(201 days)
Not Found
No
The summary describes a specimen collection and laboratory testing system for HbA1c. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of these technologies. The performance studies focus on analytical and clinical validation of the test itself, not on algorithmic performance.
No
The device is described as an in vitro diagnostic specimen collection and storage device and an in vitro diagnostic device for quantitative measurement of Hemoglobin A1C. Its purpose is for monitoring blood sugar in women with diabetes, not for treating them.
Yes
The device, specifically the Q-Pad A1c Test, is described as an "in vitro diagnostic device for the quantitative measurement of Hemoglobin A1C." It is used for "monitoring the long-term control of blood sugar (glucose) in women with diabetes," which is a diagnostic purpose.
No
The device description clearly states that the system includes physical components: the "Q-Pad Kit" which is a "specimen collection and storage device" and a "modified menstrual pad" with an "embedded blood collection strip." While there is a mobile application mentioned for instructions and results, the core of the device involves physical collection and analysis of a biological sample using hardware.
Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Explicitly Stated: The "Intended Use / Indications for Use" section clearly states: "The Q-Pad Kit is an in vitro diagnostic specimen collection and storage device..." and "The Q-Pad A1c Test is an in vitro diagnostic device for the quantitative measurement of Hemoglobin A1C...".
- Definition of IVD: IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of disease. This device collects a human specimen (menstrual blood) and performs a quantitative measurement (HbA1c) for monitoring blood sugar in women with diabetes.
Therefore, the O-Pad Test System, comprising the Q-Pad Kit and the Q-Pad A1c Test, is an IVD.
N/A
Intended Use / Indications for Use
The O-Pad Test System is comprised of the O-Pad Kit and the O-Pad A1c Test.
The Q-Pad Kit is an in vitro diagnostic specimen collection and storage device intended for the collection of menstrual blood samples by individuals 18 years and older for subsequent analysis by an assay validated for use with the Q-Pad menstrual pad.
The Q-Pad A1c Test is an in vitro diagnostic device for the quantitative measurement of Hemoglobin A1C using menstrual whole blood collected onto filter paper using the Q-Pad A1c Test is for the measurement of HbA I c on whole menstrual blood which will be self-collected by lay users at home and shipped to the laboratory by mail. Measurements obtained through this method can be used for monitoring the long-term control of blood sugar (glucose) in women with diabetes.
This test is not to be used to diagnose or screen for diabetes.
Product codes (comma separated list FDA assigned to the subject device)
LCP, QZG
Device Description
The Q-Pad Test System consists of the following: Q-Pad A1c Test (Glycosylated hemoglobin assay) and Q-Pad Kit (Menstrual Blood Collection Device). Among the components included with the Q-Pad Test System is the collection device, Q-Pad, a menstrual pad that contains filter paper. Once the Q-Pad is received in the clinical laboratory, the dried blood sample is punched, eluted, and tested using FDA-cleared laboratory reagent and analysis systems, specifically the Beckman Coulter AU480 clinical chemistry device. The Q-Pad menstrual pad (also referred to as "Q-Pad") is a modified menstrual pad which looks, feels, and is used like a normal menstrual pad. The Q-Pad has an embedded blood collection strip (Q-Strip) which can easily be removed and shipped for analysis at a laboratory. Instructions for use and results are presented in a HIPAA compliant mobile application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
lay users at home and shipped to the laboratory by mail / Qvin Labs (CLIA certified clinical laboratory)
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
Sample Matrix Equivalency Study: Forty (40) paired (venous and menstrual blood) samples that span the Analytical Measurement Range (AMR) of the assay were tested. Data source is not explicitly mentioned but implies clinical samples. Annotation protocol is not mentioned.
Precision using venous blood: Whole blood from four participants with known A1c levels of around 5%, 6.5%, 8% and 12% was obtained. A total of 320 samples were run. Each HbA1c level was tested in duplicate, twice a day for a total of 20 days (N = 80 per level). Data source is not explicitly mentioned but implies clinical samples. Annotation protocol is not mentioned.
Precision using menstrual blood: Three participants with low, mid and high HbA1c levels collected samples using the Q-Pad Kit. Samples were collected, shipped and processed according to the IFU. The samples were tested in duplicate, two times a day, over five days (N = 20 per level). Data source is self-collected clinical samples. Annotation protocol is not mentioned.
