The Triage® Drugs of Abuse Panel Plus PPX is a competitive immunoassay used for the qualitative determination of the presence of the major metabolites of amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, tricyclic antidepressants, and propoxyphene in urine.

Device Description

AI/ML Overview

The provided text describes the Triage® Drugs of Abuse Panel Plus PPX, a competitive immunoassay for qualitative determination of various drug metabolites in urine. Here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the "Summary of Performance Data" for the device, which essentially serves as the study proving the device meets its acceptance criteria. The acceptance criteria themselves are implied by the tests conducted and the statements of successful results.

Study Type	Acceptance Criteria (Implied)	Reported Device Performance
Interfering Substances	No interference with assay results from common urine substances.	"None of the substances tested caused interference with the assay results." This was evaluated by spiking samples with drug 20% above and 20% below the threshold concentration.
Specificity/Cross-reactivity	Device accurately identifies drugs and related substances.	"Drugs and related substances were added to drug-free urine and tested... to determine the concentration that produces a positive result. The results are described in the labeling." (Specific concentrations are not provided in this summary, but are stated to be in the labeling).
Imprecision	Consistent results around the threshold concentration.	"The precision results were consistent with the threshold validation results." Imprecision was determined by testing three contrived specimens (25% below, at, and 25% above threshold) ten times each by three individuals for three days.
Threshold Validation	Device able to detect drug concentrations near the established threshold and thresholds are appropriately set.	"The data indicated that the device is able to detect drug concentrations near the threshold and that the thresholds are set appropriately." This was confirmed by testing specimens spiked at 25% above and 25% below the previously established thresholds for each drug, in increments of 25%.

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

Sample Size for Test Set:
- Interfering Substances: Not explicitly stated, but "Substances that are commonly in human urine" were tested with samples spiked with drug 20% above and 20% below the threshold concentration. The number of unique samples or tests is not provided beyond this.
- Specificity/Cross-reactivity: Not explicitly stated how many different "Drugs and related substances" were tested or how many replicates per substance.
- Imprecision: For each drug, three contrived specimens (25% below, at, and 25% above threshold) were tested. Each specimen was evaluated ten times each day for three days by three individuals. This amounts to 3 specimens * 10 tests/day * 3 days * 3 individuals = 270 tests per drug panel for imprecision.
- Threshold Validation: For each drug, specimens containing concentrations at various increments (25% above and 25% below the threshold) were tested. The number of distinct concentrations and replicates for each is not specified.
Data Provenance: The studies used "human urine" and "drug-free urine" that were spiked with the substances. The country of origin is not mentioned, but given the submitter is Biosite Incorporated in San Diego, CA, it's highly probable the data originated in the USA. The studies appear to be prospective, designed specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The ground truth for this diagnostic device is based on analytical accuracy rather than expert interpretation of images or clinical data. Therefore, the concept of "experts establishing ground truth" as it applies to image interpretation or clinical diagnosis is not directly applicable here. The performance is assessed against known concentrations of analytes in a controlled environment.

However, three individuals were involved in evaluating specimens for imprecision. Their qualifications are not mentioned beyond "individuals." For the other studies, the "ground truth" (i.e., the presence and concentration of the drugs) was established by carefully spiking known quantities of drugs into drug-free urine, which is a laboratory-controlled method and does not require subjective expert consensus.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used when there is subjective interpretation involved, such as in radiology or pathology. This type of adjudication is not applicable to a quantitative/qualitative immunoassay like the Triage® Drugs of Abuse Panel Plus PPX, as the results are instrument-read detections based on chemical reactions. The "ground truth" is defined by the known concentration of spiked analytes.

For the imprecision study, "Three individuals evaluated each specimen ten times each day for three days," suggesting that their readings were aggregated or compared, but no formal adjudication process for conflict resolution is described as would be used in subjective assessments.

