(45 days)
The DSL-10-8500 ACTIVE™ Free 3-hCG Enzyme-Linked Immunosorbent Assay (ELISA) kit provides materials for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in serum. This assay is intended for in vitro diagnostic use as an aid in the detection of pregnancy.
The DSL-10-8500 ACTIVE™ Free B-hCG ELISA kit was developed for the quantitative measurement of Free ß-subunit of human chorionic gonadotropin (hCG) in human serum. The DSL ACTIVE® Free B-hCG ELISA is a two-site ELISA assay in which the free ß-hCG to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the microtitration well, the other antibody is conjugated to the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed by washing the wells. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound Free B-hCG is directly proportional to the concentration of the Free ß-hCG present in the sample.
The provided text describes a Substantial Equivalence study for the DSL ACTIVE™ Free β-hCG ELISA kit (DSL-10-8500) against a predicate device, the DSL-8300 Intact-hCG IRMA, for the quantitative determination of Free β-hCG in human serum as an aid in detecting pregnancy.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of predetermined acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy thresholds that the new device needed to meet. Instead, it relies on demonstrating substantial equivalence to an existing predicate device (DSL-8300 Intact-hCG IRMA).
The reported performance that serves as the basis for substantial equivalence is primarily through a linear regression analysis and an assessment of physiological profiles in normal individuals.
| Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (DSL-10-8500 ACTIVE™ Free β-hCG ELISA) |
|---|---|
| Strong correlation and agreement with the predicate device (DSL-8300 Intact-hCG IRMA) for pregnant patient samples across varying hCG levels. | Linear regression equation: DSL-10-8500 = 0.007(DSL-8300) - 2.7 |
| Correlation coefficient: r = 0.82 | |
| Statistical significance: p |
§ 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.