Duns Number:464176127
Device Description: The A1AT Genotyping Test uses Polymerase Chain Reaction (PCR) amplification to obtain larg The A1AT Genotyping Test uses Polymerase Chain Reaction (PCR) amplification to obtain large amounts of the target sequences in the serpin peptidase inhibitor class A member 1 (SERPINA1) gene. The A1AT Genotyping Test relies on allele-specific probes attached to color-coded microspheres, which hybridize specifically to the labeled PCR products. A subsequent fluorescent labeling step allows detection and quantification of the hybridization signal. A1AT Genotyping Test generates a simultaneousmultiplex reaction in a single well, avoiding the need to run separate methods in parallel. The software outcome is allelic variant genotypes and associated alleles. A1AT genotyping Test simultaneously detects and identifies 14 allelic variants and their associated alleles found in the Alpha-1 antitrypsin (A1AT) codifying gene SERPINA1. The test is intended for use with genomic DNA extracted from human whole blood samples collected as dry blood spots (DBS) or in EDTA. The A1AT allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with A1AT deficiency (A1ATD).
Catalog Number
1291780000
Brand Name
A1AT Genotyping Test
Version/Model Number
v1
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
K171868
Product Code
PZH
Product Code Name
Serpina1 Variant Detection System
Public Device Record Key
135856eb-d7f8-4cb2-a91a-23de7e237cfa
Public Version Date
December 17, 2018
Public Version Number
1
DI Record Publish Date
November 15, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| 3 | A medical device with high risk that requires premarket approval | 1 |