(268 days)
No
The summary describes a blood collection device and a laboratory test method. There is no mention of AI/ML in the device description, intended use, performance studies, or any other section. The analysis is performed using a standard laboratory analyzer.
No
Explanation: The device is intended solely for collecting blood samples for diagnostic testing (measuring HbA1c), not for treating or preventing disease.
No
The "Intended Use / Indications for Use" section explicitly states: "Testing performed on samples collected with this device should not be used to diagnose or screen for diabetes." This indicates it's for monitoring, not diagnosis.
No
The device description clearly outlines physical components like a blood collection device with lancets, a vacuum, channels, matrix strips, a cartridge, and a transport sleeve. It also involves laboratory testing using a physical analyzer and reagents. This is a hardware-based system for blood collection and analysis, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is for the "quantitative measurement of HbA1c for monitoring the long-term control of blood sugar (glucose) in people with diabetes." This is a diagnostic measurement performed on a biological sample (blood).
- Sample Type: The device collects capillary blood, which is a biological specimen.
- Testing Location: The samples are delivered to a "designated certified clinical laboratory for HbA1c testing." This indicates that the testing is performed in a laboratory setting, which is characteristic of IVD testing.
- Device Description: The description details how the collected blood is processed and tested using laboratory equipment (Beckman Coulter AU480 Chemistry Analyzer and A1c reagents).
- Performance Studies: The document includes performance studies like precision, method comparison, linearity, and interference, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a predicate device (K141944, Home Access Health Corp., Home Access® A1C Test and Home Access® Collection Cassette) which is also an A1C test system, further supports its classification as an IVD.
While the device itself is a blood collection device, it is part of a "Test System" that includes the collection and the subsequent laboratory testing for a diagnostic purpose (monitoring HbA1c). Therefore, the system as a whole falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LCP, PRJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm
Indicated Patient Age Range
18 years of age or older (not for use with neonates)
Intended User / Care Setting
Healthcare professional setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision (Assay) - Repeatability:
- Study type: Repeatability (within-run and within-day) precision study according to CLSI Guideline EP05-A3.
- Sample size: Blood samples spotted onto matrix strips were tested for at least 20 days, two runs per day, with each sample run in duplicate.
- Key results:
- Sample 1 (5.10% HbA1c): Repeatability SD=0.073, %CV=1.44%; Within-day SD=0.030, %CV=0.58%; Total SD=0.119, %CV=2.33%.
- Sample 2 (6.46% HbA1c): Repeatability SD=0.091, %CV=1.40%; Within-day SD=0.033, %CV=0.51%; Total SD=0.135, %CV=2.09%.
- Sample 3 (7.87% HbA1c): Repeatability SD=0.082, %CV=1.05%; Within-day SD=0.025, %CV=0.32%; Total SD=0.114, %CV=1.45%.
- Sample 4 (11.44% HbA1c): Repeatability SD=0.119, %CV=1.04%; Within-day SD=0.071, %CV=0.62%; Total SD=0.161, %CV=1.40%.
Precision (Device) - Lot-to-Lot Analysis:
- Study type: Lot-to-lot device precision study according to CLSI Guideline EP05-A3.
- Sample size: 23 participants.
- Key results: High agreement between results from the same participant, same operator, but different device lots. Range of %HbA1c was 4.84% to 7.55%. Average CV is 1.6% (range: 0.0% - 3.6%).
- 8.5% show a significant negative bias.
Product Stability:
- Study type: Stability studies in accordance with EP25-A and EP09-A3.
- Key results:
- OneDraw Blood Collection Device expiry: 12 months after manufacturing date.
- Sample storage and shipping stability: Patient samples stable for up to 21 days at room temperature.
- Extreme temperature excursions of whole blood spotted onto matrix strips do not cause a significant difference in HbA1c measurement.
Flex Studies:
- Study type: Evaluation of potential pre-analytical errors.
- Key results:
- Minimum and maximum blood volume: Spotted volumes ranging between 52.5 µL and 90 µL were within ±10% relative bias compared to 75 µL spotted samples.
- Hematocrit interference: Varying hematocrit levels do not interfere with the OneDraw A1C Test.
- Equivalency between matrix strips: No significant difference in %HbA1c results between the two matrices from the same cartridge.
