FDA product code LFY: Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
LFY is the FDA product code for enzyme linked immunoabsorbent assay, varicella-zoster. It is a Class II device, regulated under 21 CFR 866.3900 and reviewed by the Microbiology panel. FDA has cleared 17 510(k) submissions under LFY, 1 in the last five years, from 11 different applicants. The average 510(k) review took 181 days (median 139). FDA has posted 4 recalls for LFY devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster |
| Device class | Class II |
| Regulation | 21 CFR 866.3900 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LFY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 182 |
Compare with all 510(k) review times · Search every LFY clearance
Top LFY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 4 | 2007-07-05 |
| DiaSorin, Inc. | 3 | 2023-10-27 |
| Diamedix Corp. | 2 | 1998-09-28 |
| Quest Intl., Inc. | 1 | 1997-11-05 |
| Biowhittaker Molecular Applications, Inc. | 1 | 1996-03-14 |
6 more applicants have LFY clearances. See the full list in Caduvo.
Most recent LFY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K231214 | DiaSorin, Inc. | LIAISON VZV IgG HT, LIAISON Control VZV IgG HT | 2023-10-27 | 182 |
| K150375 | DiaSorin, Inc. | LIAISON VZV IgG, LIAISON Control VZV IgG | 2015-03-11 | 26 |
| K070317 | Zeus Scientific, Inc. | ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM | 2007-07-05 | 153 |
| K061820 | DiaSorin, Inc. | DIASORIN LIAISON VZV IGG | 2007-02-26 | 243 |
| K051484 | Zeus Scientific, Inc. | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. | 2005-12-05 | 182 |
Recalls for LFY devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-11-09.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code LFY?
LFY is the FDA product code for enzyme linked immunoabsorbent assay, varicella-zoster. It is a Class II device, regulated under 21 CFR 866.3900 and reviewed by the Microbiology panel.
What device class is LFY?
Class II, regulation 21 CFR 866.3900. Typical premarket route: 510(k).
How long does a 510(k) take for product code LFY?
Across 17 cleared submissions the average was 181 days from receipt to decision (median 139).
Which companies have the most LFY clearances?
Zeus Scientific, Inc. (4); DiaSorin, Inc. (3); Diamedix Corp. (2); Quest Intl., Inc. (1); Biowhittaker Molecular Applications, Inc. (1).
Have LFY devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2022-11-09.
Next steps
- Run an FDA pathway report with predicate devices for product code LFY
- Run a recall and safety report across every LFY manufacturer
- Watch product code LFY 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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