LYPHOCHEK HEMOSTASIS, MODELS 798, 799

K020878 · Bio-Rad · GGC · Apr 15, 2002 · Hematology

Device Facts

• Record ID: K020878
• Device Name: LYPHOCHEK HEMOSTASIS, MODELS 798, 799
• Applicant: Bio-Rad
• Product Code: GGC · Hematology
• Decision Date: Apr 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Lyphochek® Hemostasis Control is a lyophilized, human plasma-based quality control product used in clinical coagulation laboratories. It contains various biochemical analytes, including PT, APTT, Fibrinogen, Antithrombin III, Thrombin Time, and various clotting factors. The control is reconstituted by laboratory personnel and used to monitor the precision of laboratory testing procedures. By comparing the measured values of the control against expected ranges, clinicians and laboratory technicians verify the accuracy and reliability of their diagnostic testing equipment. This process ensures that patient test results are consistent and reliable, ultimately supporting accurate clinical decision-making for patients undergoing coagulation testing.

Clinical Evidence

No clinical data. Performance is supported by bench testing, specifically stability studies confirming reconstituted stability (8 hours at 2-25°C, except Protein S at 2-8°C) and shelf life (3 years at 2-8°C).

Technological Characteristics

Lyophilized human plasma-based control containing purified biochemicals and preservatives. Dimensions/form factor: Reconstituted liquid. Storage: 2-8°C. Analyte list includes PT, APTT, Fibrinogen, AT III, TT, Factors II, V, VII, VIII, IX, X, XI, XII, Protein S, Protein C, and Plasminogen.

Indications for Use

Indicated for use as a quality control plasma to monitor the precision of laboratory testing procedures for analytes listed in the package insert. No specific patient population, age, or gender is defined as the device is a laboratory control product.

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

• Coagulation S.A.C Assayed Control 1 (K941737)
• Coagulation S.A.C Assayed Control 2 (K941872)

Submission Summary (Full Text)

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K020878

Page 1 of 2

## Summary of Safety and Effectiveness Lyphochek® Hemostasis Control

APR 1 5 2002

#### 1.0 Submitter

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

## Contact Person

Maria Zeballos Regulatory Affairs Specialist Telephone: [phone]

### Date of Summary Preparation

March 15, 2002

#### 2.0 Device Identification

| Product Trade Name: | Lyphochek® Hemostasis Control |
|---------------------|--------------------------------------------------|
| Common Name: | Control Plasma Normal<br>Control Plasma Abnormal |
| Classifications: | Class II |
| Product Code: | GGC |
| Regulation Number: | 21 CFR 864.5425 |

#### 3.0 Device to Which Substantial Equivalence is Claimed

Coagulation S.A.C Assayed Control 1 Helena Laboratories Beaumont, Texas

Docket Number: K941737

Coaqulation S.A.C Assayed Control 2 Helena Laboratories Beaumont, Texas

Docket Number: K941872

#### 4.0 Description of Device

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

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#### Statement of Intended Use 5.0

Lyphochek® Hemostasis Control is intended for use as a quality control plasma to Eyphooner - Fromootable aboratory analytes listed in the package insert.

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

Lyphochek® Hemostasis Control claims substantial equivalence to the Coagulation S.A.C Assayed Control 1 and 2 currently in commercial distribution.

| | Bio-Rad | Helena Laboratories | Helena Laboratories |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Lyphochek® Hemostasis Control<br>(New Device) | Coagulation S.A.C.-1 Assayed<br>Control 1<br>(Predicate Device - K941737) | Coagulation S.A.C.-2 Assayed<br>Control 2<br>(Predicate Device - K941872). |
| | Similarities | | |
| Intended Use | Lyphochek® Hemostasis Control<br>is intended for use as a quality<br>control plasma to monitor the<br>precision of laboratory testing<br>procedures for analytes listed in<br>the package insert. | S.A.C.-1 is assayed control<br>plasma, which may be used in<br>many facets of testing in the<br>coagulation laboratory. | S.A.C.-2 is assayed abnormal<br>control plasma, which may be<br>used in many facets of testing in<br>the coagulation laboratory. |
| Form | Lyophilized | Lyophilized | Lyophilized |
| Matrix | Human plasma based | Human plasma based | Human plasma based |
| | Differences | | |
| Storage | 2-8°C | 2-6°C | 2-6°C |
| (Unopened) | Until expiration date | Until expiration date | Until expiration date |
| Reconstituted<br>Vial Claim | 8 hours at 2°C to 25°C with the<br>following exception:<br>Protein S will be stable for 8 hours<br>at 2°C to 8°C. | 4 hours 2-6°C | 4 hours 2-6°C |
| Analytes | Contains: Prothrombin Time (PT),<br>Activated Partial Thromboplastin<br>Time (APTT), Fibrinogen,<br>Antithrombin III (AT III) Thrombin<br>Time (TT), Factor II, V, VII, VIII, IX,<br>X, XI, XII, Protein S (Functional)<br>and Protein C (Functional),<br>Plasminogen<br>Does not Contain: Alpha-<br>Antiplasmin, von Willebrand Factor<br>Antigen, Ristocetin cofactor | Contains: Prothrombin Time<br>(PT), Activated Partial<br>Thromboplastin Time (APTT),<br>Fibrinogen, Antithrombin III (AT<br>III), Factor II, V, VII, VIII, IX, X, XI,<br>XII, Total and Free Protein S,<br>Protein C, Plasminogen, von<br>Willebrand Factor Antigen, Alpha-<br>antiplasmin, Ristocetin cofactor<br>Does not Contain: Thrombin<br>Time (TT) | Contains: Prothrombin Time<br>(PT), Activated Partial<br>Thromboplastin Time (APTT),<br>Fibrinogen, Antithrombin III (AT<br>III), Factor II, V, VII, VIII, IX, X, XI,<br>XII, Total and Free Protein S,<br>Protein C, Plasminogen,<br>Ristocetin cofactor, Alpha-<br>antiplasmin, Monoclonal Free<br>Protein S, von Willebrand Factor<br>Antigen<br>Does not Contain: Thrombin<br>Time (TT) |

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

#### Summary of Performance Data 7.0

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

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- 7.1 Reconstituted Stability: Once the control material is reconstituted, all analytes will be stable for 8 hours at 2°C to 25°C with the exception of Protein S which will be stable for 8 hours at 2ºC to 8ºC.
- Shelf Life: Three years when stored at 2 to 8 °C. 7.2

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/3/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 three human profiles facing right, with flowing lines representing hair or clothing. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# APR 1 5 2002

Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017

Re: k020878

Trade/Device Name: Lyphochek® Hemostasis Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Control Plasma Abnormal Regulatory Class: II Product Code: GGC Dated: March 15, 2002 Received: March 18, 2002

Dear Ms. Zeballos:

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 11 your de roo 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 or any I 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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Page 2

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 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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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):

Lyphochek® Hemostasis Control Device Name: Indications for Use:

Lyphochek® Hemostasis Control is intended for use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription use | <span style="text-decoration: overline;">✓</span> | or | Over-the Counter use | <span style="text-decoration: overline;"></span> |
|------------------|---------------------------------------------------|----|----------------------|--------------------------------------------------|
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| (Division/Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K020878 |