URight Hemoglobin A1c system, FORA A1c System

K142664 · Taidoc Technology Corporation · LCP · Jan 29, 2016 · Hematology

Device Facts

• Record ID: K142664
• Device Name: URight Hemoglobin A1c system, FORA A1c System
• Applicant: Taidoc Technology Corporation
• Product Code: LCP · Hematology
• Decision Date: Jan 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The URight Hemoglobin A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use. The URight Hemoglobin A1c Control Solution is intended for use as quality control material for the URight Hemoglobin A1c System. The FORA A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use. The FORA A1c Control Solution is intended for use as quality control material for the FORA A1c System.

Device Story

Desktop electric spectrophotometer; measures HbA1c % in capillary or venous whole blood. Uses dedicated cartridge pre-filled with latex reagent, antibody, and diluent. Principle: immuno-turbidimetric method; two-reagent sequence; hemolysate mixed with reagent 1; reagent 2 added to form agglutination complexes via antigen-antibody interaction. Turbidity proportional to HbA1c concentration. Used in clinical labs and point-of-care settings by professionals. Output: HbA1c percentage. Benefits: provides long-term glycemic monitoring for diabetic patients. Includes lyophilized hemolysate control solutions for quality checks.

Clinical Evidence

Bench testing only. Precision evaluated via internal and POC site studies (n=20 replicates/run, 20 days). Linearity verified across 4-16% range (R2=0.9913). Method comparison against Tosoh G8 HPLC analyzer (n=149 venous, n=146 capillary) showed strong correlation (R2 > 0.98). Interference testing confirmed no significant bias for common substances; HbF and HbS identified as interferents causing lower-than-expected results.

Technological Characteristics

Desktop spectrophotometer; immuno-turbidimetric assay; latex-enhanced. Reagents: latex, antibody, diluent. Samples: capillary/venous whole blood (EDTA/heparin). Analytical range: 4.0-16.0%. Controls: lyophilized hemolysates. Storage: 2-8°C.

Indications for Use

Indicated for quantitative measurement of HbA1c in capillary or venous whole blood (EDTA/heparin) to monitor long-term glucose control in patients with diabetes. Not for screening/diagnosis of diabetes or neonatal use. Contraindicated for patients with conditions causing shortened red blood cell survival (e.g., hemolytic diseases, pregnancy, significant blood loss).

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

• Siemens DCA Vantage (k071466)
• Hemoglobin A1c Reagent Set (k031539)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other to create a sense of depth. The profiles are connected to a flowing, ribbon-like shape that resembles a wing or a wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 29, 2016

TAIDOC TECHNOLOGY CORPORATION PAUL LIU REGULATORY AFFAIRS SPECIALIST 6F, NO. 127, WUGONG 2ND RD. WUGU DISTRICT NEW TAIPEI CITY, 24888 TAIWAN

Re: K142664 Trade/Device Name: URight Hemoglobin A1c System. FORA A1c System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JJE, JJE, JJX Dated: January 21, 2016 Received: January 27, 2016

Dear Paul Liu:

We have reviewed your 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. 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 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Courtney H. Lias -S

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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K142664

Device Name URight Hemoglobin A1c System

#### Indications for Use (Describe)

The URight Hemoglobin A I c System is intended to quantitatively measure the percent of hemoglobin A le in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A 1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.

The URight Hemoglobin A1c Control Solution is intended for use as quality control material for the URight Hemoglobin Alc System.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 [e-mail]

"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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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#### Indications for Use

510(k) Number (if known) K142664

Device Name FORA Alc System

#### Indications for Use (Describe)

The FORA A ic System is intended to quantitatively measure the percent of hemoglobin A 1 c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.

The FORA A1c Control Solution is intended for use as quality control material for the FORA A1c System.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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#### Section 9 510(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:_ K142664

# 1. Submitter Information

| Company Name: | TaiDoc Technology Corporation |
|-----------------|--------------------------------------------------------------|
| Contact Person: | Paul Liu |
| Title: | Regulatory Affairs Specialist |
| Address: | B1-7F, No. 127, Wugong 2nd Rd., Wugu Township, Taipei County |
| | 24888, Taiwan |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Prepared Date: | January 21st, 2016 |

