OneDraw A1C Test System

K183230 · Drawbridge Health, Inc. · LCP · Aug 15, 2019 · Hematology

Device Facts

• Record ID: K183230
• Device Name: OneDraw A1C Test System
• Applicant: Drawbridge Health, Inc.
• Product Code: LCP · Hematology
• Decision Date: Aug 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The OneDraw™ A1C Test System, which consists of the OneDraw Blood Collection Device and the OneDraw A1C Test, is intended to collect capillary blood from the upper arm of individuals 18 years of age or older onto filter (matrix) paper within the collection device by a healthcare professional. Samples are delivered to the laboratory for the quantitative measurement of HbA1c for monitoring the long-term control of blood sugar (glucose) in people with diabetes. Testing performed on samples collected with this device should not be used to diagnose or screen for diabetes. The OneDraw A1C Test System should not be used with neonates.

Device Story

System collects capillary blood from upper arm via vacuum extraction and lancet puncture; blood deposited onto stabilization matrix strips within single-use cartridge. Healthcare professional performs collection; cartridge mailed to designated laboratory. Laboratory staff removes matrix strip, elutes sample using Beckman HbA1c Hemolyzing Reagent, and analyzes via Beckman Coulter AU480 Chemistry Analyzer. Output is quantitative HbA1c percentage used by clinicians to monitor long-term glycemic control. System provides stabilization for transport; replaces traditional venous draw for A1c monitoring. Benefits include simplified, less invasive capillary collection for patients.

Clinical Evidence

Bench testing only. Precision studies (CLSI EP05-A3) showed total CVs 1.40-2.33%. Linearity study (n=107) demonstrated R²=0.99 (Y=1.01x+0.06) across 4.7-14.7% HbA1c range. Method comparison against venous K2 EDTA samples on Beckman Coulter AU480 showed R²=0.99 (Y=1.00x-0.11). Stability studies support 21-day room temperature storage. Interference testing confirmed no significant bias for common hemoglobin variants except HbF >8.5%.

Technological Characteristics

System includes sterile, single-use capillary blood collection device (stainless steel lancets, vacuum mechanism, hydrogel adhesive) and laboratory-based Beckman Coulter AU480 Chemistry Analyzer. Uses latex agglutination inhibition method. Traceable to NGSP/DCCT and IFCC reference methods. Sterilization via radiation (ISO 11137).

Indications for Use

Indicated for individuals 18 years or older with diabetes for monitoring long-term blood sugar control. Contraindicated for neonates, patients with conditions causing shortened red blood cell survival (e.g., hemolytic diseases, homozygous sickle cell trait, pregnancy, significant blood loss), and patients with HbF levels >8.5%.

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

• Home Access® A1C Test and Home Access® Collection Cassette (K141944)

Submission Summary (Full Text)

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August 15, 2019

Drawbridge Health, Inc. Annie Wright Associate Director, Regulatory Affairs & Quality Assurance 11535 Sorrento Valley Road, Suite 407 San Diego, CA 92121

Re: K183230

Trade/Device Name: OneDraw™ A1C Test System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, PRJ Dated: July 15, 2019 Received: July 15, 2019

Dear Annie Wright:

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. 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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K183230

Device Name OneDraw™ A1C Test System

Indications for Use (Describe)

The OneDraw™ A1C Test System, which consists of the OneDraw Blood Collection Device and the OneDraw A1C Test, is intended to collect capillary blood from the upper arm of individuals 18 years of age or older onto filter (matrix) paper within the collection device by a healthcare professional. Samples are delivered to the laboratory for the quantitative measurement of HbA1c for monitoring the long-term control of blood sugar (glucose) in people with diabetes. Testing performed on samples collected with this device should not be used to diagnose or screen for diabetes. The OneDraw A1C Test System should not be used with neonates.

| 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)

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# 510(k) SUMMARY

# OneDraw™ A1C Test System

| Applicant Name: | Drawbridge Health, Inc.<br>11535 Sorrento Valley Road, Suite 407<br>San Diego, CA 92121 USA |
|------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Annie Wright<br>Associate Director, Regulatory Affairs & Quality Assurance<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | July 25, 2019 |

