(201 days)
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.
The Q-Pad Test System consists 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. 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 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.
The provided text describes the acceptance criteria and study that proves the Q-Pad Test System meets the acceptance criteria. It focuses on the performance of a medical device designed for measuring Hemoglobin A1c (HbA1c) from menstrual blood samples.
Here's the breakdown of the information requested, based on the provided text:
Acceptance Criteria and Device Performance
A table summarizing the acceptance criteria and the reported device performance for several key studies:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision (Venous Blood) | Overall imprecision no greater than 2.56% (acceptance criterion ≤ 4%) | Low A1c: Total %CV = 1.99% |
| Elevated A1c: Total %CV = 1.82% | ||
| High A1c: Total %CV = 1.91% | ||
| Very High A1c: Total %CV = 2.44% | ||
| (All met the ≤ 4% criterion, and the overall maximum was 2.56%) | ||
| Precision (Menstrual Blood) | Overall imprecision no greater than 3.59% (acceptance criterion ≤ 4%) | Low A1c: Total %CV = 3.59% |
| Elevated A1c: Total %CV = 2.15% | ||
| High A1c: Total %CV = 1.60% | ||
| (All met the ≤ 4% criterion, and the overall maximum was 3.59%) | ||
| Intra-strip Precision | Bias 10% bias between a spiked and an unspiked sample. | No incidence of interference detected with any of the 40 tested exogenous and endogenous substances (at four HbA1c levels for each substance). |
| Exception: For Hemoglobin variant F, with variant concentration >10%, interference was observed. This resulted in a limitation in the product package insert. | ||
| Specimen Stability with Simulated Shipping | 0.95. No samples outside of total allowable error of 6%. | Slope = 1.003 (95% CI 0.987, 1.020); Intercept = -0.0461 (95% CI -0.170, 0.0669); R² = 0.99. All acceptance criteria met. Demonstrated clinical performance equivalent to the reference method (venous blood). 99% of participants successfully collected a sample. No samples outside of the stated total allowable error of 6%. |
| Usability Study | Users able to follow Instructions for Use (IFU) and successfully collect a sample leading to a valid HbA1c result. | 40 naive participants (self-reported diabetics) were able to follow IFU. 97.5% successfully collected a sample that led to a valid HbA1c result. (Met criteria) |
| Elution Stability |
§ 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).