(43 days)
The Quickstick™ One Step HCG Pregnancy Test is intended to detect the presence of Human Chorionic Gonadotropin (hCG) in Urine for the women who suspect they may be pregnant. HCG is a well known and established analyte used to confirm pregnancy because of its early appearance in urine following conception followed by a dramatic increase in concentration.
Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Early Pregnancy
Here's an analysis of the provided text regarding the Phamatech Quickstick™ One Step HCG Pregnancy Test, structured to answer your request:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clinical Sample Correlation | >95% correlation with predicate devices (implied for substantial equivalence) | >99% correlation (compared to Quidel Rapidvue and Syntron Bioresearch Be Sure) |
| Sensitivity (Lay User Study) | 100% (implied for "excellent" sensitivity for a diagnostic test) | 100% (79/79) |
| Specificity (Lay User Study) | 100% (implied for "excellent" specificity for a diagnostic test) | 100% (79/79) |
| Accuracy (Lay User Study) | 100% (implied for "excellent" accuracy for a diagnostic test) | 100% (158/158) |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria. The criteria listed above are implied by the reported performance and the claim of "excellent" results and "substantially equivalent" to other commercially available tests. For a device like a pregnancy test, very high sensitivity and specificity are generally expected for market clearance. The "substantially equivalent" claim suggests that the performance matches or exceeds that of the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Clinical Sample Correlation Study: The sample size is not explicitly stated. It mentions "clinical specimens" implying patient samples. The provenance is not explicitly stated (e.g., country of origin), but given the manufacturer's location, it likely involves samples from the USA. It is a retrospective study in the sense that the clinical specimens were already collected and then tested.
- Blind Labeled Spiked HCG Study (Lay User Study): The sample size for this test set was 158 (79 positive and 79 negative, based on the accuracy 158/158). The data provenance is not explicitly stated, but it's performed by "lay users," suggesting a user-focused study. It's likely prospective for the execution of the test by lay users.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Clinical Sample Correlation Study: The document indicates a comparison to two predicate devices: Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test. The ground truth for these clinical samples would have been established by the methods used to determine the actual pregnancy status for those predicate devices, which would typically involve clinical diagnosis, potentially follow-up testing, or established laboratory methods. The number and qualifications of experts involved in establishing this ground truth are not specified in the provided text.
- Blind Labeled Spiked HCG Study (Lay User Study): This study used "spiked HCG." This means the samples were artificially prepared with predetermined concentrations of hCG (both positive and negative). Therefore, the "ground truth" was inherently known by the study designers based on how they prepared the spiked samples. No external experts were needed to establish the ground truth for this specific study.
4. Adjudication Method for the Test Set:
- Clinical Sample Correlation Study: The adjudication method is not explicitly described. It implies a direct comparison to the results of predicate devices, so the predicate device results served as the reference.
- Blind Labeled Spiked HCG Study (Lay User Study): No adjudication method is needed or described as the ground truth was known from the spiked nature of the samples. The study assessed how accurately lay users interpreted the results against this known truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done as described in this document. The studies performed were:
* A clinical correlation study comparing the device to other existing tests.
* A blind labeled spiked study with "lay users," which focused on user interpretation.
Neither of these aligns with a typical MRMC study designed to assess reader improvement with AI assistance. This device is a simple, visual, one-step immunoassay, not an AI-powered diagnostic imaging tool where MRMC studies are common.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, in a sense, a standalone performance was evaluated through the clinical sample correlation study. This study assesses the device's ability to detect hCG in clinical specimens, and the results are then compared to predicate devices. While there's a human reading the visual result, the "performance" here refers to the immunoassay's intrinsic ability to react correctly. The lay user study, however, does involve human-in-the-loop performance (lay user interpretation).
7. The Type of Ground Truth Used:
- Clinical Sample Correlation Study: The ground truth was established by the results obtained from predicate devices (Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test) on clinical specimens. These predicate devices themselves would have been cleared based on their correlation with clinical diagnosis or established laboratory methods for pregnancy confirmation.
- Blind Labeled Spiked HCG Study (Lay User Study): The ground truth was based on the known composition of artificially "spiked" samples (i.e., samples engineered to be positive or negative for hCG at specific concentrations).
8. The Sample Size for the Training Set:
The provided text does not mention a training set or data used for training. This is expected as the Quickstick™ is a traditional immunoassay, not an AI/ML device that requires training data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.