# DEVICE IDENTIFICATION

| | Device Name: OneDraw™ A1C Test System, which consists of the following: |
|-----------------------------|---------------------------------------------------------------------------------------------------|
| Trade or Proprietary Names: | OneDraw™ A1C Test |
| Device Classification Name: | Glycosylated hemoglobin assay |
| Product Codes: | LCP |
| Regulatory Class: | Class II |
| Classification Regulation: | 21 CFR 864.7470 |
| Panel: | Hematology (81) |
| Trade or Proprietary Names: | OneDraw™ Blood Collection Device |
| Device Classification Name: | Blood specimen collection device |
| Product Codes: | PRJ |
| Regulatory Class: | Class II |
| Classification Regulation: | 21 CFR 862.1675 |
| Panel: | Chemistry (75) |
| Predicate Device: | Home Access Health Corp., Home Access® A1C Test and<br>Home Access® Collection Cassette (K141944) |

# INTENDED USE

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Image /page/4/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a blue and red abstract shape on the left, and the words "Drawbridge" and "Health" on the right. The word "Drawbridge" is in a larger, darker font than the word "Health", which is located underneath the word "Drawbridge".

The OneDraw™ A1C Test System, which consists of the OneDraw Blood Collection Device and the OneDraw A1C Test, is intended to collect capillary blood from the upper arm of individuals 18 years of age or older onto filter (matrix) paper within the collection device by a healthcare professional. Samples are delivered to the laboratory for the quantitative measurement of HbA1c for monitoring the long-term control of blood sugar (glucose) in people with diabetes. Testing performed on samples collected with this device should not be used to diagnose or screen for diabetes. The OneDraw A1C Test System should not be used with neonates.

# DEVICE DESCRIPTION

The OneDraw™ A1C Test System includes the OneDraw Blood Collection Device and the OneDraw A 1C Test. The OneDraw Blood Collection Device is a single-use, sterile, capillary blood specimen collection device. The OneDraw Blood Collection Device includes a transport sleeve, accessories, and instructions (OneDraw Blood Collection Device Instructions for Use (IFU)) which are needed to collect, package, and mail the sample to the designated certified clinical laboratory for HbA1c testing, using the OneDraw A1C Test.

The OneDraw Blood Collection Device incorporates lancets to make incisions in the skin and a vacuum to draw blood at the surface of the skin through channels to deposit the blood onto collection and stabilization matrices (matrix strips). The matrix strips are contained within a cartridge which is removed from the device after the draw is complete. The cartridge is then inserted into the transport sleeve which encloses and protects the sample during shipping to the clinical laboratory.

Once the transport sleeve containing the sample is received by the clinical laboratory, one of the dry blood sample matrices is removed. The matrix is then eluted in Beckman Hemolyzing Reagent (BHR) in 2 mL tubes or 2.2 mL deepwell plates using an orbital shaker. Next, the sample is diluted in BHR to its final concentration and tested using FDA-cleared Beckman Coulter AU480 Chemistry Analyzer and A 1 c reagents, including calibrators, (K 120199) per the OneDraw A 1 C Test IFU.

# TECHNOLOGICAL CHARACTERISTICS

The OneDraw A1C Test System has technological characteristics that are substantially equivalent to the predicate device as identified in the table below. Both the subject device and the predicate device provide a method to collect a capillary blood sample to be analyzed in a clinical laboratory for determination of Hemoglobin A1c (HbA1c) using a previously cleared reagents and analysis system.

