(48 days)
Over the Counter hCG Pregnancy tests are for those individuals who, for any reason, believe they may be pregnant. This test detects hCG in urine. HCG is a hormone produced by the placenta shortly after implantation. Since hCG is present in the urine of a pregnant woman, it is an excellent marker for confirming pregnancy. Early identification is important in the management of pregnancy. This condition must be identified so that fetal exposure to potentially harmful circumstance may be minimized or eliminated. Many individuals hesitate to seek clinical confirmation of this condition (pregnancy) due to medical examination costs and appointment scheduling difficulties. This device offers an alternative to the initial office visit and will allow for more rapid initiation of pre-natal care upon confirmation testing by trained clinical technicians.
Immunoassay for the qualitative detection of hCG in urine
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:
Device: At Home™ QuickCup Pregnancy Test (Model 9015)
Intended Use: Qualitative detection of hCG in urine for women who suspect they may be pregnant.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in numerical terms (e.g., "sensitivity must be >95%"). Instead, the document relies on a comparison to predicate devices and a general statement of "excellent accuracy." However, the performance reported for the device can be inferred as exceeding 99% agreement or accuracy.
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Substantial equivalence to predicate devices | >99% correlation with Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test | This indicates the device performs at least as well as established, legally marketed devices. |
| Excellent accuracy in lay user hands | Exceeding 99% accuracy | This addresses the performance when used by the intended lay user. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for either study.
- Data Provenance:
- Clinical Sample Correlation Study: Implied to be clinical specimens, but no country of origin is mentioned. The study is retrospective as it used clinical specimens likely collected prior to the study.
- Blind Labeled Spiked HCG Study (Consumer Study): This study involved "spiked HCG," meaning HCG was artificially added to samples. It was a "blind labeled" study for consumers. No country of origin is mentioned. It appears to be a prospective usability/performance study with contrived samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set.
- For the Clinical Sample Correlation Study, the predicate devices (Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test) were used as comparators, implying their results were considered the "ground truth" for those samples. The expertise behind the predicate devices' results is not detailed.
- For the Blind Labeled Spiked HCG Study, the "ground truth" would be known by definition, as the HCG was "spiked" into samples, so the presence or absence of HCG was controlled by the study designers.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It states "correlations studies, using clinical specimens, produced a >99% correlation when compared to the Quidel Rapidvue... and the Syntron Bioresearch Be Sure Pregnancy Test." This implies direct comparison, rather than an adjudication process involving multiple independent readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies described are:
- A clinical correlation study against predicate devices.
- A blind labeled spiked consumer study to assess accuracy in lay users.
The device is a qualitative home-use test, not an imaging or diagnostic device where MRMC studies with human readers are typically conducted. Therefore, there is no mention of an effect size for human readers improving with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Yes, the studies described assess the device's standalone performance. The "At Home™ QuickCup Pregnancy Test" is a self-contained immunoassay intended for direct visual interpretation by the user. The performance claims of ">99% correlation" and "exceeding 99% accuracy" are directly attributed to the device itself, without any human-in-the-loop assistance other than the user interpreting the visual result for the lay-user study.
7. The Type of Ground Truth Used
- Clinical Sample Correlation Study: The ground truth was established by the results of two commercially available and accepted predicate devices (Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test). This is a form of comparative ground truth against established gold standards in the field.
- Blind Labeled Spiked HCG Study: The ground truth was based on the known presence or absence of HCG in the samples, as they were "spiked" by the study designers. This is a contrived/known ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set. This device is an immunoassay, not an AI/machine learning model, so the concept of a "training set" in that context does not apply. The "performance" section describes validation studies.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/machine learning model, this question is not applicable to the provided information. The ground truth for the validation/performance studies was established as described in section 7.
§ 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.