URINE DRUG SCREENING CONTROL

K992395 · Seracare Technology · DIF · Aug 26, 1999 · Clinical Toxicology

Device Facts

• Record ID: K992395
• Device Name: URINE DRUG SCREENING CONTROL
• Applicant: Seracare Technology
• Product Code: DIF · Clinical Toxicology
• Decision Date: Aug 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

Urine Drug Screening Control is a liquid human urine based assayed quality control material intended to monitor and evaluate the precision and the accuracy of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Urine Drug Screening Control is a liquid, human urine-based quality control material containing purified drugs or drug metabolites and <0.1% sodium azide preservative. It mimics drug-containing human urine. Used in clinical laboratories to monitor the precision and accuracy of drugs-of-abuse testing procedures (screening, semi-quantitative, and confirmatory). Healthcare providers use the control results to verify that testing equipment and reagents are performing within expected parameters, ensuring the reliability of patient drug test results.

Clinical Evidence

No clinical data. Bench testing only, including accelerated stability studies to support the 30-day open-vial stability claim.

Technological Characteristics

Liquid human urine-based matrix; contains purified drugs/metabolites and <0.1% sodium azide preservative. Storage at 2-8°C. Stability: 30 days at 2-8°C (open).

Indications for Use

Indicated for use as an assayed quality control material to monitor the performance of screening, semi-quantitative, and confirmatory drugs-of-abuse testing procedures in laboratory settings.

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

• LIQUICHEK™ URINE TOXICOLOGY CONTROLS BIO-RAD Laboratories (K-971691)

Submission Summary (Full Text)

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# Product Performance and Substantial Equivalency

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _ K9239 5

| Submitter: |
|---------------------------------------------------------|
| SeraCare Technology, Inc. DBA Consolidated Technologies |
| 2170 Woodward Street |
| Austin, TX 78744-1832 |
| Phone: [phone] |
| Fax: [phone] |

Contact: Rusty Sewell Preparation date: July 13, 1999

### Product name (trade & common):

Proprietary: Urine Drug Screening Control Common: Not Applicable

#### Classification name:

Class 1 , Product code: DIF 21 CFR 862:3280 : Quality Control Material (Assayed and Unassayed)

#### Predicate device:

LIQUICHEK™ URINE TOXICOLOGY CONTROLS BIO-RAD Laboratories K-971691

#### Device description:

Urine Drug Screening Control is designed to monitor the performance of screening, semi-quantitative and confirmatory drugs-of-abuse testing procedures.

Purified drugs or drug metabolites added to a human urine based matrix to provide a stable liquid control, which closely mimics drug containing human urine. The product contains <0.1% sodium azide as a preservative.

#### Intended use:

Urine Drug Screening Control is a liquid human urine based assayed quality control material intended to monitor and evaluate the precision and the accuracy of laboratory testing procedures for the analytes listed in the package insert.

- Labeling: Vial labels see Attachment I Secondary Container label, see Attachment II Package Insert, see Attachment III

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#### 510(k) Summary (continued)

#### Comparative analysis:

The table below provides a summary of the technological characteristics between Urine Drug Screening Control and the predicate device.

| Device<br>Characteristic | Urine Drug Screening Control | LIQUICHEK Urine Toxicology<br>Controls |
|--------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| Intended use | Assayed control for monitoring<br>urine assays for drugs of abuse | Assayed control for monitoring urine<br>assays for drugs of abuse |
| Matrix | Human Urine | Human Urine |
| Form | Liquid | Liquid |
| Analytes | Common abused drugs | Common abused drugs |
| Storage | 2-8°C | 2-8°C |
| Stability | 30 days at 2-8°C, open (See Note) | 30 days at 2-8°C, open |

Note: Based on accelerated stability. Real time stability studies currently in progress

#### Conclusions:

The information provided in the pre-market notification demonstrates that Urine Drug Screening Control is substantially equivalent to the predicate device, for which there is FDA clearance. This equivalence was demonstrated through comparison of intended uses and physical properties to a commercially available device. The information supplied in the pre-market notification provides reasonable assurance that Urine Drug Screening Control is safe and effective for the stated intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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# AUG 26 1999

Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. DBA. Consolidated Technologies 2170 Woodward Street Austin, Texas 78744-1832

K992395 Re: Trade Name: Urine Drug Screening Control Regulatory Class: I Product Code: DIF

> Dated: July 13, 1999 Received: July 19, 1999

### Dear Mr. Sewell:

23

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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 2

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 Sutman

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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# INDICATIONS FOR USE STATEMENT

510(k) number (if known): K 99 23415

Urine Drug Screening Control Device name:

Indications for use:

Urine Drug Screening Control is a liquid human urine based assayed quality control material intended to monitor the performance of screening, semiquantitative and confirmatory drug-of-abuse testing procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Madin

(Division Sign-Division of Clinical La 510(k) Numb

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