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| Attribute | Predicate Device<br>Home Access® A1C Test (K141944) | Candidate Device<br>OneDraw™ A1C Test System |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities and Differences | | |
| Intended Use | The Home Access® A1C Test is an <i>in vitro</i> test method<br>for quantitative measurement of Hemoglobin A1c using<br>capillary blood collected from the fingertip, collected<br>onto filter paper via the Home Access collection<br>cassette. The Home Access A1C Test is for<br>measurement of HbA1c on blood specimens which can<br>be collected at the patient' home or in a healthcare<br>professional setting and delivered to the laboratory by<br>mail. Measurements obtained through this method can<br>be used for long-term control of blood sugar (glucose) in<br>people with diabetes.<br><br>This test is not to be used to diagnose or screen for diabete<br>Not for use with neonates. | The OneDraw™ A1C Test System, which consists<br>of the OneDraw Blood Collection Device and the<br>OneDraw A1C Test, is intended to collect capillary<br>blood from the upper arm of individuals 18 years of<br>age or older onto filter (matrix) paper within the<br>collection device by a healthcare professional.<br>Samples are delivered to the laboratory for the<br>quantitative measurement of HbA1c for monitoring<br>the long-term control of blood sugar (glucose) in<br>people with diabetes. Testing performed on samples<br>collected with this device should not be used to<br>diagnose or screen for diabetes. The OneDraw A1C<br>Test System should not be used with neonates. |
| Sample types | Dry capillary blood | Same |
| Standardization | Traceable to the International Federation of Clinical<br>Chemistry and Laboratory Medicine (IFCC) and<br>Diabetes Control and Complications Trial (DCTT)<br>reference method. Certified via the National<br>Glycohemoglobin Standardization Program (NGSP). | Same |
| Kit Components | Blood sample collection cassette containing filter<br>paper for specimen collection Sample pouch with desiccant for specimen<br>packaging 2 sterile safety lancets Gauze Pad 2 Bandages Instructions for Use/Things You Should Know<br>About A1C Prepaid Return Mailer for specimen mailing Patient Info Card for specimen labeling and consent Outer Packaging | Blood sample collection cartridge containing<br>filter paper for specimen collection Sample pouch containing desiccant for specimen<br>packaging 2 sterile lancets within the assembly Alcohol prep pad Gauze pad Bandage Instructions for Use Return Mailer (Chipboard) for specimen mailing Outer Carton |
| Sample Preparation | Finger stick blood collected on a filter paper within the<br>cassette | Blood drawn from upper arm and is collected on a<br>filter paper within the cartridge |
| Location of collection | Sample collected at home or HCP setting | Healthcare Professional (HCP) setting |
| Location of analysis | Laboratory | Same |
| Distribution | Prescription and Over the Counter | Prescription |
| Analysis | Mail to laboratory | Same |
| Report | Mailed to user | Mailed to healthcare professional |
| Measuring Range | 4.5-14.5% HbA1c | 4.7-14.3% HbA1c |
| Puncture site | Fingertip | Upper arm |
| Mechanism of blood draw | Fingerstick | Collection device (lancet-stick and vacuum) |
| Collection method | Blood is collected using the fingerstick method | The blood is drawn into the collection device by<br>puncture of capillaries located near the surface of the<br>skin using lancets or similar small sharp objects |

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Image /page/6/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a stylized, abstract shape on the left, with the company name "Drawbridge" and the word "HEALTH" stacked below it on the right. The abstract shape is a curved, teardrop-like form with a gradient of colors, transitioning from blue at the top to red at the bottom. The text is in a dark gray color.

# PERFORMANCE TESTING

The following standards/guidance documents were used in the design and testing of OneDraw™ A1C Test System:

| Designation/Revision | Title |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLSI C44-A, 2002 | Harmonization of Glycohemoglobin Measurements; Approved Guideline |
| CLSI EP05-A3, 2014 | Evaluation of Precision Performance of Quantitative Measurement Methods; Approved<br>Guideline - Third Edition |
| CLSI-EP06-A, 2003 | Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical<br>Approach; Approved Guideline |
| CLSI-EP07-A2, 2005 | Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition |
| CLSI-EP09-A3, 2013 | Method Comparison and Bias Estimation using Patient Samples; Approved Guideline –<br>Third Edition |
| CLSI-EP17-A2, 2012 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures;<br>Approved Guideline-Second Edition |
| CLSI- EP25-A, 2009 | Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline |
| ANSI/AAMI/ISO 11137-<br>1:2006/(R)2015; A1:2013 | Sterilization of Health Care Products-Radiation - Part 1: Requirements for development,<br>validation and routine control of a sterilization process for medical devices |
| ANSI/AAMI/ISO 11137-<br>2:2013 | Sterilization of Health Care Products-Radiation - Part 2: Establishing the sterilization<br>dose |
| ANSI/AAMI/ISO 11137-<br>3:2017 | Sterilization of Health Care Products-Radiation - Part 3: Guidance on dosimetric<br>aspects. |
| ISO 10993-1:2009 | Biological Evaluation of Medical Devices-Part 1: Evaluation and testing within a risk<br>management process |
| ISO 10993-3:2014 | Biological Evaluation of Medical Devices-Part 3: Tests for genotoxicity,<br>carcinogenicity, and reproductive toxicity |
| ISO 10993-4:2002,<br>A1:2006 | Biological Evaluation of Medical Devices-Part 5: Selection of tests for interactions with<br>blood |
| ISO 10993-5, 2009 | Biological Evaluation of Medical Devices-Part 5: Test for in vitro cytotoxicity |
| ISO 10993-10, 2010 | Biological Evaluation of Medical Devices-Part 10: Test for Irritation and Skin<br>Sensitization |
| ISO 10993-11, 2006 | Biological Evaluation of Medical Devices-Part 11: Test for Systemic Toxicity |
| ASTM F1980-16 | Standard Guide for Accelerated Aging of Sterile Medical Device Packages |
| ASTM-4169-16 | Standard Practice for Performance Testing of Shipping Containers and System |
| Pouch Leak test per<br>ASTM F2096-11 | Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal<br>Pressurization (Bubble Test) |
| Pouch Seal Strength test<br>per ASTM F88/F88M-15 | Standard Test Method for Seal Strength of Flexible Barrier Materials |

