TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001

K012999 · Biosite Incorporated · DIF · Oct 3, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012999
• Device Name: TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
• Applicant: Biosite Incorporated
• Product Code: DIF · Clinical Toxicology
• Decision Date: Oct 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.

Device Story

Triage® TOX Drug Screen Controls consist of liquid human urine-based materials containing commonly abused drugs. Used in clinical laboratory settings to monitor performance of Triage® TOX Drug Screen and Triage® Meter. Controls provide known analyte concentrations; laboratory personnel compare device output against expected values to verify assay accuracy and system performance. Helps ensure reliability of patient drug screening results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid human urine matrix; assayed for commonly abused drugs; storage at -20 °C or colder. Class I, reserved device (Product Code: DIF).

Indications for Use

Indicated for use as assayed quality control materials for monitoring the performance of urine-based drugs of abuse assays in a laboratory setting.

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

• BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666)
• Dade Behring Emit Calibrators/Controls (K935230)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary of Safety and Effectiveness

# Triage® TOX Drug Screen Controls

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

510(k) Number: (To be determined)

K012999

## A. Name and Address of Submitter

| Company Name: | Biosite Incorporated |
|------------------------|---------------------------------------------|
| Address: | 11030 Roselle Street<br>San Diego, CA 92121 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Jeffrey R. Dahlen, Ph.D. |
| Date Summary Prepared: | 9/4/01 |

#### B. Device Names

- 1. Trade Name
# Triage® TOX Drug Screen Controls

- 2. Common / Usual Name
### Not Applicable

#### 3. Classification Name

Quality Control Material (Assayed and Unassayed) 21 CFR 862:3280 Class | Product Code: DIF

#### C. Predicate Devices

BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) Dade Behring Emit Calibrators/Controls (K935230)

## D. Device Description and Intended Use

The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.

{1}------------------------------------------------

# E. Summary of Comparison Data

| Characteristic | Triage® TOX Drug<br>Screen Controls | Bio-Rad<br>Liquicheck | Dade Behring<br>Emit |
|----------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Intended Use | Assayed control for<br>monitoring urine-<br>based drugs of<br>abuse assays | Assayed control for<br>monitoring urine-<br>based drugs of<br>abuse assays | Assayed control for<br>monitoring urine-<br>based drugs of<br>abuse assays |
| Matrix | Human Urine | Human Urine | Human Urine |
| Form | Liquid | Liquid | Liquid |
| Analytes | Commonly abused<br>drugs | Commonly abused<br>drugs | Commonly abused<br>drugs |
| Storage | -20 °C or colder | 2-8 °C | 2-8 °C |

The table below provides a comparison of the technical principles between the Triage® TOX Drug Screen Controls and the predicate devices.

## F. Conclusion

The information provided in the premarket notification demonstrates that the Triage® TOX Drug Screen Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® TOX Drug Screen Controls are safe and effective for their intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body and wings.

OCT - 3 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Jeffrey R. Dahlen Principal Scientist Biosite Diagnostics, Inc. 11030 Roselle Street San Diego, CA 92121

Re: k012999

> Trade/Device Name: Triage® TOX Drug Screen Controls Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: I, reserved Product Code: DIF Dated: September 5, 2001 Received: September 6, 2001

Dear Dr. Dahlen:

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 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, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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.

{3}------------------------------------------------

Page 2 -

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 nonification. The I 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, (Joase 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/cdrh/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

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known): {to-be-determined} Ko12999

Device Name: Triage® TOX Drug Screen Controls

Indications For Use:

The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kuria Alexander Sr. Juan Lopez
Division Sign Off

(Division Sign-O)
Division of Clinical Laboratory Devices
510(k) Number K012999

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96)