TRIAGE TOX DRUG SCREEN, MODEL 94400

K060791 · Biosite Incorporated · DJR · Jun 22, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060791
• Device Name: TRIAGE TOX DRUG SCREEN, MODEL 94400
• Applicant: Biosite Incorporated
• Product Code: DJR · Clinical Toxicology
• Decision Date: Jun 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only preliminary test results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.

Device Story

Triage TOX Drug Screen is a single-use fluorescence immunoassay for point-of-care urine drug screening; used with Triage MeterPlus. Input: urine sample; sample moves via capillary action through filter into reaction chamber. Principle: competitive immunoassay; urine sample competes with fluorescent drug conjugates for binding to murine monoclonal fluorescent antibody conjugates on solid phase. Output: qualitative result (positive/negative) based on fluorescence intensity inversely related to drug concentration. Meter reads device; displays results. Healthcare providers use results for preliminary screening; positive results require GC/MS confirmation. Benefits: rapid, point-of-care identification of drug presence to inform clinical decision-making.

Clinical Evidence

Method comparison study performed using 102 clinical urine specimens. Overall agreement was 96.1% compared to predicate. Discordant samples analyzed via GC/MS confirmed performance characteristics. No other clinical data provided.

Technological Characteristics

Fluorescence immunoassay; point-of-care diagnostic. Analyzes urine samples for 10 drug classes. Utilizes Triage MeterPlus for signal detection and processing. Qualitative output based on established threshold concentrations.

Indications for Use

Indicated for point-of-care qualitative detection of drugs of abuse and metabolites in urine. Patient population includes individuals requiring drug screening. Contraindications: None stated; test provides preliminary results only and requires confirmatory testing.

Regulatory Classification

Identification

A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.

Special Controls

*Classification.* Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Triage® TOX Drug Screen (k042342)

Submission Summary (Full Text)

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

In accordance with the provisions of Section 4 of the Safe Medical Devices Act of 1990 and 21 CFR 807.92, the following summary is provided. Biosite requests that this document be maintained CONFIDENTIAL until such time that the product is cleared by the Food and Drug Administration via the 510(k) Notification Process and in accordance with the provisions of the Act.

#### 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: | 03/22/06 |

#### B. Device Names

Triage® TOX Drug Screen

### C. Predicate Devices

Biosite Triage® 8 Panel for Drugs of Abuse [FDA file number K973784] Biosite Triage® TOX Drug Screen [FDA file number K043242]

### D. Device Description and Intended Use

The Triage TOX Drug Screen Methadone assay is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of methadone in urine.

The Triage Methadone assay is identical in principle, reagents and procedure to the previously cleared Triage TOX Drug Screen (FDA file number K043242). The only difference between the two tests is that an assay for methadone has been added

### E. Summary of Comparison Data

A method comparison of the Triage TOX Drug Screen Methadone assay with the Biosite Triage 8 Panel for Drugs of Abuse was performed using 102 specimens obtained from clinical sources. The overall agreement was 96.1%. Discordant samples were determined by GC/MS to contain I-methadone at concentrations greater than 175 ng/mL (the established threshold concentration of the GC/MS method for the i-methadone enantiomer) but less than the threshold concentration of the Triage 8 Panel for Drugs of Abuse (300 ng/mL). Based on this, the percent agreement versus the claimed specificity for the distinct methadone enantiomers would be 100%. The analytical performance characteristics of the assay were equivalent with predicate methods.

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### F. Conclusion

In conclusion, these studies demonstrate the substantial equivalence of the Triage TOX Drug Screen Methadone assay to existing products already marketed for detecting the presence of various drugs of abuse. They further demonstrate the suitability of the product for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.

: . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 22 2006 Ms. Robin Weiner Vice President, Regulatory and Government Affairs Biosite Incorporated 9975 Summers Ridge Road San Diego, CA 92121

Re: k060791

> Trade/Device Name: Triage® TOX Drug Screen Regulation Number: 21 CFR8862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: June 6, 2006 Received: June 9, 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 ne [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto G.

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): K060791

Device Name: Triage® TOX Drug Screen

Indications For Use:

The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.

The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

The threshold concentrations are provided below:

| Acetaminophen/Paracetamol | APAP | 5 µg/mL |
|---------------------------|------|------------|
| Amphetamines | AMP | 1000 ng/mL |
| Methamphetamines | mAMP | 1000 ng/mL |
| Barbiturates | BAR | 300 ng/mL |
| Benzodiazepines | BZO | 300 ng/mL |
| Cocaine | COC | 300 ng/mL |
| Methadone | MTD | 300 ng/mL |
| Opiates | OPI | 300 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| THC | THC | 50 ng/mL |
| Tricyclic Antidepressants | TCA | 1000 ng/mL |

This test provides only preliminary test results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method.

A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.

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 D ODRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

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