FACTOR DEFICIENT PLASMA

{0} UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014 OCT 10 1996 K961929 # Non-Confidential Summary of Safety and Effectiveness May 15, 1996 page 1 of 3 Universal Reagents, Inc. 2858 N. Pennsylvania St. Indianapolis, IN 46205 Tel - (317) 926-0006 Fax - (317) 926-0014 **Official contact:** Jorge Miller, Director, Coagulation Products **Proprietary or Trade Name:** Factor deficient coagulation plasma - II, V, VII, VIII, IX, X, XI, XII **Common/Usual Name:** Factor deficient coagulation plasma - II, V, VII, VIII, IX, X, XI, XII **Classification Name:** Factor deficient coagulation plasma **Intended device:** Factor deficient coagulation plasma - II, V, VII, VIII, IX, X, XI, XII **Predicate devices:** Behring Factor Deficient Plasmas - K924394 - Factor V, K924396 - Factor VIII, IX, XI, XII K924400 - Factor II, VII, X and Medical Diagnostics Technologies - K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, K893533 - Factor V, K893534 - Factor XII, K893535 - Factor VII, K893536 - Factor XI, K900133 - Factor II. **Device description:** Factor deficient plasma to be free of antigen of Factor II, V, VII, VIII, IX, X, XII, XII, respectively, utilized in *in vitro* diagnostic use. **Intended use:** Indicated use - Factor deficient plasma, Factor - II, V, VII, VIII, IX, X, XI, XII, is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay. Factor VIII is human plasma and bovine material. **Environment of use -** Hospital, laboratories page 3 of 25 {1} page 4 of 25 # Non-Confidential Summary of Safety and Effectiveness (continued) May 15, 1996 page 2 of 3 ## Comparison to predicate devices: (continued) | Attribute | Intended products | Behring | Medical Diagnostics Technologies | | --- | --- | --- | --- | | Use | | | | | Indicated for use in determination of coagulation of plasma | Yes | Yes | Yes | | In vitro diagnostic use | Yes | Yes | Yes | | Used as a quantitative assay | Yes | Yes | Yes | | Design | | | | | Factor deficient plasmas offered - II, V, VII, VIII, IX, X, XI, XII | Yes | Yes | Yes | | Packaging either - Frozen or Dry / lyophilized | Yes | Yes | Yes | | Can be used with different instruments and reagents per manufacturer instructions | Yes | Yes | Yes | | Materials | | | | | Donor human plasma | Yes | Yes | Yes | | Bovine enhanced factor VIII | Yes | Yes | Yes | | Various buffers | Yes | Yes | Yes | | Performance Testing | | | | | Compare assay to known sample | Yes | Yes | Yes | | Negative by FDA approved test for HIV 1/2 and HBsAG | Yes | Yes | Yes | {2} page 5 of 25 # Non-Confidential Summary of Safety and Effectiveness (continued) May 15, 1996 page 3 of 3 ## Comparison to predicate devices: (continued) | Attribute | Intended products | Behring | Medical Diagnostics Technologies | | --- | --- | --- | --- | | Performance Testing (continued) | | | | | Negative by FDA approved test for HCV and HIV-1ag | Yes | not known | not known | | Donor criteria | | | | | Deficiency of relevant factor less than 1% | Yes | not know | Yes | | Negative for HIV and HBsAG | Yes | Yes | Yes | | Negative for HCV, HIV-1ag | Yes | not known | not known | | No inhibitor present | Yes | not known | Yes | ## B. Differences The only difference is that the intended products are claimed to be negative for HCV and HIV-1ag by an FDA approved test. Any differences that do exist would not have a significant effect on the safety or effectiveness of the device.