LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529

K020610 · Bio-Rad · DIE · Apr 22, 2002 · Clinical Toxicology

Device Facts

• Record ID: K020610
• Device Name: LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
• Applicant: Bio-Rad
• Product Code: DIE · Clinical Toxicology
• Decision Date: Apr 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The new Lyphochek® Whole Blood Metals Control is an assayed control used for monitoring the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Lyphochek Whole Blood Metals Control is a lyophilized, human whole blood-based quality control material; used by laboratory personnel to monitor precision of testing procedures for specific metals and analytes. Device is reconstituted by laboratory staff; stored at 2-8°C. Output is a stable control sample with known analyte concentrations; used to verify accuracy and precision of clinical laboratory assays. Benefits include ensuring reliability of patient test results for heavy metals and folate.

Clinical Evidence

Bench testing only. Stability studies performed to validate shelf life (3 years and 3 months unopened at 2-8°C) and open-vial stability (14 days for most analytes, 1 day for red cell folate at 2-8°C).

Technological Characteristics

Lyophilized human whole blood matrix with added chemicals and stabilizers. Intended for use as an assayed quality control. Storage 2-8°C. No electronic, software, or mechanical components.

Indications for Use

Indicated for use as an assayed quality control to monitor the precision of laboratory testing procedures for analytes including Arsenic, Cadmium, Mercury, Thallium, Red Cell Folate, and Lead in human whole blood samples.

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 Metals Control (K984477)

Submission Summary (Full Text)

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K020610

# APR 2 2 2002

Summary of Safety and Effectiveness Lyphochek® Whole Blood Metals Control

#### 1.0 Submitter

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

## Contact Person

Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: [phone]

# Date of Summary Preparation

February 21, 2002

#### 2.0 Device Identification

Lyphochek® Whole Blood Metals Control Product Trade Name: Multi-Analyte Controls, (Assayed and unassayed) Common Name: Class I Classifications:

75JJY Product Code: CFR 862.1660 Requlation Number:

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

Lyphochek® Whole Blood Metals Control Bio-Rad Laboratories

510 (k) Number: K984477

#### Description of Device 4.0

The Lyphochek® Whole Blood Metals Control is a lyophilized control prepared from human whole blood with pure chemicals and stabilizers added. The control is provided in lyophilized form for increased stability.

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#### 5.0 Statement of Intended Use

The new Lyphochek® Whole Blood Metals Control is an assayed control used for monitoring the precision of laboratory testing procedures for the analytes listed in the package insert.

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

This control is substantially equivalent to the following quality control material for whole blood metals analysis that is currently in the market:

Lyphochek® Whole Blood Metals Control Bio-Rad Laboratories

510 (k) Number: K984477

### Table 1. Similarities and Differences between new and predicate device.

| Characteristics | Lyphochek® Whole Blood<br>Metals Control<br>(New Device) | Lyphochek® Whole Blood Metals<br>Control<br>(Predicate Device) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Lyphochek® Whole Blood Metals<br>Control is intended for use as a<br>assayed quality control to monitor<br>the precision of laboratory testing<br>procedures for the analytes listed<br>in the package insert. | Lyphochek® Whole Blood Metals<br>Control is intended for use as a<br>assayed quality control to monitor<br>the precision of laboratory testing<br>procedures for the analytes listed<br>in the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human Whole Blood | Human Whole Blood |
| Storage<br>(Unopened) | 2°C to 8°C<br>until expiration date | 2°C to 8°C<br>until expiration date |

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| Differences | | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte listing | The Lyphochek® Whole Blood<br>Metals Control may be used to<br>test for:<br>Arsenic Cadmium Mercury Thallium Red Cell Folate Lead | The Lyphochek® Whole Blood<br>Metals Control may be used to test<br>for:<br>Red Cell Folate Lead |
| Storage<br>(Opened) | Once opened all analytes will be<br>stable for 14 days with the<br>following exception: red cell folate<br>will be stable for 1 day. | Once opened all analytes will be<br>stable for 14 days with the<br>following exception: red cell folate<br>will be stable for 3 days.<br>[No claims for Arsenic, Cadmium,<br>Mercury, and Thallium]. |

#### Summary of Performance Data 7.0

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

- 7.1 Once the control is reconstituted, all analytes will be stable for 14 days when stored at 2-8°C with the following exception: red cell folate will be stable for 1 day.
- The control is stable for 3 years and 3 months when stored unopened at 7.2 2 - 8°C.

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/2 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the staff and a snake winding around it.

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APR 2 2 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017

Re: k020610

Trade/Device Name: Lyphochek® Whole Blood Metals Control Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I reserved Product Code: DIE Dated: February 21, 2002 Received: February 25, 2002

Dear Ms. Lloyd:

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 I mis lower will and it your ding of substantial equivalence of your device to a legally marketed predication. THE I Dir 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, [phone]: Tradition 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 miorination on your respons and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/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):____________________________________________________________________________________________________________________________________________________

Lyphochek® Whole Blood Metals Control Device Name:

Indications for Use:

An assayed quality control serum to monitor the precision of laboratory An assuyou quality for analytes listed in the package insert.

Tom Coon

vision of Clinical Laboratory Devices 0911410 510(k) Number

(Please Do not WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use_

or

Over-the Counter use