The Triage® TOX Drug Screen is a fluorescence immunoassay intended for use in the semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.

The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage® Meter for the point-of-care semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.

Device Description

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Triage® TOX Drug Screen, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in a table format with specific pass/fail thresholds. Instead, it describes various performance studies and their general outcomes. The acceptance criteria can be inferred from the reported study objectives and conclusions.

Performance Characteristic	Acceptance Criteria (Inferred)	Reported Device Performance
Analytical Sensitivity	Analytical sensitivity must be below the reportable range of the test for all analytes.	"In all cases, the analytical sensitivity was below the reportable range of the test."
Interfering Substances	No common urine substances should interfere with assay results when drugs are present at 25% above or below the threshold.	"None of the substances tested caused interference with the assay results."
Specificity/Cross-reactivity	Device should accurately detect specific drugs and related substances, with cross-reactivity properties documented in labeling.	"Drugs and related substances were added to drug-free urine and tested using the Triage® TOX Drug Screen to determine the concentration that produces a positive result. The results are described in the labeling." (Exact results not provided in the summary, but the study implies specific concentrations were successfully determined.)
Imprecision	Acceptable within-day and total imprecision at concentrations 25% below, at, and 25% above the threshold.	"The within-day and total imprecision for each analyte are described in the labeling." (Exact precision values not provided, but the study was conducted to determine them.)
Threshold Challenge	Device results should parallel expected agreement based on the coefficient of variation when challenged with concentrations 25% above and below established thresholds.	"The data paralleled the expected agreement based on the coefficient of variation of the assays."
Overall Conclusion	The device is safe and effective for semi-quantitative or qualitative evaluation of drugs of abuse in urine.	"The results of performance studies demonstrate that the Triage® TOX Drug Screen is a safe and effective method for the semi-quantitative or qualitative evaluation of drugs of abuse in urine."

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

Analytical Sensitivity: No specific sample size is mentioned, but "all cases" implies a comprehensive assessment across all analytes.
Interfering Substances: No specific sample size is mentioned for the number of urine samples or interfering substances, but it states "Substances that are commonly in human urine were tested."
Specificity/Cross-reactivity: No specific sample size is mentioned, but "Drugs and related substances were added to drug-free urine."
Imprecision: "Three contrived specimens" were used, each evaluated multiple times to determine within-day and total imprecision.
Threshold Challenge: No specific sample size is mentioned for the number of specimens at each concentration increment, but it states "specimens containing each drug or drug metabolite spiked into drug-free urine at concentrations in increments of 25% above and 25% below the threshold. Each specimen was tested using the Triage® TOX Drug Screen."

Data Provenance:
All studies appear to use contrived specimens (drug or related substances spiked into drug-free urine) or spiked human urine for interference testing. This suggests the data is primarily prospective and controlled, generated specifically for these studies. The country of origin is not explicitly stated, but given Biosite Incorporated is based in San Diego, CA, USA, it's highly probable the studies were conducted in the USA.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Ground Truth Establishment: The ground truth for the test set was established through the known concentration of spiked drugs or metabolites in the urine samples. This is a common method for analytical performance testing of in vitro diagnostic devices.
Number of Experts: No experts were directly used to "establish" the ground truth in the sense of making diagnoses or interpretations like in imaging studies. The ground truth was based on the controlled preparation of the samples.
Qualifications of Experts: Not applicable, as expert consensus or interpretation was not the method for ground truth. However, the imprecision study notes that it was evaluated by "individuals without training as clinical laboratorians," suggesting the device is user-friendly and robust even with non-expert operators.

3. Adjudication Method for the Test Set:

Not applicable. The studies involved analytical measurements against known concentrations or expected outcomes, not subjective interpretations requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) fluorescence immunoassay, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data alongside an algorithm. The "readers" mentioned in the imprecision study were "individuals without training as clinical laboratorians," not expert diagnosticians whose performance would be compared or improved by an AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Yes, a standalone study was done. The entire summary describes the performance of the Triage® TOX Drug Screen as a standalone analytical device. While it is intended for use with the "Triage® Meter," the performance data presented is for the assay system itself, without human interpretation influencing the final analytical result. The output of the device (semi-quantitative or qualitative determination) is the direct result of the immunoassay and meter.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used was spiked concentrations of drugs and drug metabolites in drug-free urine. This is a form of analytical truth or definitive truth established by controlled laboratory preparation and confirmed by reference methods (like GC/MS and HPLC, which are mentioned as predicate comparisons, implying their role in validating the concentrations).

7. The sample size for the training set:

The 510(k) summary does not provide information on a training set sample size. This is typical for an immunoassay device. Immunoassays are based on biochemical reactions and often characterized analytically rather than "trained" in the machine learning sense. The device's performance is described through various validation studies (analytical sensitivity, interference, specificity, imprecision, threshold challenge) using the described test sets, not a separate training set.

8. How the ground truth for the training set was established:

Not applicable. As a traditional immunoassay, there isn't a "training set" in the context of machine learning, so the method for establishing ground truth for a training set is not relevant. The device operates based on predefined antibody-antigen reactions and calibration, not machine learning from a training dataset.

