FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

AI/ML Overview

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

Drug Class	Analyte	Threshold Concentration (Acceptance Criteria)	Reported Device Performance (Overall Agreement)
Acetaminophen/Paracetamol	APAP	5 µg/mL	97.1% (with GC/MS)
Amphetamines	AMP	1000 ng/mL	Not explicitly stated in the provided text
Methamphetamines	mAMP	1000 ng/mL	Not explicitly stated in the provided text
Barbiturates	BAR	300 ng/mL	Not explicitly stated in the provided text
Benzodiazepines	BZO	300 ng/mL	Not explicitly stated in the provided text
Cocaine	COC	300 ng/mL	Not explicitly stated in the provided text
Opiates	OPI	300 ng/mL	Not explicitly stated in the provided text
Phencyclidine	PCP	25 ng/mL	Not explicitly stated in the provided text
THC	THC	50 ng/mL	Not explicitly stated in the provided text
Tricyclic Antidepressants	TCA	1000 ng/mL	Not explicitly stated in the provided text

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.

Summary

Regulation Number and Section

§ 862.3030 Acetaminophen test system.

(a)
Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.(b)
Classification. Class II.