LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)

K971952 · Bio-Rad · JJY · Jun 16, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971952
• Device Name: LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

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

Device Story

Lyphochek Hypertension Markers Control is an assayed quality control serum used in clinical laboratories to monitor the precision of testing procedures for specific hypertension-related analytes. The device is prepared from defibrinated human plasma supplemented with human-origin constituents and pure chemicals. It is provided in a lyophilized form to enhance stability and requires reconstitution before use. The control is intended for professional use by laboratory personnel to verify the performance of diagnostic assays. By providing a stable, assayed matrix, it allows clinicians to assess the consistency and reliability of their laboratory testing, ensuring that results used for patient management are accurate.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized quality control serum derived from defibrinated human plasma. Contains 0.1% sodium azide as a preservative. Provided in three levels. Storage at 2-8°C. Open-vial stability of 21 days at 2-8°C (except ACTH).

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

• Renin Control Ciba Corning Diagnostics

Submission Summary (Full Text)

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K971952

Image /page/0/Picture/1 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.

**Bio-Rad**
Laboratories

OS F Miraloma Avenu heim. CA 92806 lephone (714) 630-640 I Free [phone]

JUN 16 1997

## 510(k) Summary

Submitter Bio-Rad Laboratories, ECS Division 3726 E. Miraloma Avenue Anaheim. CA 92806 [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation May 27, 1997

Device (Trade & Common Name) Lyphochek Hypertension Markers Control

Classification Name Class 1, 75JJY CFR 862.1660: Quality Control Material (Assayed and Unassayed)

Devices to Which Substantial Equivalence is Claimed Renin Control Ciba Corning Diagnostics

## Statement of Intended Use

Medfield, MA

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

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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad. The logo is white text on a black rounded rectangle. The text is in all caps and bolded.

**Bio-Rad**
**Laboratories**

ECS Division 3726 E. Miraloma Avenue Anaheim. CA 92806 Telephone [phone] Toll Free [phone]

## Description of the Device

Lyphochek Hypertension Markers Control is prepared from defibrinated human plasma with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability.

This product contains 0.1% sodium azide as a preservative.

## Statement of How Technological Characteristics Compare to Substantial Equivalence Device

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

| | Bio-Rad Lyphochek Hypertension<br>Markers Control | Ciba Corning Diagnostics<br>Renin Control |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | An assayed quality control serum<br>to monitor the precision of<br>laboratory testing procedures for<br>the analytes listed in the<br>package insert. | To monitor the precision and the<br>accuracy of clinical chemistry test<br>procedures which analyze renal<br>and adrenal function. |
| Levels | Three | Two |
| Form | lyophilized | lyophilized |
| Open<br>Vial<br>Claim | 21 Days at 2-8°C with the<br>exception of ACTH which should<br>be assayed immediately after<br>reconstitution | 8 hours at 2-8°C<br>-- |
| Matrix | defibrinated human plasma | human plasma |
| Storage | 2-8°C | 2-8°C |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 6 1997

Elizabeth Platt Staff Regulatory Affairs Representative Bio-Rad Laboratories 3726 E. Miraloma Avenue Anaheim, California 92806

Re: K971952 Lyphochek Hypertension Markers Control Requlatory Class: I Product Code: JJY Dated: May 27, 1997 Received: May 28, 1997

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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlation (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 requlation 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

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971952 510(k) Number: Device Name: Lyphochek Hypertension Markers Control 参 Indications for Use:

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

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

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

(Concurrence of CDRH, Office of Device Evaluation)

Prescription Use

(1

Over-The Counter Use _ OR

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