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

No MRMC comparative effectiveness study was done. This type of study assesses how human readers' performance changes with AI assistance versus without. The Triage® Drugs of Abuse Panel Plus PPX is a standalone diagnostic device, not an AI-assisted interpretation tool for human readers. Its primary output is a qualitative determination (present/absent) of drug metabolites.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire "Summary of Performance Data" describes the standalone performance of the algorithm/device. The device's ability to detect different drug concentrations (threshold validation), its specificity, its imprecision, and its resistance to interference were all assessed as a standalone system without human-in-the-loop interpretation.

7. The Type of Ground Truth Used

The type of ground truth used for this device's performance studies is analytical ground truth based on known concentrations of analytes.

For interfering substances, specificity, and threshold validation, the ground truth was established by spiking known concentrations of drugs and related substances into drug-free urine. This allows for precise control over the presence and quantity of the target analytes.
For imprecision, contrived specimens with known drug concentrations (25% below, at, and 25% above the threshold) were used.

8. The Sample Size for the Training Set

The document does not mention a training set or any machine learning/AI components that would require one. This device is described as a "competitive immunoassay," which is a traditional biochemical assay, not an AI-driven system. Therefore, the concept of a "training set" is not relevant here.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

Summary

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KC14247

JUN 0 3 2002

510(k) Summary

Triage® Drugs of Abuse Panel plus PPX

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: (To be determined)

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:	3/5/02

B. Device Names

1. Trade Name
  Triage® Drugs of Abuse Panel plus PPX
1. Common / Usual Name
  Test System for Drugs of Abuse
1. Classification Name
  Amphetamine test system

Barbiturate test system

Benzodiazepine test system

Cocaine and cocaine metabolite test system

Opiate test system

Cannabinoid test system

Tricyclic antidepressant drugs test system

Propoxyphene test system

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

C. Predicate Devices

Triage® Drugs of Abuse Panel plus TCA (Biosite Incorporated), and the TDX/TDXFLX Propoxyphene test (Abbott Laboratories).

D. Device Description and Intended Use

E. Summary of Performance Data

Interfering Substances: Substances that are commonly in human urine were tested for interference with results in samples spiked with drug 20% above the threshold concentration and samples spiked with drug 20% below the threshold concentration. None of the substances tested caused interference with the assav results.

Specificity/Cross-reactivity: Drugs and related substances were added to drug-free urine and tested using the Triage® Drugs of Abuse Panel plus PPX 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. Three individuals evaluated each specimen ten times each day for three days. The precision results were consistent with the threshold validation results.

Previously established thresholds (amphetamines 1000, Threshold: methamphetamines 1000, barbiturates 300, benzodiazepines 300, tricvolic 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% above and 25% below the threshold. Each specimen was tested using the

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Triage® Drugs of Abuse Panel plus PPX. The data indicated that the device is able to detect drug concentrations near the threshold and that the thresholds are set appropriately.

F. Conclusion

The results of performance studies demonstrate that the Triage® Drugs of Abuse Panel plus PPX is substantially equivalent to currently marketed devices.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The eagle is facing right, and the profiles are stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 0 3 2002

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

Re: K014247

Trade/Device Name: Triage® Drugs of Abuse Panel plus PPX Regulation Number: 21 CFR 862.3100; 21 CFR 862.3150; 21 CFR 862.3170; 21 CFR 862.3870; 21 CFR 862.3250; 21 CFR 862.3650; 21 CFR 862.3700; 21 CFR 862.3910 Regulation Name: Amphetamine test system; Barbiturate test system; Benzodiazepine test system; Cannabinoid test system; Cocaine and cocaine metabolite test system; Opiate test system; Propoxyphene test system; Tricyclic antidepressant drugs test system Regulatory Class: Class II Product Code: DKZ; DIS; JXM; LDJ; DIO; DJG; LCM; JXN; LFG Dated: May 21, 2002

Received: May 22, 2002

Dear Dr. Dahlen:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html

Sincerely yours,

Steven Routman

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

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Page 1 of 1

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

Device Name: Triage® Drugs of Abuse Panel Plus PPX

Indications For Use:

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K014247

(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) √

Over-The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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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).