← Product Code [GGN](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN) · K964963 # LYPHOCHEK COAGULATION CONTROL (K964963) _Bio-Rad · GGN · Feb 20, 1997 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K964963 ## Device Facts - **Applicant:** Bio-Rad - **Product Code:** [GGN](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN.md) - **Decision Date:** Feb 20, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5425 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems. ## Device Story Lyphochek Coagulation Control is a lyophilized human plasma-based quality control product; contains added constituents of non-human origin and purified biochemicals. Used in clinical laboratory settings by technicians to monitor precision of citrated coagulation systems. Product is reconstituted and analyzed alongside patient samples in PT, APTT, and fibrinogen assays. Provides three levels of control to verify assay performance; helps ensure accuracy and reliability of coagulation testing; aids in identifying potential system errors or reagent degradation. ## Clinical Evidence Bench testing only. Comparison of technological characteristics and intended use provided to demonstrate equivalence to predicate device. ## Technological Characteristics Lyophilized human plasma matrix with added non-human constituents and purified biochemicals. Storage at 2-8°C. Three levels provided. Compatible with PT, APTT, and fibrinogen assays. ## Regulatory Identification A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays. ## Special Controls *Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. ## Predicate Devices - ThromboScreen Coagulation Control Plasma ([K820450](/device/K820450.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} BIO-RAD Bio-Rad Laboratories ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737 FEB 20 1997 K964903 # 510(k) Summary ## Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 (714)630-6400 Fax (714)666-1383 ## Contact Person Elizabeth Platt ## Date of Summary Preparation November 27, 1996 ## Device (Trade & Common Name) Lyphochek Coagulation Control ## Classification Name Class II, 81GGN CFR 864.5425: Plasma Coagulation Control ## Devices to Which Substantial Equivalence is Claimed - ThromboScreen Coagulation Control Plasma - Pacific Hemostasis - K820450 ## Statement of Intended Use Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems. 37 {1} BIO-RAD Bio-Rad Laboratories ECS Division 3726 E. Miraloma Avenue Anaheim, CA 92806 Telephone (714) 630-6400 Toll Free (800) 854-6737 ## Description of the Device Lyphochek Coagulation Control is prepared from human plasma with added constituents of non-human origin and purified biochemicals. The control is provided in lyophilized form for increased stability. ## Statement of How Technological Characteristics Compare to Substantial Equivalence Device A table is provided below comparing the similarities between the Bio-Rad Lyphochek Coagulation Control and the devices to which substantial equivalence is claimed. | | Bio-Rad Lyphochek Coagulation Control | Pacific Hemostasis ThromboScreen Coagulation Control Plasma | | --- | --- | --- | | Intended Use | A quality control plasma to monitor the precision of citrated coagulation systems. | A control in prothrombin time and partial thromboplastin time determinations | | Form | Lyophilized | Lyophilized | | Matrix | Human plasma | Human Plasma | | Storage | 2 - 8°C | 2 - 8°C | | Open Vial Claim | 16 hours at 2-25°C | 8 hours at 2-8°C | | Levels | Level 1, 2 and 3 | Level 1, 2 and 3 | | Assays | prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Level 1) | prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen (Level 1) | --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K964963](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K964963) **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