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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.

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.

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:

1. 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

2. 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.

3. 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.

4. 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.

5. 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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • No. This is a control material, not an algorithm.

7. 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.

8. 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.

9. 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.

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The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.

The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

This test provides only preliminary test results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method.

A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.

The Triage TOX Drug Screen Methadone assay is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of methadone in urine.

The Triage Methadone assay is identical in principle, reagents and procedure to the previously cleared Triage TOX Drug Screen (FDA file number K043242). The only difference between the two tests is that an assay for methadone has been added.

Here's a breakdown of the acceptance criteria and study information for the Triage® TOX Drug Screen Methadone assay, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document focuses on the substantial equivalence of the new Methadone assay to a previously cleared device. The primary performance metric presented is the overall agreement with the predicate device and the confirmation by GC/MS for discordant samples.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: 102 specimens
• Data Provenance: Obtained from clinical sources (retrospective, collected from patients for whom testing was clinically indicated). The country of origin is not specified, but the submission is to the FDA in the US, suggesting the data is likely from the US.

3. Number of Experts and Qualifications for Ground Truth

• The document does not specify the number of experts used to establish the ground truth or their qualifications.
• The primary ground truth for discordant samples was established using Gas Chromatography/Mass Spectroscopy (GC/MS), which is an analytical chemical method and not a human expert consensus.

4. Adjudication Method

• Not applicable / None specified for clinical samples. The comparison relies on the Triage 8 Panel for Drugs of Abuse as a predicate and GC/MS for discrepancy resolution. There's no indication of multiple human readers adjudicating results.

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

• No, an MRMC study was not done. This device is an in vitro diagnostic (IVD) assay designed for qualitative determination of substances, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, the concept of improving human readers with AI assistance does not apply in this context.

6. Standalone (Algorithm Only) Performance Study

• Yes, in effect. The study described is a direct comparison of the Triage Methadone assay ("algorithm only") against a predicate device and GC/MS. The device's performance (96.1% overall agreement, 100% agreement with GC/MS for specific enantiomers) is a standalone performance metric. The "Triage MeterPlus" performs the fluorescence immunoassay without human interpretation of the raw signal.

7. Type of Ground Truth Used

• Predicate Device/Clinical Samples and GC/MS Confirmation: For the initial comparison, the "ground truth" was established by the predicate device (Biosite Triage® 8 Panel for Drugs of Abuse). For the discordant samples between the Triage Methadone assay and the predicate, the definitive ground truth was established by GC/MS (Gas Chromatography/Mass Spectroscopy), an objective analytical gold standard for drug confirmation. Specifically, it determined the presence of l-methadone at concentrations greater than 175 ng/mL.

8. Sample Size for the Training Set

• The document does not explicitly mention a training set sample size. This type of IVD device is typically developed and optimized during its creation phase, and the comparison study is a validation of the finalized assay. The "training" would be part of the R&D process, not typically a separate, reported clinical training set like in AI/ML models.

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

• Not explicitly stated/not applicable in the context of a "training set" as understood in AI/ML. For immunoassay development, ground truth for optimization and calibration would typically be established using known concentrations of analytes (e.g., methadone standards) prepared in a suitable matrix (e.g., synthetic urine or stripped urine), often confirmed by methods like GC/MS. The document focuses on the validation against clinical samples and a well-established reference method.

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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.

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.

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:

1. 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.

2. 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.

3. 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.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Adjudication method: Not applicable/Not specified.

5. 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.

6. 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.

7. 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.

8. 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."

9. 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.

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The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of the presence of major metabolites above the threshold concentrations of up to 8 distinct drug classes, including assays for methamphetamines, acetaminophen/paracetamol, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the common confirmatory method.

A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.

