A1C GEAR SYSTEM

K130014 · Sakae Corporation · LCP · Apr 4, 2014 · Hematology

Device Facts

• Record ID: K130014
• Device Name: A1C GEAR SYSTEM
• Applicant: Sakae Corporation
• Product Code: LCP · Hematology
• Decision Date: Apr 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Alc GEAR System is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A 1 (%HbA1c) from finger-stick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbAlc is recommended to monitor long-term glycemic control of persons previously diagnosed with diabetes mellitus. This test is not for screening or diagnosis of diabetes.

Device Story

Fully automated desktop electric spectrophotometer; measures %HbA1c in human whole blood. Input: finger-stick or venous whole blood sample in dedicated reagent cartridge (latex, antibody, diluent). Operation: illuminates 660 nm LED through test material; measures light absorbance changes; calculates %HbA1c via non-linear calibration curve. Output: quantitative %HbA1c result displayed on LCD; printed via thermal printer. Used in clinical laboratories and point-of-care settings by professional operators. Provides objective HbA1c data to assist healthcare providers in monitoring long-term glycemic control for diabetic patients. Benefits: rapid, automated, point-of-care monitoring of glycemic status.

Clinical Evidence

Bench testing only. Precision studies (internal and external) conducted per CLSI EP5-A2; total CVs ranged from 1.06% to 5.25%. Linearity verified per CLSI-EP06-A (r²=1.00, range 4.0-13.1%). Method comparison studies against predicate and reference analyzers (Arkray HA8170, Tosoh G7/G8) showed strong correlation (r=0.98-0.995). Interference studies identified significant bias with hemoglobin variants C, D, E, S, and F (>10%), resulting in a boxed warning in labeling.

Technological Characteristics

Desktop spectrophotometric analyzer; 660 nm LED light source. Immuno-turbidimetric assay using latex-enhanced agglutination. Reagents: R1 (latex, triethanolamine, sodium azide, bicine buffer) and R2 (mouse monoclonal anti-human HbA1c, goat anti-mouse IgG, bis-tris buffer). Connectivity: manual entry or barcode reader for reagent lot verification. No wireless transmission. Sterilization: N/A. Software: complies with IEC 62304.

Indications for Use

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

Reference Devices

• Tosoh G8
• Primus Ultra Boronate Affinity HPLC

Submission Summary (Full Text)

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K130014

Phone: [phone], Fax: [phone]

### 510(k) Summary

APR 0 4 2014

1 Applicant SAKAE CORPORATION 239 Onishi, Fujioka, Gunma, 370-1401 JAPAN Phone: [phone] Fax: [phone]

### 2 Contact Information:

Erika B. Ammirati, R. A. C., MT (ASCP) Regulatory Consultant to SAKAE CORPORATION Phone: [phone] E-mail: [e-mail]

3 Device Trade Name: Alc GEAR System

## 4 Device Common Name:

Glycated hemoglobin assay and discrete photometric chemistry analyzer for clinical use

## 5 Manufacturer Address

SAKAE CORPORATION 239 Onishi, Fujioka, Gunma, 370-1401 JAPAN Phone: [phone] Fax: [phone]

## 6 Device Classification:

SAKAE CORPORATION A1c GEAR System (new) is a Class II device and reagent, and is classified by FDA under 21 CFR 864.7470 Glycosylated hemoglobin assay and the FDA Product Code is LCP.

A lc GEAR (the instrument) is a Class I device and is classified by FDA under 21 CFR 862.2160, Discrete photometric chemistry analyzer for clinical use, and the FDA Product Code is JJE.

## 7 Device Description:

The Alc GEAR instrument is a fully automated desktop electric spectrophotometer that measures %HbAlc in human whole blood using a dedicated reagent (MEDIDAS HbA1c). The system illuminates a 660 nm LED (Light Emitting Diode) through the test material and quantitatively measures the percent of hemoglobin Alc in the total hemoglobin (%HbA1c) by means of light absorbance changes and a non-linear calibration curve. The system includes the Hemoglobin A Ic Analyzer (Alc GEAR), thermal printer, barcode reader, power cable, and fan filter.

