FDA product code LKP: Anti-Sm Antibody, Antigen And Control
LKP is the FDA product code for anti-sm 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 28 510(k) submissions under LKP, from 22 different applicants. The average 510(k) review took 99 days (median 62). FDA has posted 1 recall for LKP devices.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Sm 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 LKP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 54 |
| 2021 | 1 | 352 |
Compare with all 510(k) review times · Search every LKP clearance
Top LKP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phadia AB | 2 | 2021-07-14 |
| Bio-Rad | 2 | 2003-01-15 |
| Quest Intl., Inc. | 2 | 1998-06-15 |
| General Biometrics, Inc. | 2 | 1991-05-07 |
| Shield Diagnostics, Ltd. | 2 | 1990-12-07 |
17 more applicants have LKP clearances. See the full list in Caduvo.
Most recent LKP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202067 | Phadia AB | EliA SmDP-S | 2021-07-14 | 352 |
| K183007 | Phadia AB | EliA SmDP Immunoassay | 2018-12-24 | 54 |
| K132631 | Phadia US, Inc. | EIA SMDP IMMUNOASSAY | 2014-08-29 | 372 |
| K123593 | Inova Diagnostics, Inc. | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, | 2013-04-17 | 147 |
| K051066 | Theratest Laboratories, Inc. | THERATEST EL-ANA PROFILES | 2005-10-07 | 164 |
Recalls for LKP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-12-28.
Frequently asked questions
What is FDA product code LKP?
LKP is the FDA product code for anti-sm 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 LKP?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code LKP?
Across 28 cleared submissions the average was 99 days from receipt to decision (median 62).
Which companies have the most LKP clearances?
Phadia AB (2); Bio-Rad (2); Quest Intl., Inc. (2); General Biometrics, Inc. (2); Shield Diagnostics, Ltd. (2).
Have LKP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-12-28.
Next steps
- Run an FDA pathway report with predicate devices for product code LKP
- Run a recall and safety report across every LKP manufacturer
- Watch product code LKP 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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