FDA product code LSW: Anti-Dna Antibody, Antigen And Control
LSW is the FDA product code for anti-dna 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 8 510(k) submissions under LSW, from 7 different applicants. The average 510(k) review took 152 days (median 111). FDA has posted 1 recall for LSW devices.
Classification
| Field | Value |
|---|---|
| Device name | Anti-Dna 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 LSW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 197 |
Compare with all 510(k) review times · Search every LSW clearance
Top LSW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aesku Diagnostics | 2 | 2008-05-13 |
| Aesku.Diagnostics GmbH & Co. KG | 1 | 2018-02-16 |
| Inova Diagnostics, Inc. | 1 | 2016-04-11 |
| Phadia US, Inc. | 1 | 2007-12-07 |
| Biomedical Diagnostics (Bmd) SA | 1 | 2006-05-02 |
2 more applicants have LSW clearances. See the full list in Caduvo.
Most recent LSW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172348 | Aesku.Diagnostics GmbH & Co. KG | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | 2018-02-16 | 197 |
| K152013 | Inova Diagnostics, Inc. | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | 2016-04-11 | 265 |
| K081251 | Aesku Diagnostics | MODIFICATION TO AESKULISA DS DNA G | 2008-05-13 | 11 |
| K072393 | Phadia US, Inc. | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | 2007-12-07 | 102 |
| K060380 | Biomedical Diagnostics (Bmd) SA | FIDIS DSDNA | 2006-05-02 | 77 |
Recalls for LSW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-12-14.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code LSW?
LSW is the FDA product code for anti-dna 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 LSW?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code LSW?
Across 8 cleared submissions the average was 152 days from receipt to decision (median 111).
Which companies have the most LSW clearances?
Aesku Diagnostics (2); Aesku.Diagnostics GmbH & Co. KG (1); Inova Diagnostics, Inc. (1); Phadia US, Inc. (1); Biomedical Diagnostics (Bmd) SA (1).
Have LSW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-12-14.
Next steps
- Run an FDA pathway report with predicate devices for product code LSW
- Run a recall and safety report across every LSW manufacturer
- Watch product code LSW 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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