TRIAGE TOX DRUG SCREEN CONTROLS

K050037 · Biosite Incorporated · DIF · Mar 22, 2005 · Clinical Toxicology

Device Facts

• Record ID: K050037
• Device Name: TRIAGE TOX DRUG SCREEN CONTROLS
• Applicant: Biosite Incorporated
• Product Code: DIF · Clinical Toxicology
• Decision Date: Mar 22, 2005
• 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 Drug Screen tests and Triage MeterPlus to assist the laboratory in monitoring test performance.

Device Story

Triage TOX Drug Screen Controls consist of drug and drug metabolites dissolved in preserved human urine; provided in two levels (analyte negative and analyte positive). Used in laboratory settings to monitor performance of Biosite Triage TOX Drug Screen tests and Triage MeterPlus. Controls are processed as typical samples per instrument instructions. Output assists laboratory personnel in verifying test outcomes and monitoring system performance. Addition of acetaminophen to existing toxicology control formulation.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Toxicology control material consisting of drug/metabolite analytes in preserved human urine. Formulated in two levels (negative/positive). Designed for use with Biosite Triage family of meters. Storage requirement: -20°C.

Indications for Use

Indicated for use by laboratory professionals to monitor the performance of Triage TOX Drug Screen tests and the Triage MeterPlus system.

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

• Triage TOX Drug Screen Controls (K012999)

Submission Summary (Full Text)

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K 050037

#### 510(k) Summary of Safety and Effectiveness 11.

# 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.

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

# 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: | 1/6/2005 |

# 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 I Product Code: DIF

#### C. Predicate Devices

Triage TOX Drug Screen Controls (K012999) BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) Dade Behring Emit Calibrators/Controls (K935230)

#### D. Device Description and Intended Use

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The Triage TOX Drug Screen Controls are to be used with the Triage TOX The Thage TOX Drug Triage MeterPlus to assist the laboratory in monitoring test performance.

# 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 devices.

| 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 |

### 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized stripes representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# MAR 2 2 2005

Jeffrey R. Dahlen, Ph.D Director, Clinical & Regulatory Affairs Biosite Inc. 11030 Roselle Street San Diego, CA 92121

K050037 Re:

Trade Name: Triage TOX Drug Screen Controls Regulatory Number: 21 CFR 862.3280 Regulatory Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: February 18, 2005 Received: February 22, 2005

Dear Dr. Dahlen:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(th promaint is substantially equivalent (for the referenced above and have determined the to legally marketed predicate devices marketed in indications for use stated in the cholosary w regional date of the Medical Device interstate colliments, or to devices that have been reclassified in accordance with the provisions of Amendments, of to devices that have boon frequire approval of a premarket the Federal FOOd, Drug, and Cosment Pres (116) - Market the device, subject to the general approval application (1 Mr.). - 1 ove general controls provisions of the Act include controls provisions of the rec. "The gentiration 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 If your device is classinod (occ as a rey in a controls. Existing major regulations affecting (FMA), it may be subject to flact adally f Federal Regulations, Title 21, Parts 800 to 895. In your device can be found in the becan nouncements 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 mean that 117A has made a decemmaregulations administered by other Federal agencies. of the Act of ally I ederal states and virenents, including, but not limited to: registration r ou must compry with and 807); labeling (21 CFR Parts 801 and 809); and good alla listing (21 CF RT Part 001) Master 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) I his letter will anow you to ocgin marketing your avvalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your accruits premarket notification: "The PDT Intention 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, of fr If you desire specific information advertising of your device, please contact the Office of In of questions on the promotion 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 I ou may obtain other general mormational 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,

Sean M. Cooper, MS, DUM

Jean M. Cooper, MS, D.V.M. 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): K050037

Device Name: Triage TOX Drug Screen Controls

Indications For Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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)

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(Division Sign-C Division of Clinical Laboratory Devices 510(k) Number_KOS OO S OO S OO S 7