LKP · Anti-Sm Antibody, Antigen And Control
Immunology · 21 CFR 866.5100 · Class 2
Overview
| Product Code | LKP |
|---|---|
| Device Name | Anti-Sm Antibody, Antigen And 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 28)
Showing 20 most recent of 28 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202067 | EliA SmDP-S | Phadia AB | Jul 14, 2021 | SESE |
| K183007 | EliA SmDP Immunoassay | Phadia AB | Dec 24, 2018 | SESE |
| K132631 | EIA SMDP IMMUNOASSAY | Phadia US, Inc. | Aug 29, 2014 | SESE |
| K123593 | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, | Inova Diagnostics, Inc. | Apr 17, 2013 | SESE |
| K051066 | THERATEST EL-ANA PROFILES | Theratest Laboratories, Inc. | Oct 7, 2005 | SESE |
| K042629 | VARELISA SM ANTIBODIES, MODEL 18296 | Sweden Diagnostics (Germany) GmbH | Dec 8, 2004 | SESE |
| K024219 | LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 | Bio-Rad | Jan 15, 2003 | SESE |
| K013263 | FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST | Fred Hutchinson Cancer Research Center | Jul 29, 2002 | SESE |
| K000755 | RHIGENE MESACUP2 TEST- SM | Rhigene, Inc. | May 9, 2000 | SESE |
| K000312 | VARELISA SM ANTIBODIES | Pharmacia & Upjohn Co. | Mar 17, 2000 | SESE |
| K990625 | AUTOSTAT II ANTI-SM ELISA | Cogent Diagnotics , Ltd. | Apr 28, 1999 | SESE |
| K984479 | LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 | Bio-Rad | Dec 22, 1998 | SESE |
| K983420 | THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO | Zeus Scientific, Inc. | Nov 18, 1998 | SESE |
| K980540 | SERAQUEST ANTI-SM | Quest Intl., Inc. | Jun 15, 1998 | SESE |
| K980811 | SERAQUEST ANTI-SM/RNP | Quest Intl., Inc. | May 12, 1998 | SESE |
| K954830 | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY | Orgentec | May 8, 1996 | SESE |
| K954896 | HYTEC AUTOIMMUNE KITS (SM) | Hycor Biomedical, Inc. | Mar 22, 1996 | SESE |
| K940510 | ENZYME IMMUNOASSAY ANTI-SM ANTIBODY TEST KIT | Helix Diagnostics, Inc. | Apr 20, 1994 | SESE |
| K930141 | SYNELISA SM ABS/RNP-SM ABS | Elias U.S.A., Inc. | May 11, 1993 | SESE |
| K911851 | IMMUNOWELL SM ANTIBODY TEST | General Biometrics, Inc. | May 7, 1991 | SESE |
Top Applicants
- Shield Diagnostics, Ltd. — 2 clearances
- Quest Intl., Inc. — 2 clearances
- Phadia AB — 2 clearances
- Lipogen, Inc. — 2 clearances
- General Biometrics, Inc. — 2 clearances
