skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)

K173127 · Skyla Corporation H.S.P.B · LCP · Sep 25, 2018 · Hematology

Device Facts

• Record ID: K173127
• Device Name: skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
• Applicant: Skyla Corporation H.S.P.B
• Product Code: LCP · Hematology
• Decision Date: Sep 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The skyla Hi Hemoglobin A1c System, consisting of the skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in venous and finger-stick capillary whole blood. The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus. This system is intended for clinical laboratory and point-of-care use. This test is not for screening or diagnosis of diabetes.

Device Story

System measures HbA1c % in venous or finger-stick capillary whole blood; uses immunoturbidimetric latex agglutination assay. Input: whole blood sample collected via capillary tube into reagent pack; reagent pack contains cell lysis buffer and latex particles; analysis cartridge contains freeze-dried HbA1c-specific mouse monoclonal antibodies and rabbit anti-mouse polyclonal antibodies. Operation: analyzer performs automated analysis; light scattering measured at 650 nm; absorbance correlates to HbA1c concentration via internal calibration curve. Used in clinical labs and point-of-care settings by professionals. Output: quantitative HbA1c % result displayed to provider. Assists in monitoring long-term glycemic control; not for daily glucose management. Benefits: rapid, standardized HbA1c quantification for diabetes management.

Clinical Evidence

Method comparison study conducted at POC sites with 243 samples. Compared skyla Hi system (venous and finger-stick blood) against Bio-Rad VARIANT II Hemoglobin testing system (venous blood). Regression for venous blood: y = 0.9945x + 0.0779; regression for finger-stick blood: y = 0.9993x + 0.0589. Non-clinical testing included precision (repeatability, between-run, between-day) across multiple sites with CVs ranging from 0.6% to 3.0%.

Technological Characteristics

Quantitative immunoassay using latex agglutination. Analyte: HbA1c. Measuring interval: 4-14%. Calibration: automated via barcode on analysis cartridge. Connectivity: USB interface for barcode scanner. Energy: skyla Hi Analyzer. Traceability: NGSP-certified, traceable to DCCT reference method. Materials: glass capillary sampling device.

Indications for Use

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

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

• Alere Afinion Hba1c and Alere Afinion AS100 Analyzer (K151809)

Reference Devices

• Bio-Rad VARIANT II Turbo System

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" written in blue capital letters.

September 25, 2018

Skyla Corporation H.S.P.B. % Feng-Yu Lee, Regulatory Principal Consultant IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675

Re: K173127

Trade/Device Name: skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin Alc Reagent Kit) Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JJE Dated: August 10, 2018 Received: August 22, 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Kellie B. Kelm -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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) k173127

Device Name

The skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit)

Indications for Use (Describe)

The skyla Hi Hemoglobin A1c System, consisting of the skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA Ic %) in venous and finger-stick capillary whole blood.

The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus.

This system is intended for clinical laboratory and point-of-care use.

This test is not for screening or diagnosis of diabetes.

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is k173127.

#### APPLICANT INFORMATION: I.

Name: Skyla Corporation Hsinchu Science Park Branch

Address: 1F, No. 8, Dusing Road, Hsinchu Science Park, Hsinchu 300, Taiwan, R.O.C. [phone] Phone: Fax: [phone] Contact: Ian Lee

c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928

Date Summary Prepared: September 24th, 2018

#### II. DEVICES INFORMATION:

#### Trade Name:

The skyla Hi Hemoglobin Alc System (skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit)

#### Classification name, product code, and regulation number:

| Regulation<br>Description | Product<br>Code | Device<br>Class | Regulation | Panel |
|----------------------------------------------------------------|-----------------|-----------------|--------------------|-------------------|
| Glycosylated Hemoglobin<br>Assay | LCP | II | 21 CFR<br>864.7470 | Hematology,<br>81 |
| Discrete photometric<br>chemistry analyzer for<br>clinical use | JJE | I | 962.2160 | Chemistry,<br>75 |

{4}------------------------------------------------

#### III. PREDICATE DEVICE

The following table identifies the legally marketed device to which Skyla claims equivalence.

