LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405

K990928 · Bio-Rad · DIE · Apr 16, 1999 · Clinical Toxicology

Device Facts

• Record ID: K990928
• Device Name: LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405
• Applicant: Bio-Rad
• Product Code: DIE · Clinical Toxicology
• Decision Date: Apr 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

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

Device Story

Lyphochek Urine Metals Control is an assayed quality control material derived from human urine supplemented with trace elements, heavy metals, and other chemical compounds. Provided in lyophilized form for stability; reconstituted for use. Used in clinical laboratory settings by laboratory personnel to monitor the precision of testing procedures for specific analytes. The control provides a reference point for laboratory assays; results help verify the accuracy and reliability of patient sample testing. Benefits include ensuring consistent performance of laboratory diagnostic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Matrix: Human urine. Form: Lyophilized. Storage: 2-8°C. Stability: 5 days when stored tightly capped at 2-8°C. Analyte composition includes trace elements, heavy metals, and chemical compounds (Hippuric Acid, Mandelic Acid, Pentachlorophenol, Phenol, Phenylglyoxylic Acid, Trichloroacetic Acid).

Indications for Use

Indicated for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for analytes listed in the package insert. No specific patient population or contraindications described.

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 Urine Metals Control (K891691/A)

Submission Summary (Full Text)

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aboratories

990928

alifornia 92618-201 ne: (949) 598-1

# 510(k) Summary

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

Contact Person Elizabeth Platt

Date of Summary Preparation March 18, 1999

Device (Trade & Common Name) Lyphochek Urine Metals Control

Classification Name Class I, 91DIE CFR 862.3280: Materials, Heavy Metals Control

Devices to Which Substantial Equivalence is Claimed Lyphochek Urine Metals Control Bio-Rad Laboratories Irvine, California K891691/A

Statement of Intended Use

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

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Bio-Rad Laboratories

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

#### Description of the Device

Lyphochek Urine Metals Control is prepared from human urine with added trace elements, heavy metals and other chemical compounds. 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 Urine Metals Control and the devices to which substantial equivalence is claimed.

| | Bio-Rad Lyphochek Urine Metals<br>Control<br>New Submission | Bio-Rad Lyphochek Urine Metals<br>Control<br>Prior Submission |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | An assayed quality control urine to monitor<br>the precision of laboratory testing procedures<br>for the analytes listed in the package insert. | An assayed quality control urine to<br>monitor the precision of laboratory<br>testing procedures for the analytes<br>listed in the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human urine. | Human urine. |
| Storage | 2-8°C | 2-8°C |
| Open Vial<br>Claim | 5 days when stored tightly capped at 2-8°C. | 5 days when stored tightly capped<br>at 2-8°C. |
| Differences | Domestic and International products have been combined. Same claims as the substantially equivalent device plus claims for:<br>Hippuric Acid, Mandelic Acid,<br>Pentachlorophenol, Phenol,<br>Phenylglyoxylic Acid, and Trichloroacetic Acid. | Domestic and International products are separate. Refer to substantially equivalent package insert. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three faces.

APR 1 6 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017

Re: K990928

Trade Name: Lyphochek Urine Metals Control Regulatory Class: I Product Code: DIE Dated: March 18, 1999 Received: March 19, 1999

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 (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 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 [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Dutman

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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Page 1 of 1

Kagogy 8 510(k) Number:

Device Name: Lyphochek Urine Metals Control

Indications for Use:

Lyphochek Urine Metals Control is intended for use as an assayed quality control urine 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)

(Concurrence of CDRH, Office of Device Evaluation)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number

| Prescription Use | <div>✓</div> |
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OR Over-The Counter Use