← Product Code [GGP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP) · K964459 # UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA (K964459) _Universal Reagents, Inc. · GGP · Dec 18, 1996 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K964459 ## Device Facts - **Applicant:** Universal Reagents, Inc. - **Product Code:** [GGP](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP.md) - **Decision Date:** Dec 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.7290 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use Factor deficient plasma, Factor - X 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 - X is human plasma immunodepleted of Factor X; used in clinical laboratories for in vitro diagnostic quantitative determination of Factor X levels via clotting assay. Device aids diagnosis of congenital or acquired Factor X deficiency. Product supplied frozen or lyophilized; used with various instruments and reagents per manufacturer instructions. Safety profile includes donor screening negative for HIV 1/2, HBsAG, HCV, and HIV-1ag, with factor deficiency <1% and no inhibitors present. ## Clinical Evidence Bench testing only; performance verified by comparing assay results to known samples. ## Technological Characteristics Human plasma immunodepleted of Factor X; contains various buffers. Supplied frozen or lyophilized. Compatible with various coagulation instruments and reagents. No software or electronic components. ## Predicate Devices - Sigma - Factor X ([K843310](/device/K843310.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 DEC 18 1996 # Non-Confidential Summary of Safety and Effectiveness November 1, 1996 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 - X **Common/Usual Name:** Qualitative and Quantitative Factor Deficiency Test - X **Classification Name:** Qualitative and Quantitative Factor Deficiency Test **Intended device:** Factor deficient coagulation plasma - X **Predicate devices:** Sigma - K843310 - Factor X **Device description:** Factor deficient plasma to be free of antigen of Factor X utilized in *in vitro* diagnostic use. **Intended use:** Indicated use - Factor deficient plasma, Factor - X 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 | Sigma | | --- | --- | --- | | 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 | page 3 of 34 {1} page 4 of 34 # Non-Confidential Summary of Safety and Effectiveness (continued) November 1, 1996 page 2 of 2 ## Comparison to predicate devices: (continued) | Attribute | Intended products | Sigma | | --- | --- | --- | | Design | | | | 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 | | 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 | | Donor criteria | | | | 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/GGP/K964459](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GGP/K964459) **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