(251 days)
The Hyperion VisiQuant™ ANA Test Kit is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the invitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.
VisiQuant™ ANA is a unique ANA IFA. The test samples are assayed with a single dilution as in the traditional qualitative procedure to determine positive and pattern while obtaining a VisiQuant titer from the same image. The stained slides are read objectively with a digital camera through the FAN microscope to measure the fluorescence intensity of reacted substrate (Hip-2 calls). The Visiguant tive of the test sample is interpolated from a standard curve. VisiQuant ANA uses a unique fluorophore, La Jolla Blue (LJB), which has a longer fluorescence life (photostability) than fluorescent. LJJP has nearinfrared peak excitation and emission wavelengths to minimize autofluoresconce commonly present in biological substances.
The Hyperion VisiQuant™ ANA Test Kit is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the in-vitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.
1. Table of acceptance criteria and the reported device performance:
Agreement in Test Results (Qualitative)
| Criteria | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Agreement for negative results | High agreement, similar to predicate device | 98.92 % |
| Agreement for positive results | High agreement, similar to predicate device | 94.12 % |
Pattern Agreement (for positive samples)
| Criteria | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Pattern agreement (both positive, VisiQuant pattern matches Bion pattern) | High agreement, similar to predicate device | 94.79 % |
| Pattern agreement (Bion positive, VisiQuant pattern matches Bion pattern) | High agreement, similar to predicate device | 89.21 % |
Quantitative Correlation (VisiQuant Titer vs. Bion IFA Titer)
| Criteria | Acceptance Criteria (Implicit) | Reported Device Performance (R-value) |
|---|---|---|
| Correlation for all positive patterns | Strong positive correlation | 0.731 (N=96, p |
§ 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).