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Phone: [phone],

MEDIDAS HbAIc is composed of a test cartridge, capillary, pipette tip and master calibration card. The cartridge is pre-filled with reagent; latex (reagent R1), antibody (reagent R2), and sample dilute solution.

# 8 Indications for Use

The Alc GEAR System is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A 1 (%HbA1c) from finger-stick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbAlc is recommended to monitor long-term glycemic control of persons previously diagnosed with diabetes mellitus. This test is not for screening or diagnosis of diabetes.

# 9 Limitations

- This test should not be used in monitoring daily glucose control. ●
- . Should not be used to replace daily home testing of urine and blood glucose levels.
- 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.

# 10 Expected Values and Reference (non-diabetic) Level

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 is above 8%

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

American Diabetes Association Standards of Medical Care in Diabetes 2012. 35 (Supplement1), S11-S63

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239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan Phone: [phone], Fax: [phone]

# 11 Predicate Device

DCA Vantage, a test system for hemoglobin A1c by Siemens Medical Solutions Diagnostics, K071466. The predicate device has the same intended use, uses substantially the same assay methodology, and is substantially equivalent to the A 1c GEAR System.

| Manufacturer | SAKAE CORPORATION | Siemens Medical Solutions Diagnostics |
|------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Trade Name | A1c GEAR System | DCA Vantage |
| 510(k) Number | K130014 | K071466 |
| Product Code | LCP | LCP |
| Regulation Number | 864.7470 | 864.7470 |
| Indications for use: | Quantitative measurement of percent<br>hemoglobin A1c in human whole<br>blood | Quantitative measurement of percent<br>hemoglobin A1c in human whole blood |
| Methodology | Immuno-turbidimetric | Immuno-turbidimetric (inhibition) |
| Sample | Finger-stick blood or venous whole<br>blood collected in K2 EDTA or<br>sodium fluoride | Finger-stick blood or venous whole blood<br>collected in EDTA, heparin,<br>fluoride/oxalate, and citrate |
| Visual Display | LCD | LCD |
| Hemolysate preparation | Automatic | Automatic |
| Detection Method | Transmission | Transmission |
| Calibration | User; calibration card | User; calibration card |
| Recommended testing<br>environment | Professional use; point of care | Professional use; point of care |
| Throughput | 6-7 minutes per sample | 6-7 minutes per sample |
| Analytical Range | 4.3-12.5% | 2.5-14.0% |
| Reagent Storage | 2-8 degrees Celsius (36-46 degrees<br>Fahrenheit) | 2-8 degrees Celsius (36-46 degrees<br>Fahrenheit) |
| Accuracy (Comparison) | Versus HPLC method<br>$Y=1.03x-0.33$ , $R=0.99$ N=158 | Versus DCCT reference method (HPLC)<br>$Y=1.02x-0.00$ , $R=0.98$ N=100 |
| NGSP Certification Status | Certified | Certified |
| Complies with IEC 60601-1 | Yes | Yes |
| Complies with IEC 60601-1-2 | Yes | Yes |

#### Device Comparison Chart

# 12 Performance Data

## 12.1 Linearity

Linearity of the Alc GEAR System was verified with the use of two whole blood samples collected into EDTA tubes. Sample low (L: 4.0% HbA1c, result from ion-exchange HPLC) and high (H: 15.0% HbA1c, result from ion-exchange HPLC) were mixed in different proportions to obtain a series of 11 samples were measured in triplicate. Recovery rate was used as an indicator for the degree of the deviation of expected values. The linear regression analysis was performed.

