(44 days)
Artron One-Step hCG Urinary Pregnancy Test Device is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine to help in the early determination of pregnancy. The device is designed for over-the-counter use as well as professional use.
For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result.
Not Found
The provided document (K060019) is a 510(k) clearance letter for the Artron One-Step Human Chorionic Gonadotropin (hCG) Urinary Pregnancy Test Device. This type of document generally confirms substantial equivalence to a predicate device and does not contain detailed study information, acceptance criteria, or performance metrics in the format requested. The letter states that the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, the requested information regarding acceptance criteria, specific study design details (sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance), and ground truth establishment for this specific device's clearance study is not available within the provided text.
The document primarily focuses on the regulatory confirmation of market clearance based on substantial equivalence. It does not include the detailed performance data or study specifics that would be submitted to FDA as part of the 510(k) application itself.
However, based on the general nature of an hCG urinary pregnancy test, we can infer typical performance expectations and study types, but these are not explicitly stated in this document.
To provide a hypothetical response, assuming such information were present for a similar diagnostic device, here's how it would be structured, with placeholders where the specific information is missing from the provided text:
Hypothetical Response (Information Not Present in Provided Document K060019):
The provided 510(k) clearance letter (K060019) for the Artron One-Step hCG Urinary Pregnancy Test Device confirms its substantial equivalence to predicate devices but does not contain the detailed acceptance criteria and study data requested. The letter confirms the device's market clearance but does not provide the specifics of the performance studies conducted to demonstrate its efficacy.
To answer your request, information regarding acceptance criteria, sample sizes, expert qualifications, and study methodologies would typically be found in the actual 510(k) submission document accompanying this clearance letter, which is not provided here.
However, for a diagnostic device like a pregnancy test, the general types of performance studies and criteria might include:
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical):
| Metric | Acceptance Criteria (Hypothetical for hCG Test) | Reported Device Performance (Not in document) |
|---|---|---|
| Sensitivity | ≥ 99% (at 25 mIU/mL hCG concentration) | [Not provided in document] |
| Specificity | ≥ 99% (no cross-reactivity with interfering substances relevant to pregnancy testing) | [Not provided in document] |
| Accuracy | ≥ 99% agreement with a reference method | [Not provided in document] |
| Limit of Detection (LoD) | ≤ 25 mIU/mL hCG in urine | [Not provided in document] |
| Precision/Reproducibility | Consistent results across different operators/batches | [Not provided in document] |
| Interfering Substances | No significant interference from common substances (e.g., aspirin, caffeine) | [Not provided in document] |
| Hook Effect | No hook effect observed at high hCG concentrations | [Not provided in document] |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided in document. Typically, for in vitro diagnostic devices like pregnancy tests, a significant number of urine samples (e.g., hundreds) from pregnant and non-pregnant women would be tested.
- Data Provenance: Not provided in document. Such studies are typically prospective, using freshly collected urine samples, potentially from various clinical sites to ensure diversity. The country of origin would usually be the country where the clinical trials or performance evaluations were conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided in document.
- Qualifications: Not provided in document. For hCG tests, the "ground truth" is typically established by laboratory reference methods (e.g., quantitative serum hCG assays) rather than expert radiographic or clinical interpretation of the test device itself.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable in the conventional sense for a quantitative diagnostic marker like hCG in a pregnancy test. The ground truth is determined by objective laboratory measurements (e.g., quantitative serum hCG levels) and clinical confirmation (e.g., ultrasound for pregnancy). The device's result is then compared to this objective ground truth.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: Not applicable. This device is a rapid diagnostic test for hCG, not an AI-assisted imaging device. Its interpretation is typically straightforward (presence/absence of lines) and does not involve complex human reading tasks or AI assistance in a diagnostic image sense.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the performance of the immunoassay strip/cassette/midstream itself would be evaluated in a standalone manner against known concentrations of hCG and clinical samples. The "human-in-the-loop" component is the visual interpretation of the test result by the user, but the primary performance metrics (sensitivity, specificity, LoD) relate to the device's chemical and biological detection capabilities.
7. The type of ground truth used:
- Ground Truth Type: Most likely a combination of:
- Reference Laboratory Methods: Quantitative serum hCG assays (considered the gold standard for hCG levels).
- Clinical Confirmation: For pregnant samples, confirmed pregnancy by other clinical methods (e.g., ultrasound).
- Known hCG Spiked Samples: For analytical sensitivity and specificity, urine samples spiked with known concentrations of hCG and interfering substances.
8. The sample size for the training set:
- Training Set Sample Size: Not provided in document. Immunoassay devices typically do not have a "training set" in the machine learning sense. Instead, product development involves iterative testing and refinement using various samples until desired performance is achieved. If any calibration or algorithm tuning were involved (unlikely for a simple rapid test), samples would be used for that purpose.
9. How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable in the machine learning sense. For traditional immunoassay development, samples with known hCG concentrations (established by reference methods) are used to calibrate and optimize the test format (e.g., antibody concentrations, reagent formulation).
In summary, the provided FDA clearance letter confirms the regulatory status of the device but does not detail the technical performance studies. The requested information would typically be available in the full 510(k) submission, which is not part of this document.
§ 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.