LTT · Class II · 21 CFR 866.1640

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., Dade Microscan, Inc. and Pasco Laboratories, Inc..

50
Total
50
Cleared
108d
Avg days
1995
Since
50 devices
25–48 of 50
Cleared Mar 06, 2003
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K024353
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Jun 20, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
K021184
Dade Microscan, Inc.
Microbiology · 66d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
K021078
Dade Microscan, Inc.
Microbiology · 64d
Cleared Jun 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
K021111
Dade Microscan, Inc.
Microbiology · 62d
Cleared May 17, 2002
MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE
K020939
Dade Microscan, Inc.
Microbiology · 56d
Cleared May 06, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXACIN
K020627
Dade Microscan, Inc.
Microbiology · 69d
Cleared Apr 26, 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
K020626
Dade Microscan, Inc.
Microbiology · 59d
Cleared Mar 14, 2002
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
K020160
Dade Behring, Inc.
Microbiology · 56d
Cleared Nov 20, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013368
Trek Diagnostic Systems, Inc.
Microbiology · 40d
Cleared Nov 07, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
K013195
Trek Diagnostic Systems, Inc.
Microbiology · 43d
Cleared Aug 22, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010418
Dade Behring, Inc.
Microbiology · 191d
Cleared Jul 27, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010159
Dade Microscan, Inc.
Microbiology · 191d
Cleared Apr 24, 2001
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
K011116
Pasco Laboratories, Inc.
Microbiology · 62d
Cleared Apr 23, 2001
PASCO MIC AND MIC/ID PANELS
K010508
Pasco Laboratories, Inc.
Microbiology · 61d
Cleared Jan 09, 2001
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K003619
Dade Microscan, Inc.
Microbiology · 48d
Cleared Aug 04, 2000
PASCO MIC AND MIC/ID PANELS
K001721
Pasco Laboratories, Inc.
Microbiology · 59d
Cleared Dec 02, 1999
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K993102
Dade Microscan, Inc.
Microbiology · 77d
Cleared Dec 18, 1998
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH GREPAFLOXACIN
K983306
Accumed Intl., Inc.
Microbiology · 88d
Cleared Dec 14, 1998
SENSITITRE 19 - 24 HOUR SUSCEPTIBILITY PLATES WITH LEVOFLOXACIN
K983309
Accumed Intl., Inc.
Microbiology · 84d
Cleared Nov 14, 1997
PASCO MIC AND MIC/ID PANELS
K973317
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Oct 10, 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972799
Dade Microscan, Inc.
Microbiology · 74d
Cleared Aug 16, 1996
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K962150
Dade Intl., Inc.
Microbiology · 73d
Cleared Apr 09, 1996
SENSITITRE 18 HOUR SUSCEPTIBILITY PLATES
K960366
Accumed Intl., Inc.
Microbiology · 75d
Cleared Apr 14, 1995
DRIED GRAM-NEGATIVE MIC//COMBO PANELS
K935704
Baxter Diagnostics, Inc.
Microbiology · 500d