(56 days)
The One-Step Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine, for the early detection of pregnancy. For Over-The -Counter l Jse.
The One-Step Pregnancy Test is to be used for detecting human Chorionic Gonadotropin (hCG) in urine. The presence of hCG usually appears about the seventh day after fertilization. The One-Step Pregnancy Test will detect hCG in urine at a concentration level of 25 mIU/ml. The One-Step Pregnancy Test will be sold for under private label in the Over-the-Counter Market.
Here's a breakdown of the acceptance criteria and study details for the One-Step Pregnancy Test, based on the provided 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance:
The submission does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, the study aimed to demonstrate "substantial equivalence" to a predicate device, for which "100% performance" appears to be the implied acceptance.
| Performance Metric | Implied Acceptance Criteria (relative to predicate) | Reported Device Performance |
|---|---|---|
| Sensitivity | Substantially Equivalent (ideally 100%) | 100% |
| Specificity | Substantially Equivalent (ideally 100%) | 100% |
| Agreement | Substantially Equivalent (ideally 100%) | 100% |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the document. The wording "A clinical trial was done" and "These data clearly demonstrate..." suggests a sufficient sample size was used to achieve 100% agreement, sensitivity, and specificity, but the exact number of participants or samples is not provided.
- Data Provenance: The document does not specify the country of origin. The study was a "clinical trial," which implies a prospective collection of data comparing the device to a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not explicitly stated.
- Qualifications: The ground truth was "confirmed by physical examination and/or ultrasound." This implies that licensed medical professionals (e.g., physicians, sonographers) were involved in establishing the ground truth, but their specific number, experience level, or specialty are not detailed.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated. The ground truth was based on "physical examination and/or ultrasound," which implies an independent clinical assessment rather than a consensus among multiple readers of the device's output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No, an MRMC comparative effectiveness study was not done. The study compared the device's performance to another FDA-cleared pregnancy test and confirmed its results with clinical outcomes, not by evaluating human readers' interpretation with and without AI assistance.
6. Standalone Performance Study:
- Was a standalone study done? Yes, the performance data provided (Sensitivity, Specificity, Agreement) reflects the standalone performance of the One-Step Pregnancy Test. The device itself produced the results, which were then compared to the predicate device and clinical ground truth. The statement "Testing by untrained women of childbearing years confirmed that the test can be effectively performed by untrained individuals" also points to testing the device's standalone usability.
7. Type of Ground Truth Used:
- Ground Truth Type: Clinical outcomes data. Specifically, "All pregnancy results were confirmed by physical examination and/or ultrasound."
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device is a biochemical assay (lateral flow immunoassay), not an AI/machine learning model, so there is no training set in the conventional sense. The device's performance is inherently based on its chemical/biological design and manufacturing, not a learned algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device. The "ground truth" for developing and validating the assay's ability to detect hCG would have come from established biochemical principles, spiked samples with known hCG concentrations, and clinical samples with confirmed pregnancy status.
§ 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.