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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 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® 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 "Sensititre® 18 - 24 hour MIC or Breakpoint Susceptibility System" is an in vitro diagnostic product for clinical susceptibility testing of gram positive and gram negative organisms. This 510(k) is for addition of Minocycline in the dilution range of 0.03 - 32μg/ml for testing gram negative and gram positive isolates on the Sensititre® 18 - 24 hour Susceptibility system. The approved primary "Indications for Use" and clinical significance of Minocycline is for: Aerobic and facultative Gram-negative and Gram-positive microorganisms: Escherichia coll Klebsiella spp. Enterobacter aerogenes Acinetobacter spp. Staphylococcus aureus* *Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.

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The Sensititre® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility plate is and I he Sellstitle= Huemophilus influence&oldid=918888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888888 Streptococcus species. This 510(k) is for the addition of Streptococcus spps to cefepime (0.12 - 8 ug/mL), ceftrianone (0.06-2 I I IIIS SIV(K) is for the addition of Shippoooooal vipps Sensitite® Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC Susceptibility Plates . oneumonde (HF) MIC Susceptionity Frates - Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes With activity against: Streptococcus agalactiae " " Sheptococcas agatachas for use" and clinical significance of ceftriaxone is for Viridans group streptococci. Streptococcus pneumoniae, Streptococcus pyogenes The following in vitro data are available but their clinical significance is unknown: Streptococcus agalactiae " "Streptococcas ugadestions for use" and clinical significance of chloramphenicol is for: Streptococcus pneumoniae Streptococcus spp.

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The Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate is an in vitro diagnostic product for clinical susceptibility testing of Haemophilus/Streptococcus pneumoniae. The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive organisms. This 510(k) is for the addition of Telithromycin in the dilution range of 0.002-16µg/ml to the Sensititre Haemophilus/Streptococcus pneumoniae (HP) MIC Susceptibility plate for testing Haemophilus/Streptococcusion pneumoniae and the Sensititre 18 - 24 hour MIC panel for testing gram positive isolates. The approved primary "Indications for Use" and clinical significance for Telithromycin is for: Streptococcus_pneumoniae (including multi-drug resistant isolates [MDRSP]), Haemophilus influenzae, and Staphylococcus aureus (methicillin and erythromycin susceptible isolates only). In vitro data, without clinical correlation is provided for: Streptococcus pyogenes(erythromycin susceptible isolates only).

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