The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus.

The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.

Device Description

PixoTest® POCT System consists of the following devices:

PixoTest® POCT Analyzer
Include:

PixoHealth POCT A1c App
USB Charger
USB Type C Charge Cable
PixoTest POCT Calibration Card

PixoTest® POCT A1c Test Kit
Include:

A1c Test Strip
Spoit with Latex-Tablet
Buffer Solution Tube

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

Device: PixoTest® POCT System - PixoTest® POCT Analyzer and PixoTest® A1c Test Kit

Intended Use: Quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples for monitoring long-term glycemic control in individuals previously diagnosed with diabetes mellitus. Intended for clinical laboratory and Point-of-Care Professional use.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list specific quantitative acceptance criteria values prior to the study for each performance metric, but it does state that the study results "demonstrate that the accuracy specifications... meet the acceptance criteria." The study focused on accuracy compared to a laboratory reference method.

Performance Metric	Acceptance Criteria (Implied / Stated Goal)	Reported Device Performance (Study Results)
Accuracy	Meets accuracy specifications.	Study demonstrated that accuracy specifications were met. (No specific numerical results/tables are provided in this summary, only the qualitative statement of meeting criteria).

Note: For a full regulatory submission, specific acceptance criteria for accuracy (e.g., bias, precision measured by CV%, correlation coefficient R^2, Bland-Altman agreement with reference method, allowable total error) would typically be defined and presented numerically. This summary only provides a high-level conclusion.

2. Sample Size and Data Provenance

Test Set Sample Size: 120 subjects
Data Provenance: The location of data collection is not explicitly stated as a country but it was collected at "3 point-of-care sites." It's reasonable to infer these are clinical sites that conducted the study. The study appears to be prospective as it involved collecting samples from subjects for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

This device is an in-vitro diagnostic (IVD) for measuring HbA1c, not a diagnostic imaging AI. Therefore, the concept of "experts" establishing ground truth in the traditional sense (e.g., radiologists for images) does not directly apply.
Ground Truth Establishment: The ground truth for the test set was established by comparison with a laboratory reference instrument. In this case, it was the "TOSOH G7 Analyzer lab instrument." This is a standard approach for IVD device validation, where a known, highly accurate, and often predicate or gold-standard laboratory method serves as the reference. Qualified laboratory personnel, following validated procedures, operate such reference instruments.

4. Adjudication Method for the Test Set

As this is an IVD device measuring an analyte (HbA1c) against a reference instrument, an "adjudication method" in the sense of multiple human readers resolving disagreements (e.g., 2+1, 3+1) is not applicable. The comparison is quantitative between the new device and the reference laboratory instrument.

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

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with AI vs. without AI assistance) is relevant for AI-powered diagnostic imaging devices where human interpretation is part of the clinical workflow.
The PixoTest POCT system is an automated in-vitro diagnostic device that provides a quantitative measurement. It does not involve human "reading" or a human-in-the-loop AI assistance model in the way an imaging AI would.

6. Standalone Performance Study

Yes, a standalone performance study was done. The core of the clinical evaluation was to compare the performance of the PixoTest POCT Analyzer and PixoTest A1c Test Kit (the device itself) against a well-established laboratory reference method (TOSOH G7 Analyzer).
The study "comparing venous whole blood A1c values on the PixoTest POCT Analyzer and PixoTest A1c Test Kit with values on TOSOH G7 Analyzer lab instrument" directly assesses the standalone analytical performance of the device.

7. Type of Ground Truth Used

Reference Laboratory Instrument / Expert Consensus on Reference Method: The ground truth was established by values obtained from a TOSOH G7 Analyzer lab instrument. This represents a highly accurate and accepted reference method for HbA1c measurement in a clinical laboratory setting, effectively serving as the "gold standard" or expert consensus (via established, validated methodology). It's not pathology (histology), or direct outcomes data, but rather a robust, analytical measurement from a validated reference device.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size of a training set. This is typical for regulatory summaries of IVD devices where the underlying technology (reflectance photometry, immunoassay) relies on established principles of analytical chemistry and does not inherently involve complex data-driven "training" in the machine learning sense that would require a large, labeled training dataset of the same type as the test set. While there might be internal algorithm development and calibration data, it is not described as a "training set" in the context of a typical AI/ML submission, nor is its size reported here.

