(144 days)
The DiaSorin LIAISON® XL HCG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the quantitative determination of total human chorionic gonadotropin (hCG and ßhCG) in human serum for early detection of pregnancy. Total hCG is the measurement of intact and beta-hCG.
The method for the quantitative determination of hCG is a sandwich chemiluminescence immunoassay. A specific mouse monoclonal antibody is coated on the magnetic particles (solid phase); another monoclonal antibody is linked to an isoluminol derivative (isoluminol-antibody conjugate). All assay steps and incubations are performed by the LIAISON® XL Analyzer.
During the first incubation, hCG present in calibrators, samples or controls binds to the solid phase monoclonal antibody, and subsequently after a washing step in a second incubation the antibody conjugate reacts with hCG already bound to the solid phase.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU, relative light units) and is directly related to hCG concentration present in calibrators, samples or controls.
Here's an analysis of the DiaSorin LIAISON® XL HCG Premarket Notification (K131037) based on the provided text, focusing on acceptance criteria and study details:
Acceptance Criteria and Device Performance for DiaSorin LIAISON® XL HCG
The DiaSorin LIAISON® XL HCG assay is a chemiluminescent immunoassay (CLIA) for the quantitative determination of total human chorionic gonadotropin (hCG and βhCG) in human serum for early detection of pregnancy. The submission aims to demonstrate substantial equivalence to the Roche ELECSYS® HCG +Beta Test (K003178).
The document details several performance studies to support the device's claims.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" as pass/fail thresholds for each performance characteristic. Instead, it reports the results of the performance studies which implicitly serve as the basis for demonstrating substantial equivalence. For the purpose of this analysis, I will infer the intended acceptance of "good performance" based on the reported values and comparison to the predicate where applicable.
| Performance Characteristic | Implicit Acceptance Criteria (or Reference) | Reported Device Performance (DiaSorin LIAISON® XL HCG) |
|---|---|---|
| Method Comparison | Good correlation with predicate device | y = 0.973x - 0.2233; R² = 0.9933 (vs. predicate) |
| Reference Range | Clearly defined ranges for non-pregnant populations | - Premenopausal ( |
§ 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.