Duns Number:092815364
Device Description: The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, The Alethia Group B Streptococcus (GBS) assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic for the detection of Streptococcus agalactiae in enriched cultures obtained from vaginal/rectal swab specimens from antepartum women. Enriched cultures are obtained by 18-24 hour incubation of vaginal/rectal swab specimens in selective broth medium, either Lim Broth, TransVag Broth or Carrot Broth.The Alethia GBS assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Streptococcus agalactiae by targeting a segment of the Streptococcus agalactiae genome. Results from the Alethia GBS assay can be used as an aid in establishing the GBS colonization status of antepartum women. This assay does not diagnose or monitor treatment for GBS infections.The Alethia GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.Alethia Group B Streptococcus is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.
Catalog Number
480350
Brand Name
Alethia™ Group B Streptococcus
Version/Model Number
480350
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NJR
Product Code Name
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Public Device Record Key
0ec73687-2948-48c3-a797-73a5e90c91d6
Public Version Date
February 08, 2019
Public Version Number
1
DI Record Publish Date
January 08, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 149 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 46 |
| 3 | A medical device with high risk that requires premarket approval | 1 |