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

K192369 · Ixensor Co, Ltd. · LCP · Oct 29, 2019 · Hematology

Device Facts

• Record ID: K192369
• Device Name: PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
• Applicant: Ixensor Co, Ltd.
• Product Code: LCP · Hematology
• Decision Date: Oct 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2
• Attributes: Pediatric

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 fingerstick capillary and 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

System measures HbA1c in fingerstick capillary or venous whole blood; utilizes PixoTest POCT Analyzer and PixoTest A1c Test Kit. Blood sample mixed with buffer in spoit; erythrocytes lysed; mixture applied to test strip membrane. HbA1c migrates via capillary action; binds to anti-HbA1c antibody-coated line; blue-dyed latex microparticles indicate HbA1c concentration. Optical system in analyzer measures intensity of hemoglobin color and blue conjugate line; algorithm converts optical data to %HbA1c. Used in clinical labs and point-of-care settings by professionals. Output provides quantitative HbA1c percentage; assists clinicians in monitoring long-term glycemic control in diabetic patients.

Clinical Evidence

Method comparison study conducted at three point-of-care sites with 158 subjects. Fingerstick capillary samples tested in singlicate and compared to venous blood samples analyzed via TOSOH G7 (K011434). HbA1c range 4.8% to 13.0%. Pooled results showed high correlation (R=0.988) with a slope of 0.985 and intercept of 0.1110. Usability assessment confirmed no difficulties for intended operators.

Technological Characteristics

Quantitative immunoassay; uses anti-HbA1c antibody-coated membrane and blue-dyed latex microparticles. Measures HbA1c via optical reflectance. Sample volume 5μL. System includes analyzer, test strips, spoit, and buffer. Traceable to IFCC reference material. Software-based algorithm converts optical intensity to %HbA1c. Operates on fingerstick capillary or venous whole blood (K2-EDTA, lithium heparin, sodium heparin, or sodium fluoride).

Indications for Use

Indicated for quantitative measurement of %HbA1c in fingerstick capillary and venous whole blood to monitor long-term glycemic control in patients previously diagnosed with diabetes mellitus. Not for diagnosis or screening of diabetes; not for use 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.

Submission Summary (Full Text)

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K192369

B Applicant

iXensor Co. Ltd.

C Proprietary and Established Names

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

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LCP | Class II | 21 CFR 864.7470 - Glycosylated Hemoglobin Assay | HE - Hematology |

## II Submission/Device Overview:

A Purpose for Submission:

Addition of fingerstick capillary whole blood sample claim to the previously cleared PixoTest POCT System – PixoTest POCT Analyzer and PixoTest A1c Test Kit (k181915)

B Measurand:

Glycosylated hemoglobin (HbA1c)

C Type of Test:

Quantitative Immunoassay

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## III Intended Use/Indications for Use:

### A Intended Use(s):

See Indications for Use below.

### B Indication(s) 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 fingerstick capillary and 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.

### C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

- This test should not be used in monitoring daily glucose control and should not be used to replace daily home testing of urine and blood glucose levels.
- This test should not be used for analyzing samples from patients with conditions causing shortened red blood cell survival, such as hemolytic diseases, pregnancy and significant acute or chronic blood loss.
- For professional use in clinical laboratory and point-of-care settings.
- This test is not intended for use in the diagnosis of or screening for diabetes.
- This test is not intended for use on neonates.
- For in-vitro diagnostic use only.
- If the total hemoglobin result is outside the range of 7-23g/dL, the test result could be inaccurate.
- Collect venous whole blood using K2-EDTA, lithium heparin, sodium heparin or sodium fluoride tubes only. Do not use tubes with any other anticoagulants.
- Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from the PixoTest POCT System show that there is no significant interference for samples containing Hemoglobin C (≤ 36%), Hemoglobin D (≤ 41%), Hemoglobin E (≤ 28%), Hemoglobin S (≤ 40%), Hemoglobin F (≤ 19%), and Hemoglobin A2 (< 6.5%).

### D Special Instrument Requirements:

PixoTest POCT Analyzer

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## IV Device/System Characteristics:

### A Device Description:

The iXensor PixoTest POCT System consists of the following components:

1) PixoTest POCT Analyzer, including
- PixoHealth POCT A1c App
- USB Charger
- USB Type C Charge Cable
- PixoTest POCT Calibration Card
- Instructions for Use

2) PixoTest A1c Test Kit, including
- PixoTest A1c Test Strips
- Spoits (to acquire 5μl blood sample by capillary action and to mix blood and buffer together) with Latex-Tablets (containing blue dyed latex micro particles conjugated to specific antibodies for detection of HbA1c)
- Buffer Solution Tubes
- Instructions for Use

### B Principle of Operation:

The 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 β-chain of hemoglobin A0. When whole blood is added to the buffer solution tube and mixed with the spoit, the erythrocytes are instantly lysed to release the glycated hemoglobin (hereafter, HbA1c). When 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 HbA1c is then immobilized onto the anti-HbA1c 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 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 uses an algorithm to convert the result into the percentage HbA1c in the sample.