# 2. Device name

| Proprietary Name: | URight Hemoglobin A1c System |
|-------------------|-----------------------------------------|
| | URight Hemoglobin A1c Control Solution |
| | FORA A1c System |
| | FORA A1c Control Solution |
| Common Name: | Glycosylated hemoglobin assay |
| | Discrete photometric chemistry analyzer |
| | Analyte controls |
| Product Code: | LCP |
| | JJE |
| | JJX |

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| Classification Panel: | Hematology<br>Clinical Chemistry<br>Clinical Chemistry |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Class II<br>Class I<br>Class I |
| Regulation Citation: | 21 CFR 864.7470, Hemoglobin A1c test system<br>21 CFR 862.2160, Discrete photometric chemistry analyzer<br>for clinical use.<br>21 CFR862.1660, Quality control material (assayed and<br>unassayed) |

# 3. Predicate Device

| Proprietary Name: | DCA VANTAGE (k071466) |
|-------------------|--------------------------------------|
| | HEMOGLOBIN A1C REAGENT SET (K031539) |
| Common Name: | Glycosylated hemoglobin assay |
| | Analyte controls |

# 4. Intended Use

# URight Hemoglobin A1c System

The URight Hemoglobin A1c System is intended to quantitatively measure the percent of hemoglobin A 1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A 1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.

The URight Hemoglobin A1c Control Solution is intended for use as quality control material for the URight Hemoglobin A1c System.

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# FORA A1c System

The FORA A1c System is intended to quantitatively measure the percent of hemoglobin A1c in capillary finger-stick or venous whole blood collected in EDTA (K2 and K3) or sodium heparin for clinical laboratory and point of care use. The measurement of hemoglobin A1c concentration is for use in monitoring long-term glucose control of persons with diabetes. The system is for in vitro diagnostic use and is not for use in diagnosis or screening of diabetes or for neonatal use.

The FORA A1c Control Solution is intended for use as quality control material for the FORA A1c System.

# 5. Device Description:

The hemoglobin A1c system is comprised of a fully automated desktop electric spectrophotometer that measures HbA1c in capillary or venous whole blood samples collected in EDTA (K2 and K3) or sodium heparin using a dedicated cartridge, which is pre-filled with the reagent; latex (reagent 1), antibody and sample dilute solution (reagent 2). The hemoglobin A1c system shines a light through the test material and measures the quantity of hemoglobin A1c in the total hemoglobin (HbA1c %) based on the lot-specific reagent parameters and changes in light absorbency caused by antigen-antibody reactions.

Two levels of hemoglobin A1c control are provided for routine quality checks - level 1 in the normal HbA1c range and level 2 in the elevated HbA1c range. The HbA1c controls are lyophilized hemolysates prepared from packed human erythrocytes.

# 6. Test Principle:

The hemoglobin A1c system is an immuno-turbidimetric method enhanced by latex particles using a two-reagent sequence. Hemolysate is mixed with the reagent 1. Addition of the reagent 2 leads to agglutination complexes, formed by the interaction between latex-bound HbA1c and the corresponding antibodies. Turbidity created by these aggregates is proportional to the amount of latex-bound HbA Ic therefore is proportional to the % of HbA1c in the total hemoglobin.

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# 7. Comparison with Predicate

# Hemoglobin A1c test system

| Similarities and Differences | | | | |
|------------------------------|-----------------------------|------------------------|--|--|
| Item | New Device | Predicate Device | | |
| Intended Use | Quantitative measurement | Same | | |
| | of the percent Hemoglobin | | | |
| | A1c in human whole blood. | | | |
| Methodology | Immuno-turbidimetric | Same | | |
| Sample Type | whole blood samples, | Whole blood and finger | | |
| | venous whole blood (K2 or | stick samples | | |
| | K3 EDTA or sodium | | | |
| | heparin) or capillary whole | | | |
| | blood from fingertips | | | |
| Recommended Testing | Professional and Point of | Same | | |
| Environment | Care Use | | | |
| Analytical Range | 4.0-16.0% | 2.5 - 14.0% | | |
| Reagent storage | 2-8°C | Same | | |

# Hemoglobin A1c control

| Similarities and Differences | | | | |
|------------------------------|--------------------------------------------------|------------------------------|--|--|
| Item | New Device | Predicate Device | | |
| Intended Use | Intended for use as quality<br>control materials | Same | | |
| Format (Material) | Lyophilized hemolysates | Same | | |
| Levels | Level 1, Level 2 | Same | | |
| Storage Conditions | 2-8°C | Same | | |
| Use Lifetime | 3 weeks after reconstitution | 4 weeks after reconstitution | | |

