LTT · Panels, Test, Susceptibility, Antimicrobial
Microbiology · 21 CFR 866.1640 · Class 2
Overview
| Product Code | LTT |
|---|---|
| Device Name | Panels, Test, Susceptibility, Antimicrobial |
| Regulation | 21 CFR 866.1640 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 52)
Showing 20 most recent of 52 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) | Beckman Coulter, Inc. | Aug 20, 2025 | SESE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) | Beckman Coulter, Inc. | Aug 15, 2025 | SESE |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) | Beckman Coulter, Inc. | Jul 18, 2025 | SESE |
| K202343 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) | Beckman Coulter, Inc. | Nov 16, 2020 | SESE |
| K201423 | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) | Beckman Coulter, Inc. | Jun 29, 2020 | SESE |
| K193536 | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) | Beckman Coulter, Inc. | Mar 18, 2020 | SESE |
| K193358 | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) | Beckman Coulter, Inc. | Mar 3, 2020 | SESE |
| K183127 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) | Beckman Coulter, Inc. | Feb 12, 2019 | SESE |
| K172337 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) | Beckman Coulter, Inc. | Dec 15, 2017 | SESE |
| K172912 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL) | Beckman Coulter, Inc. | Dec 7, 2017 | SESE |
| K172255 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) | Beckman Coulter, Inc. | Dec 1, 2017 | SESE |
| K162740 | MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) | Beckman Coulter, Inc. | Mar 21, 2017 | SESE |
| K150039 | MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) | Siemens Healthcare Diagnostics, Inc. | Jul 2, 2015 | SESE |
| K131275 | MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS | Siemens Helathcare Diagnostics, Inc. | Nov 8, 2013 | SESE |
| K123933 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE | Siemens Healthcare Diagnostics, Inc. | Mar 14, 2013 | SESE |
| K111394 | MICROSCAN MICROSTEP | Siemens Healthcare Diagnostics, Inc. | Jun 22, 2011 | SESE |
| K091949 | MICROSCAN MICROSTREP PLUS, MODEL B1027-201 | Siemens Healthcare Diagnostics | Jan 26, 2010 | SESE |
| K091264 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017 | Siemens Healthcare Diagnostics | Jul 22, 2009 | SESE |
| K083262 | MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML) | Siemens Healthcare Diagnostics | Feb 18, 2009 | SESE |
| K062773 | MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN | Dade Behring, Inc. | Oct 13, 2006 | SESE |
Top Applicants
- Beckman Coulter, Inc. — 12 clearances
- Dade Microscan, Inc. — 10 clearances
- Pasco Laboratories, Inc. — 6 clearances
- Dade Behring, Inc. — 5 clearances
- Trek Diagnostic Systems, Inc. — 4 clearances
