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

Device Description

The Triage TOX Drug Screen Controls are to be used with the Triage TOX The Thage TOX Drug Triage MeterPlus to assist the laboratory in monitoring test performance.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study, structured according to your request:

Based on the provided document, there is no detailed information about acceptance criteria or a specific study proving the device meets those criteria. The document is a 510(k) summary for a Class I medical device (Quality Control Material), which typically relies on demonstrating substantial equivalence to a predicate device rather than extensive clinical efficacy studies with predefined acceptance criteria.

The document focuses on the substantial equivalence of the Triage® TOX Drug Screen Controls to existing predicate devices (Triage TOX Drug Screen Controls K012999, BIO-RAD Liquicheck Urine Toxicology Controls, Dade Behring Emit Calibrators/Controls). The "Summary of Comparison Data" section compares characteristics like intended use, matrix, form, analytes, and storage, aiming to show that the new device is fundamentally similar to the already approved devices.

Therefore, many of the requested points cannot be answered from the provided text as the nature of the submission does not require such detailed efficacy or performance studies with acceptance criteria as might be expected for a Class II or Class III medical device or a device making novel performance claims.

However, I will extract what can be inferred or directly stated, noting where information is absent:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics. The underlying acceptance criterion for this 510(k) is "substantial equivalence" to predicate devices.
- Reported Device Performance: Not reported in terms of specific performance metrics (e.g., accuracy, precision, sensitivity, specificity). The performance is implicitly assumed to be equivalent to the predicate devices due to the similar characteristics.

Acceptance Criterion (Inferred)	Reported Device Performance (Inferred)
Substantial Equivalence to Predicate Devices	Meets characteristics of predicate devices (Intended Use, Matrix, Form, Analytes, Storage)

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 specified.
- Data Provenance: Not specified. The document only references "information provided in the premarket notification," which might include internal testing data.
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)
- Number of experts: Not applicable/Not specified. This type of quality control material typically wouldn't use expert-derived ground truth in the same way a diagnostic imaging device would.
- Qualifications of experts: Not applicable/Not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/Not specified.
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: No. This is a quality control material, not an AI-assisted diagnostic device, so an MRMC study is not relevant or described.
- Effect size of human improvement with AI: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a quality control material, not an algorithm. Its "performance" refers to its consistency and accuracy in verifying the performance of other diagnostic tests.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not explicitly stated. For quality control materials, ground truth would typically refer to the known, certified concentration of analytes within the control solution. This would be established through highly accurate analytical methods (e.g., mass spectrometry) during the manufacturing and characterization process of the controls themselves.
The sample size for the training set
- Sample Size: Not applicable. This device is not an AI algorithm and does not have a "training set."
How the ground truth for the training set was established
- How ground truth was established: Not applicable.

Summary of Study (Based on Provided Information):

There is no "study" in the traditional sense of a clinical trial or performance evaluation with specific acceptance criteria detailed in the provided document. The submission is a 510(k) premarket notification which demonstrates substantial equivalence to already legally marketed predicate devices.

The "study" that proves the device meets the (inferred) acceptance criteria is the comparison of technical characteristics between the Triage® TOX Drug Screen Controls and the predicate devices, as presented in "Summary of Comparison Data" section E. This comparison focuses on:

Intended Use: Assayed control for monitoring urine-based drugs of abuse assays.
Matrix: Human Urine.
Form: Liquid.
Analytes: Commonly abused drugs.
Storage: -20 °C or colder (Triage TOX), 2-8 °C (Bio-Rad, Dade Behring).

The conclusion states: "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."

This confirms that for a Class I device of this nature, the "proof" is centered on a strong technical comparison showing it is not significantly different from current market offerings, rather than a de novo clinical performance study against specific metrics.

Summary

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K 050037

510(k) Summary of Safety and Effectiveness 11.

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.

(To be determined) 510(k) Number:

A. Name and Address of Submitter

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:	1/6/2005

B. Device Names

1. Trade Name
  Triage® TOX Drug Screen Controls
1. Common / Usual Name
  Not Applicable
1. Classification Name
  Quality Control Material (Assayed and Unassayed) 21 CFR 862:3280 Class I Product Code: DIF

C. Predicate Devices

Triage TOX Drug Screen Controls (K012999) BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) Dade Behring Emit Calibrators/Controls (K935230)

D. Device Description and Intended Use

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The Triage TOX Drug Screen Controls are to be used with the Triage TOX The Thage TOX Drug Triage MeterPlus to assist the laboratory in monitoring test performance.

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 devices.

Characteristic	Triage TOX DrugScreen Controls	Bio-RadLiquicheck	Dade BehringEmit
Intended Use	Assayed control formonitoring urine-based drugs ofabuse assays	Assayed control formonitoring urine-based drugs ofabuse assays	Assayed control formonitoring urine-based drugs ofabuse assays
Matrix	Human Urine	Human Urine	Human Urine
Form	Liquid	Liquid	Liquid
Analytes	Commonly abuseddrugs	Commonly abuseddrugs	Commonly abuseddrugs
Storage	-20 °C or colder	2-8 °C	2-8 °C

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized stripes representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 2 2005

Jeffrey R. Dahlen, Ph.D Director, Clinical & Regulatory Affairs Biosite Inc. 11030 Roselle Street San Diego, CA 92121

K050037 Re:

Trade Name: Triage TOX Drug Screen Controls Regulatory Number: 21 CFR 862.3280 Regulatory Name: Clinical toxicology control material Regulatory Class: Class I Product Code: DIF Dated: February 18, 2005 Received: February 22, 2005

Dear Dr. Dahlen:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(th promaint is substantially equivalent (for the referenced above and have determined the to legally marketed predicate devices marketed in indications for use stated in the cholosary w regional date of the Medical Device interstate colliments, or to devices that have been reclassified in accordance with the provisions of Amendments, of to devices that have boon frequire approval of a premarket the Federal FOOd, Drug, and Cosment Pres (116) - Market the device, subject to the general approval application (1 Mr.). - 1 ove general controls provisions of the Act include controls provisions of the rec. "The gentiration 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 If your device is classinod (occ as a rey in a controls. Existing major regulations affecting (FMA), it may be subject to flact adally f Federal Regulations, Title 21, Parts 800 to 895. In your device can be found in the becan nouncements 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 mean that 117A has made a decemmaregulations administered by other Federal agencies. of the Act of ally I ederal states and virenents, including, but not limited to: registration r ou must compry with and 807); labeling (21 CFR Parts 801 and 809); and good alla listing (21 CF RT Part 001) Master 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) I his letter will anow you to ocgin marketing your avvalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your accruits premarket notification: "The PDT Intention 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, of fr If you desire specific information advertising of your device, please contact the Office of In of questions on the promotion 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 I ou may obtain other general mormational 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,

Sean 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): K050037

Device Name: Triage TOX Drug Screen Controls

Indications For Use:

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

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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)

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Albert tert

(Division Sign-C Division of Clinical Laboratory Devices 510(k) Number_KOS OO S OO S OO S 7

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.