(71 days)
Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
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.
The provided text is a 510(k) summary for a medical device called "Lyphochek Coagulation Control." This document describes a quality control product used to monitor the precision of coagulation systems, not a diagnostic or AI-powered device.
Therefore, the information requested in your prompt (such as acceptance criteria, details of a study on device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable to this type of document or device.
The document focuses on demonstrating substantial equivalence to a predicate device based on intended use, form, matrix, storage, open vial stability, and assay claims, which are typical for a quality control product submission.
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Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black background. The text is bold and sans-serif.
Bio-Rad
Laboratories
ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
Telephone (714) 630-6400
Toll Free (800) 854-6737
FEB 20 1997
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.
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black rounded rectangle. The text is "BIO-RAD" with a plus sign between "BIO" and "RAD".
Bio-Rad
Laboratories
ECS Division 3726 E. Miraloma Avenue naheim, 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 LyphochekCoagulation Control | Pacific HemostasisThromboScreen CoagulationControl Plasma | |
|---|---|---|
| IntendedUse | A quality control plasma tomonitor the precision ofcitrated coagulationsystems. | A control in prothrombin timeand partial thromboplastintime determinations |
| Form | Lyophilized | Lyophilized |
| Matrix | Human plasma | Human Plasma |
| Storage | 2 - 8°C | 2 - 8°C |
| Open Vial | 16 hours at 2-25°C | 8 hours at 2-8°C |
| Claim | ||
| Levels | Level 1, 2 and 3 | Level 1, 2 and 3 |
| Assays | prothrombin time (PT),activated partialthromboplastin time (APTT),fibrinogen (Level 1) | prothrombin time (PT),activated partialthromboplastin time (APTT),fibrinogen (Level 1) |
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
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.(b)
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.