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BK120022 510(k) SUMMARY


 

3    510(k) SUMMARY

3.1     Applicant Information

Owner’s Name:               Noel Brown

Address:                       Hemo bioscience Inc.
                                  801 Capitola Drive
                                  Suite 9
                                  Durham, NC 27713
                                  Telephone: (919) 313-2888
                                  Fax:  (919) 313-2894
                                  Email: n.brown@hemobioscience.com

Contact Person:             Noel Brown
                                  President
                                  Telephone: (919) 313-2888
                                  Fax:  (919) 313-2894
                                  Email: n.brown@hemobioscience.com

Date Summary was Prepared:             04/24/2012                             

Device Information

Trade Name:                C3 Control Cells

Common Name:           C3 Complement Coated Control Cells

Classification Name:     Quality Control for Blood Banking Reagents       

  1. FR 864.9650, Class II, Product Code KSF)

3.3    Predicate Device  

The American National Red Cross-DMD “Control Cells” (Common name: IgG coated red blood cells). The 510(k) cleared under BK090021 for use as a control for the anti globulin test.

Performance Standard

No US standard of potency exists. Hemo bioscience performs lot release using --(b)(4)-
poly AHG anti-IgG,-C3d; ---(b)(4)--- poly AHG anti- IgG,-C3d; ---(b)(4)-- IgG anti-IgG; (b)(4) C3d AHG anti-C3d.

3.5   Device Description

C3 Control Cells is a single 3 mL fill in a 5 mL vial of group O red blood cells coated with C3b (C3c/C3d) and suspended in a preservative diluent.  These red blood cells have been manufactured and prepared at a hematocrit of 2 to 4%.

 The diluent is a buffered alsevers solution containing chloramphenicol ---(b)(4)---, neomycin sulfate ---(b)(4)--- and --------(b)(4)---------- as preservatives.

Intended Use

Hemo bioscience C3 Control Cells are used as a control of the antiglobulin test performed with Anti-Human Globulin containing anti-C3.

Summary of Technological Characteristics

Red blood cells coated with C3b (C3c/C3d) are added to the AHG containing anti-C3.  The red blood cells agglutinate confirming that active anti-C3 is present in the test system and that neutralization of the AHG has not occurred.

The C3 Control Cells and the predicate device are identical in intended use as a control for AHG test and in mode of use.

Summary of Performance Study

Verification of performance for the new device consisted of determining whether reactivity with a range of anti-C3 AHG‘s was acceptable as defined as achieving a reaction strength of 1+ or greater.

Hemo bioscience performed a study in-house and also conducted external evaluations in three hospital blood bank laboratories.

In conclusion these studies demonstrate that C3 Control Cells performance is acceptable for use as a control in the direct and indirect anti-human globulin tests.

Summary of C3 Control Cells Stability Study

The C3 Control Cells stability study was conducted over a period of time with different batches of C3 Control Cells manufactured by Hemo bioscience.

The study was performed by adding control red blood cells coated with C3b (C3c/C3d) directly to an anti-human globulin reagent in an appropriately marked tube, centrifuged and read for macroscopic agglutination. The tubes were then incubated for 5 min at RT and again read for agglutination.  A series of anti-human globulin reagents from different manufacturers were used.

Conclusion

The above mentioned studies confirm the satisfactory performance of the C3 Control Cells and their suitability as a control reagent. They also demonstrate that the C3 Control Cells are substantially equivalent to the predicate device (ARC-DMD Control Cells) for their intended use.