The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, and oximetry in whole blood. The ABL80 FLEX CO-OX analyzer system 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.

Indications for use:

These tests are only performed under a physicians order:

pH, pO2.and pCO2 . pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acidbase 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, neonatal hypoglycemia, 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.

sO2: oxygen saturation, more specifically the ratio between the concentration of 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.

Device Description

The ABL80 FLEX CO-OX with AQURE connectivity is a portable, automated system intended for in vitro testing of samples of whole blood. The device is manufactured by SenDx Medical Inc, Carlsbad, CA, USA.

ABL80 FLEX CO-OX consists of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes and solution packs are available. The various sensor cassette models include models for the different parameter configurations.

Four measuring principles are employed in ABL80 FLEX analyzers.

Potentiometry: The potential of a sensor chain is recorded using a voltmeter, and related ● to the concentration of the sample (the Nernst equation).
. Amperometry: The magnitude of an electrical current flowing through a sensor chain is proportional to the concentration of the substance being oxidized or reduced at an electrode in the chain.
. Conductometry: Specific impedance of a sample as measured by two conducting electrodes held at a constant voltage is directly proportional to the conductive properties of that sample.
. Spectrophotometry: Light passes through a cuvette containing a hemolyzed blood sample. The specific wavelengths absorbed and their intensity generates an absorption spectrum used to calculate oximetry parameters. This measuring principle is used in the ABL80 FLEX CO-OX analyzer only.

The modification consists of integration with the Data Management software called AQURE system. The software enables the initiation of device actions on connected ABL80 FLEX analyzers.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the ABL80 FLEX CO-OX with AQURE connectivity, primarily focusing on the integration of data management software. It states that the performance characteristics of the device were not affected by this change. Therefore, the document does not contain specific acceptance criteria for the diagnostic performance of the measured parameters (pH, blood gases, electrolytes, glucose, oximetry) nor does it detail a study proving the device meets such criteria.

Instead, the document highlights the validation of the remote functionality introduced by the AQURE connectivity, stating that "Remote functionality was verified and validated on both ABL80 FLEX and ABL80 FLEX CO-OX analyzers, and the acceptance criteria was met." However, it does not elaborate on what those specific acceptance criteria for remote functionality were, nor does it provide details of the verification and validation study.

The document explicitly states: "No performance characteristics are affected by the change. The performance data submitted in the original submission (K051804 as modified by K080370) still apply." This indicates that the diagnostic performance data for the measurement of pH, blood gases, electrolytes, glucose, and oximetry parameters would be found in the referenced predicate device submissions (K051804 and K080370), not in this particular 510(k) filing.

Given this, I can only address aspects described in the provided document regarding the AQURE connectivity:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Function	Acceptance Criteria	Reported Device Performance
Remote functionality for ABL80 FLEX and ABL80 FLEX CO-OX	Not explicitly stated in the provided document.	"Remote functionality was verified and validated... and the acceptance criteria was met."
Performance Characteristics (diagnostic measurements)	Not explicitly stated in the provided document for this submission (K151856). Refers to K051804 and K080370.	"No performance characteristics are affected by the change." "The performance data submitted in the original submission (K051804 as modified by K080370) still apply."
FMEA Risk Analysis	All identified hazards mitigated to an acceptable level as per ISO 14971.	"mitigated all identified hazards to an acceptable level as per ISO 14971, and verified software mitigations by using test protocols. Results met predefined acceptance criteria."

Regarding the study that proves the device meets acceptance criteria:

The document states that "Remote functionality was verified and validated on both ABL80 FLEX and ABL80 FLEX CO-OX analyzers." This indicates a verification and validation study was conducted for the new AQURE connectivity features. However, the details of this study are not provided in the text.

2. Sample size used for the test set and the data provenance: Not specified in the provided text for the remote functionality study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified, as the study focused on technical software functionality rather than clinical diagnostic performance necessitating expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not specified.

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 device is a blood gas analyzer with data management connectivity, not an AI-assisted diagnostic imaging device requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an "algorithm only" device as described for AI. The device itself is an automated analyzer, and the study focused on the proper functioning of its remote connectivity.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the remote functionality, the "ground truth" would likely be defined by system specifications and expected behavior, verified through testing.

8. The sample size for the training set: Not applicable for this type of device and study.

9. How the ground truth for the training set was established: Not applicable.

Summary

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

August 6, 2015

SENDX MEDICAL INC. LASSE MOLLER REGULATORY AFFAIRS SPECIALIST AAKANDEVEJ 21 BROENSHOEJ 2700 DENMARK

Re: K151856

Trade/Device Name: ABL80 FLEX CO-OX with AQURE Connectivity 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, GKR, DQA, GHS, JPI Dated: July 3, 2015 Received: July 8, 2015

Dear Lasse Moller:

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 Parts 801 and 809); 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 regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney H Lias -S

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) K151856

Device Name ABL80 FLEX CO-OX with AQURE connectivity

Indications for Use (Describe)

Intended Use:

Indications for use:

These tests are only performed under a physicians order:

pH, pO2.and pCO2 . pH, pCO2 and pO2 measurements are used in the diagnosis and treatment of life-threatening acidbase 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.

sO2: oxygen saturation, more specifically the ratio between the concentration of 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Date Prepared: August 5, 2015

Section 5. 510(k) Summary

1. Administrative

Submitter

Company Name:	SenDx Medical Inc
ER Number:	2027541
Address:	1945 Palomar Oaks WayCarlsbad, CA 92011USA
Contact Person:	Vibeke Agerlin, Director of QA/RA
Phone:	+1 760 930 6300
Fax:	+1 760 930 6310

