(69 days)
The MiniStick Pregnancy Test is a monoclonal antibody-based immunoassay intended for the visual qualitative detection of human Chorionic Gonadotropin (HCG) in urine as an early indicator of pregnancy. Its intended use is identical to that of several professional products currently available for use in clinical laboratories or physicians' offices.
The MiniStick Pregnancy Test is an immunodiagnostic system that detects the presence of HCG in the urine sample through the formation of a complex which is held together by the HCG molecule. The patient's urine sample enters a paper reservoir which is in contact with a pad containing a dried conjugate of colloid gold-monoclonal antibody (reddish in color). The urine sample will then reconstitute the dried conjugate. If HCG is present in the sample, it will react with the monoclonal antibody to form a complex of colloid gold-monoclonal antibody-HCG. This complex migrates up a membrane strip chromatographically and through a band of immobilized goat anti-HCG. Because the antibody of this immobilized goat anti-HCG is able to bind the HCG molecule of the migrating complex, a visible reddish band is formed along the exact location of the immobilized goat anti-HCG antibody. If there is no HCG present in the sample, the colloid gold-monoclonal antibody conjugate will pass through the immobilized goat anti-HCG band and no colored line will form -a negative test result. Further up the membrane, past the anti-HCG test region consisting of a band of immobilized goat anti-mouse IgG. This band of antibody will bind only conjugate and form a colored line, regardless of whether HCG is present in the urine or not. Appearance of the control line assures reagent integrity as well as correct testing procedure.
The provided document describes the MiniStick Pregnancy Test, a qualitative visual test system for the detection of human Chorionic Gonadotropin (HCG) in urine.
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1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Accuracy (Laboratory Testing) | "virtually 100% accurate in laboratory testing" |
| Accuracy (Clinical Trials / Clinical Performance) | "greater than 99% accurate in clinical trials" |
| Correlation with substantially equivalent predicate device | "100% correlation in test results between the MiniStick Pregnancy Test and the HOMECLINIC One-Step Pregnancy Test" |
| User Acceptance of direct urine stream application (if applicable for consumer use) | "All the women participating in the study had a favorable response to performing the test by holding the device in their urine stream to obtain a sample." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 206 clinical urine specimens (55 positive and 151 negative).
- Data Provenance: The study was conducted by "Vanguard personnel" through "laboratory testing." The origin of the urine samples (e.g., country) is not specified, but they are referred to as "clinical urine specimens," implying they were collected from human patients. The study is retrospective as it used pre-collected urine specimens.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications used to establish the ground truth for the 206 clinical urine specimens. It simply states that the specimens were "55 positive and 151 negative," implying a pre-existing classification.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The ground truth (positive/negative status of the 206 specimens) appears to be pre-established. The study focused on comparing the MiniStick to the HOMECUNIC One-Step Pregnancy Test against this pre-established ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study compares two devices (MiniStick and HOMECLINIC) for their accuracy in detecting HCG, not the performance of human readers with or without an AI assistant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a qualitative visual immunoassay pregnancy test, which fundamentally requires human interpretation of a visual line. Therefore, a purely standalone algorithm performance in the modern sense (i.e., AI interpreting the test) was not performed. The "standalone" performance here refers to the device itself providing a visual result that a human then reads. The study evaluates the accuracy of this device's visual output.
7. The Type of Ground Truth Used
The ground truth used was the known HCG status (positive or negative) of the 206 clinical urine specimens. This implies a reference method or prior clinical testing was used to determine the true HCG status of each sample.
8. The Sample Size for the Training Set
The document does not mention a separate training set. This is not an AI or machine learning device in the modern sense. It's an immunoassay. The concept of "training set" as used in AI does not apply here. The "training" in this context would be the original development and optimization of the immunoassay reagents and design.
9. How the Ground Truth for the Training Set was Established
As there's no explicit training set mentioned for an AI context, this question is not applicable. For the immunoassay development, the ground truth would have been established through known concentrations of HCG and other related hormones, and clinical samples with confirmed HCG status, to optimize the monoclonal antibody specificity andassay parameters. However, specific details of this development are not provided in the 510(k) summary.
§ 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.