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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
Generic NameSusceptibility test cards, antimicrobial
ApplicantBiomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood, MO 63042
PMA NumberN50510
Supplement NumberS139
Date Received04/12/2000
Decision Date06/26/2000
Reclassified Date12/28/2001
Product Codes LON LTW 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC TRIMETHOPRIM/SULFAMETHOXAZOLE AT CONCENTRATIONS OF 2/38, 8/152, 16/304 AND 32/608 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO TRIMETHOPRIM/SULFAMETHOXAZOLE IN THE RANGE OF <=0.5/9.5 TO >=16/304
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