FDA product code LKO: Anti-Rnp Antibody, Antigen And Control
LKO is the FDA product code for anti-rnp antibody, antigen and control. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel. FDA has cleared 23 510(k) submissions under LKO, from 18 different applicants. The average 510(k) review took 105 days (median 62). FDA has posted 1 recall for LKO devices.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Rnp Antibody, Antigen And Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5100 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LKO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 184 |
Compare with all 510(k) review times · Search every LKO clearance
Top LKO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Euroimmun US | 2 | 2014-12-09 |
| Rhigene, Inc. | 2 | 2002-08-14 |
| General Biometrics, Inc. | 2 | 1991-05-07 |
| Shield Diagnostics, Ltd. | 2 | 1990-12-13 |
| Lipogen, Inc. | 2 | 1989-11-06 |
13 more applicants have LKO clearances. See the full list in Caduvo.
Most recent LKO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K191085 | Genalyte, Inc. | Maverick RNP Assay and Maverick Diagnostic System | 2019-10-25 | 184 |
| K140224 | Euroimmun US | EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) | 2014-12-09 | 314 |
| K123261 | Euroimmun US | EUROIMMUN ANTI-NRNP/SM ELISA (IGG) | 2013-06-12 | 237 |
| K083117 | Phadia US, Inc. | ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01 | 2009-05-28 | 218 |
| K071210 | Biomedical Diagnostics (Bmd) SA | MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 | 2007-12-19 | 232 |
Recalls for LKO devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-10-21.
Frequently asked questions
What is FDA product code LKO?
LKO is the FDA product code for anti-rnp antibody, antigen and control. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel.
What device class is LKO?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKO?
Across 23 cleared submissions the average was 105 days from receipt to decision (median 62).
Which companies have the most LKO clearances?
Euroimmun US (2); Rhigene, Inc. (2); General Biometrics, Inc. (2); Shield Diagnostics, Ltd. (2); Lipogen, Inc. (2).
Have LKO devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-10-21.
Next steps
- Run an FDA pathway report with predicate devices for product code LKO
- Run a recall and safety report across every LKO manufacturer
- Watch product code LKO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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