LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563

K022041 · Bio-Rad Laboratories, Inc. · JJY · Jul 16, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022041
• Device Name: LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 16, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• 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 the package insert.

Device Story

Lyphochek® Whole Blood Control is a lyophilized, multi-analyte quality control material derived from human whole blood lysate. It is used in clinical laboratories to monitor the precision of testing procedures for specific analytes (Cyclosporine, Lead, Red Cell Folate, Tacrolimus, and Sirolimus). The control is reconstituted by laboratory personnel and used to verify the accuracy and consistency of analytical instruments. By comparing observed results against established target values, clinicians ensure the reliability of patient diagnostic testing. The device provides a stable reference point for laboratory quality assurance programs.

Clinical Evidence

Bench testing only. Stability studies confirmed reconstituted stability of 14 days at 2°C to 8°C (3 days for Red Cell Folate) and a shelf life of three years and three months at 2°C to 8°C.

Technological Characteristics

Lyophilized processed human whole blood lysate; contains stabilizers. Analytes include Cyclosporine, Lead, Red Cell Folate, Tacrolimus, and Sirolimus. Storage: 2-8°C. Reconstituted stability: 14 days at 2-8°C (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 analytes including Cyclosporine, Lead, Red Cell Folate, Tacrolimus, and Sirolimus.

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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102204/

JUL 1 6 2002 Bio-Rad Laboratories Premarket Notification Section 510(k) for Lyphochek Whole Blood Control Summary of Safety and Effectiveness

Page 1 of 2

# Summary of Safety and Effectiveness Lyphochek® Whole Blood Control

#### 1.0 Submitter

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

### Contact Person

Maria Zeballos Regulatory Affairs Specialist [phone] Telephone:

### Date of Summary Preparation

June 18, 2002

#### 2.0 Device Identification

| Product Trade Name: | Lyphochek® Whole Blood Control |
|---------------------|-------------------------------------------------|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |

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

Lyphochek® Whole Blood Control Bio-Rad Laboratories Irvine, California

Docket Number: K980871

#### 4.0 Description of Device

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

#### 5.0 Statement of Intended Use

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

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

Lyphochek® Whole Blood Control claims substantial equivalence to the Lyphochek® Whole Blood Control currently in commercial distribution (K980871). The new Lyphochek® Whole Blood Control contains Sirolimus and the current product does not.

| Characteristics | Bio Rad<br>Lyphochek® Whole Blood Control<br>(New Device) | Bio Rad<br>Lyphochek® Whole Blood Control<br>(Predicate Device) |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | Lyphochek® Whole Blood Control is intended for<br>use as an assayed quality control material to<br>monitor the precision of laboratory testing<br>procedures for the analytes listed in the package<br>insert. | Lyphochek® Whole Blood Control is intended for<br>use as an assayed quality control material to<br>monitor the precision of laboratory testing<br>procedures for the analytes listed in the package<br>insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Processed Human Whole Blood Lysate | Processed Human Whole Blood Lysate |
| | Differences | |
| Storage<br>(Unopened) | 2-8°C<br>until expiration date | 2-8°C<br>until expiration date |
| Reconstituted<br>Vial Claim | 14 days at 2°C to 8 °C<br>Exception: Red cell folate will be stable for 3<br>days at 2°C to 8°C. | 14 days at 2°C to 8 °C<br>Exception: Red cell folate will be stable for 3 days<br>at 2°C to 8°C. |
| After<br>reconstituting<br>and freezing | After reconstituting and freezing the control, all<br>analytes will be stable for 30 days when stored<br>tightly capped at -10 to -20°C. | After reconstituting and freezing the control, all<br>analytes will be stable for 30 days when stored<br>tightly capped at -10 to -20°C. |
| Analytes | Contains: Cyclosporine, Lead, Red Cell Folate,<br>Tacrolimus and Sirolimus. | Contains: Cyclosporine, Lead, Red Cell Folate,<br>Tacrolimus<br>Does not Contain: Sirolimus |

## Table 1, Similarities and Differences hetween new and predicate device

#### 7.0 Summary of Performance Data

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

- 7.1 Reconstituted Stability: Once the control material is reconstituted, all analytes will be stable for 14 days at 2℃ to 8 ℃ with the following the exception: Red Cell Folate will be stable for 3 days at 2°C to 8°C.
- 7.2 Shelf Life: Three years and three months when stored at 2 to 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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# リリー 1 6 2002

Ms. Elizabeth Platt Regulatory Affairs/Quality Assurance Manager Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618

Re: k022041 Trade/Device Name: Lyphochek® Whole Blood Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 18, 2002 Received: June 24, 2002

Dear Ms. Platt:

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 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 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, 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/odrb/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 Control Device Name: 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 the package insert.

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

or

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ Prescription use______________________________________________________________________________________________________________________________________________________________

Over-the Counter use_

Olan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. KO22041