BK220753 Summary
BK220753 Summary Diagnostic Grifols, S.A. 510(k) Premarket Notification DG Reader Net
5-1
Section 5 510(k) Summary
Submitter's Details: Name Address Establishment Registration Number: Contact Person:
Date of Summary:
Diagnostic Grifols S.A. Passeig Fluvial, 24, Parets del Valles Barcelona, 08150, Spain 3002772505 Elvira Estapé Egea Regulatory Affairs Manager elvira.estape@grifols.com Phone: (34) 670-922-237 August 3rd, 2022
Name of Device:
Trade Name: Classification Name: Device Class: Product Code: Regulation Number:
DG Reader Net Automated Blood Grouping and Antibody Test System II KSZ 21 CFR 864.9175
Identification of the Legally Marketed Device (Predicated Device):
Trade Name:
DG Reader Net
Classification Name:
Automated Blood Grouping and Antibody Test System
510(k) Number:
BK190379
Device Class:
II
Product Code:
KSZ
Regulation Number: Clearance Letter
21 CFR 864.9175 October 11th, 2019
Device Description:
The DG Reader Net is a workstation especially designed to read the reactions and give the results according to the grading scales as defined in the Instructions for Use of the DG Gel 8 cards, allowing laboratories to:
· Increase process safety and traceability by reducing possible identification and eliminating transcription errors.
· Increase analytical reliability interpreting results with objective criteria.
The DG Reader Net reads and interprets the following gel immunohematology tests: · ABO Red Cell and Serum Grouping. · Rh(D) Typing. · Antigen Typing. · Antibody detection.
Diagnostic Grifols, S.A. 510(k) Premarket Notification DG Reader Net
5-2
· Antibody identification. · Antibody titration. · Direct Antiglobulin test. · Compatibility Tests (Crossmatching).
Indications for Use: The DG Reader Net is a device designed to read, interpret, and report the results of the processed DG Gel 8 cards. The instrument also identifies DG Gel 8 cards by reading their barcodes.
As a stand-alone or interfaced to the customer's Laboratory Information System (LIS), the instrument automates data management requirements using DG Gel 8 cards and digital image processing.
Comparison to Predicate Device:
Parameter
Indications for Use Statement
Classification Product Code Regulation number Common name
Test performed
Predicate Device Diagnostic Grifols S.A. DG Reader Net (BK190379)
General The DG Reader Net is a device designed to read, interpret, and report the results of the processed DG Gel 8 cards. The instrument also identifies DG Gel 8 cards by reading their barcodes.
Subject Device Diagnostic Grifols S.A.
DG Reader Net
The DG Reader Net is a device designed to read, interpret, and report the results of the processed DG Gel 8 cards. The instrument also identifies DG Gel 8 cards by reading their barcodes.
As a stand-alone or interfaced to the customer's Laboratory Information System (LIS), the instrument automates data management requirements using DG Gel 8 cards and digital image processing.
II
KSZ
As a stand-alone or interfaced to the customer's Laboratory Information System (LIS), the instrument automates data management requirements using DG Gel 8 cards and digital image processing.
II
KSZ
21 CFR 864.9175
Automated Blood Grouping and Antibody Test System
- ABO Red Cell and Serum Grouping. - Rh(D) Typing. - Antigen Typing. - Antibody detection. - Antibody identification. - Direct Antiglobulin test. - Compatibility Tests (Crossmatching).
21 CFR 864.9175
Automated Blood Grouping and Antibody Test System - ABO Red Cell and Serum Grouping. - Rh(D) Typing. - Antigen Typing. - Antibody detection. - Antibody identification. - Antibody titration. - Direct Antiglobulin test. - Compatibility Tests (Crossmatching).
Diagnostic Grifols, S.A. 510(k) Premarket Notification DG Reader Net
5-3
Parameter
Useful life
Grifols gel card loading capacity Reading system
Barcode Reading Automated test interpretation
Predicate Device Diagnostic Grifols S.A. DG Reader Net (BK190379) 7 years considering 8 hours a day of continuous operation at maximum throughput (read 12 cards/hour), 250 days a year.
Hardward
1 card
High-resolution color reading using a color CCD camera.
Software Sample Identification Reagent Nº and Expiration Date Yes. According to predefined rules stated in a definition file.
Subject Device Diagnostic Grifols S.A.
DG Reader Net 7 years considering 8 hours a day of continuous operation at maximum throughput (read 12 cards/hour), 250 days a year.
1 card
High-resolution color reading using a color CCD camera.
Sample Identification Reagent Nº and Expiration Date Yes. According to predefined rules stated in a definition file.
Performance: All new risks and hazard analysis related to the addition of the antibody titration technique into the DG Gel System have been performed and documented per ISO 14971 guidelines.
A total of 172 plasma or serum samples containing a known ABO or non-ABO antibody but with unknown titer, were tested with three (3) DG Reader Net and FDA-licensed reagents. DG Gel 8 Anti-IgG (rabbit) and DG Gel 8 Neutral cards were read in parallel, in DG Reader Net (method under validation) and visually by the operator. Afterwards, the obtained titers were compared. The selected plasma or serum samples covered the common blood group antigens (ABO, Rh, K, Kidd, Duffy, MNS, etc.).
The results obtained in the Method Comparison studies supported the conclusion that the semi-automated antibody titration using the DG Reader Net was equivalent to the manual DG Gel 8 titration technique, up to a titer of 64 (higher titers are considered not reached in DG Reader Net).
Conclusions: Diagnostic Grifols S.A. concludes, based on all the information submitted and discussed in this submission and in this summary that DG Reader Net, when used for the defined indications for use, performs as well as or better than the legally marketed predicate device DG Reader Net (BK190379). In addition, all the requirements for a product to be marketed in the United Stated has been demonstrated.