Intra-strip Precision Study: Nine (9) participants were enrolled based on anticipated A1c levels. For each sample, three punches were selected by the operator and analyzed. Data source is not explicitly mentioned but implies clinical samples. Annotation protocol is not mentioned.
Inter-strip Precision Study: Nine (9) participants were enrolled based on anticipated A1c levels. Data source is not explicitly mentioned but implies clinical samples. Annotation protocol is not mentioned.
Linearity menstrual blood: High and low %HbA1c menstrual DBS samples were extracted and then serially diluted to create a nine-member known interval menstrual blood panel. Data source and annotation protocol are not explicitly mentioned.
Interfering Substances Study: Forty (40) substances were evaluated, each tested at four HbA1c levels. Data source and annotation protocol are not explicitly mentioned.
Hemoglobin variants Study: Hemoglobin C, -D, -E, -F, and -S were tested at three HbA1c levels each. Samples were dosed onto a Q-strip, dried and run according to standard laboratory procedures. Measured values were compared to reference %HbA1c values supplied by NGSP. Data sourced from a NGSP reference laboratory. Annotation protocol not mentioned.
Specimen Stability with Simulated Shipping Study: Eight (8) participants with known A1c levels, spanning the range of the assay used the Q-Pad Kit. Data source is not explicitly mentioned but implies clinical samples. Annotation protocol is not mentioned.
Reference Interval Study: Samples from 128 healthy participants were collected to establish a reference range for the Q-Pad Test System. Data source is not explicitly mentioned but implies clinical samples. Annotation protocol is not mentioned.
Clinical Validation Study (Method Comparison): IRB approval was obtained for participant enrollment and 396 specimens from 198 participants were utilized in the study. Samples were collected using the Q-Pad kit according to the Instructions for Use (IFU) and were returned to the laboratory using USPS First-class Return Service. A venous blood draw was performed by a phlebotomist to provide the reference sample. Both samples were received and processed at Qvin Labs (CLIA certified clinical laboratory) using the Beckman Coulter Hemoglobin A1c Test on an AU480 chemistry analyzer. Data source is clinical samples. Annotation protocol is not mentioned.
Usability Study: 40 naive participants, who were self-reported diabetics, received the Q-Pad kit. Users followed the provided Instructions for Use to collect their sample and returned it to Qvin Labs via USPS First-Class Return Service. Each participant provided answers to a questionnaire regarding the use of the Q-Pad kit, the Qvin app and the mock results provided to them. Data source is self-reported diabetics. Annotation protocol not mentioned.
Elution Stability Study: Samples from four (4) participants were used. Data source is not explicitly mentioned but implies clinical samples. Annotation protocol is not mentioned.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sample Matrix Equivalency Study:
- Study Type: CLSI EP35 based study to assess sample matrix equivalency.
- Sample Size: Forty (40) paired (venous and menstrual blood) samples.
- Key Results: Regression analysis between venous and menstrual blood resulted in a slope of 0.969 (95% Cl 0.944-0.994), an intercept of 0.181 (95% CI -0.017 to 0.380) and an R² of 0.997. The systematic difference between specimens at the 6.5 %HbA1c predetermined medical decision point (MDP) was 0.3% (the absolute systemic difference between the specimens being 0.02) and the 95% confidence interval was 6.42 to 6.54 %HbA1c. The study results demonstrated that venous blood and menstrual DBS are equivalent sample types for measurement of HbA1c.
Precision using venous blood:
- Study Type: CLSI EPO5-A3 based precision study.
- Sample Size: 320 samples from four participants.
- Key Results: Overall, within-run, and within-day precision results show an imprecision of no greater than 2.56% (acceptance criterion ≤ 4%).
Precision using menstrual blood:
- Study Type: CLSI EPO5-A3 based precision study.
- Sample Size: N = 20 per level (low, mid, high HbA1c from three participants).
- Key Results: Overall imprecision of no greater than 3.59% (acceptance criterion ≤ 4%).
Lot-to-Lot Precision:
- Study Type: Method comparison study and shelf-life studies.
- Sample Size: Not explicitly stated for this part, but includes multiple lots.
- Key Results: Negligible risk of imprecision due to different lots.
Intra-strip Precision:
- Study Type: Flex study to assess imprecision from various locations on a Q-Strip.
- Sample Size: Nine (9) participants.
- Key Results: Maximum bias of 4.90% with a maximum CV between punches of 2.92%. Acceptance criteria (10% bias).
