(77 days)
The assay is intended for use in detecting antibodies to Scl-70 antigen in a single human serum sample. The results of the assay are to be used as an aid in the diagnosis of autoimmune disorders.
The Is-anti-Scl-70 Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to Scl-70 antigen in human serum.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Is-anti-Scl-70 Test System:
This document focuses on the performance characteristics of an in vitro diagnostic device (IVD), specifically an Enzyme-Linked Immunosorbent Assay (ELISA) for detecting antibodies to Scl-70 antigen. For IVDs, "acceptance criteria" are usually demonstrated through tests of sensitivity, specificity, accuracy (agreement), precision, linearity, and and cross-reactivity compared to a predicate device or established reference methods. The "study" described is the validation study performed to demonstrate these characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as distinct numerical thresholds for approval. Instead, it presents performance characteristics and compares them to a predicate device. For IVDs, the reported performance is what demonstrates the device is "safe and effective for its intended use" as compared to the predicate.
Given the context of a 510(k) summary, the implicit acceptance criteria would be substantial equivalence to the predicate device. This means the new device performs at least as well as, or comparably to, the legally marketed predicate device.
| Performance Metric | Acceptance Criteria (Implicit: Comparable to Predicate) | Reported Device Performance (Manual) | Reported Device Performance (MAGO) |
|---|---|---|---|
| Relative Sensitivity | High agreement with predicate device for positive samples. | 88% (21/24) with 95% CI: 68-97% | 92% (22/24) with 95% CI: 73-99% |
| Relative Specificity | High agreement with predicate device for negative samples. | 100% (138/138) with 95% CI: 97-100% | 99% (138/139) with 95% CI: 96-100% |
| Agreement | High overall agreement with predicate device. | 98% (159/162*) with 95% CI: 95-100% | 98% (160/163) with 95% CI: 95-100% |
| Linearity | High degree of linearity throughout the testing range. | R-squared = 0.9873 | R-squared = 0.9888 |
| Precision (Intra-CV%) | Acceptable variability for both negative and positive samples. (Implicit: typically |
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).