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BK120044 Summary

BKSection 5 - 510(k) Summary

Submitter: Diagnostic Grifols S.A.
PasseigFluvial, 24, Parets del Valles
Barcelona, 08150, Spain
Contact Person: Catherine Wong
Director, Regulatory Affairs
catherine.wong@grifols.com
Phone: (323) 227-7280
Date Prepared: July 24, 2012
Trade Name: Grifols Diluent
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 devices: Micro Typing System, Inc. (Ortho-Clinical Diagnostics) MTS Diluent 2 (BK920013) and MTS Diluent 2 PLUS (BK930030)
Device Description: Grifols Diluent is a low ionic strength buffered solution with EDTA. This diluent contains chloramphenicol and neomycin sulfate as preservatives.
Indications For Use: Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Gel 8 cards.
For in vitro diagnostic use.
Functional and Safety Testing: Not Applicable.
Substantial Equivalence Similarities: Parameter Subject Device
Grifols Diluent
Predicate
MTS Diluent 2
Predicate
MTS Diluent 2
PLUS
Indications for Use Grifols Diluent is for use in preparing human red blood cell suspensions used with the DG Gel 8 cards. MTS Diluent 2 is a red blood cell diluent for exclusive use with tests performed in the IDMicro Typing System.AME MTS Diluent 2 PLUS is a red blood cell diluent for exclusive use with tests performed in the ID-Micro Typing System.
Reagents used For processing techniques using:
Blood Grouping Reagents (Anti-A, Anti-B, Anti-A,B, Anti-D, Anti-K, Anti- C, Anti-E, Anti-c, Anti-e,), Anti-Human Globulin (Anti-IgG) and Neutral gel
For processing techniques using:
Anti-human Globulin (Anti-IgG) and Buffered gel
For processing techniques using:
Blood Grouping Reagents (Anti-A, Anti-B, Anti-A,B, Anti-D, Anti-K, Anti-C, Anti-E, Anti-c, Anti-e,) and Buffered gel
Composition Hypotonic buffered saline solution with preservative SAME SAME
Action This diluent is used to give the appropriate pH and ionic strength. SAME SAME
Storage conditions 2-8ºC SAME SAME
Reagent preparation The diluent is provided ready to use SAME SAME
Substantial Equivalence Differences: Parameter Subject Device
Grifols Diluent
Predicate
MTS Diluent 2
Predicate
MTS Diluent 2
PLUS
Classification Class II; 21 CFR 864.9175 Class II; 21 CFR 864.9600 Class II; 21 CFR 864.9600
Product Code PBC KSG KSG
Common Name Manual Blood Grouping and Test Systems Potentiating media for in vitro diagnostic use Potentiating media for in vitro diagnostic use
Composition Contains EDTA No EDTA Contains EDTA
Preservative Chloramphenicol and neomycin sulfate Trimethoprim and Sulfamethoxazole Trimethoprim and Sulfamethoxazole
Presentation 2 bottles of 100mL 5 bottles of 100mL 5 bottles of 100mL
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 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 Grifols Diluent is substantially equivalent to the predicate devices and has been demonstrated to be a safe and effective product to be marketed in the United States.