(46 days)
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. This device is intended for clinical laboratories (labs) and physician's office labs (POLs) as an IVD test for the qualitative measurement of hCG in urine. Clinical labs can include hosptials and reference labs. POLs can include mini-clinics.
Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Early Pregnancy. The QuickStick ProTM HCG Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.
The provided text describes the 510(k) summary for the QuickStick Pro™ HCG Test, a device intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for early pregnancy confirmation.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in a quantitative numerical format (e.g., "sensitivity must be >95%"). However, it implies the acceptance criteria by stating that the QuickStick Pro™ HCG Test exhibited "excellent sensitivity (>99%), specificity (>99%), and accuracy (>99%)" and a ">99% correlation" with predicate devices. This suggests that achieving high percentages in these metrics was the de facto acceptance benchmark, aligned with the performance of substantially equivalent devices.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | >99% | >99% |
| Specificity | >99% | >99% |
| Accuracy | >99% | >99% |
| Correlation | >99% with predicate devices | >99% with predicate devices |
2. Sample Size Used for the Test Set and Data Provenance
The text states that "Correlations studies, using clinical specimens, produced a >99% correlation." It also mentions "A clinical laboratory study was performed."
- Sample Size: The document does not explicitly state the sample size used for the test set or clinical studies.
- Data Provenance: The data came from "clinical specimens" and "a clinical laboratory study." The country of origin is not specified, and it is described as a "clinical sample correlation study," which implies it was based on retrospective clinical samples or a prospective collection during a clinical study. The blind labeled spiked HCG study would involve a controlled, possibly laboratory-based, prospective experiment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth. It vaguely refers to "professional users" for the clinical laboratory study, but this refers to the users operating the device, not necessarily those establishing the ground truth.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set.
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 as described in the provided text. The study conducted was a correlation study against predicate devices and a clinical laboratory study, focusing on the device's standalone performance in the hands of "professional users," not specifically on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was conducted. The QuickStick Pro™ HCG Test is a qualitative immunoassay kit. The "clinical laboratory study" and "blind labeled spiked HCG study" focused on the performance characteristics (sensitivity, specificity, accuracy) of the device itself (the "algorithm only," in the context of an immunoassay) when handled by "professional users." The device provides a visual result, which is then interpreted by a human, but the core performance metrics are intrinsic to the device's ability to detect hCG. The "correlation" studies compare its results directly with predicate devices.
7. The Type of Ground Truth Used
The ground truth for the clinical sample correlation study and the clinical laboratory study likely relied on one or a combination of the following, although not explicitly stated:
- Reference Laboratory Testing: Comparison with established, more sensitive, or quantitative laboratory tests for hCG.
- Predicate Device Results: The text explicitly mentions correlation against Quidel Rapidvue and Syntron Bioresearch Be Sure Pregnancy Test, indicating their results served as a form of "ground truth" or reference for comparison.
- Clinical Confirmation/Outcomes Data: For actual pregnancy status, clinical confirmation or follow-up outcomes would typically be used, though not detailed here.
- Spiked HCG Samples: For the "blind labeled spiked HCG study," the ground truth was the known concentration of hCG that was intentionally added (spiked) into the samples.
8. The Sample Size for the Training Set
The document does not provide information on a separate "training set" or its sample size. This is a characteristic typically associated with machine learning or AI algorithm development, which is not the focus of this immunoassay device approval. The studies described are for validation of the finalized product.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of this device's development and validation, this information is not applicable or provided in the document. Immunoassay devices like the QuickStick Pro™ are typically developed based on established biochemical principles and then validated through performance studies, rather than "trained" on data.
§ 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.