(113 days)
The GSP Neonatal IRT kit is intended for the quantitative determination of IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP® instrument.
The GSP Neonatal IRT assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the IRT molecule. Calibrators, controls or test specimens containing IRT are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the IRT molecule and europium-labeled monoclonal antibodies (directed against a different antigenic site) in assay buffer. The assay buffer elutes IRT from dried blood on filter paper disks. The complete assay requires only one incubation step. DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of the DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of IRT in the sample.
The provided text describes the GSP Neonatal IRT kit, a device for screening newborns for cystic fibrosis. It compares the new device to a predicate device (AutoDELFIA Neonatal IRT kit) and presents information on its performance characteristics.
Here’s a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K0003668) | Reported Device Performance (GSP Neonatal IRT kit) |
|---|---|---|
| Intended Use / Indications for Use | Quantitative determination of human IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the 1235 AutoDELFIA automatic immunoassay system. | Quantitative determination of IRT in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis using the GSP® instrument. |
| Instrument | 1235 AutoDELFIA Instrument | GSP Instrument |
| Dissociation solution | Enhancement Solution | DELFIA Inducer |
| Antibody Cross-Reactions | ||
| α2-macroglobulin |
§ 862.1725 Trypsin test system.
(a)
Identification. A trypsin test system is a device intended to measure the activity of trypsin (a pancreatic enzyme important in digestion for the breakdown of proteins) in blood and other body fluids and in feces. Measurements obtained by this device are used in the diagnosis and treatment of pancreatic disease.(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.