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Image /page/7/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a stylized, abstract shape on the left, resembling a rounded, elongated teardrop or a stylized ribbon. The shape transitions in color from a light blue at the top to a reddish-orange at the bottom. To the right of the shape is the text "Drawbridge" in a dark gray sans-serif font, with the word "HEALTH" in a smaller font size directly below it.

#### 1. Precision

## A. Precision (Assay) - Repeatability

Repeatability (within-run and within-day) precision was determined according to CLSI Guideline EP05-A3. Blood samples spotted onto matrix strips and tested using different Beckman reagent lot combinations and one Beckman analyzer were analyzed for at least 20 days, two runs per day. A run was defined as running each sample in duplicate.

| | Mean | Repeatability<br>(within-run) | | Repeatability<br>(within-day) | | Total | |
|--------|--------|-------------------------------|-------|-------------------------------|-------|-------|-------|
| Sample | %HbA1c | SD | %CV | SD | %CV | SD | %CV |
| 1 | 5.10 | 0.073 | 1.44% | 0.030 | 0.58% | 0.119 | 2.33% |
| 2 | 6.46 | 0.091 | 1.40% | 0.033 | 0.51% | 0.135 | 2.09% |
| 3 | 7.87 | 0.082 | 1.05% | 0.025 | 0.32% | 0.114 | 1.45% |
| 4 | 11.44 | 0.119 | 1.04% | 0.071 | 0.62% | 0.161 | 1.40% |

Table 1a: Repeatability Precision (n=80*)

*total of 81 data points was collected, an additional data point for Sample 1

### B. Precision (Device) - Lot-to-Lot Analysis

A lot-to-lot device precision study was conducted to demonstrate the reproducibility of collecting samples using different lots of manufactured OneDraw Blood Collection Devices across collection sites in accordance with CLSI Guideline EP05-A3. Figure 1a shows high agreement between results from the same participant, same operator, but different device lots. The range of %HbA1c was 4.84% to 7.55%. The average CV is 1.6% (range: 0.0% - 3.6%).

Image /page/7/Figure/10 description: The image is a scatter plot showing %HbA1c values on the y-axis and SID ordered by %HbA1c on the x-axis. There are three data series plotted: Blue, Green, and Orange. The %HbA1c values range from approximately 5.0 to 7.5, with the data points generally increasing from left to right.

Figure 1a: %HbA1c results for samples collected from two or three device lots across 23 participants

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| %HbA1c<br>group | Mean<br>%HbA1c | Within Lot %CV<br>(95% CI) | Between-Lot %CV<br>(95%CI) | Total %CV<br>(95%CI) |
|-----------------|----------------|----------------------------|----------------------------|----------------------|
| < 6 | 5.23 | 1.95% (1.53, 2.36) | 0.37% (0.29, 0.44) | 1.99% (1.57, 2.42) |
| ≥ 6 | 6.58 | 1.04% (0.70, 1.34) | 0.36% (0.24, 0.48) | 1.10% (0.74, 1.45) |

# Table 1b: Precision, Within and Between Lots and Total %CV

# C. Precision (Device) - Operator-to-Operator

An inter-operator precision study was conducted to demonstrate the reproducibility of collecting samples by different operators across collection sites using the same lot of manufactured OneDraw Blood Collection Devices in accordance with CLSI Guideline EP05-A3. Figure 1b shows high agreement between results from the same participant, same lot of devices, by different operators. The range of %HbA1c was 4.66% - 14.38%. The average CV is 1.5% (range: 0.1% - 4.8%).

