AccessGUDID - DEVICE: Idylla™ MSI Test (15415219000758)

GUDID

Device Identifier (DI) Information

Brand Name: Idylla™ MSI Test
Version or Model: 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Biocartis NV

Primary DI Number: 15415219000758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 400686169 *Terms of Use

Device Description: The Idylla MSI Test, for use on the Idylla System, uses formalin-fixed, paraffin embedded (FFPE) tissue sections of human CRC tumor, from which nucleic acids are liberated, then analyzed using PCR amplification of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) and subsequent melt-curve analysis. The Idylla MSI Test reports results as either microsatellite stable (MSS), or microsatellite instability high (MSI-H) or invalid.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60202	Microsatellite instability IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for determining microsatellite instability [abnormal repeated sequences of deoxyribonucleic acid (DNA)] within a tumour tissue specimen, using a nucleic acid technique (NAT). This phenomenon which is associated with defective DNA mismatch repair genes is a feature of certain cancer types including hereditary nonpolyposis colon cancer (HNPCC).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZJ	Lynch Syndrome Test System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211181	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 63928393-c368-4a96-a344-1dfedde40b5f
Public Version Date: May 11, 2023
Public Version Number: 1
DI Record Publish Date: May 03, 2023