FDA product code LLL: Extractable Antinuclear Antibody, Antigen And Control
LLL is the FDA product code for extractable antinuclear 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 182 510(k) submissions under LLL, 5 in the last five years, from 45 different applicants. The average 510(k) review took 110 days (median 76); 246 days on average over the last three years. FDA has posted 4 recalls for LLL devices.
Classification
| Field | Value |
|---|---|
| Device name | Extractable Antinuclear 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 LLL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 73 |
| 2019 | 1 | 255 |
| 2023 | 1 | 711 |
| 2025 | 2 | 224 |
| 2026 | 2 | 267 |
Compare with all 510(k) review times · Search every LLL clearance
Top LLL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 37 | 2023-09-29 |
| Hemagen Diagnostics, Inc. | 16 | 1995-06-05 |
| Diamedix Corp. | 10 | 1998-04-23 |
| Hycor Biomedical, Inc. | 10 | 1997-03-07 |
| Immco Diagnostics, Inc. | 8 | 2015-03-31 |
40 more applicants have LLL clearances. See the full list in Caduvo.
Most recent LLL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253817 | Immunodiagnostics Systems Limited | IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La | 2026-08-21 | 266 |
| K253367 | Phadia AB | EliA CTD 13 Screen | 2026-06-25 | 268 |
| K250666 | Zeus Scientific | Alegria Flash CTD Screen | 2025-10-22 | 231 |
| K250408 | Zeus Scientific | Alegria Flash ENA Screen | 2025-09-19 | 218 |
| K213403 | Inova Diagnostics, Inc. | Aptiva CTD Essential Reagent | 2023-09-29 | 711 |
Recalls for LLL devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-08-06.
Frequently asked questions
What is FDA product code LLL?
LLL is the FDA product code for extractable antinuclear 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 LLL?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code LLL?
Across 182 cleared submissions the average was 110 days from receipt to decision (median 76).
Which companies have the most LLL clearances?
Inova Diagnostics, Inc. (37); Hemagen Diagnostics, Inc. (16); Diamedix Corp. (10); Hycor Biomedical, Inc. (10); Immco Diagnostics, Inc. (8).
Have LLL devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2012-08-06.
Next steps
- Run an FDA pathway report with predicate devices for product code LLL
- Run a recall and safety report across every LLL manufacturer
- Watch product code LLL 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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