Search Results

The APAS Independence is an in vitro diagnostic system comprised of an instrument for automated imaging of agar plates and a software analysis module for the following uses: 1. The APAS Independence, when using its IC MRSA Chromogenic BD Analysis Module, automates culture plate imaging and interpretation to detect the presence of colonies with colors suggestive of methicillin-resistant Staphylococcus aureus (MRSA) growth on Beckton Dickinson BBL™ CHROMagar™ MRSA II agar that has been inoculated with anterior nares swabs and incubated at 36°C ± 1°C for 24 hours. The APAS Independence, when using its IC MRSA Chromogenic BD Analysis Module, provides an aid in routine screening for colonization with MRSA. It provides one of two screening results: Presumptive MRSA or Negative. All culture plates that are identified as Presumptive MRSA by the APAS Independence, when using the IC MRSA Chromogenic BD Analysis Module require review by a trained microbiologist. 2. The APAS Independence, when using its IC MRSA Chromogenic TFS/S Analysis Module, automates culture plate imaging and interpretation to detect the presence of colonies with colors suggestive of methicillin-resistant Staphylococus aureus (MRSA) growth on Thermo-Fisher Spectra™ MRSA agar that has been inoculated with anterior nares swabs and incubated at 36°C ± 1°C for 24 hours. The APAS Independence, when using its IC MRSA Chromogenic TFS/S Analysis Module, provides an aid in routine screening for colonization with MRSA. It provides one of three screening results: Presumptive MRSA, Presumptive non-MRSA, or Negative. All culture plates that are identified as Presumptive MRSA or Presumptive non-MRSA by the APAS Independence, when using the IC MRSA Chromogenic TFS/S Analysis Module, require review by a trained microbiologist.

APAS Independence is a device designed to be used in a microbiology laboratory to automate the initial screening of specimens for the presence of growth on culture plates. It is an in vitro diagnostic device and has no direct contact with patients. The APAS Independence consists of an automated plate handling mechanism to move culture plates through the instrument, an imaging station to capture images of culture plates, and software for image analysis (e.g., determination of growth) and presentation of reports. The APAS Independence is intended to be installed with multiple software (analysis) modules, each of which will provide an assessment of growth for a specific clinical indication. More than one analysis module may be developed for the same indication to allow APAS to assess growth on culture plates from multiple agar manufacturers sold for the same indications. This submission includes two MRSA analysis modules that have been developed for the same indication, which is to be used in a microbiology laboratory to automate the initial screening for the presence of presumptive methicillin-resistant Staphylococcus aureus (MRSA) growth on culture plates. It is indicated for the screening of MRSA colonization from swabs, where a specimen is collected from the anterior nares by non-invasive sampling techniques and plated onto specified chromogenic MRSA agars. No quantification of growth is required. APAS Independence with IC MRSA Chromogenic BD Analysis Module is designed to interpret growth on BBL™ CHROMagar™ MRSA II agar from Becton Dickinson, and APAS Independence with IC MRSA Chromogenic TFS/S Analysis Module is designed to interpret growth on Spectra™ MRSA agar from Thermo Fisher Scientific (Remel).

The APAS Independence is an in vitro diagnostic system comprised of an instrument and software analysis module(s) for specific indications that are used to automate imaging and interpretation of microbial colonies on plates of solid culture media. The APAS Independence, when using its urine analysis module, automates urine culture plate imaging and interpretation to detect the presence or absence of microbial growth on sheep blood and MacConkey agar culture plates that are inoculated with a 1µL sample volume. The APAS Independence, when using its urine analysis module, provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Independence, when using its urine analysis module, must be reviewed by a trained microbiologist.

APAS Independence with Urine Analysis Module is a device designed to be used in a microbiology laboratory to automate the initial screening for the presence of growth on urine culture plates. It is an in vitro diagnostic device and has no direct contact with patients. APAS Independence consists of an automated plate handling mechanism to move the plates through the instrument, an imaging station to capture an image of the culture plate, combined with software for analysis of the image, determination of growth and presentation of reports. The APAS Independence with Urine Analysis Module is intended to determine whether growth is present or not, and to provide a semi-quantitative assessment of the colony count (if present). This information will then be combined with other available clinical information to screen out biological samples without growth. All other plates will be presented to a microbiologist for examination, determination of status and further testing according to conventional laboratory practice. This enables the microbiologist to focus on plates with potentially significant growth, thereby reducing the time until results can be reported. The APAS Independence is intended to have different software modules, each of which will provide an assessment of growth for specific clinical indications. This submission covers only the APAS Independence with Urine Analysis Module. The APAS Independence with Urine Analysis Module is indicated for screening of culture plates for assessment of urinary tract infections where the urine specimens are collected and 1μl is plated onto Blood and MacConkey Agars and incubated at 35±2°C for 18 to 22 hours.

The APAS Compact is an in vitro diagnostic system comprised of an instrument for automated imaging of agar culture plates and a software analysis module for the following use: The APAS Compact, when using its urine analysis module, automates urine culture plate imaging and interpretation to detect the presence of microbial growth on sheep blood and MacConkey agar culture plates that are inoculated with a 1uL sample volume. The APAS Compact, when using its urine analysis module, provides a semiquantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist.

The APAS Compact with Urine Analysis Module is an instrumented system that is designed for screening of urine culture plates for the presence of microbial growth. The device comprises an imaging station for capture of digital images of the culture plates, together with software for analysis of the images, the determination and enumeration of microbial growth and reporting of results.