← Product Code [GJT](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT) · K970593 # UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA (K970593) _Universal Reagents, Inc. · GJT · Apr 25, 1997 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K970593 ## Device Facts - **Applicant:** Universal Reagents, Inc. - **Product Code:** [GJT](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT.md) - **Decision Date:** Apr 25, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.7290 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use Factor deficient plasma, Factor - VIII 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. ## Device Story Factor deficient coagulation plasma - VIII is human plasma immunodepleted of Factor VIII antigen. Used in clinical laboratories by technicians to perform clotting assays for quantitative determination of Factor VIII levels. Device aids in diagnosing congenital or acquired coagulation protein deficiencies. Product supplied frozen or lyophilized; utilizes donor human plasma, enhanced bovine factor V, and buffers. Performance verified via assay comparison to known samples; safety ensured by testing negative for HIV 1/2, HBsAG, HCV, and HIV-1ag. ## Clinical Evidence Bench testing only. Performance verified by comparing assay results to known samples. Safety validated by testing negative for HIV 1/2, HBsAG, HCV, and HIV-1ag using FDA-approved methods. Deficiency of Factor VIII confirmed at less than 1%. ## Technological Characteristics Human plasma immunodepleted of Factor VIII; contains enhanced bovine factor V and various buffers. Supplied in frozen or lyophilized form. Compatible with various coagulation instruments and reagents per manufacturer instructions. ## Predicate Devices - OTC Factor VIII ([K823453](/device/K823453.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} UNIVERSAL REAGENTS, INC. 2858 North Pennsylvania Street Indianapolis, Indiana 46205 PHONE: (317) 926-0015 FAX: (317) 926-0014 K970593 APR 25 1997 # Non-Confidential Summary of Safety and Effectiveness February 17, 1997 page 1 of 2 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 - VIII **Common/Usual Name:** Qualitative and Quantitative Factor Deficiency Test - VIII **Classification Name:** Qualitative and Quantitative Factor Deficiency Test **Intended device:** Factor deficient coagulation plasma - VIII **Predicate devices:** OTC Factor VIII - K823453 **Device description:** Factor deficient plasma to be free of antigen of Factor VIII utilized in *in vitro* diagnostic use. **Intended use:** Indicated use - Factor deficient plasma, Factor - VIII 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. **Environment of use:** Clinical laboratories **Comparison to predicate devices:** | Attribute | Intended product | OTC | | --- | --- | --- | | Use | | | | Indicated for use in determination of coagulation of plasma | Yes | Yes | | In vitro diagnostic use | Yes | Yes | | Used as a quantitative assay | Yes | Yes | | Design | | | | Factor VIII deficient plasma offered | Yes | Yes | page 3 of 36 {1} page 4 of 36 # Non-Confidential Summary of Safety and Effectiveness (continued) February 17, 1997 page 2 of 2 ## Comparison to predicate devices: (continued) | Attribute | Intended products | OTC | | --- | --- | --- | | Packaging either - Frozen or Dry / lyophilized | Yes | Yes | | Can be used with different instruments and reagents per manufacturer instructions | Yes | Yes | | Materials | | | | Donor human plasma | Yes | Yes | | Enhanced bovine factor V | Yes | Yes | | Various buffers | Yes | Yes | | Performance Testing | | | | Compare assay to known sample | Yes | Yes | | Negative by FDA approved test for HIV 1/2 and HBsAG | Yes | Yes | | Negative by FDA approved test for HCV and HIV-1ag | Yes | not known | | Deficiency of relevant factor less than 1% | Yes | not known | | Negative for HIV and HBsAG | Yes | Yes | | Negative for HCV, HIV-1ag | Yes | not known | | No inhibitor present | Yes | not known | ## Differences The only difference is that the intended product is claimed to be negative for HCV and HIV-1ag by an FDA approved test. Any other differences that do exist would not have a significant effect on the safety or effectiveness of the device. --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K970593](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJT/K970593) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com