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510(k) Data Aggregation
K Number
K173903Device Name
Granada Medium
Manufacturer
Hardy Diagnostics
Date Cleared
2018-03-22
(90 days)
Product Code
PQZ, POZ
Regulation Number
866.2360Why did this record match?
Product Code :
PQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Granada Medium is a selective and differential agar which is intended for the qualitative detection of Group B Streptococus (GBS) from LIM Broth enrichment cultures of vaginal/rectal swabs from antepartum women following 18-24 hours of incubation.
Recovery of orange colored colonies on Granada Medium is a positive result for presence of β-hemolytic GBS. Results can be interpreted after 18-24 hours of anaerobic incubation. Due to the properties of Granada Medium, white colonies recovered on Granada Medium must undergo additional testing to confirm absence of GBS colonies must be performed for conducting susceptibility testing as recommended for penicillin- allergic women. A lack of growth or the absence of orange colonies on Granada Medium does not presence of GBS. Granada Medium is not intended to diagnose infection, or to guide or monitor treatment for infections.
Device Description
Hardy Diagnostics Granada Medium agar utilizes the Granada reaction and contains the necessary components for pigment detection of beta-hemolytic GBS. The production of a light orange to dark orange pigmented colony is a unique characteristic of hemolytic GBS on Granada Medium due to a reaction with substrates such as starch, peptone, serum, and folate pathway inhibitors.
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K Number
K170586Device Name
Strep B Carrot Broth One-Step
Manufacturer
Hardy Diagnostics
Date Cleared
2017-05-22
(83 days)
Product Code
PQZ, POZ
Regulation Number
866.2360Why did this record match?
Product Code :
PQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Strep B Carrot Broth™ One-Step is a selective and differential medium which is intended for the detection of Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women. The color change reaction from white to orange is representative of a positive result for presence of GBS. The medium requires 24 hours of incubation but positive results can be interpreted as early as 16 hours. Due to the properties of Strep B Carrot Broth™ One-Step, non-hemolytic GBS cannot be detected by the medium's color change and require subculture for identification. Any presumptive negative indicated by lack of color change at the incubation period must be subcultured to a non-selective medium (e.g. Tryptic Soy Agar with 5% Sheep Blood) to confirm absence of GBS. Subculture must also be performed to recover isolates for conducting susceptibility testing as recommended for penicillin-allergic women.
Device Description
Strep B Carrot Broth™ One-Step is a selective and differential medium with selective components designed to enrich for Group B Streptococci. The production of a light orange, or red-orange pigment is a unique characteristic of hemolytic GBS due to reaction with substrates such as starch, peptone, serum, and folate pathway inhibitors. GBS detection with Strep B Carrot Broth™ One-Step is only possible with β-hemolytic Group B Streptococci colonies, providing evidence of a direct genetic linkage between pigment production in this media and hemolysin production. Non-hemolytic GBS can be recovered from Strep B Carrot Broth™ One-Step upon subculture to 5% sheep blood agar plates.
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K Number
K170481Device Name
Strep B Carrot Broth Kit
Manufacturer
Hardy Diagnostics
Date Cleared
2017-05-16
(89 days)
Product Code
PQZ, POZ
Regulation Number
866.2360Why did this record match?
Product Code :
PQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Strep B Carrot Broth™ Kit is a selective and differential medium which is intended for the detection of Group B Streptococus (GBS) from anovaginal specimens collected from pregnant women. The medium is used as an aid in the qualitative determination of GBS colonization in pregnant women. The color change reaction from white to orange is representative of a positive result for presence of GBS. The medium requires 24 hours of incubation but positive results can be interpreted and reported as early as 16 hours. Due to the properties of Strep B Carrot Broth™ Kit, non-hemolytic GBS cannot be detected by the medium's color change and require subculture for identification. Any presumptive negative indicated by lack of color change at the end of the incubation period must be subcultured to a non-selective medium (e.g., Tryptic Soy Agar with 5% Sheep Blood) to confirm absence of GBS. Subculture must also be performed to recover isolates for conducting susceptibility testing as recommended for penicillin-allergic women.
Device Description
Strep B Carrot Broth™ is a selective and differential medium with selective components designed to enrich for Group B Streptococci. The production of a light orange, or red-orange pigment is a unique characteristic of β-hemolytic GBS due to reaction with substrates such as starch, and folate pathway inhibitors. GBS detection by color with Strep B Carrot Broth™ is only possible with β-hemolytic Group B Streptococci colonies, which provides evidence of a direct genetic linkage between pigment production in this media and hemolysin production. Non-hemolytic GBS can be recovered Strep B Carrot Broth™ upon subculture to 5% sheep blood agar plates.
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K Number
K163042Device Name
chromID Strepto B agar
Manufacturer
bioMerieux, Inc.
Date Cleared
2017-01-27
(88 days)
Product Code
PQZ, POZ
Regulation Number
866.2360Why did this record match?
Product Code :
PQZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
chromID® Strepto B agar is a selective chromogenic medium that is intended to aid in the qualitative determination of Group B Streptococcus (GBS) colonization in pregnant women. This medium supports the growth of, but does not differentiate between, hemolytic and non-hemolytic GBS strains. The test is performed on 18-24 hour LIM broth enrichments of vaginal/rectal swabs obtained from pregnant women. chromID® Strepto B agar results can be interpreted after 24 hours incubation with confirmation of characteristic GBS colonies from the media.
chromID® Strepto B agar is not intended to diagnose infection nor to guide or monitor treatment for infections. chromID® Strepto B agar does not provide susceptibility results. Subculture to non-selective media should be performed as needed for susceptibility testing. chromID® Strepto B agar is intended for use by laboratory health practitioners in a clinical laboratory.
Device Description
chromID Strepto B agar consists of a nutritive base combining different peptones, chromogenic substrates and antibiotics. These components enable the screening of S. agalactiae by the spontaneous appearance of pale pink to red colonies. Most other bacterial species and yeasts do not grow on this medium or do not produce typical colonies.
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