LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529

K984477 · Bio-Rad · JJY · Jan 29, 1999 · Clinical Chemistry

Device Facts

• Record ID: K984477
• Device Name: LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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

Device Story

Lyphochek Whole Blood Metals Control is an assayed quality control product used in clinical laboratories to monitor the precision of testing procedures for lead and red cell folate. The device consists of human whole blood supplemented with pure chemicals and stabilizers, provided in a lyophilized form for stability. It is intended for professional use by laboratory personnel. By running this control alongside patient samples, clinicians verify the accuracy and precision of their diagnostic testing equipment. The control helps ensure that laboratory results are reliable, thereby supporting accurate clinical decision-making and patient management.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Lyophilized human whole blood matrix with added chemicals and stabilizers. Storage at 2-8°C. Open-vial stability of 14 days (3 days for red cell folate). Analyte profile: Lead and Red Cell Folate.

Indications for Use

Indicated for use as an assayed quality control 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 this is an in vitro diagnostic control product used by clinical laboratories.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Lyphochek Whole Blood Control (K980871)

Submission Summary (Full Text)

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JAN 29 1999

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Laboratories

0 Jeronimo Road ine, California 92618-2 lephone: (949) 598-120

## 510(k) Summary

Submitter Bio-Rad Laboratories, ECS Division 9500 Jeronimo Road Irvine, CA 92618 [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation December 16, 1998

Device (Trade & Common Name) Lyphochek Whole Blood Metals Control

Classification Name Class I, CFR 862.1660: Multi-Analyte Control (Assayed and Unassayed) 75JJY

Devices to Which Substantial Equivalence is Claimed Lyphochek Whole Blood Control Bio-Rad Laboratories, Irvine, California K980871

Statement of Intended Use

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

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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in black and white and features the company name in a bold, sans-serif font. The logo is encased in a rounded rectangle.

Bio-Rad Laboratories

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

## Description of the Device

Lyphochek Whole Blood Metals Control is prepared from human whole blood with pure chemicals and stabilizers added. 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 Whole Blood Metals Control and the device to which substantial equivalence is claimed.

| | Lyphochek Whole Blood Metals<br>Control | Lyphochek Whole Blood Control |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | An assayed quality control to<br>monitor the precision of<br>laboratory testing procedures for<br>the analytes listed in the<br>package insert. | An assayed quality control material<br>to monitor the precision of<br>laboratory testing procedures for<br>the analytes listed in the package<br>insert. |
| Form | Lyophilized | Lyophilized |
| Open<br>Vial<br>Claim | 14 days when stored tightly<br>capped at 2-8°C with the<br>following exception: red cell<br>folate will be stable for 3 days. | 14 days when stored tightly<br>capped at 2-8°C with the following<br>exception: red cell folate will be<br>stable for 3 days. |
| Matrix | Human Whole Blood | Human Whole Blood |
| Storage | 2-8°C | 2-8°C |
| Analytes | Lead, Red Cell Folate | Cyclosporine, FK-506, Lead, Red<br>Cell Folate |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 29 1999

Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories ECS 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K984477

> Trade Name: Lyphochek Whole Blood Metals Control Regulatory Class: I Product Code: 75 JJY Dated: December 16, 1998 Received: December 16, 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 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 (OS) 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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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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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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K98-4477

Device Name: Lyphochek Whole Blood Metals Control

Indications for Use:

510(k) Number:

Lyphochek Whole Blood Metals Control is intended for use as an assayed quality Eyphoonen vnitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number K984477

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

(Concurrence of CDRH, Office of Device Evaluation)

Prescription Use

Over-The Counter Use __ OR

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