(271 days)
The Access Total (BhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems. The assay is intended for use as an aid in the early detection of pregnancy.
The Access Total BhCG (5th IS) calibrators are intended to calibrate the Access Total BhCG (5" IS) assay for the quantitative determination of total BhCG levels in human serum and plasma using the Access Immunoassay Systems.
The Access Total βhCG (5" IS) assay (standardized to WHO 5" International Standard), Access Total BhCG (5th IS) calibrators, and the Access Immunoassay analyzers comprise the Access Immunoassay System for the quantitative determination of total βhCG in human serum and plasma.
The provided text describes the performance of the Beckman Coulter Access Total βhCG (5th IS) Assay and Calibrators. The primary "acceptance criteria" for this device, as presented in the 510(k) summary, are derived from various analytical performance studies, which aim to demonstrate substantial equivalence to a predicate device.
Here's an analysis based on your requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" as a separate compiled list. Instead, performance characteristics are presented as results from various studies. I will infer the acceptance criteria from the reported results and the context of device validation for regulatory submission (e.g., meeting established thresholds for imprecision, linearity, etc.).
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Method Comparison (vs. Predicate): | |
| Slope of Passing-Bablok regression: Approximately 1.00 (CI around 1.00) | Slope = 1.04 (95% CI: 1.02 to 1.06) |
| Intercept of Passing-Bablok regression: Approximately 0 mIU/mL | Intercept = 2.87 mIU/mL |
| Pearson correlation (r): Close to 1.00 | r = 0.99 |
| Imprecision (CV% or SD): | |
| Total imprecision for concentrations > 3.9 mIU/mL: |
§ 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.