The ABL837 FLEX analyzer is intended for:
. in vitro testing of pleural fluid samples for the pH parameter
The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.
Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of <7.3 are referred as complicated parapneumonic effusions; they are exudative in nature.

Device Description

The ABL837 FLEX analyzer is a member of the ABL800 FLEX blood gas analyzer family for the whole blood measurement of blood gas, pH (whole blood and pleural fluid), electrolyte, metabolite, co-oximetry, creatinine and expired air for the parameters pO2 and pCO2.

AI/ML Overview

This document describes the acceptance criteria and supporting study for the ABL837 FLEX analyzer's new indication for measuring pH in pleural fluid.

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

Study/Parameter	Acceptance Criteria	Reported Device Performance
Precision (Repeatability - S₀)	Not explicitly stated, but typically low variability is expected.	pH 7.1: 0.012 pH 7.3: 0.009 pH 7.5: 0.006
Precision (Total Precision - Sₓ)	Not explicitly stated, but typically low variability is expected.	pH 7.1: 0.029 pH 7.3: 0.020 pH 7.5: 0.028
Method Comparison (Slope of linear fit)	Difference in slope within 10% compared to predicate.	1.056 (5.6% difference from slope of 1 for identity line)
Method Comparison (Intersection with Y-axis)	Not explicitly stated, but ideally close to 0.	-0.393
Method Comparison (Coherence with predicate)	Identity line (X=Y, representing predicate data) lies within 95% confidence interval of linear regression in the pathological range (pH 7.0 to 7.5).	Identity line lies within 95% CI; good agreement shown.
Method Comparison (Bias at critical decision interval)	Considered acceptable if within clinically reasonable limits, taking into account sample nature and imprecision of clinical decision points.	0.0159 above the predicate (Roche analyzer) at pH 7.3. Considered acceptable.
Linearity (R² value)	Not explicitly stated, but typically high R² (closer to 1) for good linear fit.	0.993
Linearity (Data point distribution)	Data points sufficiently distributed in the pathological range and form a straight line.	Data points from 58 samples sufficiently distributed and form a straight line.

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

Precision Study:
- Sample Size:
  - pH 7.1: 244 observations
  - pH 7.3: 256 observations
  - pH 7.5: 244 observations
Method Comparison and Linearity Studies:
- Sample Size: 58 samples
Data Provenance: Not explicitly stated, but given the nature of the device (in vitro diagnostic analyzer) and the studies (precision, method comparison, linearity), it is highly likely that these were retrospective or prospectively collected clinical samples or spiked samples, run in a laboratory setting. The document does not specify the country of origin of the data.

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

This information is not provided in the document. The studies performed (precision, method comparison, linearity) are analytical performance studies comparing the device's measurements to itself (precision) or to a predicate device (method comparison, linearity). These types of studies typically do not involve human expert interpretation for "ground truth" in the same way clinical diagnostic studies might.

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

This information is not applicable/not provided as the studies are analytical performance assessments of a laboratory device measuring a quantitative parameter (pH), not human-in-the-loop diagnostic studies requiring adjudication of interpretations.

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:

No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic analyzer for measuring pH in pleural fluid, not an AI-assisted diagnostic tool that would involve human readers' interpretation.

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

Yes, the performance studies described (Precision, Method Comparison, Linearity) represent the standalone performance of the ABL837 FLEX analyzer. The device functions automatically to measure pH in pleural fluid.

7. The type of ground truth used:

Precision Study: The ground truth is the inherent variability of the device when repeatedly measuring samples with known (or consistently stable) pH values.
Method Comparison and Linearity Studies: The ground truth for these studies was established by comparing the ABL837 FLEX analyzer's measurements to those of the predicate device, the Roche Omni C analyzer (K050423). The Roche device's measurements are effectively considered the reference or "ground truth" for comparison in this context.

8. The sample size for the training set:

This information is not applicable/not provided. The ABL837 FLEX analyzer is a device based on potentiometric technology for pH measurement, not a machine learning or AI-driven system that requires a "training set" in the conventional sense. Its operational parameters are based on established electrochemical principles and internal factory calibration/settings, not on data-driven training.

