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 Description

AI/ML Overview

Acceptance Criteria and Study for Triage® TOX Drug Screen

This response details the acceptance criteria and the study proving the Triage® TOX Drug Screen meets these criteria, based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

Drug Class	Analyte	Threshold Concentration (Acceptance Criteria)	Reported Device Performance (Overall Agreement)
Acetaminophen/Paracetamol	APAP	5 µg/mL	97.1% (with GC/MS)
Amphetamines	AMP	1000 ng/mL	Not explicitly stated in the provided text
Methamphetamines	mAMP	1000 ng/mL	Not explicitly stated in the provided text
Barbiturates	BAR	300 ng/mL	Not explicitly stated in the provided text
Benzodiazepines	BZO	300 ng/mL	Not explicitly stated in the provided text
Cocaine	COC	300 ng/mL	Not explicitly stated in the provided text
Opiates	OPI	300 ng/mL	Not explicitly stated in the provided text
Phencyclidine	PCP	25 ng/mL	Not explicitly stated in the provided text
THC	THC	50 ng/mL	Not explicitly stated in the provided text
Tricyclic Antidepressants	TCA	1000 ng/mL	Not explicitly stated in the provided text

Note: The provided 510(k) summary only explicitly reports the agreement for Acetaminophen/Paracetamol. For other drug classes, the summary states that "The analytical performance characteristics of the assay were equivalent to predicate methods," but does not provide specific agreement percentages or studies for each individual drug class in the provided text. The table above reflects the information available in the given document. The acceptance criterion for each drug class is its specified threshold concentration.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- For Acetaminophen/Paracetamol: 102 specimens were used for the method comparison study.
- Specifically, 20 of these specimens were within ±25% of the cutoff concentration.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The summary only mentions "specimens" without further details on their source.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided 510(k) summary does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

The provided 510(k) summary does not mention an adjudication method. For the Acetaminophen/Paracetamol study, the comparison was made directly against a reference method (GC/MS).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated fluorescence immunoassay (point-of-care qualitative determination) and does not involve human readers interpreting images or data where AI assistance would typically be evaluated for reader improvement.

6. Standalone Performance Study

Yes, a standalone performance study was done for the Acetaminophen/Paracetamol assay. The summary describes a "method comparison of acetaminophen results with GC/MS" and reports an "overall agreement of 97.1%." This is the algorithm's (device's) performance without human-in-the-loop. The summary also states, "The analytical performance characteristics of the assay were equivalent to predicate methods," implying similar standalone performance evaluations for other drug classes, although specific data is not provided in this extract.

7. Type of Ground Truth Used

For the Acetaminophen/Paracetamol assay, the ground truth was established using an alternate chemical method: Gas Chromatography/Mass Spectroscopy (GC/MS). For acetaminophen/paracetamol specifically, "A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method." The summary implies GC/MS as the common confirmatory method for other drug classes generally.

8. Sample Size for the Training Set

The provided 510(k) summary does not mention a training set or its sample size. This type of device (fluorescence immunoassay) typically relies on chemical and biological parameters rather than machine learning models that require training sets in the same way.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned for this device, information on how its ground truth was established is not applicable based on the provided document.

Summary

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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 StreetSan Diego, CA 92121
Telephone:	(858) 455-4808
Fax:	(858) 535-8350
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.

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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:

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.

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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).

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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 (240)276-0484. 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 (800) 638-2041 or (301) 443-6597 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

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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

Regulation Number and Section

§ 862.3030 Acetaminophen test system.

(a)
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.(b)
Classification. Class II.