LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783

K012722 · Bio-Rad · GGN · Sep 18, 2001 · Hematology

Device Facts

• Record ID: K012722
• Device Name: LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
• Applicant: Bio-Rad
• Product Code: GGN · Hematology
• Decision Date: Sep 18, 2001
• 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 human plasma-based quality control material used in clinical laboratories to monitor the precision of coagulation testing systems. The control is provided in a lyophilized form for stability and must be reconstituted before use. It contains purified biochemicals and preservatives but is formulated without constituents of animal origin. Laboratory technicians use the control to verify the performance of coagulation analyzers, such as the MLA ELECTRA series and Dade BBL Fibrometer, by measuring analytes including PT, APTT, Fibrinogen, AT III, and TT. By comparing observed results against expected values, clinicians ensure the accuracy and reliability of patient coagulation testing, thereby supporting informed clinical decision-making regarding patient hemostasis and anticoagulant therapy.

Clinical Evidence

Bench testing only. Stability studies were conducted to validate shelf life (two years at 2-8°C) and open-vial stability (24 hours at 2-8°C) for all analytes (PT, APTT, Fibrinogen, AT III, TT).

Technological Characteristics

Lyophilized human plasma control; contains purified biochemicals and preservatives; animal-origin free. Analytes: PT, APTT, Fibrinogen, AT III, TT. Storage: 2-8°C. Open-vial stability: 24 hours at 2-8°C.

Indications for Use

Indicated for use as a quality control plasma to monitor the precision of citrated coagulation systems for assays including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, Antithrombin III (AT III), and Thrombin Time (TT).

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

• Lyphochek® Coagulation Control (K990858)

Submission Summary (Full Text)

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K012722

Page 1 of 2

# SEP 1 8 2001

Summary of Safety and Effectiveness Lyphochek® Coagulation Control

## 1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 [phone] Telephone: [phone] Fax:

# Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

# Date of Summary Preparation

August 15, 2001

## 2.0 Device Identification

| Product Trade Name: | Lyphochek® Coagulation Control |
|---------------------|--------------------------------|
| Common Name: | Plasma Coagulation Control |
| Classifications: | Class II |
| Product Code: | GGN |
| Regulation Number: | 21 CFR 864.5425 |

# Device to Which Substantial Equivalence is Claimed 3.0

Lyphochek® Coagulation Control Bio-Rad Laboratories Irvine, California

Docket Number: K990858

#### 4.0 Description of Device

Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemical and preservatives. The control is provided in lyophilized form for increased stability.

#### 5.0 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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# Comparison of the new device with the Predicate Device 6.0

The new Lyphochek® Coagulation Control claims substantial equivalence to the Lyphochek® Coagulation Control currently in commercial distribution (K990858). The new Lyphochek® Coagulation Control does not contain constituents of animal origin and the current product does.

| | Table 1. Similarities and Differences between new and predicate device. |
|--|-------------------------------------------------------------------------|
|--|-------------------------------------------------------------------------|

| Characteristics | Bio Rad<br>Lyphochek® Coagulation Control<br>(New Device) | Bio Rad<br>Lyphochek® Coagulation Control<br>(Predicate Device) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Lyphochek® Coagulation Control is<br>intended for use as a quality control<br>plasma to monitor the precision of citrated<br>coagulation systems. | Lyphochek® Coagulation Control is<br>intended for use as a quality control<br>plasma to monitor the precision of citrated<br>coagulation systems. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human plasma | Human plasma |
| Storage<br>(Unopened) | 2-8°C<br>until expiration date | 2-8°C<br>until expiration date |
| Analytes | Prothrombin Time (PT)<br>Activated Partial Thromboplastin Time<br>(APTT), Fibrinogen,<br>Antithrombin II (AT III)<br>Thrombin Time (TT) | Prothrombin Time (PT)<br>Activated Partial Thromboplastin Time<br>(APTT), Fibrinogen,<br>Antithrombin II (AT III)<br>Thrombin Time (TT) |
| Differences | | |
| Open Vial Claim | 24 hours at 2-8°C | 24 hours at 2-25°C |
| Formulation | Does not contain constituents of animal<br>origin | Contain constituents of animal origin |
| Catalog Number | 781, 782, 783 | 787, 788, 789 |
| Fill size | 1 mL | 2 mL |

## 7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Coagulation Control. Product claims are as follows:

- Open vial: Once the control material is reconstituted, all analytes will be stable for 7.1 24 hours when stored tightly capped at 2-8°C
- Shelf Life: Two years when stored at 2-8 °C 7.2
- 7.3 Real time studies will be ongoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its body and wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 8 2001

Ms. Elizabeth Platt Regulatory Affairs Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618

Re: k012722

Trade/Device Name: Lyphochek® Coagulation Control Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN Dated: August 15, 2001 Received: August 15, 2001

Dear Ms. Platt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known): K 01 2722

Lyphochek® Coagulation Control Device Name:

Indications for Use:

Lyphochek® Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.

Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen and Antithrombin III (AT III) are assayed on the MLA ELECTRA series. Thrombin Time (TT) is assayed on the Dade BBL Fibrometer (Becton Dickinson).

(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Prescription use______________________________________________________________________________________________________________________________________________________________

Josephine Battista

Clinical Laboratory Devices

510(k) Number K0/2722