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 oxyhemoqlobin plus reduced hemoglobin.

FO2Hb: oxyhemoqlobin as a fraction of total hemoglobin.

FCOHb: carboxyhemoqlobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoqlobin 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, chloride, glucose, lactate, and co-oximetry parameters (total hemoqlobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF).

AI/ML Overview

This document describes modifications to the ABL90 FLEX device, specifically software changes to suppress glucose results under certain low pO2 conditions. The following is a summary of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Hazard	Validation/Verification Activity	Pre-determined 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	Interference study at different pO2 levels and at different glucose levels covering the reportable range of the analyzer using fresh heparinized whole blood samples.	Bias: ≤10% for glucose when pO2 is > 10 mmHg when compared to the control	6 different pO2 levels (+ pO2 ≥90 mmHg as control), 7 different glucose levels, 3 analyzers, 6 tests of each sample on each analyzer, 2 runs. Total of 1512 measurements. The results are valid under the conditions that: - all glucose results are suppressed when the pO2 level of the sample is below 10 mmHg. - all glucose results are suppressed when pO2 level of the sample is between 10 mmHg and 25 mmHg and the glucose level is above 270 mg/dL. All acceptance criteria are met: Bias < 10%. Detailed Interference Study Results: CV% (XTEST - XCONTROL) at various pO₂ and cGLu levels:	pO₂ [mmHg]
49/Too low Glucose result in the lower and medium reportable range obtained from samples with low pO2 level	Precision study at different pO2 levels and at different glucose levels representing clinical decision points at low, medium and high glucose.	CV%: ≤ 10%	20 days, 3 different pO2 levels, 3 different glucose levels, 2 tests of each sample each day, 2 runs. Total of 2160 measurements. The results are valid under the conditions that: - all glucose results are suppressed when the pO2 level of the sample is below 10 mmHg. - all glucose results are suppressed when pO2 level of the sample is between 10 mmHg and 25 mmHg and the glucose level is above 270 mg/dL. All acceptance criteria are met: CV% < 10%. Detailed Precision Study Results:	cGlu level
48/Unacceptable bias on Glucose results obtained from samples with pO2 levels above 25 mmHg	(Covered by Interference Study)	(Covered by Interference Study)	(Covered by Interference Study)	Passed
(General Performance) Method Comparison	Method comparison study versus a comparative analyzer (ABL735).	Slope: 0.9 - 1.1Intercept: 0Correlation Coefficient: ≥ 0.95	Linear regression of the pooled data gives a slope of 0.9206, intercept of 0.084 and an R² ≥ 0.95.	Passed

2. Sample Sizes and Data Provenance

Interference Study (Test Set):

Sample Size:
- 6 different pO2 levels (including a control at ≥90 mmHg)
- 7 different glucose levels
- 3 analyzers
- 6 tests of each sample on each analyzer
- 2 runs
- Total: 1512 measurements
Data Provenance: Fresh heparinized whole blood samples. The document does not specify the country of origin but implies an in-house study ("Radiometer Medical ApS"). The samples are likely prospective as they are "fresh heparinized whole blood samples" and "untreated donor samples in combination with spiked donor blood."

Precision Study (Test Set):

Sample Size:
- 20 days
- 3 different pO2 levels
- 3 different glucose levels
- 2 tests of each sample each day
- 2 runs
- Total: 2160 measurements
Data Provenance: Serum pool sample of glucose. The document does not specify the country of origin but implies an in-house study ("Radiometer Medical ApS"). likely prospective.

Method Comparison Study:

Sample Size: A total of 52 different donors and approximately 500 samples.
Data Provenance: In-house study using untreated donor samples in combination with spiked donor blood where necessary. Likely prospective.

3. Number of Experts and Qualifications for Ground Truth

The studies described are for an in vitro diagnostic device measuring blood analytes. The ground truth for such devices is typically established through a reference method or comparator device, not clinical expert consensus in the way image analysis or clinical diagnosis algorithms would.

Interference Study: The ground truth for bias calculation was established by comparing results to a "control" pO2 level (≥90 mmHg). This relies on the established accuracy of the glucose measurement at optimal pO2.
Precision Study: The ground truth is inherent in the known concentrations of glucose levels in the serum pool samples used.
Method Comparison Study: The ground truth was established by comparison to results from a "comparative analyzer (ABL735)," which is a predicate device.

Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in the context of clinical interpretation (e.g., radiologists for images) is not applicable here. The ground truth is based on laboratory-defined reference measurements or a well-established predicate device.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used for subjective assessments where multiple human readers disagree (e.g., interpreting medical images or clinical notes). This document describes performance studies for an in vitro diagnostic device, where results are quantitative measurements. Discrepancies would be resolved through re-testing, calibration, or investigation of instrument malfunction, not clinical adjudication by experts. Therefore, no formal adjudication method of this type is mentioned or expected.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing the impact of AI on human reader performance, typically in diagnostic imaging or similar fields where human interpretation is central. This document focuses on the analytical performance of an in vitro diagnostic device, specifically the impact of a software modification on glucose measurement accuracy under certain pO2 conditions. The comparisons are between the device's results and reference methods/predicate devices, not between human readers with and without AI.

6. Standalone Performance

Yes, standalone performance was done. The entire submission describes the standalone analytical performance of the ABL90 FLEX device, particularly its glucose measurement under varying pO2 conditions, after the proposed software modification. The studies (Interference, Precision, Method Comparison) evaluate the device's inherent measurement capabilities and the impact of the software suppression logic without human intervention in the continuous measurement process. The modification itself involves the device automatically suppressing results based on pO2 and glucose levels.

7. Type of Ground Truth Used

Interference Study: The ground truth for bias calculation was primarily reference measurements at optimal pO2 (≥90 mmHg) and the known concentrations of spiked glucose.
Precision Study: The ground truth was based on the known concentrations of glucose in the serum pool samples used.
Method Comparison Study: The ground truth was established through comparison with a predicate device (ABL735) and likely involved reference methods for its initial validation.

In essence, the ground truth for these analytical performance studies is rooted in established reference values, comparator devices, and controlled experimental conditions where "true" concentrations or performance characteristics are either known or determined by a validated reference standard.

8. Sample Size for the Training Set

The document does not explicitly state a separate "training set" sample size. This is common for analytical performance studies of this nature, especially when the modification is primarily a software rule change based on understanding of the underlying chemistry (glucose oxidase co-reaction with oxygen). The "training" in such cases might involve development and initial testing against known samples to define the suppression rules, which is not typically formalized as a distinct "training set" in the context of a 510(k) submission for IVDs. The "test set" described above (1512 measurements for interference, 2160 for precision) serves as the primary validation data.

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

As noted above, a formal "training set" with ground truth establishment in the machine learning sense is not explicitly described or necessarily applicable here. The software modification (suppression rules) likely emerged from:

Understanding of the underlying scientific principle: The document states, "The linearity of the glucose is dependent on the oxygen tension of the sample. This dependence is due to the co-reaction of glucose and oxygen by the enzyme glucose oxidase." This foundational knowledge guides the need for suppression.
Prior internal R&D data/experiments: Radiometer would have conducted extensive internal studies to characterize the glucose sensor's performance across various pO2 and glucose concentrations to determine the thresholds (e.g., <10 mmHg, 10-25 mmHg, >270 mg/dL) at which accuracy is compromised. This data, if it exists, would have informed the development of the suppression logic.

Therefore, the "ground truth" for developing these rules would be based on analytical measurements from controlled experiments using samples with known glucose and pO2 concentrations, helping to define the performance boundaries.

Summary

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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 circled "R" symbol, which is a registered trademark symbol. The text is horizontally aligned and centered.

P 1 7 2013

510(k) Summary

K131988

1. Administrative

Device Information ABL90 Flex Device Name: Blood gases (pCO2 and pO2) and blood pH test system Common Name:

CHL, JGS, CEM, JFP, CGZ, CGA, KHP, GKR, GHS, KQI, JJY, JIX Product Code: 21 CFR 862.1120, 862.1600, 862.1345, 862.1170, 864.7425, 864.5620, Device Classification: 862.1145, 862.1665, 862.1150, 864.7455, 862.1660, 862.1450 Class II, II, II, II, II, II, II, II, II, II, II, I (reserved), I (limitation to Classification: · exemption per 21 CFR 862.9 (c)(9)), respectively. Clinical Chemistry (75) and Hematology (81) Classification Panel:

Purpose of submission: Introduction of a modification that consists of labeling and software changes that suppress glucose results obtained from samples with pO2 levels below 10mmHg, and to suppress glucose results >270mg/dL obtained from samples with 10mmHg < p02 < 25mmHg.