Image /page/8/Figure/6 description: The image is a scatter plot showing %HbA1c values for different SIDs, ordered by %HbA1c. The y-axis represents %HbA1c, ranging from 4 to 14, while the x-axis represents SIDs. There are four categories of data points, CF, GH, LS, and MM, each represented by a different color. The %HbA1c values generally increase from left to right along the x-axis.

Figure 1b: %HbA1c results for samples collected by two or three operators across 25 participants

| %HbA1c<br>group | Mean<br>%HbA1c | Within Operator<br>%CV (95% CI) | Between-<br>Operator %CV<br>(95%CI) | Total %CV<br>(95%CI) |
|-----------------|----------------|---------------------------------|-------------------------------------|----------------------|
| <6 | 5.21 | 1.97% (1.55, 2.38) | 1.06% (0.84, 1.30) | 2.24% (1.76, 2.72) |
| ≥ 6 | 7.74 | 1.23% (0.83, 1.62) | 0.16% (0.11, 0.21) | 1.24% (0.84, 1.64) |

Table 1c: Precision, Within and Between Operators and Total %CV

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### 2. Method Comparison

The method comparison study was conducted to demonstrate the equivalence of HbA1c measurement using blood samples collected and tested using the OneDraw A1C Test System as compared to results using blood samples collected using standard venipuncture (tested using Beckman's NGSP-certified method on the Beckman Coulter AU480 Analyzer). Blood collections were conducted at two different clinical sites and sample analysis was conducted at the designated test laboratory.

| | Estimate | 95% lower bound | 95% upper bound |
|-----------------------------------------------------------|-------------|-----------------|-----------------|
| Slope | 1.00 | 0.97 | 1.03 |
| Intercept | -0.11 | | |
| Pearson correlation coefficient (R) | 0.9907 | 0.9864 | 0.9937 |
| Number of participants | 107 | | |
| Range tested (OneDraw A1C Test<br>System results, %HbA1c) | 4.70 – 14.3 | | |
| Range tested (venipuncture,<br>%HbA1c) | 4.76 - 14.7 | | |

Table 2: Regression analysis results (Passing-Bablok)

### 3. Linearity

The linearity of the OneDraw A1C Test is established as 4.70-14.3 % HbA1c (DCCT/NGSP) and in accordance with CLSI-EP6-A, determined the following linear fit, Y = 1.01x + 0.06; R=0.99.

### 4. Interference

Interference was assessed following EP07-A2. Studies were performed to assess common or known exogenous and endogenous substances that could interfere with the OneDraw A1C Test. The exogenous substances were Acetaminophen, Acetylsalicylic Acid, Ibuprofen, L-ascorbic Acid, Metformin, Glyburide; the endogenous substances were Rheumatoid Factors, Triglycerides, Bilirubin (conjugated and unconjugated); and Hemoglobin Variants (HbC, HbD, HbE, HbF, and HbS).

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Image /page/10/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a stylized, abstract shape in blue and pink on the left, followed by the words "Drawbridge" in gray. Below "Drawbridge" is the word "HEALTH" in smaller, gray letters. The logo is clean and modern, with a focus on the company name.

Interference was calculated as the difference between (a) measurement of blood specimens with interferent as compared to (b) measurement of control group specimens without interferent. Interference is claimed when the difference is equal to or exceeds ±10% bias from the following substances:

| Substance | Substance<br>description | Highest<br>concentration tested | Interference observed<br>With highest test<br>concentration |
|--------------------------|---------------------------------|---------------------------------|-------------------------------------------------------------|
| Acetaminophen | Analgesic | 20 mg/dL | No |
| Acetylsalicylic acid | Analgesic | 65 mg/dL | No |
| Glyburide | Antidiabetic | 0.2 mg/dL | No |
| Ibuprofen | Anti-inflammatory,<br>analgesic | 50 mg/dL | No |
| Metformin | Antidiabetic | 4.0 mg/dL | No |
| L-ascorbic acid | Antioxidant | 3.0 mg/dL | No |
| Triglycerides | Endogenous | 3400 mg/dL | No |
| Bilirubin - conjugated | Endogenous | 33.2mg/dL | No |
| Bilirubin - unconjugated | Endogenous | 30mg/dL | No |
| Rheumatoid factor | Endogenous | 600 IU/mL | No |

