TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414

K060788 · Biosite Incorporated · DIF · Jul 10, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060788
• Device Name: TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
• Applicant: Biosite Incorporated
• Product Code: DIF · Clinical Toxicology
• Decision Date: Jul 10, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Intended Use

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Screen tests and Triage Meters to assist the laboratory in monitoring test performance. For prescription use

Device Story

Triage TOX Drug Screen Controls are liquid, human urine-based assayed control materials. They are used in clinical laboratory settings to monitor the performance of Triage TOX Drug Screen tests and Triage Meters. By providing known samples, the controls allow laboratory personnel to verify the accuracy and reliability of the testing system. This monitoring process ensures that the diagnostic equipment is functioning correctly, thereby supporting the validity of patient drug screening results and assisting healthcare providers in making informed clinical decisions regarding drug abuse testing.

Clinical Evidence

No clinical data. Bench testing only. Value assignment and verification were performed by analyzing 90 replicates of each control across three lots and two operators over three days, confirming expected positive/negative results for all analytes.

Technological Characteristics

Liquid human urine matrix. Positive control contains d/l-methadone, acetaminophen, d-amphetamine, d-methamphetamine, pentobarbital, estazolam, desipramine, phencyclidine, morphine, benzoylecgonine, and tetrahydrocannabinol. Concentrations are 2-4 times the assay cutoff. Storage at -20°C or below. Single-use, closed-vial format.

Indications for Use

Indicated for use by laboratory professionals to monitor the performance of Triage TOX Screen tests and Triage Meters for the qualitative detection of drugs of abuse.

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

• Biosite Triage® TOX Drug Screen Controls (K050037)

Submission Summary (Full Text)

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### 510(k) Summary of Safety and Effectiveness

# (JUL 1 0 2006

#### 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.

k 060788 510(k) Number: (To be determined)

#### A. Name and Address of Submitter

| Company Name: | Biosite Incorporated |
|------------------------|------------------------------------------------|
| Address: | 9975 Summers Ridge Road<br>San Diego, CA 92121 |
| Telephone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Robin Weiner |
| Date Summary Prepared: | 03/21/06 |

#### B. Device Names

- 1. Trade Name
Triage® TOX Drug Screen Controls

- 2. Common / Usual Name
TOX Drug Screen Controls

- 3. Classification Name
Drug Mixture Control Materials 21 CFR 862.3280 Class I

Product Code: DIF

#### C. Predicate Devices

Biosite Triage® TOX Drug Screen Controls (K050037)

## D. Device Description and Intended Use

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

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## E. Summary of Comparison Data

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

| Characteristic | Triage TOX Drug<br>Screen Controls<br>(proposed) | Triage TOX Drug<br>Screen Controls<br>(K050037) |
|----------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 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 |
| Matrix | Human Urine | Human Urine |
| Form | Liquid | Liquid |
| Analytes | Commonly abused<br>drugs | Commonly abused<br>drugs |
| Storage | -20 °C or colder | -20 °C or colder |

#### 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle, with the eagle in the center.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 0 2006

Ms. Robin Weiner Vice President Regulatory and Government Affairs Biosite Incorporated 9975 Summers Ridge Road San Diego, CA 92121

k060788 Re:

Trade/Device Name: Triage® TOX Drug Screen Controls Regulation Number: 21 CFR§862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: June 23, 2006 Received: June 26, 2006

Dear Ms. Weiner:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Albert Gutt

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K060788

Device Name: Triage® TOX Drug Screen Controls

Indications For Use:

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

Prescription Use X ____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carl Benson

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Livision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K060788