# 8. Performance Characteristics:

# • Linearity

Varying amounts two fresh EDTA blood samples, 4.3% and 13% HbA1c, were mixed to in different proportions to obtain 11 samples. Two additional samples, 14.3% and 15.5% HbA1c, were created by spiking fresh blood sample. A linear regression was calculated

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based on the Tosoh G8 vs. measured % HbA1c values.

| Slope | Intercept | R2 | Recovery (%) |
|--------|-----------|--------|--------------|
| 1.0037 | 0.0355 | 0.9913 | 95-104 |

## • Precision

Two levels HbA1c control solutions and three levels of blood samples were used for precision evaluation on three different sites. The expected values were determined by Tosoh G8. Within-run precision was perform measurements from each sample with 20 tests. Between day precision were tested from each sample in duplicate twice a day for 20 days.

| Sample | Site | n | Expected<br>value | Within run | | | Between run | | | n | Between day | | |
|----------|----------|----|-------------------|------------|------|-------|-------------|------|-------|-----|-------------|------|-------|
| | | | | Mean | SD | %CV | Mean | SD | %CV | | Mean | SD | %CV |
| Control | 1 | 20 | 5.7 | 5.9 | 0.22 | 3.75% | 5.8 | 0.10 | 1.79% | 80 | 5.8 | 0.20 | 3.48% |
| solution | 2 | 20 | | 5.7 | 0.24 | 4.24% | 5.7 | 0.13 | 2.19% | 80 | 5.7 | 0.20 | 3.47% |
| Low | 3 | 20 | | 5.8 | 0.25 | 4.32% | 5.7 | 0.11 | 1.99% | 80 | 5.7 | 0.22 | 3.82% |
| level | Combined | 60 | | 5.8 | 0.25 | 4.35% | 5.7 | 0.12 | 2.02% | 240 | 5.7 | 0.21 | 3.61% |
| Control | 1 | 20 | 11.3 | 11.4 | 0.44 | 3.88% | 11.3 | 0.24 | 2.11% | 80 | 11.3 | 0.43 | 3.78% |
| solution | 2 | 20 | | 11.4 | 0.44 | 3.85% | 11.2 | 0.25 | 2.22% | 80 | 11.2 | 0.44 | 3.89% |
| High | 3 | 20 | | 11.2 | 0.40 | 3.55% | 11.3 | 0.25 | 2.24% | 80 | 11.2 | 0.46 | 4.12% |
| level | Combined | 60 | | 11.3 | 0.43 | 3.77% | 11.3 | 0.24 | 2.16% | 240 | 11.2 | 0.44 | 3.92% |
| Blood | 1 | 20 | 5.5 | 5.3 | 0.15 | 2.87% | 5.3 | 0.10 | 1.88% | 80 | 5.3 | 0.20 | 3.79% |
| sample | 2 | 20 | | 5.3 | 0.22 | 4.14% | 5.3 | 0.11 | 2.01% | 80 | 5.3 | 0.21 | 4.04% |
| Low | 3 | 20 | | 5.3 | 0.17 | 3.18% | 5.3 | 0.13 | 2.54% | 80 | 5.3 | 0.20 | 3.70% |
| level | Combined | 60 | | 5.3 | 0.18 | 3.46% | 5.3 | 0.12 | 2.18% | 240 | 5.3 | 0.20 | 3.87% |
| Blood | 1 | 20 | 7.7 | 7.9 | 0.33 | 4.18% | 7.8 | 0.13 | 1.62% | 80 | 7.8 | 0.30 | 3.91% |
| sample | 2 | 20 | | 7.7 | 0.38 | 4.95% | 7.7 | 0.10 | 1.36% | 80 | 7.6 | 0.29 | 3.85% |
| Middle | 3 | 20 | | 7.6 | 0.27 | 3.58% | 7.7 | 0.16 | 2.08% | 80 | 7.7 | 0.30 | 3.90% |
| level | Combined | 60 | | 7.7 | 0.35 | 4.50% | 7.7 | 0.14 | 1.79% | 240 | 7.7 | 0.30 | 3.92% |
| Blood | 1 | 20 | 10.3 | 10.4 | 0.34 | 3.26% | 10.4 | 0.17 | 1.66% | 80 | 10.4 | 0.36 | 3.43% |
| sample | 2 | 20 | | 10.4 | 0.37 | 3.60% | 10.5 | 0.18 | 1.67% | 80 | 10.5 | 0.36 | 3.39% |
| High | 3 | 20 | | 10.4 | 0.35 | 3.43% | 10.5 | 0.17 | 1.63% | 80 | 10.5 | 0.37 | 3.49% |
| level | Combined | 60 | | 10.4 | 0.35 | 3.38% | 10.5 | 0.18 | 1.70% | 240 | 10.5 | 0.36 | 3.46% |