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Phone: [phone], Fax: [phone]

Table 1 Linearity of the Alc GEAR System. Y: observed value, X: expected value, r': squared coefficient of correlation, recovery (%) = observed value / expected value x 100.

| Range (% HbA1c) | Regression line | r2 | Recovery (%) |
|-----------------|------------------|------|--------------|
| 4.0 - 13.1 | y = 0.98x + 0.19 | 1.00 | 98 - 103 |

# 12.2 Method Comparisons (venous to venous sampling, in-house)

Method comparison studies were performed with three comparison methods: two different ion-exchange HPLC methods and one point of care (POC, DCA Vantage) method were each compared to the Alc GEAR System. Venous whole blood collected into EDTA tubes were prepared from donors and analyzed.

Table 2 Linear regression analysis data of method comparison. Y: A1c GEAR, X: comparison method, N: number of samples, r2: squared coefficient of correlation.

| Comparison Method | र | HbA1c (%) | Regression Line | |
|---------------------------------------|-------|-----------|------------------|------|
| HPLC I | ા રેક | 4.6-10.6 | y = 1.03x - 0.33 | 0.98 |
| HPLC 2 | 40 | 4.2-9.8 | v=0.99x+0.31 | 0.98 |
| Another POC analyzer (DCA<br>Vantage) | 60 | 4.7-11.7 | y = 0.95x - 0.12 | 0.99 |

## 12.3 Matrix Comparison

Matrix comparison studies were performed to evaluate the effect of the sample matrix. A finger-stick sample and venous whole blood samples with anticoagulants EDTA or sodium fluoride (NaF), were collected from each donor and analyzed with the Alc GEAR System.

Table 3 Linear regression analysis data of matrix comparison. N: number of samples, r: squared coefficient of correlation.

| Matrix | N | HbA1c (%) | Regression line | r2 |
|------------------------------------|----|-----------|------------------|------|
| finger (y) vs. EDTA-venous (x) | 78 | 4.3-9.0 | y = 0.96x + 0.15 | 0.99 |
| NaF-venous (y) vs. finger (x) | 46 | 4.8-8.8 | y = 1.04x - 0.06 | 0.99 |
| NaF-venous (y) vs. EDTA-venous (x) | 81 | 5.3-10.9 | y = 1.01x + 0.01 | 0.99 |

#### 12.4 Precision

Precision studies were performed at both internal and external sites. The studies followed CLSI (Clinical and Laboratory Standards Institute) Guideline EP5-A2.

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PORATION

239 Onishi, Fujioka-shi, Gunma, 3 Phone: [phone], Fax: [phone]

Within-run (repeatability), between-day, and total precision were determined for two control materials (control L and H) and three EDTA whole blood samples at the internal site, and with two control materials (control L and H) and two EDTA whole blood samples at the external site. The samples were analyzed for 20 days, in duplicate, twice a day (n = 80).

| Sample | N= | Mean | Within-run CV (%) | Between-day CV (%) | Total CV (%) |
|-----------|----|------|-------------------|--------------------|--------------|
| Control L | 80 | 5.2 | 1.26 | 0.51 | 1.36 |
| Control H | 80 | 9.0 | 0.85 | 0.26 | 1.06 |
| Sample 1 | 80 | 5.5 | 0.73 | 0.80 | 1.12 |
| Sample 2 | 80 | 11.1 | 1.11 | 0.70 | 1.37 |
| Sample 3 | 80 | 12.1 | 1.14 | 1.01 | 1.52 |

# Table 4 Results from the internal site. %CV: %coefficient of variation.

Table 5 Results from the external site. %CV: %coefficient of variation.

| Sample | N= | Mean | Within-run CV (%) | Between-day CV (%) | Total CV (%) |
|-----------|----|------|-------------------|--------------------|--------------|
| Control L | 80 | 5.0 | 1.08 | 0.75 | 1.31 |
| Control H | 80 | 8.9 | 0.65 | 0.53 | 0.90 |
| Sample 1 | 80 | 5.2 | 1.18 | 0.56 | 1.34 |
| Sample 2 | 80 | 8.8 | 0.82 | 0.47 | 1.05 |

Table 6 Reproducibility estimated from the results of two sites. %CV: %coefficient of variation.

| Sample | N | Overall mean | Between-site CV (%) | Total CV (%) |
|-----------|-----|--------------|---------------------|--------------|
| Control L | 160 | 5.1 | 2.55 | 2.81 |
| Control H | 160 | 9.0 | 0.56 | 0.94 |

# 12.5 Point of Care (POC) Studies

External validation of the AIc GEAR System was performed at POC sites to evaluate precision and method comparisons.

