The ABL80 FLEX analyzer is a portable, automated analyzer that measures glucose, in whole blood. The ABL80 FLEX 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. For in vitro diagnostic use.

The ABL80 FLEX CO-OX analyzer is a portable, automated analyzer that measures glucose, 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. For in vitro diagnostic use.

Device Description

The ABL80 FLEX and ABL80 FLEX CO-OX analyzers are portable, automated systems intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, hematocrit (ABL80 FLEX analyzer only) and the oximetry parameters (ABL80 FLEX CO-OX only) total hemoqlobin, oxygen saturation, FO2Hb, FCOHb, FMetHb, and FHHb.

The ABL80 FLEX and ABL80 FLEX CO-OX analyzers each exist in two different software configurations differing in the number of parameters available.

The ABL80 FLEX and ABL80 FLEX CO-OX analyzers consist of an instrument with a sensor cassette and a solution pack as the main accessories. Multiple models of sensor cassettes are available. The various sensor cassette models for different parameter combinations. For each parameter combination, models allowing for different test loads are available. The solution pack is available in four model for each of the four different configurations of the analyzer.

AI/ML Overview

The provided text describes modifications to the ABL80 FLEX and ABL80 FLEX CO-OX analyzers and their substantial equivalence to a predicate device, focusing on glucose measurement. The performance study specifically addresses the glucose pO2 dependence.

Here's an analysis of the acceptance criteria and the study, extracting the requested information:

1. Table of Acceptance Criteria

The document does not explicitly state "acceptance criteria" in a pass/fail quantifiable manner for the modifications. However, it presents the defined glucose linearity ranges based on pO2 levels, which can be interpreted as the performance specifications the device meets under different pO2 conditions.

Parameter	Acceptance Criteria (Defined Linearity Range)	Reported Device Performance (Met Criteria)
Blood Glucose (cGlu)	36 – 180 mg/dL (2 – 10 mmol/L)	36 – 180 mg/dL (2 – 10 mmol/L)
when pO2 range is 20 - 40 mmHg
Blood Glucose (cGlu)	36 - 270 mg/dL (2 – 15 mmol/L)	36 - 270 mg/dL (2 – 15 mmol/L)
when pO2 range is ≥ 41 mmHg

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

Sample Size: The document does not specify the exact sample size used for the pO2 dependence study. It merely states "A study has been conducted... to characterize the impact of, or interference from, limitations on the amounts of oxygen in the sample."
Data Provenance: Not explicitly stated. The manufacturer is SenDx Medical Inc, Carlsbad, CA, USA, and Radiometer Medical ApS, Brønshøj, Denmark. This suggests the study could have been conducted in either location or obtained samples from those regions, but no specific country of origin for the data is provided. The study type is prospective as it's a characterization study conducted to determine performance under specific conditions.

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

Not applicable. This is a study for an in vitro diagnostic device measuring a chemical analyte (glucose), not an imaging or diagnostic device that requires expert interpretation for ground truth. The ground truth for glucose measurements would typically be established by a reference method/instrument.

4. Adjudication method for the test set

Not applicable, as expert adjudication is not relevant for this type of chemical measurement validation.

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 AI-assisted diagnostic device or an imaging device requiring human reader interpretation. The device is an automated analyzer for chemical measurements.

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

Yes, the study described is a standalone performance evaluation of the ABL80 FLEX and ABL80 FLEX CO-OX analyzers in measuring glucose, specifically demonstrating its performance in relation to pO2 levels. The description of "Automated handling by the software of certain glucose results depending on the pO2 value in the sample" indicates an algorithm-only component.

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

The document implies the ground truth for "glucose linearity" would be established by comparison to a reference method or instrument for glucose measurement, as is standard practice for in vitro diagnostic devices. It does not explicitly state which reference method was used, but it's not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This document describes a performance validation study for a device. It does not refer to a "training set" in the context of machine learning, but rather the validation of instrument performance. If an algorithm was developed through machine learning, its training set details are not provided here.

