DHN · Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Immunology · 21 CFR 866.5100 · Class 2
Overview
| Product Code | DHN |
|---|---|
| Device Name | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Regulation | 21 CFR 866.5100 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 110)
Showing 20 most recent of 110 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201956 | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | Zeus Scientific, Inc. | Apr 29, 2022 | SESE |
| K172745 | ImmuGlo HEp-2 Elite IFA | Immco Diagnostics, Inc. | Jun 5, 2018 | SESE |
| K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | Aesku Systems GmbH&Co.Kg | Jul 28, 2016 | SESE |
| K160265 | Image Navigator by Immuno Concepts | Immuno Concepts, N.A. , Ltd. | Jun 17, 2016 | SESE |
| K141827 | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | Euroimmun Us, Inc. | Apr 17, 2015 | SESE |
| K150155 | NOVA Lite DAPI ANA Kit | Inova Diagnostics, Inc. | Apr 8, 2015 | SESE |
| K131791 | IFA 40: HEP-20-10 | Euroimmun US | Feb 26, 2014 | SESE |
| K120889 | AESKUSLIDES ANA HEP-2 | Aesku Diagnostics | Oct 15, 2012 | SESE |
| K070763 | EUROIMMUN ANA IFA: HEP-20-10 | Euroimmun Us, LLC | May 22, 2007 | SESE |
| K042680 | RHIGENE HEP-ANA TEST SYSTEM | Corgenix, Inc. | Nov 19, 2004 | SESE |
| K024220 | LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 | Bio-Rad | Jan 17, 2003 | SESE |
| K024230 | LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 | Bio-Rad | Jan 15, 2003 | SESE |
| K024229 | LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 | Bio-Rad | Jan 15, 2003 | SESE |
| K024227 | LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 | Bio-Rad | Jan 15, 2003 | SESE |
| K024225 | LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 | Bio-Rad | Jan 15, 2003 | SESE |
| K024224 | LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 | Bio-Rad | Jan 15, 2003 | SESE |
| K024222 | LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 | Bio-Rad | Jan 15, 2003 | SESE |
| K024221 | LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 | Bio-Rad | Jan 15, 2003 | SESE |
| K024217 | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 | Bio-Rad | Jan 15, 2003 | SESE |
| K024231 | LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 | Bio-Rad | Jan 13, 2003 | SESE |
Top Applicants
- Bio-Rad — 14 clearances
- Immuno Concepts, Inc. — 7 clearances
- Zeus Scientific, Inc. — 6 clearances
- Meloy Laboratories, Inc. — 5 clearances
- Inova Diagnostics, Inc. — 4 clearances
