(32 days)
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
The Access Intrinsic Factor Ab reagents, calibrators, QC, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the detection of intrinsic factor antibody in human serum and plasma.
Here's a breakdown of the acceptance criteria and study information for the Access Intrinsic Factor Ab assay based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Access IFAb) | Predicate Device (DPC IFbAb) |
|---|---|---|---|
| Imprecision | Not explicitly stated | Within-run: 1.3% CV to 1.5% CV | Not directly comparable |
| Between-run: 4.4% CV to 5.1% CV | |||
| Total: 4.6% CV to 5.3% CV | |||
| Dilution Recovery (Linearity) | Not explicitly stated | Serial dilutions transform positive sample results to negative. (Demonstrated linearity) | Not explicitly stated |
| Methods Comparison (Agreement with Predicate) | High agreement with predicate device for substantial equivalence | Negative agreement: 100% | |
| Positive agreement: 96.4% | |||
| Overall agreement: 92.1% | |||
| Analytical Specificity | No significant interference from common substances | No significant interference from bilirubin, hemoglobin, human serum albumin, triglycerides. | Not explicitly stated |
| Samples with vitamin B12 values |
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.