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

This information is not applicable as there is no "training set" for this device in the context of machine learning. The device's fundamental operational principles are based on known scientific methods for pH measurement, and its calibration is performed using specified calibration solutions.

Summary

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Section 5

510(k) Summary

DEC 1 0 2010

1. Submitter Information

A. Establishment Registration: 3002807968

B. Manufacturing Site: Radiometer Medical ApS
C. Company Address: Aakandevej 21, DK-2700 Broenshoej, Denmark

D. Date Prepared: March 3, 2010

2. Contact Person

A. Jana S. Hellmann
B. Phone: (+45) 3827 3389

C. Fax: (+45) 3827 2727

D. Address: Aakandevej 21, DK-2700 Broenshoej, Denmark
E. E-mail: jana.hellmann@radiometer.dk

3. Application Correspondent

A. Martin Gabler

B. Phone: (+45) 3827 3114
C. Fax: (+45) 3827 2727
D. Address: Aakandevej 21, DK-2700 Broenshoej, Denmark

E. E-mail: martin.gabler@radiometer.dk

4. Device Identification

A. Trade/Proprietary Name: ABL837 FLEX analyzer
B. Classification: Class II (21CFR § 862.1120)

C. Product Code: 75CHL.

D. Subsequent Codes: CEM, JGS, JFP, CGZ, CGA, CGL, KHP, CIG, MQM, GHS, GKR, KQI, JIX, JJY

5. Device Description

6. Intended Use (added with this submission)

In vitro testing of pleural fluid samples for the pH parameter.

7. Substantial Equivalence

Predicate:

A. Trade/Proprietary Name: Roche Omni C

B. Classification: Class II (21CFR § 862.1120)

C. Product Code: CHL.

D. K-Number: 050423
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K100777

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Item	SE Device	Predicate Device
	ABL837 FLEX analyzer with pleuralpH	Roche analyzerK050423
Indications for use	New indication for measuring of pH inpleural fluids	Same
Blood Gas Measurement	pH and pCO₂ by potentiometry	Same
Calibration Method	Two-Point liquid calibration	Same
User interface	Menu driven touch screen	Same
Sensors	Traditional, discrete amperometric andpotentiometric sensors installed in theanalyzer	Same
Calibration and QCsolutions	Discrete bottles and ampoules	Same

The ABL837 FLEX analyzer is substantially equivalent to the predicate device Roche Omni C (K050423) regarding the measurement of pH in pleural fluid.

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8. Performance Characteristics:

Precision study:

Repeatability and Device/Method Precision is evaluated according to "NCCLS Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline - Second Edition, EP5-A2, Vol. 24, No. 25".

Performance Claims for Precision Performance, Repeatability (So) and Total Precision (SQ)

pH	Number ofObservations	Mean	Repeatability (S₀)	Total Precision (Sₓ)
7.1	244	7.153	0.012	0.029
7.3	256	7.294	0.009	0.020
7.5	244	7.517	0.006	0.028

The test verifies that the use of this new pleural fluid measuring mode produces pH results with acceptable precision.

Method Comparison:

Method comparison study has been conducted according to NCCLS quideline AP9-A2 "Method Comparison and Bias Estimation Using Patient Samples".

The slope of the linear fit to the data is 1.056 for the ABL837, and the intersection with the Yaxis is at -0.393. The linear fit intersects the identity line X = Y (and thus the Roche data) at pH 7.016. Furthermore, the graph clearly shows coherence between the ABL837 data and the Roche data in the sense that the X=Y line. representing the Roche data. Iies within the 95% confidence interval of the linear regression, in the entire pathological range from pH 7,0 to 7,5, and the difference in slope of 5.6% is well within the 10% acceptance.

At the critical decision interval fluid treatment, namely around pH 7.3, the ABL837 device measures 0.0159 above the Roche analyzer. This bias is considered acceptable, taking into account the nature of the sample material, and the fact that the clinical decision point is not defined more accurately than is the case. This means that the difference of 0.0159 pH could be contained in the rounding of the data. Finally, the placement of the critical decision point varies regionally; at some hospitals pH 7.2 is considered the critical decision point.

