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The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Cefdinir in the dilution range of 0.06 - 64 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "Indications for Use" and the clinical significance of Cefdinir is unknown when evaluating Enterobacteriaceae or any other non-fastidious gram negative rods. In vitro data, without clinical correlation is provided for Citrobacter diversus, Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis. Cefdinir is inactive against Pseudomonas and Enterobacter species.

Susceptibility Test Panel

The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Grepafloxacin in the difution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. There are no approved primary "indications for use" and the clinical significance of Grepafloxacin is unknown when evaluating Enterobacteriaceae, Pseudomonas, or any other non-fastidious gram negative rods.

Susceptibility Test Panel

The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Sparfloxacin in the dilution range of 0.002 - 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates. Organisms indicated for testing in the approved FDA Sparfloxacin package insert include Enterobacter cloacae and Klebsiella pneumoniae.

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The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Levofloxacin in the dilution range of 0.004 - 8 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing non-fastidious gram negative isolates.

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The Sensititre 18 hour MIC or Breakpoint Susceptibility system is an in vitro diagnostic product for clinical susceptibility testing of gram negative and gram positive organisms. This 510(k) is for the addition of Trovafloxacin in the dilution range of 0.002 -- 4 ug/ml to the Sensititre 18 - 24 hour MIC panel for testing gram negative isolates.

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The new TracCell™ 2000 Slide Mapping System is intended as a computeraided Slide Mapping System integrated to an automated optical microscope workstation (AccuMed International's AcCell™ Workstation). The TracCell™ 2000 Slide Mapping System is used to map adequately stained. well-preserved. cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. In addition to the present intended use as cleared by FDA, the new TracCell™ 2000 Slide Mapping System can be used for the purposes of mapping Cytyc ThinPrep® specimens. The mapping of the slide into ìpresentedî and iexcludedî fields of view is performed by segmenting the light-absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation. - 1. All cellular material within the expanded cell deposition area, comprising the standard cellular deposition area, and a narrow bleed zone immediately surrounding it, will be presented for human screening, using the minimum number of fields-of-view. - 2. All adequately stained, well preserved cells located in the annular ring, the area lying between the expanded cellular deposition area, and the imprinted boundary area and the imprinted boundaries of the slide, will be included in additional fields-of-view presented for human screening. The mapping of a Cytyc Thin Prep™ specimen is carried out in precisely the same manner as the predicate TracCell 2000 Slide Mapping System. The mapping of the slide in presented and excluded fields-of view, is performed by segmenting the light absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation. These techniques are identical to the predicate TracCell 2000™.

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The Sensititre AP90 panel is an in vitro diagnostic product intended to be used in conjunction with the Sensititre system for the automated identification of clinically significant gram positive organisms. This 510(k) is for gram positive identification.

The Sensititre AP90 panel is an in vitro diagnostic product. The panel has a 4 by 8 layout of reagents repeated 3 times across the plate. Reagents include UREA, ESCULIN, ARGININE, FR13, FR16, RHAMNOSE, FR15, MANNITOL, FR14, TREHALOSE, FR17, MALTOSE, FR18, FR19, FR20, FR21, FR22, FR23, GLYCEROL, FR24, FR25, GLUCOSE, SUCROSE, FR26, FR27, B-METHYL GLUCOSIDE, FR28, FR29, SORBITOL, FR30, FR32, FR31. FR indicates Fluorescent reagent. The Urease test requires an oil overlay.

TracCell™ 2000 System is intended as a computer-aided optical microscope system used to map adequately stained, well-preserved, cervical cytology preparations that have been prepared using a Papanicolaou or Pap-like stained protocol. The mapping of the slide into "presented" and "excluded" areas is performed by segmenting the light-absorbing objects from background material based upon standard image processing techniques for efficient presentation to a cytotechnologist or cytopathologist for diagnostic interpretation.

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The ESP Culture System II - Myco is an automated system for the growth and detection of -mycobacteria from human specimens, including the use of nucleic acid probes for the direct confirmation of positive ESP - myco bottles.

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