Anti-Rnp Antibody, Antigen And Control
Anti-RNP Antibody, Antigen and Control is a diagnostic immunoassay system used to detect antibodies against ribonucleoprotein (RNP) antigens, which are associated with mixed connective tissue disease and other autoimmune disorders. It is an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LKO, regulated under 21 CFR 866.5100, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- LKO
- Device Class
- FDA class 2
- Regulation Number
- 866.5100
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 23 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K191085 | Maverick RNP Assay and Maverick Diagnostic System | Oct 25, 2019 | Substantially Equivalent | Genalyte, Inc. |
| K140224 | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | Dec 09, 2014 | Substantially Equivalent | EUROIMMUN US |
| K123261 | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | Jun 12, 2013 | Substantially Equivalent | EUROIMMUN US |
| K083117 | ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 | May 28, 2009 | Substantially Equivalent | PHADIA US INC. |
| K071210 | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | Dec 19, 2007 | Substantially Equivalent | BIOMEDICAL DIAGNOSTICS (BMD) SA |
| K022017 | RHIGENE MESACUP-2 TEST RNP, MODEL M7741 | Aug 14, 2002 | Substantially Equivalent | RHIGENE, INC. |
| K000752 | RHIGENE MESACUP2 TEST- RNP | May 09, 2000 | Substantially Equivalent | RHIGENE, INC. |
| K993589 | VARELISA RNP ANTIBODIES | Nov 26, 1999 | Substantially Equivalent | PHARMACIA & UPJOHN CO. |
| K990624 | AUTOSTAT II ANTI-SM/RNP ELISA | Apr 28, 1999 | Substantially Equivalent | COGENT DIAGNOTICS LTD. |
| K984476 | LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 | Dec 22, 1998 | Substantially Equivalent | BIO-RAD |
| K983465 | THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Nov 18, 1998 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K954831 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY | May 08, 1996 | Substantially Equivalent | ORGENTEC |
| K954897 | HYTEC AUTOIMMUNE KITS (RNP) | Mar 22, 1996 | Substantially Equivalent | HYCOR BIOMEDICAL, INC. |
| K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | Apr 20, 1994 | Substantially Equivalent | HELIX DIAGNOSTICS, INC. |
| K930142 | SYNELISA U1-SNRNP (68KDA)-ANTIBODIES | May 11, 1993 | Substantially Equivalent | ELIAS USA, INC. |
| K911850 | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST | May 07, 1991 | Substantially Equivalent | GENERAL BIOMETRICS, INC. |
| K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | May 07, 1991 | Substantially Equivalent | GENERAL BIOMETRICS, INC. |
| K905194 | DIASTAT ANTI-RO (SS-A) | Dec 13, 1990 | Substantially Equivalent | SHIELD DIAGNOSTICS, LTD. |
| K905193 | DIASTAT ANTI-LA (SS-B) | Dec 13, 1990 | Substantially Equivalent | SHIELD DIAGNOSTICS, LTD. |
| K895997 | RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES | Nov 06, 1989 | Substantially Equivalent | LIPOGEN, INC. |
| K895338 | ANTI-RNP AND ANTI-SM ANTIBODY TEST | Oct 17, 1989 | Substantially Equivalent | IMMCO DIAGNOSTICS, INC. |
| K874152 | RNP ANTIBODY TEST KIT | Mar 11, 1988 | Substantially Equivalent | LIPOGEN, INC. |
| K831292 | ANTI-ENA TEST | Jul 18, 1983 | Substantially Equivalent | MELOY LABORATORIES, INC. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.