In the precision study, three levels of controls were analyzed for 20 days and three levels of patient samples were analyzed for 10 days by POC operators.

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239 Onishi, Fujioka-shi, Gunma, 370-1401 Japan Phone: [phone], Fax: [phone]

| Sample | N = | Site | Mean | Within-site<br>CV (%) | Overall mean | Reproducibility<br>Total CV (%) |
|---------------|-----|------|-------|-----------------------|--------------|---------------------------------|
| Control 1 | 120 | 1 | 5.19 | 2.85% | 5.22 | 2.26% |
| | 120 | 2 | 5.21 | 1.92% | | |
| | 120 | 3 | 5.27 | 1.46% | | |
| Control 2 | 120 | 1 | 7.01 | 2.53% | 7.06 | 2.11% |
| | 120 | 2 | 7.07 | 1.73% | | |
| | 120 | 3 | 7.10 | 1.73% | | |
| Control 3 | 120 | 1 | 11.05 | 3.37% | 11.04 | 2.55% |
| | 120 | 2 | 11.09 | 2.48% | | |
| | 120 | 3 | 11.00 | 1.35% | | |
| Sample Low | 60 | 1 | 5.80 | 3.14% | 5.84 | 3.12% |
| | 60 | 2 | 5.83 | 3.28% | | |
| | 60 | 3 | 5.89 | 2.63% | | |
| Sample Middle | 120 | 1 | 8.01 | 3.31% | 8.07 | 4.16% |
| | 128 | 2 | 7.87 | 2.30% | | |
| | 120 | 3 | 8.34 | 2.91% | | |
| Sample High | 120 | 1 | 10.55 | 3.22% | 10.84 | 5.25% |
| | 128 | 2 | 10.59 | 2.46% | | |
| | 120 | 3 | 11.38 | 3.21% | | |

# Table 7 Results of precision study at three external sites. %CV: %coefficient of variation.

In the method comparison study, a finger-stick sample and a venous EDTA sample were collected from each donor. The finger-stick blood samples were analyzed with the AIc GEAR System by POC operators and the venous blood samples were analyzed with an ion-exchange HPLC (Tosoh, G8) reference method by qualified laboratory technicians at a reference laboratory.

Table 8 Linear regression analysis of method comparison study at three external sites. N: number of samples, r: coefficient of correlation.

| Study<br>site | N | Min | Max | Slope<br>(95% confidence interval) | Intercept<br>(95% confidence interval) | r |
|---------------|----|-----|------|------------------------------------|----------------------------------------|-------|
| 1 | 47 | 4.9 | 11.9 | 0.968<br>(0.941 to 0.994) | 0.04<br>(-0.16 to 0.24) | 0.995 |
| 2 | 41 | 5.4 | 10.8 | 0.976<br>(0.936 to 1.015) | 0.12<br>(-0.15 to 0.40) | 0.990 |
| 3 | 46 | 5.0 | 9.6 | 0.989<br>(0.952 to 1.027) | 0.08<br>(-0.18 to 0.35) | 0.990 |

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239 Onishi, Fujioka-shi, G Phone: [phone], Fax: [phone]

