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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.

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

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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

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