Section 5 - 510(k) Summary
|Submitter:||Diagnostic Grifols S.A. |
PasseigFluvial, 24, Parets del Valles
Barcelona, 08150, Spain
|Contact Person:||Joaquín Alberto Tamaprillas |
Phone: (34) 670-924-623
|Date Prepared:||August 26, 2013|
|Trade Name:||WADiana® Compact|
|Classification:||Class II |
Automated Blood Grouping and Antibody Test System
21 CFR 864.9175
|Predicate Device:||The subject device is substantially equivalent to the following device: Micro Typing System, Inc. (Ortho-Clinical Diagnostics) ORTHO ProVueTM Analyzer (BK110029).|
|Device Description:||WADiana® Compact Analyzer is a fully automated analyzer designed to automated in vitro immunohematological testing of human blood utilizing the DG Gel 8 cards technology, including Blood Group and antigen Typing, Antibody Screening, Antibody Identification, Compatibility Tests and Direct Antiglobulin Tests. |
The WADiana® Compact Analyzer consist of the following primary components:
The WADiana® Compact Analyzer is designed to be used with DG Gel® 8 cards and Grifols Diluent, and Grifols Medion Red Blood Cells.
|Indications For Use:||WADiana® Compact Analyzer is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing the DG Gel® 8 cards technology. As a standalone or interfaced to the customer's Laboratory Information System (LIS), the WADiana® Compact Analyzer automates test processing functions and data management requirements using DG Gel® 8 cards and digital image processing.|
|Functional and Safety Testing:||To verify that the device design met its functional and performance requirements, a representative sample of the device underwent software and system verification and validation testing and electrical testing. A risk analysis was performed per ISO 14971.|
|Substantial Equivalence Similarities:||Parameter||Predicate Device Micro Typing Systems Inc. ORTHO ProVueTM Analyzer*||Subject Device Diagnostic Grifols S.A. WADiana® Compact Analyzer|
|Indications for Use Statement||The ORTHO ProVueTM Analyzer is a modular, microprocessor-controlled instrument designed to automate in vitro immunohematological testing of human blood utilizing the ID-MTS Gel Card technology. As a standalone or interfaced to the customer's Laboratory Information System (LIS), the ORTHO ProVueTM Analyzer automates test processing functions and data management requirements using gel cards and digital image processing.||WADiana® Compact Analyzer is a fully automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing the DG Gel® 8 cards technology. As a standalone or interfaced to the customer's Laboratory Information System (LIS), the WADiana® Compact Analyzer automates test processing functions and data management requirements using DG Gel® 8 cards and digital image processing.|
|Regulation Number||21 CFR 864.9175||Same|
|Common name||Automated Blood Grouping and Antibody Test System||Same|
|Tests Performed||Blood Group and Rh(D) |
Direct Antiglobulin Test
(using gel card technology)
|Primary components||Analyzer |
Hand-held bar code reader
|Specimen Types||Plasma, Serum and Red Blood Cells||Same|
|Capability to process STAT samples||Yes||Same|
|QC procedures implemented||Yes||Same|
|Barcode Reading||Sample Identification Reagent Lot No. and Expiration Date||Same|
|Manual Entry of Sample IDs or Reagent Data||Requires Double Blind Entry||Same|
|Sample Loading Random Access||Yes||Same|
|Sample loading capacity||48 tubes simultaneously; 1 carousel||Same|
|Sample Barcode Type||Code 128 |
Mod 11, Mod 16
Code 3 of 9.
