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The Sensititre® YeastOne® Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of Candida spp. This 510(k) is for Micafungin in the dilution range of 0.008 – 16 µg/ml is intended for testing Candida spp. on the Sensititre® YeastOne® Susceptibility system. The approved primary "Indications for Use" and clinical significance of Micafungin is for: Candida albicans Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis

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The Sensititre® Vizion® is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The "Sensititre® Vizion® is an instrument that takes a digital image of a Sensitities susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Sensititre® Vizion® is an alternate manual reading method for the Sensititre® MIC plates for nonfastidious Gram positive, Gram negative and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae and Streptococci other than S. pneumoniae and Candida spp. NOTE: Please refer to the Sensititre® 18-24 hour MIC or Breakpoint Susceptibility System package insert and the YeastOne package insert for additional instructions, limitations, and references. This 510(k) is for the addition of: "Vizion® for reading Sensititre YeastOne Plates" The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor. The user determines the MIC by visually looking for the color change as indicated in the YeastOne technical insert. The "Vizion" can be used as an alternate method where the user manually reads the MIC result on the Sensititre System.

The Sensititre® Vizion® is an instrument that takes a digital image of a Sensitities susceptibility plate and magnifies it through the use of a dedicated software and a monitor. The Vizione captures an image of a Sensitite 96 well micro-titre susceptibility plate and projects it onto a touch screen monitor.

The Sensititre HP MIC Susceptibility plate with Ceftaroline (0.015-32ug/ml) and the Sensititre 18-24 hour MIC susceptibility System Test Panel with Ceftaroline (0.015-64ug/ml) are intended for use with the Sensititre MIC or BP Susceptibility System. The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates. This 510(k) is for the addition of Ceftaroline in the dilution range of 0.015-32μg/ml to the Sensititre HP MIC Susceptibility plate for testing Haemophilus influenzae and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.015-64μg/ml for testing gram negative isolates. The approved primary "Indications for Use" and clinical significance of Ceftaroline is for: Facultative Gram-negative Microorganisms: Escherichia coli Klebsiella pneumoniae Klebsiella oxytoca Haemophilus influenzae In vitro data, without clinical correlation is provided for: Facultative Gram-Negative Microorganisms: Citrobacter koseri Citrobacter freundii Enterobacter cloacae Enterobacter aerogenes Moraxella catarrhalis Morganella morganii Proteus mirabilis Ceftaroline is not active against Gram negative bacteria producing extended spectrum beta-lactamases (ESBLS) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class 8 metallobeta-lactamases or class C (AmpC cephalosporinases).

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The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram negative organisms. The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious Gram negative organisms. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre® OptiRead™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious Gram positive cocci to include Staphylococcus spp., Enterococcus spp., Streptococcus pneumoniae and, other Streptococcus spp. This 510(k) is for the addition of: "Sensititre® OptiRead™" The Sensititre OptiRead is used to read fluorescence values from the Sensititre MIC or BP Susceptibility Test System for non-fastidious and fastidious Gram positive cocci. The plate reading on the OptiRead is initiated via SWIN software and the fluorescence values from the OptiRead are then transferred back to the SWIN software where the results are generated.

The Sensititre® OptiRead™ is a fluorescence based detection instrument used to read Sensititre® MIC or BP Susceptibility plates.

The Sensititre HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of nonfastidious isolates. This 510(k) is for the addition of Ceftaroline in the dilution range of 0.004-8ug/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 - 24 hour MIC panel in the dilution range of 0.06-64ug/ml for testing gram positive isolates. The organisms which may be used for Ceftaroline susceptibility testing in this panel are: Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus pneumoniae

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The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM™ is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae, other Streptococci spp. and Candida spp.

The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.

The Sensititre® AIM™ is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIMTM is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious gram negative organisms.

The Sensititre AIM™ is a microprocessor controlled instrument that delivers inoculum in 50ul multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.

The Sensititre® Haemophilus influenza/Streptococcus pneumoniae (HP) MIC susceptibility plates and Justone are in vitro diagnostic products for quantitatively and or qualitative susceptibility testing of isolated colonies of Haemophilus influenzae, Streptococcus pneumoniae and Streptococcus species from clinical specimens. Plates can either be read manually or automatically on the Sensititre Autoreader and/or ARIS with Streptococcus pneumoniae and Streptococcus species and manually with H. influenzae. The JustOne® strip can only be read manually. This 510(k) is for the addition of Tigecycline in the dilution range of 0.004 - 8 µg/ml for testing Streptococcus pneumoniae isolates on the Sensititre® (HP) MIC susceptibility system. The additional approved primary "Indications for Use" and clinical significance of Tigecycline is for: Aerobic facultative Gram-positive microorganisms Streptococcus pneumoniae (Penicillin susceptible stains only)

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The Sensitite HP MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of fastidious isolates. The Sensititire 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non fastidious isolates. This 510(k) is for the addition of Telavancin in the dilution range of 0.001-2μg/ml to the Sensititre HP MIC Susceptibility plate for testing Streptococcus spp. and the Sensititre 18 -24 hour MIC panel in the dilution range of 0.03-16μg/ml for testing Gram positive isolates, The approved primary "Indications for Use" and clinical significance of Telavancin is for: Facultative Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus pyogenes Enterococcus faecalis Streptococcus agalactiae Streptococcus anginosus group (includes S. anginosus, S. intermidius, and S. constellatus) In vitro data, without clinical correlation is provided for: Facultative Gram-Positive Microorganisms: Enterococcus faecium (vancomycin-susceptible Isolates only) Staphylococcus haemolyticus Streptococcus dysgalactiae subsp, equisimilis Staphylococcus epidermidis

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