# 12.6 Interference

No significant interference was observed up to the following concentrations in both EDTA and NaF whole blood samples, or commercial controls:

| • | Free - bilirubin | 37.0 mg/dl |
|---|----------------------------------------|-------------------------------------|
| • | Conjugated - bilirubin | 40.4 mg/dl |
| • | Rheumatoid factor | 550 IU/ml |
| • | Chyle (mixture of lipids)<br>includes: | 3120 FTU (Formazine Turbidity Unit) |
| | Triglycerides | 170 mg/dl |
| | Phospholipids | 182 mg/dl |
| | Free fatty acids | 124 μEq/dl (approx. 1.24 mmol/l) |
| • | Triglycerides (separate study) | 2,000 mg/dl |
| • | Acetaminophen | 20.0 mg/dl |
| • | Ibuprofen | 50.0 mg/dl |
| • | Glibenclamide | 0.2 mg/dl |
| • | Metformin | 5.1 mg/dl |
| • | Ascorbic acid | 6.0 mg/dl |

NOTE: It is possible that other substances and/or factors not listed above may interfere with the test and cause false results.

# 12.7 Analytical Specificity 12.7.1 Hemoglobin (Hb) Variants

A hemoglobin variant study was performed using commercial samples known to contain Hemoglobin variants C, D, E, S and F. Samples contained both low and high levels of %HbA1c at concentrations from 4.6-11.6%. These variant samples were tested in duplicate using the A1c GEAR System versus a reference method (Primus Ultra Boronate Affinity HPLC). The results indicated samples containing Hemoglobin C were elevated by 24%, samples containing Hemoglobin D were elevated by 16%, samples containing Hemoglobin E were elevated by 13% and samples containing Hemoglobin S were elevated by 14%. Samples containing >10% Hemoglobin F were decreased by 32%. All variants tested were shown to interfere with this device.

## 12.7.2 Modified Hemoglobin

The following modified hemoglobin was prepared by incubating with the substance in parentheses and found not to affect the A1c GEAR System for both EDTA and NaF whole blood samples:

- . Carbamylated hemoglobin (sodium cyanate, 10 mg/dl)
- . Acetylated hemoglobin (acetylsalicylic acid. 200 mg/dl)
- Labile hemoglobin 트 (D-glucose, 2000 mg/dl)

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Image /page/7/Picture/0 description: The image shows the logo for Sakae Corporation. The logo consists of a stylized letter "S" on the left and the words "SAKAE CORPORATION" in bold, black letters on the right. The letter "S" is made up of three curved lines that are stacked on top of each other.

239 Onishi, Fujioka-shi, Gunma, 1 401 Japan Phone: [phone], Fax: [phone]

# 12.8 Limit of Detection

To estimate the lowest detectable value of %HbA1c for the A1c GEAR System, limit of detection (LOD) studies were performed and LOD was calculated to be 2.6% and LOB was calculated to be 2.3%.

# 12.9 Stability- Real-Time

A real time shelf life stability study was performed for MEDIDAS HbA Ic using the A1c GEAR analyzer. From these results, it was concluded that the reagent cartridge can be stored for up to one year at 2-8 °C (36-46 °F).

## 13 Conclusions

Performance studies were conducted and the data obtained indicate the AIc GEAR System is substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight, with three wavy lines below it.

Public Health Service

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

April 4, 2014

# SAKAE CORPORATION C/O ERICA AMMIRATI 575 SHIRLYNN COURT LOS ALTOS CA 94022

Re: K130014

Trade/Device Name: A 1c Gear System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: II Product Code: LCP, JJE Dated: March 28, 2014 Received: March 31, 2014

Dear Ms. Ammirati:

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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# Page 2-Ms. Ammirati

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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

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

510(k) Number (if known) K130014

#### Device Name Alc GEAR System

#### Indications for Use (Describe)

The Alc GEAR System is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A le (%HbA lc) from finger-stick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbA is recommended to monitor long-term glycemic control of persons previously diagnosed with diabetes mellitus. This test is not for screening or diagnosis of diabetes.

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 CONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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

FORM FDA 3881 (1/14)