The Triage® TOX Drug Screen Calibration Verification Controls are to be used with the Triage® TOX Drug Screen and Triage® Meter to verify the calibration of the Triage® TOX Drug Screen throughout the reportable range.

Device Description

The Triage® TOX Drug Screen Controls are to be used with the Triage® TOX Drug Screen and Triage® Meter to verify the calibration of the Triage® TOX Drug Screen throughout the reportable range.
Matrix: Human Urine
Form: Liquid
Analytes: Commonly abused drugs
Storage: -20 °C or colder

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Triage® TOX Drug Screen Calibration Verification Controls":

Please note: The provided document is a 510(k) summary for a quality control material, not a diagnostic device that directly detects disease. Therefore, many of the typical performance metrics associated with medical imaging AI (like sensitivity, specificity, AUC) are not applicable. Instead, the focus is on demonstrating substantial equivalence to predicate devices for its intended use as a control.

Acceptance Criteria and Device Performance for Triage® TOX Drug Screen Calibration Verification Controls

Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Intended Use	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	2-8 °C (for predicates)	-20 °C or colder
Safety and Effectiveness	Substantially equivalent to predicates	Deemed safe and effective (by FDA K013002 letter)

Note: For a quality control material, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to already approved predicate devices. The listed characteristics define the product's fundamental attributes, and the "reported performance" is essentially a description of these attributes affirming alignment with the predicates' intended use.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: This document does not describe specific "test set" data in the way one would for a diagnostic device. The study described is a comparison against predicate devices based on technical characteristics. Therefore, there's no mention of a traditional sample size for a test set.
- Data Provenance: Not applicable in the context of this 510(k) summary. The comparison is based on the inherent technical specifications and intended use of the control materials themselves, not patient data.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. There is no "ground truth" establishment in the traditional sense, as this is a comparison of control material characteristics, not a diagnostic's accuracy against a known true state of a patient.
Adjudication Method for the Test Set:
- Not applicable. No adjudication method is mentioned as there is no traditional "test set" with results requiring expert review or consensus.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. This document describes a quality control material, not a diagnostic algorithm for human interpretation.
Standalone (Algorithm Only) Performance Study:
- A "standalone" performance study in the context of this device would involve evaluating the control material's ability to verify calibration of the Triage® TOX Drug Screen. While the document states the controls "verify the calibration," it does not provide specific data or a study design for this verification process or its results. The focus is on the comparison of the control material itself to other control materials.
Type of Ground Truth Used:
- Not applicable. For a quality control material, the "ground truth" isn't pathology, outcomes data, or expert consensus on a diagnosis. Instead, the "truth" is that the control material is fit for its intended purpose of verifying calibration, which is established by its chemical properties and stability, implicitly benchmarked against predicate controls.
Sample Size for the Training Set:
- Not applicable. This device is a biochemical control material, not an AI/ML algorithm that requires a training set.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As this is not an AI/ML device, there's no training set or ground truth establishment relevant to algorithm training.

Summary of the Study Proving Acceptance Criteria:

The "study" described in the 510(k) summary is primarily a comparison of technical characteristics and intended use between the Triage® TOX Drug Screen Calibration Verification Controls and two predicate devices: BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) and Dade Behring Emit Calibrators/Controls (K935230).

The acceptance criteria are implicitly met by demonstrating substantial equivalence to these previously cleared devices. The key elements of this "comparison study" are presented in the table in section "E. Summary of Comparison Data":

Intended Use: All devices are for monitoring urine-based drugs of abuse assays.
Matrix: All devices use Human Urine.
Form: All devices are Liquid.
Analytes: All devices contain commonly abused drugs.
Storage: This is the only noted difference, with the Triage® controls requiring -20°C or colder storage, compared to the predicates' 2-8°C. This difference does not negate substantial equivalence, though it's a difference in handling.

Conclusion stated in the document: "The information provided in the premarket notification demonstrates that the Triage® TOX Drug Screen Calibration Verification Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® TOX Drug Screen Calibration Verification Controls are safe and effective for their intended use."

The FDA's decision letter (K013002) confirms this, stating, "We have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device, subject to the general controls provisions of the Act." This FDA letter serves as the ultimate proof that the device meets the regulatory acceptance criteria for market clearance.

Summary

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OCT - 3 2001

510(k) Summary of Safety and Effectiveness

Triage TOX Drug Screen Calibration Verification 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:

K0/3002

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:	9/4/01

B. Device Names

1. Trade Name
  Triage® TOX Drug Screen Calibration Verification 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

BIO-RAD Liquicheck Urine Toxicology Controls (K981590, K970666) Dade Behring Emit Calibrators/Controls (K935230)

D. Device Description and Intended Use

The Triage® TOX Drug Screen Controls are to be used with the Triage® TOX Drug Screen and Triage® Meter to verify the calibration of the Triage® TOX Drug Screen throughout the reportable range.

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E. Summary of Comparison Data

The table below provides a comparison of the technica! principles between the Triage® TOX Drug Screen Calibration Verification Controls and the predicate devices.

Characteristic	Triage® TOX DrugScreenCalibrationVerificationControls	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 Calibration Verification Controls are substantially equivalent to previously approved predicate devices. The information provided assures that the Triage® TOX Drug Screen Calibration Verification Controls are safe and effective for their intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head.

OCT - 3 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Jeffrey R. Dahlen Principal Scientist Biosite Diagnostics, Inc. 11030 Roselle Street San Diego, CA 92121

Re: K013002

Trade/Device Name: Triage® TOX Calibration Verification Controls Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical Toxicology Control Material Regulatory Class: I, reserved Product Code: DIF Dated: September 5, 2001 Received: September 6, 2001

Dear Dr. Dahlen:

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 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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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Page 2 -

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 regulation (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 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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) K013002

Device Name: Triage® TOX Drug Screen Calibration Verification Controls

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kinia Alexander/Ian Lopez
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K013002

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

(Optional Format 1-2-96)

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.