Whole blood containing hemoglobin variants A2 (≤5.8%), C (≤40.1%), D (≤41.2%), E (≤22%), S (≤34.8%), or low F (≤ 8.5%) do not show significant interference (over 10% absolute bias) when spotted on matrix strips were compared to the reference laboratory liquid blood values. The OneDraw A1C Test is suitable for adoption in the laboratory with the appropriate disclosure in the labeling that Hemoglobin Variant HbF (elevated) has been known to interfere with test results. The following limitation is presented in the OneDraw A1C Test labeling (OneDraw A1C Test IFU): "Hemoglobinopathies may interfere with glycated hemoglobin analysis. Studies show that there is no significant interference for HbA2 (≤5.8%), HbC (≤ 40.1%), HbD (≤ 41.2%), HbE (≤ 22%), and HbS (≤ 34.8%). Samples containing HbF levels > 8.5% show a significant negative bias with the OneDraw A1C Test. Do not use this test if the patient has this variant."

### 5. Limits of Detection

The claimed measuring range is 4.70%-14.3% for the OneDraw A1C Test, which is based on linearity testing.

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Image /page/11/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a blue and pink abstract shape on the left, followed by the words "Drawbridge" in gray, with the word "HEALTH" in smaller gray letters underneath. The abstract shape is a curved, teardrop-like form with a gradient from blue at the top to pink at the bottom.

### 6. Product Stability

In accordance with EP25-A and EP09-A3, the difference in test results using aged OneDraw Blood Collection Devices was evaluated. Four levels of HbA1c covering the measuring range were evaluated. The OneDraw Blood Collection Device has an expiry date 12 months after the date of manufacturing.

Sample storage and shipping stability studies were conducted using whole blood spotted on matrix strips. Based on these studies, patient samples are stable for up to 21 days at room temperature. The results also demonstrate that extreme temperature excursions of whole blood spotted onto the matrix strips do not cause a significant difference in the measurement of HbA1c using the OneDraw A1C Test. Overall these studies demonstrate the robustness of the matrices and transport sleeves to ensure that they are able to withstand the stressed conditions experienced during shipping and storage of the sample prior to HbA1c testing.

### 7. Flex Studies

Flex studies were conducted to assess any potential pre-analytical error that could be obtained from blood samples by the testing laboratory. These studies evaluated blood sample acceptability in terms of:

- (a) the minimum and maximum blood volume collected onto the device matrix strips
- (b) potential interference of hematocrit with the OneDraw A1C Test
- (c) the equivalency between the two matrix strips from the same cartridge for the OneDraw A1C Test
- (d) a comparison of HbA1c results for the following:
- Venous whole blood collected in EDTA tubes with venous whole blood spotted on the matrix O strips
- Venous whole blood collected in EDTA tubes with capillary blood collected using OneDraw O Blood Collection Device
- Venous whole blood spotted on the OneDraw matrix strips with capillary blood collected o using OneDraw Blood Collection Device

## Results of Flex Studies

- For minimum and maximum blood sample acceptability, two (2) HbA1c levels were tested with (a) six (6) blood volumes per level. There were 6 matrix strips per volume of blood, 72 matrix strips

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Image /page/12/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a stylized, abstract shape on the left, with the company name "Drawbridge" in a sans-serif font to the right. Below "Drawbridge" is the word "HEALTH" in a smaller font size. The abstract shape is a gradient of blue and pink.

in total. This study demonstrated that spotted volumes ranging between 52.5 µL and 90 µL were within ±10% relative bias when compared to the corresponding 75 µL spotted samples.

- The hematocrit interference study used two (2) HbA1c levels tested with the OneDraw A1C Test, (b) six matrix strips per level: six each of control, or "normal" hematocrit, high hematocrit, and low hematocrit specimens. The study demonstrated that varying hematocrit levels do not interfere with the OneDraw A1C Test.
- The two matrix strips contained within the same cartridge were analyzed and compared. The data (c) demonstrates that there is not a significant difference in %HbA1c results between the two matrices.
- (d) HbA1c results obtained from dried whole blood spotted on matrix strips and from capillary blood collected with the OneDraw Blood Collection Device are comparable to those collected via the standard phlebotomy technique (venous whole blood through venipuncture).

# CONCLUSION

The information and data in this 510(k) application demonstrate that the samples collected and tested using the OneDraw A1C Test System result in accurate and precise results that correlate well with current cleared methods. Based on the criteria stated above, this device is found to be substantially equivalent to the predicate device.