(42 days)
An hCG pregnancy test intended for over the counter use by lay persons is an in vitro diagnostic test for the qualitative identification of human Chorionic Gonadotropin (hCG), a human hormone, in urine. Measurements that are obtained by this device are used in the diagnosis of pregnancy.
Immunoassay for the Qualitative Detection of Human Chorionic Gonadotropin (hCG) in Urine for the Detection of Early Pregnancy. The QuickCard HCG One Step Pregnancy Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.
Here's a breakdown of the acceptance criteria and study information for the QuickCard HCG One Step Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for sensitivity, specificity, or accuracy. Instead, it describes performance in relation to substantial equivalence to predicate devices and "excellent" results in a lay-user study.
| Performance Metric | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance |
|---|---|---|
| Clinical Correlation Study | Substantially equivalent to predicate devices with >99% correlation. | >99% correlation when compared to Quidel RapidVue and Syntron Bioresearch Be Sure Pregnancy Test. |
| Lay-User Study (Sensitivity) | "Excellent sensitivity" (specific numerical threshold not given, but context of 122/123 suggests high). | 122/123 (99.19%) |
| Lay-User Study (Specificity) | "Excellent specificity" (specific numerical threshold not given, but context of 122/123 suggests high). | 122/123 (99.19%) |
| Lay-User Study (Accuracy) | "Excellent accuracy" (specific numerical threshold not given, but context of 244/246 suggests high). | 244/246 (99.19%) |
2. Sample Size Used for the Test Set and Data Provenance
- A specific, single "test set" sample size for the clinical correlation study is not explicitly stated. It refers to "clinical specimens" and "correlation studies."
- For the blind labeled spiked consumer study (lay-user study):
- Sample Size: Not explicitly stated as a single number of participants. The results (122/123 sensitivity, 122/123 specificity, 244/246 accuracy) suggest a total of 246 cases were evaluated (123 positive detections and 123 negative detections if perfectly balanced, or some combination leading to 246 total readings). The "Most participants received a set containing 1 coded positive sample and 1 coded negative sample. One participant received 2 coded negative samples" suggests a minimum of 123 participants, with at least one receiving two negative samples, and others receiving one positive and one negative.
- Data Provenance: The consumer study was conducted "at five geographically distinct locations" within the USA. It used "coded specimens," which implies a prospective study design where participants were given samples to test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The text does not specify the number or qualifications of experts for judging the reference methods in the clinical correlation study (Quidel RapidVue and Syntron Bioresearch Be Sure Pregnancy Test).
- For the lay-user study:
- Ground Truth: The "coded urine samples" were "prepared as follows: Samples 1 and 3 were normal pooled male urine samples spiked to 40 mIU/mL hCG (WHO 1st IRP). Samples 2 and 4 were 0 mlU/mL hCG." This indicates laboratory-prepared samples with known hCG concentrations.
- Experts: No external experts were used to establish the ground truth for these specific samples; the ground truth was established by the deliberate spiking or absence of hCG by the study designers.
4. Adjudication Method for the Test Set
- The text does not mention an adjudication method for either the clinical correlation study or the lay-user study.
- For the lay-user study, the design involved individuals following instructions and potentially recording their own interpretations, which were then compared against the known ground truth of the spiked samples. There is no indication of a separate expert review or adjudication of the lay users' interpretations described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a traditional MRMC comparative effectiveness study that measures the improvement of human readers with AI vs. without AI assistance was not done.
- The device is a standalone immunoassay for qualitative detection of HCG, not an AI system designed to assist human readers in interpreting images or data.
- The "consumer survey" involved lay users performing and interpreting the test themselves, which is a form of human performance, but not in the context of assisting professional readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence, the "Performance" section describes the standalone performance of the device itself. The device is designed to be self-interpretable (visual color change) by a human user (either clinical professional or lay person).
- The "clinical sample correlation study" assesses the device's outcome against other commercial tests, which can be seen as a standalone comparison.
- The "blind labeled spiked consumer study" assesses the device's ability to accurately detect hCG in known positive/negative samples when interpreted by lay users, essentially testing the device's performance characteristics in the hands of its intended user without further professional intervention beyond the interpretation of the test result.
7. The Type of Ground Truth Used
- For the clinical correlation study: The ground truth was established by the results of two other commercially available and established pregnancy tests (Quidel RapidVue and the Syntron Bioresearch Be Sure Pregnancy Test).
- For the lay-user study: The ground truth was based on laboratory-prepared samples with known, controlled concentrations of hCG (40 mIU/mL hCG for positive samples and 0 mIU/mL hCG for negative samples). This is a form of spike-in ground truth.
8. The Sample Size for the Training Set
- The text does not mention a training set. This device is an immunoassay (a chemical test), not an AI algorithm that requires a training set. The "samples" referred to in the performance studies are for validation of the device's performance, not for training a model.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of a training set for an AI algorithm, this question is not applicable based on the provided text.
§ 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.