(135 days)
The GSP Neonatal 17α-OH-progesterone kit is intended for the quantitative determination of human 17α-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the GSP™ instrument.
The GSP Neonatal 17x-OH-progesterone (17-OHP) assay is a solid phase, time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled 17-OHP and sample 17-OHP for a limited amount of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibody-bound and free antigen. DELFIA Inducer dissociates europium ions from the labeled antigen into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of 17-OHP in the sample.
The provided text describes the GSP Neonatal 17α-OH-progesterone kit and its comparison to a predicate device, the AutoDELFIA Neonatal 17α-OH-progesterone kit. The primary study presented focuses on the "Screening Efficacy" of the new GSP kit by comparing its results to those of the predicate device using various percentile cut-offs.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative manner (e.g., "The device must achieve X% accuracy"). Instead, it demonstrates performance by comparing the new device (GSP kit) to the legally marketed predicate device (AutoDELFIA kit) and showing high agreement.
The screening efficacy tables (Tables 1-9) implicitly demonstrate the device's acceptable performance based on its agreement with the predicate device. For the purpose of this analysis, we will consider the "Overall percent agreement" with the predicate device as the key performance metric presented.
| Characteristic | Acceptance Criteria (Implicit, based on predicate comparison) | Reported Device Performance (GSP Neonatal 17α-OH-progesterone kit) |
|---|---|---|
| Screening Efficacy (Overall Percent Agreement with Predicate Device, AutoDELFIA kit) | ||
| - 90% cutoff, ≥2500g | High agreement with predicate device | 95.9% (CI 94.9%-96.8%) |
| - 90% cutoff, 1250g-2249g | High agreement with predicate device | 98.6% (CI 97.0%-99.5%) |
| - 90% cutoff, |
§ 862.1395 17-Hydroxyprogesterone test system.
(a)
Identification. A 17-hydroxyprogesterone test system is a device intended to measure 17-hydroxyprogesterone (a steroid) in plasma and serum. Measurements of 17-hydroxyprogesterone are used in the diagnosis and treatment of various disorders of the adrenal glands or the ovaries.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.