Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in-vitro diagnostic system for measuring HbA1c using a test kit and analyzer. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.

Therapeutic

No
The device is an in-vitro diagnostic system intended to monitor long term glycemic control, not to provide therapy.

Diagnostic

Yes

The device is an in-vitro diagnostic system used for quantitative measurement of glycated hemoglobin (%HbA1c) to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components like the "PixoTest® POCT Analyzer," "USB Charger," "USB Type C Charge Cable," "PixoTest POCT Calibration Card," "A1c Test Strip," "Spoit with Latex-Tablet," and "Buffer Solution Tube," in addition to the software component ("PixoHealth POCT A1c App"). This indicates it is a system with both hardware and software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is used for the "quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples." This is a measurement performed in vitro (outside the body) on a biological sample.
In-vitro diagnostic system: The intended use also clearly labels it as an "in-vitro diagnostic system."
Device Description: The components listed (Analyzer, Test Kit, Test Strip, Buffer Solution) are typical of an IVD system used for analyzing biological samples.
Performance Studies: The performance study describes comparing results from the PixoTest system with a lab instrument using venous whole blood samples, which is characteristic of validating an IVD.
Predicate Device: The mention of a predicate device (SD A1cCare System and SD A1cCare Spoit Type Test Kit) which is also an IVD further supports this classification.

Therefore, based on the provided information, the PixoTest POCT System is clearly an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LCP, JJE

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found. It is stated that it "is not intended for use on neonates."

Intended User / Care Setting

clinical laboratory and Point-of-Care Professional use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140827

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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, Glycosylated
Hemoglobin	Class II	21 CFR 864.7470	Hematology 81
JJE; Analyzer, Chemistry
(Photometric, Discrete), for
clinical 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:

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.

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 monitor
long term glycemic control in people with
diabetes. | The SD A1cCare System is intended
for professional use to monitor long
term glycemic control in people with
diabetes. |
| Test Principle | Reflectance photometry | |
| Sample Type | Venous whole blood | Fingerstick capillary or venous whole
blood |
| 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 |

5

iXensor

| Power Supply | Meter:
5000 mAh battery, non-removable | Meter:
4x 1.5V AA Alkaline batteries or AC
Adapter | |
|-----------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------|--|
| 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 batch
Calibration Card for optical functional check | Code chip with lot-specific calibration
for associated
Test Kits | |
| Analyzer Quality
Control | Commercial Control Solutions | Check strip for assessing optical
functionality 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.

6

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.