FDA product code LSR: Reagent, Borrelia Serological Reagent
LSR is the FDA product code for reagent, borrelia serological reagent. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel. FDA has cleared 112 510(k) submissions under LSR, 6 in the last five years, from 42 different applicants. The average 510(k) review took 177 days (median 130); 227 days on average over the last three years. FDA has posted 5 recalls for LSR devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Borrelia Serological Reagent |
| Device class | Class II |
| Regulation | 21 CFR 866.3830 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for LSR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 168 |
| 2018 | 3 | 157 |
| 2019 | 4 | 88 |
| 2020 | 3 | 90 |
| 2021 | 6 | 144 |
| 2022 | 1 | 226 |
| 2023 | 1 | 106 |
| 2024 | 1 | 315 |
| 2025 | 2 | 174 |
| 2026 | 1 | 191 |
Compare with all 510(k) review times · Search every LSR clearance
Top LSR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 12 | 2019-07-29 |
| Gold Standard Diagnostics | 9 | 2021-03-22 |
| Viramed Biotech AG | 7 | 2022-08-19 |
| Mardx Diagnostics, Inc. | 6 | 1996-06-07 |
| DiaSorin, Inc. | 4 | 2021-02-18 |
37 more applicants have LSR clearances. See the full list in Caduvo.
Most recent LSR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254295 | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | 2026-07-10 | 191 |
| K252627 | Inanovate, Inc. | Lyme-ID IgG Test; Bio-ID800 | 2025-11-14 | 86 |
| K242872 | Id-Fish Technology, Inc. | iDart Lyme IgM ImmunoBlot Kit | 2025-06-12 | 262 |
| K233367 | Id-Fish Technology, Inc. | iDart Lyme IgG ImmunoBlot Kit | 2024-08-12 | 315 |
| K230863 | Zeus Scientific | ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit | 2023-07-13 | 106 |
Recalls for LSR devices
5 product recalls in 4 recall events; 1 initiated in the last five years and 3 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2021 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LSR?
LSR is the FDA product code for reagent, borrelia serological reagent. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel.
What device class is LSR?
Class II, regulation 21 CFR 866.3830. Typical premarket route: 510(k).
How long does a 510(k) take for product code LSR?
Across 112 cleared submissions the average was 177 days from receipt to decision (median 130).
Which companies have the most LSR clearances?
Zeus Scientific, Inc. (12); Gold Standard Diagnostics (9); Viramed Biotech AG (7); Mardx Diagnostics, Inc. (6); DiaSorin, Inc. (4).
Have LSR devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LSR
- Run a recall and safety report across every LSR manufacturer
- Watch product code LSR 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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