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

Given that a "training set" (in the AI/ML context) is not explicitly discussed for this device, the method for establishing its ground truth is not provided.
For IVD devices like this, calibration and validation during development typically involve using reference materials, calibrators, and control materials with known concentrations, traceable to international standards if applicable. These values are established through rigorous analytical methods by reference laboratories or manufacturers.

Summary

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April 12, 2019

iXensor Co., LTD. % Feng-Yu Lee, Principal Regulatory Consultant IVDD Regulatory Consultant 29222 Rancho Viejo Rd., Suite 218 San Juan Capistrano, CA 92675

Re: K181915

Trade/Device Name: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP. JJE Dated: July 10, 2018 Received: July 17, 2018

Dear Feng-Yu Lee:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Courtney H. Lias, Ph.D. for 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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iXensor

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

The assigned 510(k) number is: K181915

1. Submitter Identification: iXensor Co. Ltd. 6F., No.9, Aly. 2, Ln. 35, Jihu Road. Neihu Dist., Taipei City 114, Taiwan
  c/o IVDD Regulatory Consultant Contact Person: Mrs. Feng-Yu Lee Address: 29122 Rancho Viejo Rd., Suite 212, San Juan Capistrano, CA 92675 Phone: (949) 218-0929 Fax: (949) 218-0928

Date Summary Prepared: April 10, 2019

1. Name of the Device:
  PixoTest® POCT System - PixoTest® POCT Analyzer and PixoTest® POCT A1c Test Kit
1. Common or Usual Name: Glycosylated Hemoglobin Assay

Product Code	Classification	Regulation Section	Panel
LCP; Assay, GlycosylatedHemoglobin	Class II	21 CFR 864.7470	Hematology 81
JJE; Analyzer, Chemistry(Photometric, Discrete), forclinical use	Class I	21 CFR 862.2160	Clinical Chemistry 75

1. Device Description:
  PixoTest® POCT System consists of the following devices:
PixoTest® POCT Analyzer 1)
- Include:
  - PixoHealth POCT A1c App
  - USB Charger
  - USB Type C Charge Cable
  - PixoTest POCT Calibration Card
1. PixoTest® POCT A1c Test Kit Include:
- A1c Test Strip
- Spoit with Latex-Tablet
- Buffer Solution Tube

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ર. Intended Use:

6. Predicate Device Information

PixoTest POCT Analyzer and PixoTest A1c Kit is substantially equivalent to the following device: SD A1cCare System and SD A1cCare Spoit Type Test Kit Name: Device Company: SD Biosensor, Inc. K140827 510(K) Number:

7. Comparison to Predicate Devices:

Specification	Subject Device -PixoTest POCT System	Predicate Device -SD A1cCare System
Similarities & Differences
Indications for Use	The SD A1cCare System is intended for Point-of-Care Healthcare provider use to monitorlong term glycemic control in people withdiabetes.	The SD A1cCare System is intendedfor professional use to monitor longterm glycemic control in people withdiabetes.
Test Principle	Reflectance photometry
Sample Type	Venous whole blood	Fingerstick capillary or venous wholeblood
Sample Volume	5µL	Same
Measuring Range	4.0-15.0%	Same
Measuring Time	3 minutes	Same
Hematocrit	25-65%	Same
Maximum Altitude	3,000m (9,843 ft)	2,000m(6,560 feet)
Operating Temperature	59-90°F (15-32°C)	59-104°F (15-40°C)
Operating Humidity	10-90% relative humidity	Same
Shelf-Life	18 months	Same
Storage Temperature	34-86°F (1-30°C)	Same
Assay method	Immunoassay	Same
Interference Substances	Acetylsalicylic acid, Ascorbic acid,Acetaminophenol, Bilirubin, Caffeine,Hydroxyzine Dihydrochloride, Triglyceride,Glyburide, Ibuprofen, Dopamine	Same
Device Dimension	Meter:181 mm (L) x 111 mm (W) x 53mm (H)	Meter:163 x 96 x 52 (mm)
Device Weight	Meter:314.3g	Meter:500g