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## · Accuracy

| TD-4601 Hemoglobin A1c Reagent Cartridge and compared with Tosoh G8 analyzer. | | | | |
|-------------------------------------------------------------------------------|---------------------|--------------|----------------------|--------|
| Site No. | Sample type | No. of tests | regression line | R2 |
| 1 | Capillary | 49 | $y = 1.002x - 0.016$ | 0.9834 |
| 1 | K2EDTA venous blood | 49 | $y = 1.018x - 0.101$ | 0.9807 |
| 2 | Capillary | 48 | $y = 1.015x - 0.044$ | 0.9846 |
| 2 | K2EDTA venous blood | 50 | $y = 1.022x - 0.076$ | 0.9885 |
| 3 | Capillary | 49 | $y = 0.958x + 0.280$ | 0.9849 |
| 3 | K3EDTA venous blood | 50 | $y = 0.968x + 0.160$ | 0.9861 |

A method comparison study was performed with 149 EDTA venous blood and 146 capillary blood patient samples in three different sites. Samples were analyzed on TD-4601 Hemoglobin A1c Reagent Cartridge and compared with Tosoh G8 an

## • Interference

The following interfering substances at the indicated concentrations produce less than 6% deviation when tested at indicated concentration: Acetaminophen 20 mg/dL, Glibenclamide 0.19 mg/dL, Ibuprofen 50 mg/dL, Metformin 4 mg/dL, Triglycerides 3000 mg/dL, Bilirubin (unconjugate) 20 mg/dL, Ascorbic acid 3 mg/dL, Rheumatoid factor 26 IU/mL, Carbamylated Hb 5 mmol/L, and Acetylated Hb 5 mmol/L. The testing results also indicate there is no significant interference for HbC ≤37.4%, HbD ≤48.5%, HbE ≤21.4% and HbA2 < 7.0%. HbF shows interference at 21.2% and HbS shows interference at 20.3%. HbF and HbS levels tested with this assay show interference and samples containing HbF or HbS will show a lower than expected HbA1c result.

## • Matrix comparison

The study was performed using 135 samples, with a HbA1c range from 4.5-13%, collected from 3 POC sites in the matrix of capillary blood, K2EDTA venous blood, K3EDTA venous blood and sodium heparin venous blood.

| Matrix comparison | Regression line | R2 |
|------------------------------|--------------------|--------|
| EDTA vs. Capillary | y = 0.978x + 0.301 | 0.9896 |
| Sodium heparin vs. Capillary | y = 0.982x + 0.227 | 0.9885 |
| Sodium heparin vs. EDTA | y = 0.999x - 0.033 | 0.9879 |

## 9. Limitations

This test is not for screening or diagnosis of diabetes or neonatal use

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- For clinical laboratory and point-of care use .
- For prescription use only
- . This test should not be used in monitoring daily glucose control
- This test 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
- HbF and HbS levels tested with this assay show interference and samples containing HbF or HbS will . show a lower than expected HbA1c result

## 10. Reference range

The American Diabetes Association (ADA) expected value range is 4.0-6.0% HbA1c for people without diabetes. The American Diabetes Association's (ADA) most recent Clinical Practice Recommendation for diabetes specified a treatment goal of less than 7% and suggests additional action when HbA1c level is above 8%.

| HA1c Value | Glycemic Goal |
|-------------|------------------------------|
| <8% HbA1c | Less stringent |
| <7% HbA1c | General (Non-Pregnant Adult) |
| <6.5% HbA1c | More stringent |

As recommended by the ADA, patients in the range of 5.7-6.4% HbA1c would be in the category of increased risk for diabetes.

Source: American Diabetes Association. Diabetes Care 38 (2015): Suppl. 1. S8-S40

## 11. Conclusion

Based on the information provided in this submission, the URight Hemoglobin A1c System / FORA A1c System and URight Hemoglobin A1c Control Solution / FORA A1c Control Solution are substantially equivalent to the predicate device.