission (K092686) still apply
Conclusion
The ABL90 FLEX with the modification described above is substantially equivalent in Intended Use, fundamental scientified

Page 5 of 5

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of a human figure embracing the world, rendered in a dark color. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD . 20993-002

November 16, 2012

Radiometer Medical ApS c/o Martin Gabler Akandevej 21 Bronshoj 2700 Denmark

Re: K122729

Trade/Device Name: ABL90 FLEX Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (pCO2, PO2) and blood pH test system Regulatory Class: Class II Product Code: CHL, CEM, CGA, CGZ, GHS, GKR, JFP, JGS, JIX, KQI, KHP,JJY Dated: October 16, 2012 Received: October 22, 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 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.

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Page 2 -- Martin Gabler

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 Diagnostics and Radiological Health at (301) 796-5450. 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 and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson

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

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Indications for Use

510(k) Number (if known): K122729

Device Name: ABL90 Flex

Indications for Use:

Intended Use:

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.

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 Diagnostics and Radiological Health (OIR)

Division Sigh/Off

Office of In Vitro Diagnostics and Radiological Health (OIR)

Page 1 of 2

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122729

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 × (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 Diagnostics and Radiological Health (OIR)

Yung Chan

of In Vitro Diagnostics and Radiological Health (OIR)

510(k) K122729

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.