FDA product code LTT: Panels, Test, Susceptibility, Antimicrobial
LTT is the FDA product code for panels, test, susceptibility, antimicrobial. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 50 510(k) submissions under LTT, 3 in the last five years, from 11 different applicants. The average 510(k) review took 108 days (median 76); 219 days on average over the last three years. 2 PMA applications cite this product code. FDA has posted 13 recalls for LTT devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Panels, Test, Susceptibility, Antimicrobial |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LTT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 127 |
| 2019 | 1 | 91 |
| 2020 | 4 | 75 |
| 2025 | 3 | 219 |
Compare with all 510(k) review times · Search every LTT clearance
Top LTT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 12 | 2025-08-20 |
| Dade Microscan, Inc. | 10 | 2002-06-20 |
| Dade Behring, Inc. | 5 | 2006-10-13 |
| Pasco Laboratories, Inc. | 5 | 2003-04-14 |
| Trek Diagnostic Systems, Inc. | 4 | 2003-03-17 |
6 more applicants have LTT clearances. See the full list in Caduvo.
Most recent LTT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243804 | Beckman Coulter, Inc. | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | 2025-08-20 | 252 |
| K250036 | Beckman Coulter, Inc. | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | 2025-08-15 | 219 |
| K250084 | Beckman Coulter, Inc. | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | 2025-07-18 | 186 |
| K202343 | Beckman Coulter, Inc. | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) | 2020-11-16 | 90 |
| K201423 | Beckman Coulter, Inc. | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) | 2020-06-29 | 31 |
Recalls for LTT devices
13 product recalls in 8 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-09-08.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code LTT?
LTT is the FDA product code for panels, test, susceptibility, antimicrobial. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is LTT?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code LTT?
Across 50 cleared submissions the average was 108 days from receipt to decision (median 76).
Which companies have the most LTT clearances?
Beckman Coulter, Inc. (12); Dade Microscan, Inc. (10); Dade Behring, Inc. (5); Pasco Laboratories, Inc. (5); Trek Diagnostic Systems, Inc. (4).
Have LTT devices been recalled?
Yes: 13 product recalls across 8 recall events; the most recent began 2025-09-08.
Next steps
- Run an FDA pathway report with predicate devices for product code LTT
- Run a recall and safety report across every LTT manufacturer
- Watch product code LTT 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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