Submitter

Company Name:	Radiometer Medical ApS
ER Number:	3002807968
Address:	Aakandevej 21
	2700 Broenshoej
	Denmark
Phone:	+45 3827 3827
Fax:	+45 3827 2727

Application Correspondent

Name:	Gitte Juel Friis
Function:	Regulatory Affairs
E-mail:	gitte.friis@radiometer.dk
Phone:	+45 3827 3384
Fax:	+45 3827 2727

2. Description of Device Modification

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

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RADIOMETER

trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting.

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.

Chloride (cCl¯): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

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 oxyhemoqlobin plus reduced hemoglobin.

FO2Hb: oxyhemoqlobin as a fraction of total hemoglobin.

FCOHb: carboxyhemoqlobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

FMetHb: methemoqlobin 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:

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RADIOMETER R

510(k) Number/Device Manufacturer: K122729 ABL90 Flex, Radiometer Medical ApS

・

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and the same of the same of the same of the same of the same of the same of the same of the season of the season

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.	Modified caution to manual: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 10 mmHg (1.33kPa).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.
Blood Gas MeasurementpH, pO2, pCO2 by potentiometry	Modified information to manual:Impact of the pO2 level on Glucoselinearity and specifications of the ABL90FLEX analyzer If the pO2level in asample is: Then cGlu linearityspecifications only applyto cGlu values between: <10 mmHg(1.33 kPa) Linearity not specified.Glu is not usable. 10 ≤ pO2 <25 mmHg(1.3 ≤ pO2< 3.3 kPa) 0.5 - 15 mmol/L(9 - 270 mg/dL)If cGlu >270 mg/dL, thelinearity is not specifiedand the cGlu value notusable. ≥25 mmHg(3.3 kPa) 0.5 - 40 mmol/L(9 - 720 mg/dL)

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Traditional 510(k): Modification to ABL90 Flex -Specific cGlu Suppression

Predicate: ABL90 Flex (K122729)
Similarities	Differences
Electrolyte MeasurementcK+, cNa+, cCa2+, cCl- by potentiometry	Software changes:- Suppression of glucose results whenpO2 < 10 mmHg- Suppression of glucose results>270mg/dL when pO2 is between 10 -25mmHg- Message: "Glu not usable"
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 Source230/120 V mains

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6. Design Control Activities
# / Hazard	Validations and Verifications activities descriptions	Pre-determined Acceptance criteria	Testing results summary	Meet the acceptance criteria or not?
41/Too lowGlucose result inthe upperreportable rangeobtained fromsamples withlow pO2 level	Interference study atdifferent pO2levels and atdifferentglucose levelscovering thereportablerange of theanalyserusing freshheparinizedwhole bloodsamples.	Bias: ≤10%for glucosewhen pO2 is> 10 mmHgwhencompared tothe control	6 different pO2 levels+ pO2 ≥90 mmHg as control7 different glucose levels3 analyzers6 tests of each sample on eachanalyzer2 runsTotal of 1512 measurementsThe results are valid under theconditions that- all glucose results aresuppressed when the pO2level of the sample is below10 mmHg, and- all glucose results aresuppressed when pO2 level ofthe sample is between 10mmHg and 25 mmHg and theglucose level is above 270mg/dLall acceptance criteria are met:Bias < 10%	PassedThe acceptance criterion ismet under the conditionsthat all glucose results aresuppressed when the pO2level of the sample isbelow 10 mmHg, and- all glucose results aresuppressed when pO2 levelof the sample is between10 mmHg and 25 mmHgand the glucose level isabove 270 mg/dL
48/Unacceptablebias on Glucoseresults obtainedfrom sampleswith pO2 levelsabove 25 mmHg
49/Too lowGlucose result inthe lower andmediumreportable rangeobtained fromsamples withlow pO2level	Precisionstudy atdifferent pO2levels and atdifferentglucose levelsrepresentingclinicaldecisionpoints at low,medium andhigh glucose.	CV%: ≤10%	20 days3 different pO2 levels3 different glucose levels2 tests of each sample eachday2 runsTotal of 2160 measurementsThe results are valid under theconditions that- all glucose results aresuppressed when the pO2level of the sample is below10 mmHg, and- all glucose results aresuppressed when pO2 level ofthe sample is between 10mmHg and 25 mmHg and theglucose level is above 270mg/dLall acceptance criteria are met:CV% < 10%	PassedThe acceptance criterion ismet under the conditionsthat all glucose results aresuppressed when the pO2level of the sample isbelow 10 mmHg, andall glucose results aresuppressed when pO2 levelof the sample is between10 mmHg and 25 mmHgand the glucose level isabove 270 mg/dL

・

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5. Performance Characteristics

Precision

Precision was evaluated according to CLSI guideline "Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition", EP05-A2.

