TRIAGE PANEL FOR DRUGS OF ABUSE, PLUS TRICYCLIC ANTIDEPRESSANTS AND OTHER TRIAGE DRUG TESTS by BIOSITE INCORPORATED

The Triage® Panel for Drugs of Abuse plus Trycyclic Antidepressants - Oplates 2000 (and other forms of the product) The mage Faller of Drugs of Audie plus Tryoyano of the major metabolites of drugs of also Phencyclidine, Benzodiazepines, Cocain Metabolite, Amphetamines, THC, Opiates, Barbiturates, and Tricyclic Antideoressants in urine,

This test provides only a preliminary test result. A more specific atternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatographylmass spectrometry (GCMS) is the preferred Clinical consideration and Other chemical confirmation methods are available. confirmatory method. professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The tricyclic test is a qualitative screening test. A negative result does not ellminate the possibility of the presence of tricyclic antidepressants in the urine specimen at concentrations lower than 1000 ng/ml. Should confirmation of the test result for the parent compound or the metabolites be desired, an alternative method that is capable of identification and quantification should be used, e.g. HPLC, GC or GC/MS. A positive screening result may be due to the reactivity of the parent tricyclic antidepressant and the various metabolites of the respective compound.

Device Description

Not Found

AI/ML Overview

The provided document describes a 510(k) premarket notification for a device called "Triage® Panel for Drugs of Abuse plus Trycyclic Antidepressants and Opiates 2000" (and related variations). While the document lists the "Indications for Use" and the "cut off concentrations" for various drugs, it primarily focuses on the FDA's substantial equivalence determination and regulatory aspects.

The document does NOT contain information about specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment that would typically be reported in a study proving the device meets acceptance criteria.

The section titled "The above products have the screening cut-off concentrations as outlined below:" and the subsequent table define the performance specifications or target concentrations at which the device is expected to detect the drugs. These are not the acceptance criteria for a study proving performance, but rather the operational thresholds of the device.

Without the actual study report, it's impossible to fully answer your request. However, I can infer the acceptance criteria based on the information provided (the cut-off concentrations) and explain what kind of study would typically be done for such a device, and what information would ideally be in a study report.

Inference of Acceptance Criteria and a Hypothetical Study Description:

Based on the nature of the device (a rapid immunoassay for drugs of abuse), the acceptance criteria would typically relate to its ability to correctly identify the presence or absence of drugs at or above the specified cut-off concentrations.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical):

Since the document only provides the target cut-off concentrations, the acceptance criteria would likely be defined around sensitivity and specificity at these concentrations.

Analyte	Cut-off Concentration (ng/mL)	Acceptance Criterion (Hypothetical)	Reported Device Performance (Hypothetical. Not in document)
MTD (Methadone)	300	Sensitivity ≥ 95% at or above 300 ng/mL; Specificity ≥ 95% at 0 ng/mL	Sensitivity: [e.g., 98.2%] Specificity: [e.g., 97.5%]
PCP (Phencyclidine)	25	Sensitivity ≥ 95% at or above 25 ng/mL; Specificity ≥ 95% at 0 ng/mL	Sensitivity: [e.g., 96.1%] Specificity: [e.g., 98.0%]
BZO (Benzodiazepines)	300	Sensitivity ≥ 95% at or above 300 ng/mL; Specificity ≥ 95% at 0 ng ng/mL	Sensitivity: [e.g., 95.5%] Specificity: [e.g., 96.8%]
COC (Cocaine Metabolite)	1000	Sensitivity ≥ 95% at or above 1000 ng/mL; Specificity ≥ 95% at 0 ng ng/mL	Sensitivity: [e.g., 97.0%] Specificity: [e.g., 99.1%]
AMP (Amphetamines)	500 (or 1000, depending on specific formulation)	Sensitivity ≥ 95% at or above 500/1000 ng/mL; Specificity ≥ 95% at 0 ng ng/mL	Sensitivity: [e.g., 96.5%] Specificity: [e.g., 97.2%]
THC (THC-COOH)	50 (or 2000, depending on specific formulation)	Sensitivity ≥ 95% at or above 50/2000 ng/mL; Specificity ≥ 95% at 0 ng ng/mL	Sensitivity: [e.g., 97.8%] Specificity: [e.g., 98.5%]
OPI (Opiates)	300	Sensitivity ≥ 95% at or above 300 ng/mL; Specificity ≥ 95% at 0 ng ng/mL	Sensitivity: [e.g., 98.0%] Specificity: [e.g., 97.0%]
BAR (Barbiturates)	300	Sensitivity ≥ 95% at or above 300 ng/mL; Specificity ≥ 95% at 0 ng ng/mL	Sensitivity: [e.g., 95.0%] Specificity: [e.g., 98.2%]
TCA (Tricyclic Antidepressants)	1000	Sensitivity ≥ 95% at or above 1000 ng/mL; Specificity ≥ 95% at 0 ng ng/mL	Sensitivity: [e.g., 96.3%] Specificity: [e.g., 97.7%]

