LYPHOCHEK COAGULATION CONTROL

K964963 · Bio-Rad · GGN · Feb 20, 1997 · Hematology

Device Facts

• Record ID: K964963
• Device Name: LYPHOCHEK COAGULATION CONTROL
• Applicant: Bio-Rad
• Product Code: GGN · Hematology
• Decision Date: Feb 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended 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.

Indications for Use

Indicated for use as a quality control plasma in clinical laboratories to monitor the precision of citrated coagulation systems, including prothrombin time (PT), activated partial thromboplastin time (APTT), and fibrinogen assays.

Regulatory Classification

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)

Submission Summary (Full Text)

{0}

BIO-RAD
Bio-Rad Laboratories
ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
Telephone [phone]
Toll Free [phone]
FEB 20 1997
K964903

# 510(k) Summary

## Submitter
Bio-Rad Laboratories, ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
[phone]
Fax [phone]

## 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 [phone]

Toll Free [phone]

## 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) |