The study was conducted as a 20 day precision study using serum pool sample of glucose. Three levels of glucose have been analyzed in 2 runs per day with 2 replicates for each level.

Results of Precision Study:	mg/dL
cGlu level	pO₂ level	Mean	Sr	ST	CV%	n
Glu Low$17.8 ± 2.5 mg/dL$	10 mmHg	17.9	0.2	0.8	4.7	240
	30 mmHg	18.0	0.1	0.8	4.3	240
	>90 mmHg	18.1	0.1	0.7	4.1	240
Glu Mid$98.7 ± 9 mg/dL$	10 mmHg	101.7	1.1	3.8	3.7	240
	30 mmHg	101.0	0.7	3.3	3.3	240
	>90 mmHg	101.2	0.5	3.3	3.2	240
Glu High$270 ± 6 mg/dL$	10 mmHg	254.1	1.6	10.8	4.2	240
	30 mmHg	262.3	1.1	8.8	3.4	240
	>90 mmHg	271.9	1.7	7.4	2.7	240

Method Comparison

Method comparison study versus a comparative analyzer (ABL735) has been conducted according to NCCLS guideline "Method Comparison and Bias Estimation Using Patient Samples", EP09-A2.

This study was an in-house method comparison using untreated donor samples in combination with spiked donor blood where necessary. A total of 52 different donors are used in data mining and approximately 500 samples are measured

Linear regression of the pooled data qives a slope of 0.9206, intercept of 0.084 and an Re ≥ 0.95; fulfilling the requirements to slope (0.9 - 1.1), intercept (0) and correlation coefficient (≥ 0.95)

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Traditional 510(k): Modification to ABL90 Flex -Specific cGlu Suppression

Image /page/7/Figure/2 description: The image is a scatter plot titled "Average: ABL90 as function of ABL735". The x-axis is labeled "Read out ABL735", and the y-axis is labeled "Read out ABL90". There is a series of data points plotted on the graph, labeled "Series 1", and a dashed line representing y=x. The equation of the trendline is y = 0.9206x + 0.084, with an R-squared value of 0.9895.

Interference

Interference study has been conducted according to CLSI guideline "Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition", EP07-A2.

This study evaluates the pO2 tension in blood samples as an interfering substance to the glucose measurement.

Results of Interference Study
CV%(XTEST-XCONTROL)	pO₂ [mmHg]	10	15	20	25	50	80
cGLu [mg/dL]	9	3.3%	3.1%	3.4%	1.1%	3.8%	0.0%
	36	1.3%	1.3%	0.8%	0.5%	0.9%	0.2%
	79	2.0%	1.6%	0.7%	0.8%	0.9%	0.6%
	119	2.0%	1.5%	1.5%	0.9%	1.3%	0.4%
	180	4.7%	2.7%	2.5%	0.9%	0.3%	0.6%
	270	7.0%	6.1%	3.1%	2.4%	2.0%	1.1%
	450	13.6%	9.3%	7.1%	3.8%	5.0%	0.7%

6. Performance Data

The performance data submitted in the original submission (K092686) still apply.

7. Conclusion

The ABL90 FLEX with the modification described above is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate ABL90 Flex (K122729).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 17, 2013

Radiometer Medical ApS C/O Gitte Juel Friis Akandevei 21 2700 Bronshoj DENMARK

Re: K131988

Trade/Device Name: ABL90 Flex Analyzer 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 24, 2013 Received: June 28, 2013

Dear Mr. 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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S 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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Indication for Use

510(k) Number (if known): K131988

Device Name: ABL90 Flex Analyzer

Indication 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 (cKT): 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 (cCalcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

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 WඳChân -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)K131988

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Chloride (cCF): chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such a cystic fibrosis and diabetic acidosis.

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: methemogiobin 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.

And/Or

× Prescription Use (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)

YungW.Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k)K131988

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.