(67 days)
The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant.
This document is an FDA 510(k) clearance letter for "The Poly stat Serum/Urine hCG Test." As such, it does not contain the detailed study information requested in the prompt. FDA clearance letters primarily confirm that a new device is "substantially equivalent" to an already legally marketed predicate device, meaning it performs as safely and effectively.
Specifically, the letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
Therefore, I cannot extract the following information from this document:
- Table of acceptance criteria and reported device performance: This letter doesn't detail performance metrics or specific acceptance criteria.
- Sample sizes used for the test set and data provenance: No information on test set size or origin is provided.
- Number of experts used to establish ground truth and their qualifications: This is not discussed in the letter.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study results: No such study is mentioned or referenced.
- Standalone algorithm performance: This is a diagnostic test, not an AI algorithm, so this concept doesn't apply directly.
- Type of ground truth used: Not specified.
- Sample size for the training set: This refers to AI/machine learning models, which is not applicable here.
- How ground truth for the training set was established: This refers to AI/machine learning models, which is not applicable here.
The document only provides:
- Device Name: The Poly stat Serum/Urine hCG Test
- Regulation Number: 21 CFR 862.1155
- Regulation Name: Human chorionic gonadotropin (HCG) test system
- Regulatory Class: Class II
- Product Code: JHI
- Indications For Use: The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.
To obtain the detailed study information requested, one would typically need to review the original 510(k) submission document itself, which contains the scientific data and performance studies, rather than just the FDA's clearance letter.
§ 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.