TRIAGE TOX DRUG SCREEN

K043242 · Biosite Incorporated · LDP · Feb 28, 2005 · Clinical Toxicology

Device Facts

• Record ID: K043242
• Device Name: TRIAGE TOX DRUG SCREEN
• Applicant: Biosite Incorporated
• Product Code: LDP · Clinical Toxicology
• Decision Date: Feb 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3030
• Device Class: Class 2

Intended Use

The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of the presence of major metabolites above the threshold concentrations of up to 8 distinct drug classes, including assays for methamphetamines, acetaminophen/paracetamol, barbiturates, benzodiazepines, cocaine, 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 a preliminary test result. 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 common 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 competitive fluorescence immunoassay for qualitative drug detection in urine. Device uses murine monoclonal antibodies and fluorescently labeled drug metabolites. Urine sample added to device; moves via capillary action through filter to reaction chamber; reacts with fluorescent antibody conjugates. Presence of drug prevents binding of fluorescent conjugates to solid phase; unbound conjugate washed away. Fluorescence intensity on detection zone inversely proportional to drug concentration. Device inserted into Triage MeterPlus for automated reading. Used in point-of-care settings by healthcare professionals. Provides preliminary results; requires confirmatory testing (GC/MS) for clinical decision-making. Benefits include rapid, on-site screening for drug presence.

Clinical Evidence

Bench testing only. Method comparison study performed on 102 urine specimens comparing Triage TOX Drug Screen results against GC/MS. Overall agreement was 97.1%. Three discordant samples were positive on the Triage device and within 10% below the cutoff by GC/MS.

Technological Characteristics

Fluorescence immunoassay; point-of-care diagnostic test; used with Triage MeterPlus; qualitative detection of drug metabolites in urine; threshold-based detection.

Indications for Use

Indicated for point-of-care qualitative detection of major drug metabolites in urine for 8 drug classes (methamphetamines, acetaminophen/paracetamol, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, tricyclic antidepressants) at specified threshold concentrations. Intended for prescription use.

Regulatory Classification

Identification

An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.

Predicate Devices

• Triage® TOX Drug Screen (k012745)

Submission Summary (Full Text)

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

K 05/3242

# 510(k) Summary of Safety and Effectiveness

In accordance with the provisions of Section 4 of the Safe Medical Devices in aconnames with the por 92, the following summary is provided. Biosite recests that this document be maintained CONFIDENTIAL until such time that the product is cleared by the Food and Drug Administration via the 510(k) process and in accordance with the provisions of the Act.

#### Name and Address of Submitter A.

| 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: | February 22, 2005 |

#### в. Product

Triage® TOX Drug Screen (K043242)

### C. Predicate Devices

Triage TOX Drug Screen, FDA File Number 510(k) 012745

#### Device Description and Intended Use D.

The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of the presence of major metabolites above the threshold concentrations of up to 8 distinct drug classes, including assays for methamphetamines, acetaminophen/paracetamol, barbiturates, benzodiazepines, cocaine, 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.

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

| Acetaminophen/Paracetamol | APAP | 5 $\mu$ g/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 |
| Opiates | OPI | 300 ng/mL |
| Phencyclidine | PCP | 25 ng/mL |
| THC | THC | 50 ng/mL |
| Tricyclic Antidepressants | TCA | 1000 ng/mL |

The threshold concentrations are provided below:

This test provides only a preliminary test result. 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 common confirmatory method.

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

#### E. Summary of Comparison Data

A method comparison of acetaminophen results with GC/MS was performed using 102 specimens, with 20 specimens within ±25% of the cutoff concentration. The overall agreement is 97.1%. The three discordant samples were positive on the Triage TOX Drug Screen and were within 10% below the cutoff by GC/MS. The analytical performance characteristics of the assay were equivalent to predicate methods.

#### F. Conclusion

In conclusion, these studies demonstrate the substantial equivalence of the Triage TOX Drug Screen to existing products already marketed for detecting the presence of various drugs of abuse.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

FEB 2 8 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k043242 Re:

Trade/Device Name: Triage® TOX Drug Screen Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Regulatory Class: Class II
Product Code: LDP, DKZ, DIS, JXM, JXO, LAF, DJG, LCM, LDJ, LFG Dated: February 15, 2005 Received: February 16, 2005

Dear Dr. Dahlen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorobare) to tygency actment date of the Medical Device Amendments, or to conninered prov to they 2011 11:11 accordance with the provisions of the Federal Food, DNL, devices that have been require approval of a premarket approval application (PMA). and Cosmetic Hot (110) that to novice, subject to the general controls provisions of the Act. The r ou may, attrefer your in the Act include requirements for annual registration, listing of general volules profices province, 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 it may be ode joct to ouch abon 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 that 127 than intatutes 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).

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

## Page 2 –

This letter will allow you to begin marketing your device as described in your Section 5 ! (k) I his letter will anow you to ocgin mancemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thus, premarket notification. "The I DA Intuing of bassands of prour 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 Ir If you desire specific information and advertising of your device, please contact the of questions on the promotion and Safety at [phone]. Also, please note the Viro Diagnosic Device Device Livery and Berry and (2006) and Station" (21 CFF Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification" (21 CFF You may obtain other general information on your responsibilities under the Act from the I ou may outain other general meethianal 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,

Jean 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

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

Indications for Use

| 510(k) Number (if known): | K043242 |
|---------------------------|------------------------|
| 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 The Thage TOX Drug Screen is a norestende Intensible Interests of major metabolites above the MelerPlus for the point-of-calle qualitative decemination of the prooses for acelamon threshold concentrations of up to o distinst unde classes, me, opiates, phenovilli, indes, phenoyalidine, THC, amphetamines, methamplietamiles, batalturation, botherophilos, booking of the bositive results when and Incyclic antidepressunts in and or above therapeutic doses.

The threshold concentrations are provided below:

| Acetaminophen/Paracetamol | APAP | 5 ug/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 |
| Opiates | OPI | 300 ng/mL |
| Phencyclidine | РСР | 25 ng/mL |
| THC | THC | 50 ng/mL |
| Tricvclic Antidepressants | TCA | 1000 nq/mL |

This test provides only a preliminary test result. Clinical consideration and professional judgment This test provides only a preimmaly cost result, particularly in evaluating a preliminary postive must be applied to any firug of abuse toot result, a more specific alternate chemical method is result. In order to obtain a committed analytical room, a morethe common confirmatory method.

A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory A qualititutive obsitive acetaminophen/paracetamol results.

Over-The-Counter Use AND/OR X Prescription Use (Per 21 CFR 807 Subpart C) (Per 21 CFR 801.109)

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

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

Division Sign-Off
acting

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

510(k) K043342