LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789

K990858 · Bio-Rad · GGN · Apr 21, 1999 · Hematology

Device Facts

• Record ID: K990858
• Device Name: LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
• Applicant: Bio-Rad
• Product Code: GGN · Hematology
• Decision Date: Apr 21, 1999
• 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 product used in clinical laboratories to monitor the precision of citrated coagulation testing systems. The control is prepared from human plasma supplemented with animal-derived constituents, purified biochemicals, and preservatives. It is provided in a lyophilized (freeze-dried) form to ensure stability. Laboratory personnel reconstitute the control and process it through their coagulation analyzers alongside patient samples. By comparing the measured values of analytes—including Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, Antithrombin III (AT III), and Thrombin Time (TT)—against established target ranges, clinicians verify the accuracy and precision of their coagulation testing platforms. This monitoring helps ensure the reliability of patient coagulation test results, which are critical for diagnosing and managing bleeding and clotting disorders.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human plasma-based control containing animal-derived constituents, purified biochemicals, and preservatives. Analytes: PT, APTT, Fibrinogen, AT III, TT. Storage: 2-8°C. Open-vial stability: 24 hours at 2-25°C.

Indications for Use

Indicated for use as a quality control plasma to monitor the precision of citrated coagulation systems in clinical laboratory settings.

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 (K964963)

Submission Summary (Full Text)

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Bio-Rad Laboratories e (949) 598-

## 510(k) Summary

Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation March 12, 1999

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 Lyphochek Coagulation Control Bio-Rad Laboratories Irvine, California K964963

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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boratories

Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: [phone]

#### Description of the Device

Lyphochek Coagulation Control is prepared from human plasma with added constituents of animal origin, purified biochemicals and preservatives. 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<br>Control (New Device) | Bio-Rad Lyphochek Coagulation<br>Control (Substantially Equivalent<br>Device) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Intended<br>Use | A quality control plasma to monitor<br>the precision of citrated coagulation<br>systems. | A quality control plasma to monitor<br>the precision of citrated coagulation<br>systems. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human based control. | Human based control. |
| Storage | 2-8°C | 2-8°C |
| Open Vial<br>Claim | 24 hours days when stored tightly<br>capped at 2-25°C. | 24 hours days when stored tightly<br>capped at 2-25°C. |
| Analytes | Prothrombin Time (PT), Activated<br>Partial Thromboplastin Time (APTT),<br>Fibrinogen, Antithrombin III (AT III),<br>Thrombin Time (TT). | Prothrombin Time (PT), Activated<br>Partial Thromboplastin Time (APTT),<br>Fibrinogen. |

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# Premarket Notification Truthful and Accurate Statement

I certify that, in my capacity as Regulatory Affairs Supervisor of Bio-Rad Laboratories, ECS Division, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

Cabret Cluft

3/12/55
Date

Elizabeth Platt Regulatory Affairs Supervisor

Date

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Public Health Service

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APR 2 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine. California 92618-2017

Re: K990858

Trade Name: Lyphochek Coagulation Control Regulatory Class: II Product Code: GGN Dated: March 31, 1999 Received: April 2, 1999

#### Dear Ms. Platt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 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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Page 1 of 1

510(k) Number: K990858
Device Name: Lyphochek Coagulation Control

Indications for Use:

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

Peter E. Majurin

al Laboratory Devi

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

(Concurrence of CDRH, Office of Device Evaluation)

Prescription Use

OR Over-The Counter Use _