Code 2 of 5
|Reagent positions||18 positions (16 for Reagent Red Blood Cells and 2 for Diluents); 1 carousel||Same|
|Reagent Red Cell Suspension||Maintained by Rotation Movement||Same|
|Sample/Reagent Dispensing (pipetting) Unit (Substance collection and dispensing into the microtubes)||Single probe to dispense samples and reagents||Same|
|Card loading capacity||24 cards||Same|
|Card Transport System||Yes||Same|
|Incubator||Two independent temperature areas that can be set up independently at 37ºC or 24ºC.||Same. However the incubator temperature tolerance is different.|
|Centrifuge||1 Centrifuge; 12 cards capacity.||Same|
|Dispense Verification||Yes. After card processing, by image analysis.||Same|
|Results reading||Yes. Microtube Digital Image Analysis.||Same. Same charged-coupleddevices (CCD) and software algorithms. Only the image acquisition .board is different and the software parameters have been specifically set to read DG Gel cards.|
|Test interpretation||Yes. According to predefined rules stated in a definition file (specific for MTS Gel System).||Same. However interpretation rules are specific for DG Gel® 8 System.|
|Reports||Batch listing, Listing by Batch and Results by sample reports||Same|
|System solutions and waste containers||Wash Solution A |
Wash Solution B
Processed cards disposal
|Same. Same wash solutions composition although marketed under different names.|
|Total speed||22 samples (ABO/Rh cards) per hour, including forward & reverse group||Same|
|Interfaces||Bidirectional with Laboratory Information System||Same|
|Useful life||5 years minimum considering a normal function of 160 cards/day and 250 days/year||Same|
|*Diagnostic Grifols, S.A is the contract manufacturer of the ORTHO ProVueTM Analyzer, being Micro Typing System, Inc. (Ortho-Clinical Diagnostics) the Specifications Developer.|
|Substantial Equivalence Differences:||Parameter||Predicate Device Micro Typing Systems Inc. ORTHO ProVueTM Analyzer||Subject Device Diagnostic Grifols S.A. WADiana® Compact Analyzer|
|Reagents||Ortho ProVueTM is used with MTS gel cards and Ortho Clinical Diagnostic reagents and diluents.||WADiana® Compact is used with DG Gel® 8 cards, Medion Grifols Diagnostics Reagent Red Blood Cells and Grifols Diluent|
|Imbalance detection system||The instrument includes an imbalance detection system that detects when the centrifuge is imbalanced.||The imbalance detection system was found redundant and is not used. To avoid unexpected vibrations, the centrifuge is automatically loaded to guarantee a symmetrical distribution of the gel cards. If needed to ensure symmetrical loads, an unprocessed gel card is used. |
No safety concerns are raised as the instrument complies with the appropriate safety standards.
|Computer||A general purpose computer meeting the required specifications can be used||WADiana® Compact is supplied with an industrial computer Matrox 4Sight|
|Image acquisition board||The image acquisition board is the Meteor II/ Standard.||The image acquisition board is the Matrox Morphis Dual PCI-104 (the Meteor II/Standard is now obsolete).|
|Material of the probe wash station||The material of the probe wash station is polysulfone.||The material of the probe wash station is peek. The peek material is stronger than the polysulfone material.|
|Incubator Temperature Tolerance||Incubator temperature specification at 37 ºC is ±2ºC||Incubator temperature specification at 37 ºC is ±1ºC to meet the requirements of the DG Gel® 8 cards. |
To achieve ±1ºC the incubator electronic board was modified.