Summary

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K012745

510(k) Summary of Safety and Effectiveness

JAN 1 0 2002

Triage® TOX Drug Screen

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
	San Diego, CA 92121
Telephone:	(858) 455-4808
Fax:	(858) 535-8350
Contact Person:	Jeffrey R. Dahlen, Ph.D.
Date Summary Prepared:	8/15/01

B. Device Names

1. Trade Name

Triage® TOX Drug Screen

1. Common / Usual Name
  Test System for Drugs of Abuse

3. Classification Name

Amphetamıne test system

Barbiturate test system

Benzodiazepine test system

Cocaine and cocaine metabolite test system

Opiate test system

Cannabinoid test system

Methamphetamine test system

Tricyclic antidepressant drugs test system

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(Note: Phencyclidine test system the phencyclidine test system has not been classified but has the same intended use to measure phencyclidine in serum or urine.

C. Predicate Devices

Comparison to reference methods such as GC/MS and HPLC.

D. Device Description and Intended Use

E. Summary of Performance Data

Analytical Sensitivity: In all cases, the analytical sensitivity was below the reportable range of the test.

Interfering Substances: Substances that are commonly in human urine were tested for interference with results in samples spiked with drug 25% above the threshold concentration and samples spiked with drug 25% below the threshold concentration. None of the substances tested caused interference with the assay results.

Specificity/Cross-reactivity: Drugs and related substances were added to drug-free urine and tested using the Triage® TOX Drug Screen to determine the concentration that produces a positive result. The results are described in the labeling.

Imprecision: Imprecision was determined by measuring three contrived specimens with drug added at approximately 25% below the threshold concentration, the threshold concentration, and 25% above the threshold concentration. Each specimen was evaluated at three external sites by individuals without training as clinical laboratorians. The within-day and total imprecision for each analyte are described in the labeling.

Previously established thresholds (amphetamines 1000, Threshold: methamphetamines 1000, barbiturates 300, benzodiazepines 300, tricyclic antidepressants 1000, phencyclidine 25, opiates 300, cocaine 300, and THC 50) were challenged by testing specimens containing each drug or drug metabolite spiked into drug-free urine at concentrations in increments of 25%

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above and 25% below the threshold. Each specimen was tested using the Triage® TOX Drug Screen. The data paralleled the expected agreement based on the coefficient of variation of the assays.

F. Conclusion

The results of performance studies demonstrate that the Triage® TOX Drug Screen is a safe and effective method for the semi-quantitative or qualitative evaluation of drugs of abuse in urine.

11.000

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 5 2002

Jeffery R. Dahlen, Ph.D. Principal Scientist Clinical & Regulatory Affairs Biosite Diagnostics 11030 Roselle Street San Diego, CA 92121

K012745

Re:

Trade/Device Name: Triage® TOX Drug Screen Trade/Device Namber: 21 CFR 862.3100; 21 CFR 862.3250; 21 CFR 862.3870;
Regulation Number: 21 CFR 862.3100; 21 CFR 862.3250; 21 CFR 862.3870; 21 CFR 862.3650; 21 CFR 862.3150; 21 CFR 862.3170; 21 CFR 862.3610; 21CFR 862.3910 Regulation Name: Amphetamine test system; Cocaine and cocaine metabolite test system; Cannabinoid test system; Opiate test system; Barbiturate test system; Benzodiazepine test system; Darbhamphetamine test system; Tricyclic antidepressant test system Regulatory Class: Class II Regulatory Class: Class: Class II
Product Code: DKZ; DIO; LDJ; DJG; DIG; DIG; JXM; LAF; LCM; MLK Dated: November 16, 2001

Received: November 19, 2001

Dear Dr. Dahlen:

This letter corrects the substantially equivalent letter dated January 10, 2002, regarding the I his letter corrects the substantially equit regulation name and the incorrect indications for use.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) prematially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard manative te of the Medical Device American Car to commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been icelassified in accessor al of a premarket approval application (PMA). and Cosment Act (Act) that to not require approvial controls provisions of the Act. The You may, therefore, thanket the devices, bet include requirements for annual registration, listing of general controls provisions of the free 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 If your device is classified (see above) and existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of I casts oncerning your device in the Federal Register.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) prematket This letter will allow you to begin marketing your device of your device to a legally marketed notification. The FDA finding of Substantal equivalice or your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1
0 Carles of Comment of Callers) and makes been assesses the Office of Complian If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Office of additionally 809.10 for in vitro diagnostic consists on the promotion and advertising of your device, and (301) 594-4588. Additionally, for questions on are projects . Also, please note the regulation please contact the Office of Compitation at (301) of TV (21CFR 807.97). Other general
entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other ge entitled, "Misbranding by relefence to picmarse of rived from the Division of Small
information on your responsibilities under the Act may be obtains of Small information on your responsibilities under and its toll-free mumber (800) 638-2041 or
Manufacturers International and Consumer Assistance at its toll-free munder (800)" Manufacturers International and Consumer Prissiblance and Collection of the Sun anain.html".
(301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): (to be determined) K012745

Device Name: Triage® TOX Drug Screen

Indications For Use:

The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be
r and the seen is a fluorescence intent of care semi quantitative or The Triage TOX Drug Screen is a labor-of-care sem-quantitative or used with the Thage "Meter for the personites of amphetamines, qualitative determination of major metabolitos ones, cocaine, opiates,
methamphetamines, barbituralis, benzodiazepines, cocaine, opiates, methamplietamines, barbiturates, benast in urine.

Dan Coray
(Division Sign-Off)

Division of Clinical Laboratory De 510(k) Number .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).