Hemoglobin variants:
- Study Type: Interference study evaluated following CLSI EP07-Ed3.
- Sample Size: Hemoglobin C, -D, -E, -F, and -S were tested at three HbA1c levels each.
- Key Results: No interference was detected for hemoglobin variants C, -D, -E, and -S. For Hemoglobin variant F, with variant concentration above 10%, interference was observed.
Traceability:
- Study Type: Not a study, but a certification.
- Key Results: The Q-Pad Test System is certified with the National Glycohemoglobin Standardization Program (NGSP). The Q-Pad A1c Test is traceable to IFCC reference calibrators.
Specimen Stability with Simulated Shipping:
- Study Type: CLSI EP-25A based sample stability study.
- Sample Size: Eight (8) participants.
- Key Results: All measured values were within the acceptable range (10% bias.
Accuracy: Slope of 1.003, intercept of -0.0461, R² of 0.99 for method comparison.
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.
Home Access A1c Test K141944
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.
Not Found
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 6, 2023
Qurasense % Richard Lewis, Senior Regulatory Device and Biologics Expert Hyman, Phelps & McNamara P.C. 700 13th Street NW, Suite 1200 Washington, District of Columbia 20005
Re: K231465
Trade/Device Name: Q-Pad Test System Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, QZG Dated: May 19, 2023 Received: May 19, 2023
Dear Richard Lewis:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231465
Device Name Q-Pad Test System
Indications for Use (Describe)
The O-Pad Test System is comprised of the O-Pad Kit and the O-Pad A1c Test.
The Q-Pad Kit is an in vitro diagnostic specimen collection and storage device intended for the collection of menstrual blood samples by individuals 18 years and older for subsequent analysis by an assay validated for use with the Q-Pad menstrual pad.
The Q-Pad A1c Test is an in vitro diagnostic device for the quantitative measurement of Hemoglobin A1C using menstrual whole blood collected onto filter paper using the Q-Pad A1c Test is for the measurement of HbA I c on whole menstrual blood which will be self-collected by lay users at home and shipped to the laboratory by mail. Measurements obtained through this method can be used for monitoring the long-term control of blood sugar (glucose) in women with diabetes.
This test is not to be used to diagnose or screen for 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) |
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3
510(k) Summary for K231465
| Date of Summary: | December 6th, 2023 |
|---|---|
| Product Name: | Q-Pad Test System |
| Sponsor: | Qurasense |
| 3517 Edison Way, Ste. D | |
| Menlo Park, CA 94025 | |
| United States | |
| Correspondent: | Richard A. Lewis |
| Senior Regulatory Device and Biologics Expert | |
| Hyman, Phelps & McNamara, P.C. | |
| 700 13th Street, N.W., Suite 1200 | |
| Washington, D.C. 20005 | |
| Office: (202) 737-4280 | |
| RLewis@hpm.com | |
| www.hpm.com |
The Q-Pad Test System consists of the following:
| Proprietary Name: | Q-Pad A1c Test |
|---|---|
| Common Name: | Glycosylated hemoglobin assay |
| Classification Name: | Assay, glycosylated hemoglobin |
| Regulation Number: | 21 CFR §864.7470 |
| Product Code: | LCP |
| Proprietary Name: | Q-Pad Kit |
| Common Name: | Blood specimen collection device |
| Classification Name: | Menstrual Blood Collection Device |
| Regulation Number: | 21 CFR §862.1675 |
| Product Code: | QZG |
4
Substantial Equivalency
Qurasense's Q-Pad Test System has technological characteristics that are substantially equivalent to the predicate device identified in the table below. Both the proposed device and the predicate device provide the patient a method to collect a sample at home, mail the sample to the clinical laboratory, and later receive a report showing the measured Hemoglobin A1c.
Among the components included with the Q-Pad Test System is the collection device, Q-Pad, a menstrual pad that contains filter paper. Once the Q-Pad is received in the clinical laboratory, the dried blood sample is punched, eluted, and tested using FDA-cleared laboratory reagent and analysis systems, specifically the Beckman Coulter AU480 clinical chemistry device. The technological characteristics and intended use are substantially equivalent to the predicate device as summarized in the following table:
| Description | Subject Device
Q-Pad Test System | Predicate Device
Home Access A1c Test
K141944 |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Whole blood quantitative
measurement of Hemoglobin A1c. | Whole blood quantitative
measurement of Hemoglobin A1c. |
| Indications for use | The Q-Pad Test System is comprised of
the Q-Pad Kit and the Q-Pad A1c Test.