|Motor driver||The motor driver is the HTCL1100.||The motor driver is the HTCL1101 (the HTCL1100 is now obsolete).|
|Operating system||The operating systems supported by the software are the Windows 2000 Professional with Service Pack 2 or the Windows XP Professional with Service Pack 3.||The industrial computer includes the operating system Windows XP Embedded customized by Diagnostic Grifols. The software supports this operating system.|
|Centrifuge speed||The centrifuge speed is 1000 rpm to meet the requirements of the MTS gel cards||The centrifuge speed is 1228 rpm to meet the requirements of the DGGel® 8 cards.|
|Centrifugation time||The centrifugation time is 600 s to meet the requirements of the MTS gel cards||The centrifugation time is 540 s to meet the requirements of the DGGel 8 cards|
|Results||Mixed field result are reported as dp (double population)||Mixed field results are reported as mf (Mixed Fields)|
|The selectable result w+ (weak positive) is not available.||The selectable result w+ (weak positive) is available, in accordance with the DG Gel® 8 package insert.|
|Extra volume||The reagent extra volume aspirated by the probe is a fixed value.||To save reagent, the reagent extra volume aspirated by the probe is variable and its value depends on the volume required for the number of samples.|
|Test scripts||Test scripts are specific for the Ortho ProVueTM and are requested based on the market needs||Test scripts are specific for the WADiana® Compact and are requested based on the market needs|
|Reading sensitivity value||The reading sensitivity value is 100. This is the appropriate value to read reaction patterns in MTS 8 cards.||The reading sensitivity value is 98. This is the appropriate value to read reaction patterns in DG Gel® 8 cards.|
|Performance:||All required software and system verification procedures have been executed and analyzed with acceptable results. |
All risk and hazard analysis have been performed and documented per ISO 14971 guidelines. All electrical safety testing has been performed by a NRTL according to the applicable safety standards
The results of the Clinical Trials supported the conclusion that the WADiana® Compact with its DG Gel® 8 cards and Medion Grifols Diagnostics Reagent Red Blood Cells is safe and effective and yielded equivalent results to FDA licensed reagents and cleared instruments. More than 7,200 individual unique specimens representing diverse population groups in broad geographic areas and composed of approximately 70% hospital patients and 30% blood donors were successfully tested.
For the Blood Grouping Reagents (Anti-A, Anti-B, Anti-A,B, Anti-D, Anti-C, Anti-E, Anti-c, Anti-e and Anti-K), the lower confidence bounds (estimated with a level of confidence of 95%) for the Positive Percent Agreement and Negative Percent Agreement obtained by pooling all the microtubes, exceeded the 99%
For the Neutral Gel microtubes (ABO Compatibility and Reverse Grouping with A1, B and A2 cells), the lower confidence bounds (estimated with a level of confidence of 95%) calculated by pooling all the results exceeded the 99% for the Negative Percent Agreement and the 98% for the Positive Percent Agreement. However, both the Positive Percent Agreement and the Negative Percent Agreement obtained for the Reverse Grouping with cells A1 and B only, exceeded the 99%.
For the Anti-Human Globulin (Ab. Screening, Ab. Identification, Crossmatch and DAT), the lower confidence bound (estimated with a level of confidence of 95%) calculated by pooling all the results exceeded the 93% for the Positive Percent Agreement and the 90% for the Negative Percent Agreement. Several causes contributed to obtain percentages of agreement slightly lower. The study included a high percentage of samples with weak antibodies and there were frozen thawed samples with potential quality issues. Also a high percentage of samples with multiple antibodies or additional unexpected antibodies and the bias towards the gel only detected antibodies that could not be detected by the tube LISS manual Comparative Method contributed to lower the percentages of agreement
In particular, for the DAT, WADiana® Compact performed testing as well as the Comparative Method. The discrepant results could be true gel DATs due to the potential greater sensitivity of the gel method that could not be confirmed or they could indicate sample quality issues or were obtained for very weak samples.
While the number of discrepancies was higher than expected, this was mainly due to either the liminations of the Comparative Method, or due to the complex and challenging samples included in the study. Additionally, some failures for reagents were attributable to the challenges of large volume manual Comparative Method testing where the technician made errors in set up or data entry.
The Clinical Studies demonstrated that in a variety of clinical settings the laboratory personnel with varying backgrounds and experience could be trained to use the system correctly and produce reliable results comparable to those obtained using FDA licensed reagents and cleared instruments"
In addition each of the three (3) Clinical Study Sites was assigned to perform reproducibility studies.
The study was done using the same Reproducibility Panel shipped to the three (3) Clinical Study sites in accordance to the following profile: 1 lot of test cards x 3 sites x 5 days (during 20 days) x 2 runs (am/pm) x 2 replicates using the WADiana® Compact at each site.
The study demonstrates that WADiana® Compact consistently obtained the expected results in all the repetitions
|Conclusion:||Diagnostic Grifols S.A. concludes, based on all information submitted and discussed in this submission and in this summary, that the WADiana® Compact Analyzer is substantially equivalent to the predicate device and has been demonstrated to meet all requirements for a product to be marketed in the United States.|