Note: The actual acceptance criteria might also include parameters like agreement within a certain percentage of the cut-off, or detection within a certain analytical range.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the sample size for the test set. For a multi-analyte immunoassay, studies typically involve hundreds to thousands of samples, often stratified to include concentrations near the cut-off, well above the cut-off, and negative samples, as well as samples with potential cross-reactants.
Data Provenance: Not specified in the document. For such devices, clinical samples from various populations (e.g., diverse demographics, different geographic locations to capture varying drug use patterns) would be ideal. Whether retrospective or prospective is also not mentioned. Prospective collection would be preferred for avoiding bias.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: For drug of abuse testing, "experts" in the context of ground truth would typically refer to the highly trained laboratory personnel performing the gold standard confirmatory tests, not necessarily clinical experts. The ground truth method (GC/MS) is intrinsically the "expert" here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified. For analytical studies, a formal adjudication process like 2+1/3+1 is usually not directly applicable. The "adjudication" is inherent in the confirmatory method's results. If multiple runs of the confirmatory method were done, then a consensus approach might be employed, but it's not medical expert adjudication.

5. 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:

MRMC Study: This device is a diagnostic test kit for drugs of abuse. It is not an AI-assisted diagnostic imaging device. Therefore, an MRMC study or AI assistance is not applicable to this type of device. The "reader" is typically a laboratory technician interpreting a color change or a machine reading it.

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

Standalone Performance: Yes, the fundamental performance evaluation of such a device is its standalone performance. The document implies this through the cut-off concentrations. The device itself (the panel) yields a result based on chemical reactions. The "algorithm" here is the chemical reactivity. Its performance is measured against confirmatory methods (GC/MS).

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

Ground Truth Type: As explicitly stated in the document: "A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Other chemical confirmation methods are available."
- Therefore, the ground truth is established by Gas Chromatography/Mass Spectrometry (GC/MS) or other validated chemical confirmation methods. This is the gold standard for drug detection and quantification in urine.

8. The sample size for the training set:

Sample Size for Training Set: The document makes no mention of a "training set" in the context of machine learning or AI. For an immunoassay, the "training" phase involves optimizing the assay reagents and conditions during development to achieve the desired sensitivity, specificity, and cut-off levels. This isn't typically quantified as a distinct "training set size" in the same way as an AI model.

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

Ground Truth for Training Set: Not applicable in the AI sense. During the development and optimization of the immunoassay, various spiked and clinical samples would be tested, and their true concentrations (ground truth) would be established using a similar, highly accurate analytical method like GC/MS to guide the optimization of the immunoassay's performance characteristics.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 3 1997

John F. Bruni, Ph.D. . Director, Clinical and Regulatory Affairs Biosite Diagnostics 11030 Roselle Street San Diego, California 92121

K973784 Re : Triage® Panel for Drugs of Abuse plus Trycyclic Antidepressants and Opiates 2000 Regulatory Class: II Product Code: DKZ, DIS, JXM, DIO, DJR, DJG, LFG, LCM October 1, 1997 Dated: October 3, 1997 Received:

Dear Dr. Bruni:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be ... obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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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1-11 1

S 10(k) Number if known)

97 3724

Device Names: Triage® Panel for Drugs of Abuse plus Tricyclic Antidepressants - Opiates 2000 - 8 test panel Triage Panel for Drugs of Abuse -- Opiates 2000 - 7 test Panel

ITriage | Lance for Drugs of Abuse plus Methadone – Opiates 2000 – Methadone substituted for PCP

Triage 8 Panel for Drugs of Abuse - Opiates 2000 - Methadone substituted for PCP

Triage Intervention Panel for Drugs of Abuse - Opiates 2000 - 5 test panel

Triage Panel for Drugs of Abuse plus Tricyclic Antidepressants -8 test panel

Triage Panel for Drugs of Abuse - 7 test Panel

Triage Panel for Drugs of Abuse plus Methadone - Methadone substituted for PCP

8 Panel for Drugs of Abuse - Methadone substituted for PCP Triage T

Triage Intervention Panel for Drugs of Abuse - 5 test panel

The above products have the screening cut-off concentrations s outlined below:

Indications for Use:

The Triage® Panel for Drugs of Abuse plus Trycyclic Antidepressants - Oplates 2000 (and other forms of the product ) The mage Faller of Drugs of Audie plus Tryoyano of the major metabolites of drugs of also Phencyclidine, Benzodiazepines, Cocain Metabolite, Amphetamines, THC, Opiates, Barbiturates, and Tricyclic Antideoressants in urine,

The cut off concentrations are provided below:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 673784

MTD Methadone 300 no/mL РСР Phencyclidine 25 na/mL* BZO Benzodiazepines 300 ng/mL 300 ng/mL COC Cocaine (Benzoylecgonine) 1000 ng/mL* AMP Amphetamines 50 ng/mL THC THC(11-nor42-THC-9-carboxylic acid) 2000 ng/mL (300 ng/mL-other test formats) OPI Opiates (Morphine) 300 ng/mL BAR Barbiturates TCA Tricyclic Antidepressants 1000 ng/mL

Recommended Screening cut of concentrations by the Substance Abuse and Mental Health Services Administration formerly the National Institute on Drug Abuse.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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).