The Q-Pad Kit is an in vitro diagnostic
specimen collection and storage
device intended for the collection of
menstrual blood samples by
individuals 18 years and older for
subsequent analysis by an assay
validated for use with the Q-Pad
menstrual pad. The Q-Pad A1c Test is
an in vitro diagnostic device for the
quantitative measurement of
Hemoglobin A1c using menstrual
whole blood collected onto filter
paper using the Q-Pad Kit. The Q-Pad
A1c Test is for the measurement of
HbA1c on whole menstrual blood
which will be self-collected by lay
users at home and shipped to the
laboratory by mail. Measurements
obtained through this method can be
used for monitoring the long-term | The Home Access® A1C Test is an in
vitro test method for the
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's home or in a healthcare
professional setting and delivered to
the laboratory by mail. Measurements
obtained
through this method can be used
for monitoring the long-term
control of blood sugar (glucose) in
people with diabetes.
This test is not to be used to
diagnose or screen for diabetes.
Not for use on neonates. |
| Description | Subject Device
Q-Pad Test System | Predicate Device
Home Access A1c Test
K141944 |
| | control of blood sugar (glucose) in
women with diabetes. | |
| | This test is not to be used to diagnose
or screen for diabetes. | |
| Prescription/ Over-
the-
counter use | Over the counter | Prescription and Over the counter |
| Usage | Single Use | Single Use |
| Collect Sample At
Home | Yes | Yes |
| Whole Blood
Sample | Yes | Yes |
| Collection Kit
Components | (2) Q-Pads
Sample Container
Instructions for Use
Prepaid return Mailer
Outer Packaging
Patient Information Card | Blood sample collection Cassette
Sample Pouch
Sterile Safety Lancets
Gauze Pad
Bandage
Instructions for Use
Prepaid return Mailer
Patient Info Card
Outer Packaging |
| Send Samples to
CLIA certified lab | Yes. Samples can only be sent and
analyzed at Qurasense's CLIA-certified
laboratory (Qvin Labs). | Yes. Samples sent to Home Access
Health Corporation laboratory facility. |
| Analysis | Beckman Coulter A1c reagents
Beckman Coulter device AU480 | Beckman Coulter A1c reagents
Beckman Coulter device AU640e
(formerly Olympus) |
| Return Results | Yes, via mobile app or email. | Yes, mailed to the user. |
| Description | Subject Device
Q-Pad Test System | Predicate Device
Home Access A1c Test
K141944 |
| Precision | % CV 10% bias between a spiked and an unspiked sample. The list of the substances tested is shown in Table 10, no incidence of interference was detected with any substance
| Endogenous and Exogenous
Substances Tested | Test
Concentration | Topical Products Tested |
|-----------------------------------------------|-----------------------|-----------------------------------------------------|
| Acetaminophen | 20.0 mg/dL | Lube Life Water-Based Personal Lubricant |
| Acetylsalicylic Acid | 65.0 mg/dL | Good Clean Love Restore Moisturizing Vaginal Gel |
| Azo-Standard | 0.0195 mg/dL | Replens Long Lasting Vaginal Moisturizer |
| Clindamycin | 5.10 mg/dL | Bonafide Revaree Vaginal Moisturizer |
| Conjugated Bilirubin | 40 mg/dL | Medicine Mama's Apothecary Vulva Balm |
| Glyburide | 0.2 mg/dL | VCF Contraceptive Gel |
| Ibuprofen | 50.0 mg/dL | Monistat 3 Yeast Infection Treatment |
| L-Ascorbic Acid | 5.25 mg/dL | Monistat 1 Yeast Infection Treatment |
| Liraglutide | 0.0168 mg/dL | Clotrimazole 3 Day Antifungal Cream |
| Metformin | 4.0 mg/dL | Monistat Anti-itch Relief Cream |
| Metronidazole | 12.3 mg/dL | Vagisil Maximum Strength Feminine Anti-Itch Cream |
| Rheumatoid Factor | 600 IU/mL | Summer's Eve Freshening Spray |
| Semen | 25%* | Summer's Eve Refresher Mist, Feminine Spray |
| Sitagliptin | 0.115 mg/dL | Summer's Eve Island Splash Body Powder |
| Sweat | 50%* | Monistat Chafing Relief Powder Gel |
| Tinidazole | 15.3 mg/dL | BORASOL Powder |
| Triglyceride-rich Lipoproteins | 1640 mg/mL | Summer's Eve Feminine Wipes |
| Unconjugated Bilirubin | 40 mg/dL | Vagisil Anti-Itch Medicated Feminine Intimate Wipes |
| Urine | 40%* | Summer's Eve Douche Island Splash |
| Vaginal Fluid | 50%* | Summer's Eve Vinegar & Water Douche |
Table 10. List of substances evaluated for interference and the highest concentrations tested with no measured interference (when applicable)
*highest test concentration that resulted in valid results for all four HbA1c levels.