The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of the presence of major metabolites above the threshold concentrations of up to 8 distinct drug classes, including assays for methamphetamines, acetaminophen/paracetamol, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

Acceptance Criteria and Study for Triage® TOX Drug Screen

This response details the acceptance criteria and the study proving the Triage® TOX Drug Screen meets these criteria, based on the provided 510(k) summary.

1. Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary only explicitly reports the agreement for Acetaminophen/Paracetamol. For other drug classes, the summary states that "The analytical performance characteristics of the assay were equivalent to predicate methods," but does not provide specific agreement percentages or studies for each individual drug class in the provided text. The table above reflects the information available in the given document. The acceptance criterion for each drug class is its specified threshold concentration.

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

• Test Set Sample Size:
  • For Acetaminophen/Paracetamol: 102 specimens were used for the method comparison study.
  • Specifically, 20 of these specimens were within ±25% of the cutoff concentration.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The summary only mentions "specimens" without further details on their source.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• The provided 510(k) summary does not mention the use of experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

• The provided 510(k) summary does not mention an adjudication method. For the Acetaminophen/Paracetamol study, the comparison was made directly against a reference method (GC/MS).

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

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is an automated fluorescence immunoassay (point-of-care qualitative determination) and does not involve human readers interpreting images or data where AI assistance would typically be evaluated for reader improvement.

6. Standalone Performance Study

• Yes, a standalone performance study was done for the Acetaminophen/Paracetamol assay. The summary describes a "method comparison of acetaminophen results with GC/MS" and reports an "overall agreement of 97.1%." This is the algorithm's (device's) performance without human-in-the-loop. The summary also states, "The analytical performance characteristics of the assay were equivalent to predicate methods," implying similar standalone performance evaluations for other drug classes, although specific data is not provided in this extract.

7. Type of Ground Truth Used

• For the Acetaminophen/Paracetamol assay, the ground truth was established using an alternate chemical method: Gas Chromatography/Mass Spectroscopy (GC/MS). For acetaminophen/paracetamol specifically, "A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method." The summary implies GC/MS as the common confirmatory method for other drug classes generally.

8. Sample Size for the Training Set

• The provided 510(k) summary does not mention a training set or its sample size. This type of device (fluorescence immunoassay) typically relies on chemical and biological parameters rather than machine learning models that require training sets in the same way.

9. How Ground Truth for the Training Set Was Established

• As no training set is mentioned for this device, information on how its ground truth was established is not applicable based on the provided document.

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The Triage® TOX Drug Screen is a fluorescence immunoassay intended for use in the semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.

The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage® Meter for the point-of-care semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.

The Triage® TOX Drug Screen is a fluorescence immunoassay intended for use in the semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.

Here's a breakdown of the acceptance criteria and study information for the Triage® TOX Drug Screen, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria in a table format with specific pass/fail thresholds. Instead, it describes various performance studies and their general outcomes. The acceptance criteria can be inferred from the reported study objectives and conclusions.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

• Analytical Sensitivity: No specific sample size is mentioned, but "all cases" implies a comprehensive assessment across all analytes.
• Interfering Substances: No specific sample size is mentioned for the number of urine samples or interfering substances, but it states "Substances that are commonly in human urine were tested."
• Specificity/Cross-reactivity: No specific sample size is mentioned, but "Drugs and related substances were added to drug-free urine."
• Imprecision: "Three contrived specimens" were used, each evaluated multiple times to determine within-day and total imprecision.
• Threshold Challenge: No specific sample size is mentioned for the number of specimens at each concentration increment, but it states "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 Triage® TOX Drug Screen."