Identification of Predicate Device

| Subject Device | Predicate Device | | |
|-----------------------------------|------------------------------------------------------------|-----------------------|---------------|
| | Predicate Device | Manufacturer | 510(k) Number |
| skyla Hi Hemoglobin<br>A1c System | Alere Afinion Hba1c<br>and Alere Afinion<br>AS100 Analyzer | Alere Technologies AS | K151809 |

#### IV. DEVICE DESCRIPTION:

The skyla Hi Analyzer is a portable and compact system, and was designed with skyla Hi Hemoglobin A1c Reagent Kit for on-site quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in human blood.

#### INDICATIONS FOR USE v.

The skyla Hi Hemoglobin A 1 System, consisting of the skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in venous and finger-stick capillary whole blood

The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus.

This system is intended for clinical laboratory and point-of-care use.

This test is not for screening or diagnosis of diabetes.

# VI. COMPARISION OF TECHNOLOGY CHARACTERISTICS WITH THE PRIDICATE DEVICE

Below tables outline the technological characteristics of the skyla Hi Hemoglobin A 1 c System in comparison to the legally marketed predicate devices.

{5}------------------------------------------------

| Similarities | | |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Candidate Device | Predicate Device |
| | skyla Hi<br>Hemoglobin A1c System | Alere Afinion Hba1c and Alere<br>Afinion AS100 Analyzer |
| k number | k173127 | k151809 |
| Intended use | The skyla Hi Hemoglobin A1c<br>System, consisting of the skyla Hi<br>Analyzer and skyla Hi<br>Hemoglobin A1c Reagent Kit is<br>an in-vitro diagnostic test for<br>quantitative measurement of the<br>percent concentration (%) of<br>glycated hemoglobin (HbA1c %)<br>in venous and finger-stick<br>capillary whole blood<br>The measurement of % HbA1c is<br>used to monitor long-term<br>glycemic control in persons<br>previously diagnosed with<br>diabetes mellitus.<br>This system is intended for<br>clinical laboratory and point-of-<br>care use.<br>This test is not for screening or<br>diagnosis of diabetes. | Alere Afinion™ AS100<br>Analyzer System, consisting of<br>the Alere Afinion™ AS100<br>Analyzer or Alere Afinion™<br>AS100 Analyzer Connect and<br>the Alere Afinion™ Test<br>Cartridges, is for in vitro<br>diagnostic use only. The Alere<br>Afinion™ AS100 Analyzer<br>Connect comprises of the Alere<br>Afinion™ AS100 Analyzer and<br>the Alere Afinion™ Data<br>Connectivity Converter.<br>Alere Afinion™ AS100 is a<br>compact multi-assay analyzer<br>for point-of-care testing. It is<br>designed to analyze the Alere<br>Afinion™ Test Cartridges. The<br>Alere Afinion™ Analyzer<br>System is easy to use, rapid and<br>gives reliable and accurate<br>results.<br>Alere Afinion™ HbA1c is an in<br>vitro diagnostic test for<br>quantitative determination of<br>glycated hemoglobin<br>(hemoglobin A1c, HbA1c) in<br>human whole blood.<br>The measure of HbA1c is<br>recommended as a marker of<br>long-term metabolic control in<br>persons with diabetes mellitus. |
| Type of test | Quantitative in-vitro diagnostic<br>test | Quantitative in-vitro diagnostic<br>test |
| Intended users | Professionals and POC | Professionals and POC |
| Blood sampling | Standard phlebotomy techniques<br>for obtaining venous blood<br>samples. Fingerstick by use of<br>lancet. | Standard phlebotomy techniques<br>for obtaining venous blood<br>samples. Fingerstick by use of<br>lancet. |
| Design of sampling device | Collect blood with capillary tube in the reagent pack, and inserting the sampling device into the cartridge | Collect blood with capillary tube in the reagent pack, and inserting the sampling device into the cartridge |
| Cartridge barcode | For cartridge expiration and test lot calibration of HbA1c test | For cartridge expiration and test lot calibration of HbA1c test |
| Differences | | |
| Item | Candidate Device | Predicate Device |
| | skyla Hi<br>Hemoglobin A1c System | Alere Afinion Hba1c and<br>Alere Afinion AS100 Analyzer |
| Test principle | Immunoturbidimetric assay | Boronate affinity assay |
| Sampling device<br>capillary material | Glass | Plastic |
| Fill volume of sampling<br>device capillary | $0.8 \mu L$ | $1.5 \mu L$ |
| Time to result | 6 minutes | 3 minutes |