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iXensor

Power Supply	Meter:5000 mAh battery, non-removable	Meter:4x 1.5V AA Alkaline batteries or ACAdapter
Device Display	LCD
Memory Capacity	>10000 tests results with date and time	900 tests results with date and time
Coding Procedure	Code Key
Calibration	QR Code for associate test kit batchCalibration Card for optical functional check	Code chip with lot-specific calibrationfor associatedTest Kits
Analyzer QualityControl	Commercial Control Solutions	Check strip for assessing opticalfunctionality of analyzer

Statement of No Differences:

For the reasons mentioned above, it can be concluded that the PixoTest POCT Analyzer and PixoTest Alc Test Kit are substantially equivalent to the SD A1cCare System and SD A1cCare Sport Type Test Kit in commercial distribution, with respect to indications for use and technology.

8. Technology Characteristics:

The PixoTest® POCT Analyzer use photometry to measure HbA1c. Samples from venous whole blood can be used. This whole blood sample is applied to PixoTest® A1c Test Kit, and a reaction occurs to produce a color that is read by using reflectance photometry of the reagent area. The level of color produced is proportional to the concentration.

PixoTest® POCT Analyzer on PixoTest A1c Test Kit uses an anti-HbA1c (%) antibody which is specific for the first few amino acid residues of the glycated N-terminus of the ß-chain of hemoglobin A0. PixoTest® A1c Test Kit contains the PixoTest® A1c Test Strip (nitrocellulose membrane), Spoit with latex-tablet (blue dyed latex micro particles conjugated to specific antibodies) and Buffer solution tube (hemolysis reagent). When whole blood is added to the buffer solution and is mixed with the latex-tablet, the erythrocytes are instantly lysed to release the glycated hemoglobin (hereafter, HbA1c). When the sample mixture is loaded onto the sample port of the test panel, the mixture fluid migrates along the membrane of the test panel by capillary action, and the HbA 1c is then immobilized onto the anti-HbA 1c antibody coated line. The amount of the blue conjugates on the anti-HbA1c line reflects the amount of HbA1c in the sample, the intensity of hemoglobin color measured from the desired area on the membrane of test panel is measured. Chemical and immune reaction that occurs on the test strip is measured by the optical system in PixoTest® POCT Analyzer. This system measures both fractions and an algorithm which converts the result into the percentage HbA1c in the sample.

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as 9. follows:

Verification and validation tests were performed to evaluate the performance, functionality, and reliability of the PixoTest POCT Analyzer and PixoTest A1c Test Kit. The evaluations include precision, linearity and sensitivity, interference and specificity, sample volume and matrix, altitude, EMC and operation conditions.

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1. Discussion of Clinical Tests Performed:
  A system accuracy study was performed by comparing venous whole blood A1c values on the PixoTest POCT Analyzer and PixoTest A1c Test Kit with values on TOSOH G7 Analyzer lab instrument.

The evaluation was conducted on 120 subjects using 3 PixoTest POCT Analyzers and 3 test strip reagent lots, at 3 point-of-care sites.

The study results demonstrate that the accuracy specifications of PixoTest POCT Analyzer and PixoTest A1c Test Kit meet the acceptance criteria.

11. Conclusions:

Performance evaluations of the PixoTest POCT Analyzer and PixoTest A1c Test Kit demonstrate substantial equivalence to the predicate device, SD A1cCare System and SD A1cCare Spoit Type Test Kit.

Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).