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

Not applicable, as a "training set" in the machine learning sense is not described.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

December 7, 2015

SENDX MEDICAL INC SOREN BOGESTRAND SENIOR REGULATORY AFFAIRS SPECIALIST AKANDEVEJ 21 BRONSHOJ 2700, DENMARK

Re: K151639

Trade/Device Name: ABL80 FLEX ABL80 FLEX CO-OX Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA Dated: November 04, 2015 Received: November 06, 2015

Dear Soren Bogestrand:

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 (OS) 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/ResourcesforYou/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,

Katherine Serrano -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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Indications for Use

510(k) Number (if known) K151639

Device Name ABL80 FLEX ABL80 FLEX CO-OX

Indications for Use (Describe)

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)

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510(k) Summary

1. Submitter and contact information

Submitter

Company Name:	SenDx Medical Inc
ER Number:	2027541
Address:	1945 Palomar Oaks WayCarlsbad, CA 92011USA
Phone:	760 930 6300
Fax:	760 930 6310

Contact Person

Name:	Vibeke Agerlin, Director of QA/RA
Function:	Director of QA/RA
E-mail:	vagerlin@sendx.com
Phone:	760 930 6300
Fax:	760 930 6310

Date prepared

Date:	December 4, 2015
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2. a. Device Information

Device Name:	ABL80 FLEX and ABL80 FLEX CO-OX analyzer
Common Name:	Blood gases, Cooximetry, and Metabolite analyzer

Classification :

Classification name	CFR Section	Device Class	Product Code
Glucose oxidase, Glucose	862.1345	II	CGA

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2. b. Device Description

Instrument name, manufacturer, models and accessories

The names of the device are the ABL80 FLEX or ABL80 FLEX CO-OX. The device is manufactured by SenDx Medical Inc, Carlsbad, CA, USA. Radiometer Medical ApS, Brønshøj, Denmark is the legal manufacturer of the device as specified in the labelling.

The ABL80 FLEX and ABL80 FLEX CO-OX analyzers each exist in two different software configurations differing in the number of parameters available.

2. c. Purpose of submission

The purpose of this submission is twofold:

Automated handling by the software of certain glucose results depending on the pO2 value . in the sample.
To merge the Intended Uses for the analyzers into one common Intended Use statement.

3. Intended Use/Indications for use

For in vitro diagnostic use.

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4. Predicate device: ABL800 FLEX analyzer (K043218) Substantial Equivalence

The modified ABL80 FLEX and ABL80 FLEX CO-OX analyzers are substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate with regards to glucose measurements:

Predicate device: 510(k) Number, Name, Device Manufacturer:

Similarities
Issue	SE Device	Predicate Device (K043218)
Product code	Same	CGA
Measuring method	Same	Amperometric
Calibration Method	Same	Two-point liquid calibration
Intended Use	The ABL80 FLEX and ABL80 FLEXCO-OX analyzers are portable,automated analyzers thatmeasure glucose in whole blood.	Same, plus the following parameterspH, pO₂, pCO₂, potassium, sodium,calcium, chloride, glucose, lactate,total bilirubin, and co-oximetryparameters (total hemoglobin,oxygen saturation, and thehemoglobin fractions FO2Hb, FCOHb,FMetHb, FHHb and FHbF)
Glucose measuringrange	36-180 mg/dL (pO2 between 20 -40 mmHq);36-270 mg/dL (pO2 ≥ 41 mmHq)	36-270 mg/dL

1 0 חחק ומח C

Differences
Issue	SE Device	Predicate Device (K043218)
Intended use site	Laboratory and point-of-care.	Laboratory.

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5. Performance Characteristics

Glucose p02 dependence

A study has been conducted according to CLSI guideline "Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition", EP07-A2 to characterize the impact of, or interference from, limitations on the amounts of oxygen in the sample.

The test results support the glucose linearity ranges shown below and documented in the labeling:

Glucose linearity versus pO₂ level
pO₂ (mmHg)range	cGlu mg/dL (mmol/L)linearity range
20 - 40	36 – 180 (2 – 10)
≥ 41	36 - 270 (2 – 15)

Software validation has been conducted and documented for the ABL80 FLEX and ABL80 FLEX CO-OX analyzers to automatically handle certain glucose results depending on the pO2 value in the sample. This will allow to incorporate limitations of reporting glucose results when the pO₂ value of the sample is low.

6. Conclusion

Based on the substantial equivalence comparison and the results of the conducted performance evaluations it has been concluded that the modified ABL80 FLEX and ABL80 FLEX CO-OX analyzers are as safe and effective as the predicate device.

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.