{6}------------------------------------------------

# Skyla Corporation H.S.P.B

## VII. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

Verification and validation activities were performed on skyla Hi hemoglobin A1c System to establish performance, functionality, and reliability of the device system. Evaluations included precision, linearity, interference, sample volume and hematocrit. POC precision data were tabulated below:

| Sample | Site | N | Mean<br>(%) | Repeatability<br>(within run) | | Between<br>Run | | Between<br>Day | | Total | |
|--------------------|----------|-----|-------------|-------------------------------|------|----------------|------|----------------|------|-------|------|
| | | | | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| Patient 1<br>(A15) | Site 1 | 80 | 5.04 | 0.097 | 1.9% | 0.000 | 0.0% | 0.032 | 0.6% | 0.103 | 2.0% |
| | Site 2 | 80 | 5.06 | 0.082 | 1.6% | 0.039 | 0.8% | 0.034 | 0.7% | 0.097 | 1.9% |
| | Site 3 | 80 | 5.03 | 0.075 | 1.5% | 0.062 | 1.2% | 0.000 | 0.0% | 0.097 | 1.9% |
| | Combined | 240 | 5.04 | 0.085 | 1.7% | 0.038 | 0.8% | 0.014 | 0.3% | 0.095 | 1.9% |
| | Site 1 | 80 | 5.55 | 0.097 | 1.7% | 0.045 | 0.8% | 0.000 | 0.0% | 0.107 | 1.9% |