- Comparison of HbA1c results: HbA1c results 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 standard phlebotomy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Accuracy is discussed in terms of correlation, linearity and precision)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.7470 Glycosylated hemoglobin assay.
(a)
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.(b)
Classification. Class II (performance standards).
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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.
1
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 (1-800-638-2041 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
2
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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Image /page/3/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a stylized, abstract shape in shades of blue and red on the left, followed by the company name "Drawbridge" in a dark gray sans-serif font. Below the company name is the word "HEALTH" in a smaller, also dark gray, sans-serif font.
510(k) SUMMARY
OneDraw™ A1C Test System
| Applicant Name: | Drawbridge Health, Inc.
11535 Sorrento Valley Road, Suite 407
San Diego, CA 92121 USA |
|------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Annie Wright
Associate Director, Regulatory Affairs & Quality Assurance
Phone: (408) 421-1510
Email: awright@dbhealth.com |
| 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 |
| 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
Home Access® A1C Test (K141944) | Candidate Device
OneDraw™ A1C Test System |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities and Differences | | |
| Intended Use | The Home Access® A1C Test is an in vitro test method
for quantitative measurement of Hemoglobin A1c using
capillary blood collected from the fingertip, collected
onto filter paper via the Home Access collection
cassette. The Home Access A1C Test is for
measurement of HbA1c on blood specimens which can
be collected at the patient' home or in a healthcare
professional setting and delivered to the laboratory by
mail. Measurements obtained through this method can
be used for long-term control of blood sugar (glucose) in
people with diabetes.
This test is not to be used to diagnose or screen for diabete
Not for use with neonates. | 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. |
| Sample types | Dry capillary blood | Same |
| Standardization | Traceable to the International Federation of Clinical
Chemistry and Laboratory Medicine (IFCC) and
Diabetes Control and Complications Trial (DCTT)
reference method. Certified via the National
Glycohemoglobin Standardization Program (NGSP). | Same |
| Kit Components | Blood sample collection cassette containing filter
paper for specimen collection Sample pouch with desiccant for specimen
packaging 2 sterile safety lancets Gauze Pad 2 Bandages Instructions for Use/Things You Should Know
About A1C Prepaid Return Mailer for specimen mailing Patient Info Card for specimen labeling and consent Outer Packaging | Blood sample collection cartridge containing
filter paper for specimen collection Sample pouch containing desiccant for specimen
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
cassette | Blood drawn from upper arm and is collected on a
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
puncture of capillaries located near the surface of the
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 |
| Guideline - Third Edition | |
| CLSI-EP06-A, 2003 | Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical |
| 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 – |
| Third Edition | |
| CLSI-EP17-A2, 2012 | Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; |
| Approved Guideline-Second Edition | |
| CLSI- EP25-A, 2009 | Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline |
| ANSI/AAMI/ISO 11137- | |
| 1:2006/(R)2015; A1:2013 | Sterilization of Health Care Products-Radiation - Part 1: Requirements for development, |
| validation and routine control of a sterilization process for medical devices | |
| ANSI/AAMI/ISO 11137- | |
| 2:2013 | Sterilization of Health Care Products-Radiation - Part 2: Establishing the sterilization |
| dose | |
| ANSI/AAMI/ISO 11137- | |
| 3:2017 | Sterilization of Health Care Products-Radiation - Part 3: Guidance on dosimetric |
| aspects. | |
| ISO 10993-1:2009 | Biological Evaluation of Medical Devices-Part 1: Evaluation and testing within a risk |
| management process | |
| ISO 10993-3:2014 | Biological Evaluation of Medical Devices-Part 3: Tests for genotoxicity, |
| carcinogenicity, and reproductive toxicity | |
| ISO 10993-4:2002, | |
| A1:2006 | Biological Evaluation of Medical Devices-Part 5: Selection of tests for interactions with |
| 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 |
| 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 | |
| ASTM F2096-11 | Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal |
| Pressurization (Bubble Test) | |
| Pouch Seal Strength test | |
| 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
(within-run) | | Repeatability
(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
group | Mean
%HbA1c | Within Lot %CV
(95% CI) | Between-Lot %CV
(95%CI) | Total %CV
(95%CI) |
|-----------------|----------------|----------------------------|----------------------------|----------------------|
| 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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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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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.