FDA product code LTW: Susceptibility Test Cards, Antimicrobial
LTW is the FDA product code for susceptibility test cards, antimicrobial. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 16 510(k) submissions under LTW, from 4 different applicants. The average 510(k) review took 102 days (median 75). 1 PMA application cites this product code. FDA has posted 39 recalls for LTW devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Susceptibility Test Cards, 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 |
Compare with all 510(k) review times · Search every LTW clearance
Top LTW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Austin Biological Laboratories | 11 | 1985-09-16 |
| Analytical Products, Inc. | 3 | 1985-03-26 |
| Microtech Medical Systems, Inc. | 1 | 1985-09-20 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1984-11-07 |
Most recent LTW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K852613 | Microtech Medical Systems, Inc. | MIC-CONCEPT SYSTEM | 1985-09-20 | 93 |
| K853273 | Austin Biological Laboratories | PRECEPT CEFTRIAXONE | 1985-09-16 | 42 |
| K853685 | Austin Biological Laboratories | PRECEPT TM CARBENICILLIN | 1985-09-16 | 178 |
| K853772 | Austin Biological Laboratories | PRECEPT METHICILLIN | 1985-09-16 | 147 |
| K853596 | Austin Biological Laboratories | PRECEPT CEFOPERAZONE | 1985-09-16 | 20 |
Recalls for LTW devices
39 product recalls in 9 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2026-01-05.
| Year | Recalls |
|---|---|
| 2022 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LTW?
LTW is the FDA product code for susceptibility test cards, antimicrobial. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is LTW?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code LTW?
Across 16 cleared submissions the average was 102 days from receipt to decision (median 75).
Which companies have the most LTW clearances?
Austin Biological Laboratories (11); Analytical Products, Inc. (3); Microtech Medical Systems, Inc. (1); Bd Becton Dickinson Vacutainer Systems Preanalytic (1).
Have LTW devices been recalled?
Yes: 39 product recalls across 9 recall events; the most recent began 2026-01-05.
Next steps
- Run an FDA pathway report with predicate devices for product code LTW
- Run a recall and safety report across every LTW manufacturer
- Watch product code LTW 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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