(24 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.
Immunoassay for the Qualitative Detection of Human Chorioni Gonadotropin (hCG) in Urine for the Early Pregnancy. The QuickCard Pro™ HCG Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.
Here's an analysis of the provided text regarding the QuickCard Pro™ HCG Test, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Correlation to Predicate Devices | Substantially equivalent to commercially available tests, >99% correlation | >99% correlation (compared to Quidel Rapidvue and Syntron Bioresearch Be Sure) |
| Sensitivity | >99% | >99% |
| Specificity | >99% | >99% |
| Accuracy | >99% | >99% |
Note: The acceptance criteria are "implied" because the document states the device needs to be "substantially equivalent to the reported performance characteristics of other commercially available tests" and then reports actual performance which exceeds 99% for all metrics. It doesn't explicitly state "acceptance criteria must be >99%" but this is the threshold achieved for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document states:
- "The product performance characteristics of the QuickCard Pro™ HCG Pregnancy Test were evaluated in a clinical sample correlation study and a blind labeled spiked HCG study."
- "Correlations studies, using clinical specimens, produced a >99% correlation..."
- "A clinical laboratory study was performed..."
Sample Size: The exact sample size for the test set is not explicitly stated in the provided text.
Data Provenance: The data came from "clinical sample correlation study" and "clinical laboratory study" using "clinical specimens." This suggests prospective collection from human subjects, although the specific country of origin is not mentioned. Given the manufacturer's location (San Diego, California, USA) and the FDA submission, it's highly probable the studies were conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document makes no mention of specific "experts" used to establish ground truth or their qualifications. The ground truth for this type of immunoassay is typically derived from the results of a highly accurate reference method or a predicate device.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For a quantitative test like hCG detection, adjudication (e.g., 2+1 or 3+1 reader consensus) is generally not applicable in the same way it would be for subjective image interpretation. The outcome (positive/negative for hCG) is typically determined by a threshold or comparison to a reference.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. This is not typically relevant for a simple positive/negative immunoassay where human interpretation is minimal beyond observing a color change. The study evaluated the device's performance directly, not how human readers improve with or without AI assistance, as "AI" is not involved in this device.
6. Standalone (Algorithm Only) Performance
This device is a standalone test (an immunoassay), and its performance metrics (sensitivity, specificity, accuracy, correlation) directly represent its "standalone" performance. There is no human-in-the-loop component in the evaluation of its core analytical function; it produces a result based on the chemical reaction. The "professional users" in the clinical laboratory study are performing the test according to instructions and observing its output, not providing an independent interpretation that is then augmented by the device.
7. Type of Ground Truth Used
The ground truth was established by:
- Comparison to predicate devices: "Correlations studies, using clinical specimens, produced a >99% correlation when compared to the Quidel Rapidvue (San Diego, CA 92121) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083)." These predicate devices themselves would have established their accuracy against a recognized gold standard for hCG detection (e.g., a laboratory reference assay or clinical confirmation).
- "Blind labeled spiked HCG study": This indicates that samples with known, controlled concentrations of hCG (both positive and negative) were used, providing a definitive ground truth.
Therefore, the ground truth is a combination of reference device comparison and known spiked samples, which themselves are validated against established medical science for hCG detection.
8. Sample Size for the Training Set
The document does not mention a training set size. This device is an immunoassay, not a machine learning or AI-based diagnostic tool that would typically involve a "training set" in the computational sense. Its performance is based on the chemical principle and validation with physical samples.
9. How the Ground Truth for the Training Set Was Established
As there is no concept of a "training set" for this type of immunoassay in the context of an algorithm, the question of how ground truth was established for it is not applicable. The device's design and manufacturing are based on established immunochemical principles, not on iterative machine learning from a dataset.
§ 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.