LYPHOCHEK WHOLE BLOOD CONTROL

K980871 · Bio-Rad · DIF · Apr 6, 1998 · Clinical Toxicology

Device Facts

• Record ID: K980871
• Device Name: LYPHOCHEK WHOLE BLOOD CONTROL
• Applicant: Bio-Rad
• Product Code: DIF · Clinical Toxicology
• Decision Date: Apr 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

Lyphochek Whole Blood Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package Insert.

Device Story

Lyphochek Whole Blood Control is an assayed quality control material prepared from human whole blood with added pure chemicals. It is provided in lyophilized form to ensure stability. The device is used in clinical laboratory settings by laboratory personnel to monitor the precision of testing procedures for specific analytes, including Cyclosporine, FK-506, Lead, and Red Cell Folate. By comparing results obtained from the control against established values, clinicians and laboratory staff can verify the accuracy and reliability of their diagnostic testing equipment and methods, ultimately ensuring the quality of patient test results.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized human whole blood matrix with added pure chemicals. Analytes include Cyclosporine, FK-506, Lead, and Red Cell Folate. Storage at 2-8°C. Open vial stability of 14 days (3 days for red cell folate).

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for specific analytes in human whole blood. No specific patient population, age, or gender restrictions apply as it is a laboratory control material.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

Predicate Devices

• Lyphochek Whole Blood Control (K8a2a02)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/3 description: The image shows the logo for Bio-Rad. The logo is white text on a black, rounded rectangle. The text is in a bold, sans-serif font.

aboratories

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

KA80871

## 510(k) Summary

APR - 6 1998

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

Contact Person Elizabeth Platt

Date of Summary Preparation March 24, 1998

Device (Trade & Common Name) Lyphochek Whole Blood Control

Classification Name CFR 862.1660: Quality Control Material (Assayed and Unassayed)

Devices to Which Substantial Equivalence is Claimed

Lyphochek Whole Blood Control Bio-Rad Laboratories, Irvine, CA K8a2a02

Statement of Intended Use

Lyphochek Whole Blood Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package Insert.

## Description of the Device

Lyphochek Whole Blood Control is prepared from human whole blood with added pure chemicals. The control is provided in iyophilized form for increased stability.

Statement of How Technological Characteristics Compare to Substantial Equivalence Device

{1}------------------------------------------------

Image /page/1/Picture/3 description: The image shows the logo for Bio-Rad. The logo is in white text on a black background. The text is in a bold, sans-serif font and is enclosed in a rounded rectangle.

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

A table is provided below comparing the similarities between the Bio-Rad Lyphochek Whole Blood Control and the device to which substantial equivalence is claimed.

| | Lyphochek Whole Blood<br>Control | Lyphochek Whole Blood<br>Control<br>(new submission) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | An assayed quality control<br>material to monitor the<br>precision of laboratory<br>testing procedures for the<br>analytes listed in the<br>package insert. | An assayed quality control<br>material to monitor the<br>precision of laboratory<br>testing procedures for the<br>analytes listed in the<br>package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Whole Blood | Whole Blood |
| Storage | 2-8°C | 2-8°C |
| Analytes | Cyclosporine, Lead, Red<br>Cell Folate | Cyclosporine, FK-506, Lead,<br>Red Cell Folate |
| Open Vial<br>Claim | 14 days when stored tightly<br>capped at 2-8°C with the<br>following exception: (1) red<br>cell folate will be stable for 3<br>days. | 14 days when stored tightly<br>capped at 2-8°C with the<br>following exception: (1) red<br>cell folate will be stable for 3<br>days. |
| Differences | Previous product did not<br>contain FK-506 | Contains FK-506 |

{2}------------------------------------------------

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 2098 Gaither Road APR = 6 1908 Rockville MD 20850

Elizabeth Platt Acting Requlatory Affairs/Quality Assurance Manager Bio Rad Laboratories 9500 Jeronimo Road Irvine, California 92618-2017

Re : K980871 Lyphochek Whole Blood Control Requlatory Class: I & III Product Code: DIF Dated: March 24, 1998 Received: March 27, 1998

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 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 setmas as 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 In addition, FDA may publish further announcements action. 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.

{3}------------------------------------------------

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/dsmamain.html".

Sincerely yours,
Steven Litman

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

{4}------------------------------------------------

510(k) Number:

Device Name: Lyphochek Whole Blood Control

Indications for Use:

Lyphochek Whole Blood Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

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

(Concurrence of CDRH, Office of Device Evaluation)

| Prescription Use | <div> <span>✓</span> </div> |
|------------------|-----------------------------|
|------------------|-----------------------------|

OR

| Over-The Counter Use | |
|----------------------|--|
|----------------------|--|

| (Division Sign-Off) | |
|-----------------------------------------|--|
| Division of Clinical Laboratory Devices | |

7

| 510(k) Number | K980871 |
|---------------|---------|
|---------------|---------|