(22 days)
Quik-Check™ Home Pregnancy is intended for mon-professional/Over-The Counter Quik-Check - Tome Proghancy is more of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.
The Quik-Check™ Home Pregnancy Test Device is intended for non-professional/Over-determination of for the Quik-Checker" Home Pregiancy Tost Dones in thCG) in urine to add in the determination of for the identification of numan Chonomic Golladoneyal (no operioral antibody reagents to selectively pregnancy. The test utilizes a collibination of including unine to the test device and observing for the programments regent with the defect elevated levels of ICC. The assay is conceeded of paillary action along the membrate on formation of comments and forma formation of colored lines. The speciment migrates the specific antibody-hCG-colored conjugate and form a colored conjugate. Postive specificals react with the suggests a negative result.
colored line on the "Test Region" of the membrane. Absence of this suggests anegatives of t colored line on the "rest Region" of the membrant." Hosener of the version will always appear regardless of the presence or absence of hCG.
The Quik-Check™ Home Pregnancy test detects hCG concentrations of 25 mU/ml and geater. The test H has been standardized to the World Health Organization Third International Standard. The addition of M.H.H. has been standardized to the World Italin Organization Introdult to negative (0 mIU/ml hCG) and positive (25 mIU/ml hCG) urine showed no cross-reactivity.
Quik-Check™ Home Pregnancy Test Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Detects hCG concentrations of 25 mU/ml and greater | Detects hCG concentrations of 25 mU/ml and greater (standardized to WHO Third International Standard) |
| No cross-reactivity with negative and positive urine | No cross-reactivity observed with 0 mIU/ml hCG (negative) and 25 mIU/ml hCG (positive) urine |
| Suitable for over-the-counter pregnancy testing | Clinical trials confirmed suitability for over-the-counter use, with participants finding the test easy to use, understand, and interpret. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 117 female participants.
- Data Provenance: Not explicitly stated, but based on the context of a clinical trial for a home pregnancy test intended for the US market, it is likely that the data was collected in the USA and was prospective in nature.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Not applicable as the ground truth for pregnancy status was not established by experts, but rather by the presence or absence of hCG in urine samples, which is a biological marker.
4. Adjudication Method for the Test Set
- Not applicable. The determination of hCG levels is a direct measurement, and adjudication by experts for interpreting the results of a home pregnancy test is not typically part of the described method. The study focused on the device's ability to detect hCG and user comprehension.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is more relevant for diagnostic imaging or subjective interpretation tasks where human readers' performance with and without AI assistance is being evaluated. This device is a and over-the-counter test designed for self-interpretation.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone study was performed. The "clinical trials" described assess the device's ability to detect hCG and for users to correctly interpret the results, operating independently as a diagnostic tool.
7. Type of Ground Truth Used
- Biological/Quantitative Measurement: The ground truth for the device's accuracy was the presence or absence of human Chorionic Gonadotropin (hCG) in urine at specific concentrations (0 mIU/ml for negative, 25 mIU/ml for positive). This is a direct biological measurement.
- User Comprehension/Interpretation: Additionally, user comprehension of instructions and interpretation of results served as a ground truth component for "suitability for over-the-counter use."
8. Sample Size for the Training Set
- The document does not provide information about a separate training set. For in vitro diagnostic devices like home pregnancy tests, "training" often refers to the internal development and calibration processes rather than a distinct clinical training dataset used for machine learning.
9. How Ground Truth for the Training Set Was Established
- Not explicitly stated. For such devices, the "training" (development and calibration) would typically involve using known concentrations of hCG in urine samples to ensure the test consistently produces the correct result at and above its stated detection limit (25 mU/ml) and no false positives at 0 mU/ml. This would involve laboratory testing with characterized samples.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.