{7}------------------------------------------------

# Skyla Corporation H.S.P.B

| Patient 2<br>(A12) | Site 2 | 80 | 5.59 | 0.095 | 1.7% | 0.032 | 0.6% | 0.000 | 0.0% | 0.100 | 1.8% |
|----------------------|----------|-----|-------|-------|------|-------|------|-------|------|-------|------|
| | Site 3 | 80 | 5.56 | 0.100 | 1.8% | 0.065 | 1.2% | 0.000 | 0.0% | 0.119 | 2.1% |
| | Combined | 240 | 5.56 | 0.097 | 1.7% | 0.049 | 0.9% | 0.000 | 0.0% | 0.110 | 2.0% |
| Patient 3<br>(A20) | Site 1 | 80 | 6.57 | 0.105 | 1.6% | 0.062 | 0.9% | 0.057 | 0.9% | 0.134 | 2.0% |
| | Site 2 | 80 | 6.53 | 0.111 | 1.7% | 0.086 | 1.3% | 0.000 | 0.0% | 0.141 | 2.2% |
| | Site 3 | 80 | 6.54 | 0.110 | 1.7% | 0.057 | 0.9% | 0.040 | 0.6% | 0.130 | 2.0% |
| | Combined | 240 | 6.54 | 0.109 | 1.7% | 0.070 | 1.1% | 0.038 | 0.6% | 0.135 | 2.1% |
| Patient 4<br>(A24) | Site 1 | 80 | 7.93 | 0.126 | 1.6% | 0.099 | 1.3% | 0.067 | 0.8% | 0.174 | 2.2% |
| | Site 2 | 80 | 7.95 | 0.132 | 1.7% | 0.112 | 1.4% | 0.112 | 1.4% | 0.207 | 2.6% |
| | Site 3 | 80 | 7.99 | 0.150 | 1.9% | 0.097 | 1.2% | 0.115 | 1.4% | 0.212 | 2.7% |
| | Combined | 240 | 7.96 | 0.137 | 1.7% | 0.103 | 1.3% | 0.100 | 1.3% | 0.198 | 2.5% |
| Patient 5<br>(B01-7) | Site 1 | 80 | 12.07 | 0.243 | 2.0% | 0.188 | 1.6% | 0.000 | 0.0% | 0.308 | 2.5% |
| | Site 2 | 80 | 12.10 | 0.250 | 2.1% | 0.189 | 1.6% | 0.000 | 0.0% | 0.313 | 2.6% |
| | Site 3 | 80 | 12.13 | 0.212 | 1.7% | 0.138 | 1.1% | 0.096 | 0.8% | 0.270 | 2.2% |
| | Combined | 240 | 12.10 | 0.236 | 2.0% | 0.173 | 1.4% | 0.000 | 0.0% | 0.292 | 2.4% |
| Control 1<br>(Y1) | Site 1 | 80 | 5.24 | 0.092 | 1.8% | 0.085 | 1.6% | 0.033 | 0.6% | 0.130 | 2.5% |
| | Site 2 | 80 | 5.18 | 0.115 | 2.2% | 0.000 | 0.0% | 0.055 | 1.1% | 0.128 | 2.5% |
| | Site 3 | 80 | 5.20 | 0.118 | 2.3% | 0.067 | 1.3% | 0.000 | 0.0% | 0.136 | 2.6% |
| | Combined | 240 | 5.20 | 0.109 | 2.1% | 0.060 | 1.2% | 0.029 | 0.6% | 0.130 | 2.5% |
| Contro2<br>(Y2) | Site 1 | 80 | 9.70 | 0.200 | 2.1% | 0.142 | 1.5% | 0.143 | 1.5% | 0.284 | 2.9% |
| | Site 2 | 80 | 9.71 | 0.208 | 2.1% | 0.022 | 0.2% | 0.096 | 1.0% | 0.230 | 2.4% |
| | Site 3 | 80 | 9.68 | 0.228 | 2.4% | 0.000 | 0.0% | 0.171 | 1.8% | 0.285 | 3.0% |
| | Combined | 240 | 9.69 | 0.213 | 2.2% | 0.052 | 0.5% | 0.140 | 1.4% | 0.260 | 2.7% |
| Calibrator 1<br>(L5) | Site 1 | 80 | 13.59 | 0.085 | 0.6% | 0.100 | 0.7% | 0.000 | 0.0% | 0.131 | 1.0% |
| | Site 2 | 80 | 13.57 | 0.084 | 0.6% | 0.132 | 1.0% | 0.000 | 0.0% | 0.156 | 1.2% |
| | Site 3 | 80 | 13.60 | 0.081 | 0.6% | 0.094 | 0.7% | 0.000 | 0.0% | 0.124 | 0.9% |
| | Combined | 240 | 13.58 | 0.083 | 0.6% | 0.110 | 0.8% | 0.000 | 0.0% | 0.138 | 1.0% |

## VIII. Discussion of Clinical Tests Performed:

#### Method Comparison (POC User Performance Study)

The method comparison study was performed in POC sites by intended operators. It is concluded that either venous whole blood samples or finger-stick capillary samples from candidate device are both comparable to comparative device whole blood testing results.

A total of 243 samples were analyzed. For skyla Hi Hemoglobin A1c System, both venous whole blood sample and finger-stick capillary sample were tested, while for

{8}------------------------------------------------

Bio-Rad VARIANT II Hemoglobin testing system, only venous whole blood sample was tested.

Result for POC Methoad Comparison Study:

Regression line for venous whole blood: y = 0.9945x + 0.0779

Regression line for finger-stick blood: y = 0.9993x + 0.0589

### IX. CONCULSIONS

The clinical and non-clinical tests performed for skyla Hi Hemoglobin A1c System, demonstrate that the test system is safe, effective and substantially equivalent to the legally marketed device identified above.