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Vaccines, Blood & Biologics

BK120043 Summary

Section 5 - 510(k) Summary

Submitter: Diagnostic Grifols S.A.
PasseigFluvial, 24, Parets del Valles
Barcelona, 08150, Spain
Contact Person: Catherine Wong
Director, Regulatory Affairs
Phone: (323) 227-7280
Date Prepared: July 20, 2012
Trade Name: DG Gel 8 Neutral
Classification: Class II
Manual Blood Grouping and Test Systems
21 CFR 864.9175
Product Code: PBC
Predicate Device: The subject device is substantially equivalent to the following device: Micro Typing System, Inc. (Ortho-Clinical Diagnostics) MTS Buffered Gel Card (BK920016)
Device Description: DG Gel 8 Neutral card consists of a plastic support with eight microtubes containing gel in a buffered medium.
The microtubes, without antibodies, are used in techniques where antibodies react directly with the red blood cells.
Indications For Use: The DG Gel 8 Neutral card is used for the detection of antibodies to red blood cell antigens in human blood samples.
For use with the DG Gel system.
For in vitro diagnostic use.
Functional and Safety Testing: Not Applicable.
Substantial Equivalence Similarities: Similarities
Parameter Subject Device
DG Gel 8 Neutral
MTS Buffered Gel Card
Indications for Use For the detection of antibodies to red blood cells SAME
Techniques For determination of ABO Reverse group SAME
For antibody testing (For cold, room temperature, 37ºC and enzyme treated red blood cells) (including ABO Compatibility tests) SAME
Composition Gel in buffered medium with sodium azide as a preservative SAME
Principle of the test The test is based on the immunohematology gel technique described by Yves Lapierre. SAME
Storage conditions 2-25ºC SAME
Reagent preparation The gel card is provided ready to use. SAME
Substantial Equivalence Differences: Parameter Subject Device
DG Gel 8 Neutral
MTS Buffered Gel Card
Classification Class II; 21 CFR 864.9175 Class II; 21 CFR 864.9285
Product Code PBC KSN
Common Name Manual Blood Grouping and Test Systems Centrifuge, cell-washing, automated for immunohematology
Number of microtubes 8 6
Note: All the 510(k)s , i.e., DG Therm incubator, DG Spin centrifuge, DG Gel 8 Neutral Gel Card, and Grifols Diluent, are submitted as a test system under Product Code "PBC" for Manual Blood Grouping and Test Systems under the regulation 21 CFR 864.9175.
Performance: All required performance tests have been conducted with acceptable results. All performance comparison studies in this submission have demonstrated the device is safe and effective.
Conclusion: Grifols concludes, based on all information submitted and discussed in this submission and in this summary that DG Gel 8 Neutral is substantially equivalent to the predicate device and has been demonstrated to be a safe and effective product to be marketed in the United States.

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