Application Correspondent

Name:	Lasse Post Møller
Function:	Regulatory Affairs Specialist
E-mail:	lpm@radiometer.dk
Phone:	+45 3827 3436
Fax:	+45 3827 2727

2. Device description

Device Information

Device Name:	ABL80 FLEX CO-OX with AQURE connectivity
Common Name:	Blood gas analyzer
Product Code:	CHL (JGS, CEM, JFP, CGZ, CGA, GKR, DQA, GHS, JPI)
Code description:	Blood gases and blood pH test system
Regulation Number:	21 CFR 862.1120
Classification:	Class II
Classification Panel:	Clinical Chemistry

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Four measuring principles are employed in ABL80 FLEX analyzers.

Potentiometry: The potential of a sensor chain is recorded using a voltmeter, and related ● to the concentration of the sample (the Nernst equation).
. Amperometry: The magnitude of an electrical current flowing through a sensor chain is proportional to the concentration of the substance being oxidized or reduced at an electrode in the chain.
. Conductometry: Specific impedance of a sample as measured by two conducting electrodes held at a constant voltage is directly proportional to the conductive properties of that sample.
. Spectrophotometry: Light passes through a cuvette containing a hemolyzed blood sample. The specific wavelengths absorbed and their intensity generates an absorption spectrum used to calculate oximetry parameters. This measuring principle is used in the ABL80 FLEX CO-OX analyzer only.

3. Device Modification

The modification consists of integration with the Data Management software called AQURE system. The software enables the initiation of device actions on connected ABL80 FLEX analyzers.

4. Intended Use

Indications for use:

These tests are only performed under a physicians 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.

parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

Chloride (cCI-): 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, neonatal hypoqlycemia, and idiopathic hypoqlycemia, 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.

sO2: oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoqlobin plus reduced hemoqlobin.

FO2Hb: oxyhemoqlobin as a fraction of total hemoqlobin

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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.

5. Substantial Equivalence

The modified ABL80 FLEX CO-OX analyzer is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate (K080370).

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Similarities
Issue	SE Device	Predicate Device(K080370)
Intended Use	Same	The ABL80 FLEX CO-OX analyzer is a portable,automated analyzer that measures pH, blood gases,electrolytes, glucose, and oximetry in whole blood. TheABL80 FLEX CO-OX analyzer system is intended for useby trained technologists, nurses, physicians andtherapists. It is intended for use in a laboratoryenvironment, near patient or point-of-care setting.
Blood GasMeasurement	Same	pH, pCO2 by potentiometry,pO2 by amperometry
ElectrolyteMeasurement	Same	cK+, cNa+, cCa2+, cCl- by potentiometry
MetaboliteMeasurement	Same	cGlu by amperometry
OximetryMeasurement	Same	ctHb, sO2, FO2Hb, FHHb, FCOHb, FMetHb byspectrophotometry
PerformanceCharacteristics	Same	Identical Performance Characteristics
Calibration	Same	Two-Point liquid calibration at configured intervals, tHbcalibration every 90 days
Computerspecifications	Same	Microsoft Windows®XP Embedded operating systemMinimum 1 GB hard driveETX single board CPUMinimum 512 MB EDO-RAM
Sample Introduction	Same	Aspiration
Interfaces	Same	8.4" color TFT-LCD, resolution 800 × 600 SVGA Touchscreen, Barcode reader, Serial line RS232, RJ45,Ethernet port, 2 USB 1.1, PS2 keyboard
Software version	Same	Software version 3.12

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Differences
Issue	SE Device	Predicate Device(K080370)
AQURE system	Data management software (MDDS) functionality:Remote display of test results Receival of data from connected devices at the point-of-care or laboratory Transfer of test results to the HIS/LIS Centralized operator administration – Transmission of operator data to ABL80 FLEX CO-OX Remote approval of patient results	Analyzer functionalities are:Local display of test results Direct transfer of test results to the HIS/LIS Local Operator Administration at the analyzer
	Remote initiation of the following device actions on ABL80 FLEX CO-OX from AQURE system:System Cycle Rinse Lock/Unlock analyzer Lock/Unlock parameter Set analyzer message Enter/Exit standby 2 point calibration	Local initiation of device actions through device touch screen interface

6. Registration history

ABL80 FLEX was originally cleared with K051804 (measures pH, blood gases, electrolytes, glucose, hematocrit (ABL80 FLEX analyzer only), and then modified in K080370 with the addition of an oximetry Module - a configuration of the analyzer adding the oximetry parameters ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, and FHHb.

7. Performance Data

Remote functionality was verified and validated on both ABL80 FLEX and ABL80 FLEX CO-OX analyzers, and the acceptance criteria was met.

No performance characteristics are affected by the change. The performance data submitted in the original submission (K051804 as modified by K080370) still apply.

8. Summary of Design Control activities

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We conducted an FMEA risk analysis and mitigated all identified hazards to an acceptable level as per ISO 14971, and verified software mitigations by using test protocols. Results met predefined acceptance criteria.

9. Conclusion

The ABL80 FLEX CO-OX with AQURE connectivity described above is substantially equivalent in Intended Use, fundamental scientific technology, safety, effectiveness and characteristics to the predicate ABL80 Flex CO-0X (K080370). Implementation of the change design control principles (risk management, verification and validation) have been applied which indicated that the modification is of no impact to the performance of the device.

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.