The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

Device Description

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

AI/ML Overview

This appears to be a 510(k) summary for a medical device called "Triage® TOX Drug Screen Controls." This specific document is a premarket notification for a control material, not a diagnostic device or an AI-powered system that requires performance studies with acceptance criteria in the traditional sense described in your request.

The core of this submission is to demonstrate substantial equivalence to an existing predicate device (Biosite Triage® TOX Drug Screen Controls K050037). Therefore, the "study" is a comparison to a legally marketed device rather than a performance study against predefined clinical acceptance criteria.

Here's how to address your questions based on the provided document:

A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for performance in the way a diagnostic device would (e.g., sensitivity, specificity, accuracy thresholds). The acceptance criterion implicitly is "substantial equivalence" to the predicate device.
Reported Device Performance: Instead of performance metrics, the document provides a table comparing characteristics to the predicate device. This comparison serves as the "proof" of substantial equivalence.

Characteristic	Acceptance Criteria (Implicit: Substantially Equivalent to Predicate)	Reported Device Performance (Proposed Device Characteristics)
Intended Use	Assayed control for monitoring urine-based drugs of abuse assays	Assayed control for monitoring urine-based drugs of abuse assays
Matrix	Human Urine	Human Urine
Form	Liquid	Liquid
Analytes	Commonly abused drugs	Commonly abused drugs
Storage	-20 °C or colder	-20 °C or colder

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This is not a clinical performance study with patient samples. The "test set" is essentially the characteristics of the proposed control material being compared to the predicate.
- Data Provenance: Not applicable. The "data" here refers to the specifications and qualitative characteristics of the control materials themselves, not clinical data from patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There is no "ground truth" in the sense of expert assessment of clinical cases. The ground truth for the control material is its chemical composition and intended function as defined by the manufacturer for monitoring performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This isn't a study involving human readers or interpretation.
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. This is a control material, not a diagnostic device involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a control material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a control material is its manufactured composition and the established values/ranges determined during its production, ensuring it challenges the assay appropriately. This document implies that the "truth" is that the proposed control is essentially the same as the predicate in its fundamental properties.
The sample size for the training set
- Not applicable. This is a physical control material, not an AI model or a device requiring a training set in that context.
How the ground truth for the training set was established
- Not applicable. See point 8.

In summary: This 510(k) pertains to a control material used to monitor the performance of drug screen tests, not a diagnostic device or an AI-powered system that would typically undergo the types of performance studies you've outlined. The "study" here is a qualitative comparison demonstrating the new control material is substantially equivalent in its characteristics and intended use to a previously cleared predicate device.

Summary

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510(k) Summary of Safety and Effectiveness

(JUL 1 0 2006

Triage® TOX Drug Screen Controls

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

k 060788 510(k) Number: (To be determined)

A. Name and Address of Submitter

Company Name:	Biosite Incorporated
Address:	9975 Summers Ridge RoadSan Diego, CA 92121
Telephone:	(888) 246-7483
Fax:	(858) 586-7543
Contact Person:	Robin Weiner
Date Summary Prepared:	03/21/06

B. Device Names

1. Trade Name
  Triage® TOX Drug Screen Controls
1. Common / Usual Name
  TOX Drug Screen Controls
1. Classification Name
  Drug Mixture Control Materials 21 CFR 862.3280 Class I

Product Code: DIF

C. Predicate Devices

Biosite Triage® TOX Drug Screen Controls (K050037)

D. Device Description and Intended Use

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

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E. Summary of Comparison Data

The table below provides a comparison of the technical principles between the Triage TOX Drug Screen Controls and the predicate device.

Characteristic	Triage TOX DrugScreen Controls(proposed)	Triage TOX DrugScreen Controls(K050037)
Intended Use	Assayed control formonitoring urine-based drugs ofabuse assays	Assayed control formonitoring urine-based drugs ofabuse assays
Matrix	Human Urine	Human Urine
Form	Liquid	Liquid
Analytes	Commonly abuseddrugs	Commonly abuseddrugs
Storage	-20 °C or colder	-20 °C or colder

F. Conclusion

The information provided in the premarket notification demonstrates that the Triage TOX Drug Screen Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage TOX Drug Screen Controls are safe and effective for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle, with the eagle in the center.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 0 2006

Ms. Robin Weiner Vice President Regulatory and Government Affairs Biosite Incorporated 9975 Summers Ridge Road San Diego, CA 92121

K060788 Re:

Trade/Device Name: Triage® TOX Drug Screen Controls Regulation Number: 21 CFR§862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: June 23, 2006 Received: June 26, 2006

Dear Ms. Weiner:

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 Title 21, Code of 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 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 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 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Albert Gutt

Alberto Gutierrez, Ph.D. 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): K060788

Device Name: Triage® TOX Drug Screen Controls

Indications For Use:

The Triage TOX Drug Screen Controls are to be used with the Triage TOX Screen tests and Triage Meters to assist the laboratory in monitoring test performance.

Prescription Use X ____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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

Carl Benson

Page 1 of 1

Livision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K060788

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). 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.