Data Provenance:
All studies appear to use contrived specimens (drug or related substances spiked into drug-free urine) or spiked human urine for interference testing. This suggests the data is primarily prospective and controlled, generated specifically for these studies. The country of origin is not explicitly stated, but given Biosite Incorporated is based in San Diego, CA, USA, it's highly probable the studies were conducted in the USA.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Ground Truth Establishment: The ground truth for the test set was established through the known concentration of spiked drugs or metabolites in the urine samples. This is a common method for analytical performance testing of in vitro diagnostic devices.
• Number of Experts: No experts were directly used to "establish" the ground truth in the sense of making diagnoses or interpretations like in imaging studies. The ground truth was based on the controlled preparation of the samples.
• Qualifications of Experts: Not applicable, as expert consensus or interpretation was not the method for ground truth. However, the imprecision study notes that it was evaluated by "individuals without training as clinical laboratorians," suggesting the device is user-friendly and robust even with non-expert operators.

3. Adjudication Method for the Test Set:

• Not applicable. The studies involved analytical measurements against known concentrations or expected outcomes, not subjective interpretations requiring adjudication.

4. 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, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) fluorescence immunoassay, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data alongside an algorithm. The "readers" mentioned in the imprecision study were "individuals without training as clinical laboratorians," not expert diagnosticians whose performance would be compared or improved by an AI.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone study was done. The entire summary describes the performance of the Triage® TOX Drug Screen as a standalone analytical device. While it is intended for use with the "Triage® Meter," the performance data presented is for the assay system itself, without human interpretation influencing the final analytical result. The output of the device (semi-quantitative or qualitative determination) is the direct result of the immunoassay and meter.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth used was spiked concentrations of drugs and drug metabolites in drug-free urine. This is a form of analytical truth or definitive truth established by controlled laboratory preparation and confirmed by reference methods (like GC/MS and HPLC, which are mentioned as predicate comparisons, implying their role in validating the concentrations).

7. The sample size for the training set:

• The 510(k) summary does not provide information on a training set sample size. This is typical for an immunoassay device. Immunoassays are based on biochemical reactions and often characterized analytically rather than "trained" in the machine learning sense. The device's performance is described through various validation studies (analytical sensitivity, interference, specificity, imprecision, threshold challenge) using the described test sets, not a separate training set.

8. How the ground truth for the training set was established:

• Not applicable. As a traditional immunoassay, there isn't a "training set" in the context of machine learning, so the method for establishing ground truth for a training set is not relevant. The device operates based on predefined antibody-antigen reactions and calibration, not machine learning from a training dataset.

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The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.

The Triage® TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.

This 510(k) submission is for the Triage® TOX Drug Screen Controls, which are assayed materials used to monitor the performance of drug screen tests. This device is not an AI-powered diagnostic tool, but rather a quality control material for laboratory use. Therefore, many of the requested categories related to AI performance, such as human reader improvement with AI, standalone AI performance, and AI training data, are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria or performance metrics for the Triage® TOX Drug Screen Controls. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "Summary of Comparison Data" section compares the characteristics of the new device to two predicate devices.

The difference in storage temperature is noted but not presented as a failure to meet an acceptance criterion. The overall conclusion is that the device is substantially equivalent, implying that its performance as a quality control material is deemed acceptable for its intended use, similar to the predicate devices.

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

This information is not provided in the submission. As a quality control material, the "test set" would typically refer to internal validation data, which is not detailed here.

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

This information is not applicable/provided. For a quality control material, the "ground truth" would likely be established through chemical analytical methods or certified reference materials, rather than expert consensus on diagnostic images or clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable/provided.

5. 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

This information is not applicable. This device is a quality control material, not an AI-powered diagnostic device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a quality control material, not an AI-powered diagnostic algorithm.

7. The Type of Ground Truth Used

For a quality control material like this, the "ground truth" for its contained analytes would typically be established through analytical testing methods traceable to reference standards, rather than expert consensus, pathology, or outcomes data in the context of diagnostic interpretation. The document does not explicitly state how the "ground truth" (i.e., the certified values of the control material) was established.

8. The Sample Size for the Training Set

This information is not applicable. This device is a quality control material, not an AI-powered diagnostic device that requires a training set.

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

This information is not applicable. This device is a quality control material, not an AI-powered diagnostic device.

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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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