PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit

K181915 · Ixensor Co, Ltd. · LCP · Apr 12, 2019 · Hematology

Device Facts

• Record ID: K181915
• Device Name: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
• Applicant: Ixensor Co, Ltd.
• Product Code: LCP · Hematology
• Decision Date: Apr 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

PixoTest POCT System measures HbA1c in venous whole blood; utilizes immunoassay principle. System components: PixoTest POCT Analyzer, PixoTest A1c Test Kit (test strips, buffer, spoit with antibody-conjugated blue latex microparticles). User mixes blood with buffer/latex via spoit; applies to test strip. Capillary action moves mixture; HbA1c binds to anti-HbA1c antibody-coated line. Analyzer uses optical system to measure intensity of hemoglobin color and blue conjugates; algorithm converts optical data to %HbA1c. Used in clinical labs and point-of-care settings by professionals. Provides quantitative results for monitoring glycemic control; aids clinical decision-making regarding diabetes management. Benefits include rapid, professional-grade HbA1c monitoring.

Clinical Evidence

System accuracy study compared venous whole blood HbA1c values from the PixoTest POCT System against the TOSOH G7 Analyzer. Study conducted at 3 point-of-care sites with 120 subjects using 3 analyzers and 3 test strip lots. Results demonstrated that accuracy specifications met acceptance criteria.

Technological Characteristics

Reflectance photometry system. Components: nitrocellulose membrane test strip, blue-dyed latex microparticles conjugated to anti-HbA1c antibodies, hemolysis buffer. Measures HbA1c via immunoassay. Connectivity: USB Type C. Power: 5000 mAh non-removable battery. Calibration: QR code and calibration card. Dimensions: 181mm x 111mm x 53mm. Weight: 314.3g.

Indications for Use

Indicated for quantitative measurement of %HbA1c in venous whole blood to monitor long-term glycemic control in individuals previously diagnosed with diabetes mellitus. Not for use in diabetes diagnosis/screening or on neonates.

Regulatory Classification

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.

Predicate Devices

• SD A1cCare System and SD A1cCare Spoit Type Test Kit (k140827)

Reference Devices

• TOSOH G7 analyzer (k011434)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone]

Date Summary Prepared: April 10, 2019

- 2. Name of the Device:
PixoTest® POCT System - PixoTest® POCT Analyzer and PixoTest® POCT A1c Test Kit

- 3. Common or Usual Name: Glycosylated Hemoglobin Assay

| Product Code | Classification | Regulation Section | Panel |
|--------------------------------------------------------------------------|----------------|--------------------|-----------------------|
| LCP; Assay, Glycosylated<br>Hemoglobin | Class II | 21 CFR 864.7470 | Hematology 81 |
| JJE; Analyzer, Chemistry<br>(Photometric, Discrete), for<br>clinical use | Class I | 21 CFR 862.2160 | Clinical Chemistry 75 |

- 4. 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
- 2) 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 -<br>PixoTest POCT System | Predicate Device -<br>SD A1cCare System |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Similarities & Differences | | |
| Indications for Use | The SD A1cCare System is intended for Point-<br>of-Care Healthcare provider use to monitor<br>long term glycemic control in people with<br>diabetes. | The SD A1cCare System is intended<br>for professional use to monitor long<br>term glycemic control in people with<br>diabetes. |
| Test Principle | Reflectance photometry | |
| Sample Type | Venous whole blood | Fingerstick capillary or venous whole<br>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,<br>Acetaminophenol, Bilirubin, Caffeine,<br>Hydroxyzine Dihydrochloride, Triglyceride,<br>Glyburide, Ibuprofen, Dopamine | Same |
| Device Dimension | Meter:<br>181 mm (L) x 111 mm (W) x 53mm (H) | Meter:<br>163 x 96 x 52 (mm) |
| Device Weight | Meter:<br>314.3g | Meter:<br>500g |

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# iXensor

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

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- 10. 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.