### V Substantial Equivalence Information:

#### A Predicate Device Name(s):

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

#### B Predicate 510(k) Number(s):

K181915

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C Comparison with Predicate(s):

| Device & Predicate Device(s): | K192369 | K181915 |
| --- | --- | --- |
| Device Trade Name | PixoTest POCT System – PixoTest POCT Analyzer and PixoTest A1c Test Kit | Same |
| General Device Characteristic Similarities | | |
| Intended Use | Quantitative determination of percent hemoglobin A1c to monitor long term glycemic control in individuals previously diagnosed with diabetes. | Same |
| Test principle | Immunoassay | Same |
| Intended use environment | Clinical laboratories and point-of-care settings | Same |
| Measuring range | 4.0% - 15.0% | Same |
| Sample volume | 5 μL | Same |
| Sample pretreatment tools | Spoit, buffer tube | Same |
| General Device Characteristic Differences | | |
| Sample Type | Fingerstick capillary and venous whole blood | Venous whole blood |

VI Standards/Guidance Documents Referenced:

ISO 14971:2007, Medical devices - Application of risk management to medical devices

ISO 15223-1:2016, Medical Devices – Symbols to be used with medical device labels, labeling, and information to be supplied – Part 1: General requirements

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

Within-run precision, intermediate precision, and reproducibility was established in k181915.

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2. Linearity:

Linearity was established in k181915.

The reportable range for the PixoTest POCT System is 4.0% to 15.0% HbA1c.

3. Analytical Specificity/Interference:

Potential interference from endogenous substances, exogenous substances, hemoglobin derivatives, hemoglobin variants, and total hemoglobin was established in k181915.

The labeling contains the following limitation regarding hemoglobin variant interference:

Hemoglobinopathies may interfere with glycated hemoglobin analysis. The results from the PixoTest POCT System show that there is no significant interference for samples containing Hemoglobin C (≤ 36%), Hemoglobin D (≤ 41%), Hemoglobin E (≤ 28%), Hemoglobin S (≤ 40%), Hemoglobin F (≤ 19%) and Hemoglobin A2 (≤ 6.5%).

The claimed total hemoglobin range is 7 to 23 g/dL.

4. Assay Reportable Range:

The reportable range for the PixoTest POCT System is 4.0% to 15.0% HbA1c. See Linearity (section VII.A.2.) above.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

Traceability:

The PixoTest POCT System is traceable to the International Federation of Clinical Chemistry (IFCC) reference material.

6. Detection Limit:

The claimed HbA1c measuring range of 4.0% to 15.0% for the PixoTest POCT System is based on linearity. See Linearity (section VII.A.2.) above.

7. Assay Cut-Off:

Not applicable.

B Comparison Studies:

1. Method Comparison with Predicate Device:

A method comparison study was conducted at three point of care sites with three intended use operators at each site. Fingerstick capillary whole blood samples from 158 subjects were collected and tested in singlicate with the PixoTest POCT System using one lot of PixoTest A1c Test Kits per site (three lots total). The results obtained with the PixoTest POCT System were compared to the results obtained for paired K2-EDTA anticoagulated venous blood

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samples measured with the TOSOH G7 comparative method (k011434). The range of HbA1c tested was 4.8% to 13.0% as determined by the TOSOH G7 method. Results of the linear regression analysis are shown below. A usability assessment completed by all intended use operators did not reveal any difficulties with using the device.

| | N | HbA1c range (%) | Intercept | Slope | R |
| --- | --- | --- | --- | --- | --- |
| Site 1 | 50 | 4.8 to 12.2 | 0.0678 | 0.982 | 0.980 |
| Site 2 | 58 | 5.0 to 13.0 | 0.1400 | 0.987 | 0.991 |
| Site 3 | 50 | 4.8 to 10.6 | -0.1300 | 1.020 | 0.985 |
| Pooled sites | 158 | 4.8 to 13.0 | 0.1110 | 0.985 | 0.988 |

2. Matrix Comparison:
Not applicable.

C Clinical Studies:

1. Clinical Sensitivity:
Not applicable.

2. Clinical Specificity:
Not applicable.

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.

D Clinical Cut-Off:
Not applicable.

E Expected Values/Reference Range:

The American Diabetes Association (ADA) recommended a reasonable A1c goal for many non-pregnant adults is < 7 % (53 mmol/mol). Providers might reasonably suggest more stringent A1C goals (such as 6.5 % [48 mmol/mol]) for selected individual patients if this can be achieved without significant hypoglycemia or other adverse effects of treatment.

Reference: American Diabetes Association. Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan; 41 Suppl. 1: S55-S64.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

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IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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