13
Hemoglobin variants
Interference from Hemoglobin Variants, sourced from a NGSP reference laboratory, was evaluated following CLSI EP07-Ed3. Hemoglobin C, -D, -E, -F, and -S were tested at three HbA1c levels each. Samples were dosed onto a Q-strip, dried and run according to standard laboratory procedures. Measured values were compared to reference %HbA1c values supplied by NGSP. Significant interference was defined as a bias of >10% from the reference value.
No interference was detected for hemoglobin variants C, -D, -E, and -S. For Hemoglobin variant F, with variant concentration above 10%, interference was observed. The sponsor will include the following limitation in the product package insert, listed in the warnings and limitations section:
"This device has significant negative interference with fetal hemoglobin (HbF). HbA1c results are invalid for patients with abnormal amounts of HbF including those with known Hereditary Persistence of Fetal Hemoglobin.".
Traceability
The Q-Pad Test System is certified with the National Glycohemoglobin Standardization Program (NGSP). See NGSP website for current certification at http://www.ngsp.org. The Q-Pad A1c Test is traceable to IFCC reference calibrators.
Specimen Stability with Simulated Shipping
A sample stability with simulated shipping study, based on CLSI EP-25A, was performed on Q-Pad Kit collected menstrual blood samples. Eight (8) participants with known A1c levels, spanning the range of the assay used the Q-Pad Kit. Samples were exposed to 13 days of simulated summer/spring and winter temperature profiles. A reference measurement was taken at the following time points: Day-6, Day-10, Day-14, Day-28, and Day-31. At each time point, samples were punched once and run in triplicate. The acceptance criteria for each time point was 0.95.
Participant HbA1c values ranged from 4.6% to 14.2%. 99% of participants successfully collected a sample. Linear regression analysis was performed to compare the results from the Q-Pad to the venous blood reference method using Passing-Bablok analysis, see Table 11.
| Method | Slope | 95% Cl | y-Intercept | 95% Cl |
|---|---|---|---|---|
| Passing-Bablok | 1.003 | 0.987 - 1.02 | -0.046 | -0.170 - 0.067 |
Table 11. Summary of the clinical validation data
99% of study subjects successfully collected and returned samples to the laboratory for analysis verifying the effectiveness of the Instructions for Use. The comparative methods exhibited strong correlation. No samples were outside of the stated total allowable error of 6%. The overall linear regression showed a slope of 1.003 (95% Cl 0.987, 1.020), intercept of -0.0461 (95% Cl -0.170, 0.0669) and R² of 0.99. The study met all acceptance criteria and demonstrated that the clinical performance of the Q-pad Test system is equivalent to the reference method using venous blood.
Usability Study
A dedicated usability study was conducted following the FDA Human Factors guideline. 40 naive participants, who were self-reported diabetics, received the Q-Pad kit. Users followed the provided Instructions for Use to collect their sample and returned it to Qvin Labs via USPS First-Class Return Service. Each participant provided answers to a questionnaire regarding the use of the Q-Pad kit, the Qvin app and the mock results provided to them. The usability study showed that all 40 women were able to follow the Instruction for Use for the Q-Pad Kit, with 97.5% successfully collecting a sample that led to a valid HbA1c result.
Flex Studies
Elution Stability
The purpose of this study was to verify the stability of eluted menstrual blood samples collected using the Q-Pad Kit for up to 4 hours after extraction. Samples from four (4) participants were used. Samples were
16
extracted, aliquoted, and run immediately on the Beckman AU480. Additional aliquots were run at the following time points after extraction: 1, 1.5, 2, 3, and 4 hours. All samples were run in triplicate and the results from each timepoint were compared to the initial timepoint for each sample. Acceptance criteria was