FDA Product Code LTT: Panels, Test, Susceptibility, Antimicrobial
Under FDA product code LTT, antimicrobial susceptibility test panels are cleared for the determination of minimum inhibitory concentrations in clinical microbiology.
These multi-well panels contain dilution series of multiple antibiotics used in broth microdilution testing to determine the MIC of each antibiotic against a clinical isolate, providing quantitative susceptibility data for antibiotic dosing and stewardship decisions.
LTT devices are Class II medical devices, regulated under 21 CFR 866.1640 and reviewed by the FDA Microbiology panel.
Leading manufacturers include Beckman Coulter, Inc. and Dade Behring, Inc..
50
Total
50
Cleared
108d
Avg days
1995
Since
Growing category -
3 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
219d
recently vs 101d historically
FDA 510(k) Cleared Panels, Test, Susceptibility, Antimicrobial Devices (Product Code LTT)
50 devices
Cleared
Aug 20, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
Beckman Coulter, Inc.
Microbiology
252d
Cleared
Aug 15, 2025
MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)
Beckman Coulter, Inc.
Microbiology
219d
Cleared
Jul 18, 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
Beckman Coulter, Inc.
Microbiology
186d
Cleared
Nov 16, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
Beckman Coulter, Inc.
Microbiology
90d
Cleared
Jun 29, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
Beckman Coulter, Inc.
Microbiology
31d
Cleared
Mar 18, 2020
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
Beckman Coulter, Inc.
Microbiology
89d
Cleared
Mar 03, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
Beckman Coulter, Inc.
Microbiology
90d
Cleared
Feb 12, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
Beckman Coulter, Inc.
Microbiology
91d
Cleared
Dec 15, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
Beckman Coulter, Inc.
Microbiology
135d
Cleared
Dec 07, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)
Beckman Coulter, Inc.
Microbiology
73d
Cleared
Dec 01, 2017
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
Beckman Coulter, Inc.
Microbiology
128d
Cleared
Mar 21, 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
Beckman Coulter, Inc.
Microbiology
172d
Cleared
Oct 13, 2006
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
Dade Behring, Inc.
Microbiology
25d
Cleared
Oct 10, 2006
MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN
Dade Behring, Inc.
Microbiology
22d
Cleared
Feb 25, 2004
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
Dade Behring, Inc.
Microbiology
68d
Cleared
Mar 14, 2002
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
Dade Behring, Inc.
Microbiology
56d
Cleared
Aug 22, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
Dade Behring, Inc.
Microbiology
191d
About Product Code LTT - Regulatory Context
510(k) Submission Activity
50 total 510(k) submissions under product code LTT since 1995, with 50 receiving FDA clearance (average review time: 108 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - LTT Product Code
Recent submissions under LTT have taken an average of 219 days to reach a decision - up from 101 days historically. Manufacturers should account for longer review timelines in current project planning.
LTT devices are reviewed by the Microbiology panel. Browse all Microbiology devices →