Parsortix® PC1 system

Basic Information

• Brand Name: Parsortix® PC1 system
• Primary DI: 05056364200070
• Version / Model: N/A
• Company Name: ANGLE PLC
• Labeler DUNS: 737269212
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-01
• Public Version: 2
• Public Version Date: 2025-12-23
• Public Version Status: Update
• Public Device Record Key: b477ac0e-a26a-49e4-9bcd-bcd2b6464d7d
• Distribution End Date: 2025-12-22

Device Description

IVD Parsortix® PC1 system, US

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QSA	Circulating Tumor Cell (Ctc) Enrichment Device	Immunology	866.6110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66502	Circulating tumour cell separation system IVD	A collection of devices including an electrically-powered laboratory instrument, microfluidic cassette and control materials, intended to be used to separate and collect circulating tumour cells of a specified size and/or deformity from a whole blood specimen using a mechanical separation method (e.g., microfluidics). The instrument channels the blood specimen through the microfluidic cassette, where the circulating tumour cells are concentrated and contained for subsequent in vitro diagnostic analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05056364200070	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN200062	000