Summarizing our findings, we find that the results of this test clearly demonstrate that the ABL837 analyzer correctly measures pH in pleural fluid, since the measurements show a good agreement with those of the predicate device.

Linearity:

The data to proof the linear fit of the method has been taken from the method comparison study.

The data points from the 58 samples lie sufficiently distributed in the pathological range, and form a straight line, when plotting the ABL837 pH values against the Roche pH values. An R2 value of 0.993 is found when doing a linear regression on the data, plotting randomly selected single ABL837 measurements against the Roche average of two measurements.

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Conclusion:

Taken the results from the performance studies and the comparison of the new device with the predicate devices into consideration, we believe that the ABL837 with pleural pH is as safe and effective as the predicate devices.

Calibration and Quality Control

Since the measuring technology for pH in pleural fluid is the same as in blood no new calibration or quality controls have been introduced for the new indication. The existing calibration and OC solutions are listed below.

Calibration

The following are the calibration solution relevant for the pH electrode.

S1827 Calibration Solution 1

Use: For calibration of the pH, electrolyte and metabolite electrodes in the ABL837 FLEX analyzer.

S1837 Calibration Solution 2

Use: For calibration of the pH, electrolyte and metabolite electrodes in the ABL837 FLEX analyzer,

Quality Controls

AutoCheck6+ and Cleaning Met II Solution

Use: This quality control system can be used for quality control of the ABL837 FLEX analyzer from Radiometer.

Parameter	S7835Level 1	S7845Level 2	S7855Level 3	S7865Level 4
pH	7.1	7.4	7.6	6.8

Range+ QUALICHECK

Use: Range+ QUALICHECK quality control systems can be used for quality control of the ABL77, ABL700 Series and ABL800/8x7 FLEX analyzers from Radiometer.

Parameter	S7930Level 1	S7940Level 2	S7950Level 3
pH	6.8	7.0	7.8

Technology

The technology has not been altered for the new indication of measuring pH in pleural fluids.

Potentiometric Method

The potential of an electrode chain is recorded using a voltmeter, and related to the concentration of the sample (the Nernst equation).

The electrode chain consisting of a sample, electrode, reference electrode, voltmeter, membranes and electrolyte solutions.

The reference electrode maintains a stable, fixed potential against which other potential differences can be measured. The potential is not altered by sample composition.

The pH electrode (E777) is a pH-sensitive glass electrode. The pH-sensitive glass membrane is located at the tip and seals the inner buffer solution with a constant and known pH

Modes of Operation

The instrument is an automated, random access, stat instrument. The specimens are withdrawn from a sampling device and drawn into the closed fluid transport system within the instrument for analysis.

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The FLEXQ allows the capability of automatic sampling from up to three blood samplers. Automatic measurements are accomplished via bar coding on the patient samples. The required tests for the identified sample are retrieved from a networked server. If required, manual introduction of a blood sample may be performed as well.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Radiometer Medical ApS c/o Martin Gabler Regulatory Affairs Specialist Akandevej 21 Bronshoj, Denmark DK-2700

DEC 1 0 2010

Re: K100777 Trade Name: Radiometer Medical ApS ABL837 FLEX analyzer Regulation Number: 21 CFR §862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system. Regulatory Class: Class II Product Code: CHL Dated: November 8, 2010 Received: November 15, 2010

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 Parts 801 and 809), 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 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 tolloffre no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

CJC.

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

Enclosure

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Indications for Use

510(k) Number (if known): K100777

DEC 1 0 2010

Device Name: ABL837 FLEX analyzer

Intended Use:

The ABL837 FLEX analyzer is intended for:

. in vitro testing of pleural fluid samples for the pH parameter

Indications for use:

The pH measurement of pleural fluid can be a clinically useful tool in the management of patients with parapneumonic effusions.

Critical values: pH >7.3 is measured in uncomplicated parapneumonic effusions. All pleural effusions with a pH of <7.3 are referred as complicated parapneumonic effusions; they are exudative in nature.

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): K100777

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.