Quidel Triage® TOX Drug Screen, 94600

K200363 · Quidel Cardiovascular, Inc. · DKZ · Mar 11, 2020 · Clinical Toxicology

Device Facts

• Record ID: K200363
• Device Name: Quidel Triage® TOX Drug Screen, 94600
• Applicant: Quidel Cardiovascular, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Mar 11, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Indications for Use

The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below: AMP (Amphetamines) 500 ng/mL, mAMP (Methamphetamines) 500 ng/mL, BAR (Barbiturates) 200 ng/mL, BZO (Benzodiazepines) 200 ng/mL, COC (Cocaine) 150 ng/mL, EDDP (Methadone Metabolite) 100 ng/mL, OPI (Opiates) 300 ng/mL, THC (Cannabinoids) 50 ng/mL, TCA (Tricyclic Antidepressants) 1000 ng/mL. This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.

Device Story

Single-use lateral flow immunofluorescence test device; used with Quidel Triage® MeterPro. Input: human urine specimen. Principle: competitive immunoassay; urine flows through filter; reacts with fluorescent antibody/drug conjugates; capillary action moves mixture through device. Presence of drug prevents binding of fluorescent conjugates to solid phase; unbound conjugates washed into waste reservoir. MeterPro measures fluorescence in measurement zones; displays results in ~15 minutes. Used in clinical settings; operated by healthcare professionals. Output: qualitative preliminary drug presence/absence. Results stored in meter; can be transmitted to hospital information systems. Assists clinicians in rapid drug screening; requires confirmatory testing for positive results.

Clinical Evidence

No clinical data. Bench testing only. Analytical specificity study performed to evaluate cross-reactivity of four additional compounds (Metharbital, p-Hydroxyphenobarbital, Talbutal, Alprazolam glucuronide-OH) on the Triage TOX Drug Screen device.

Technological Characteristics

Lateral flow immunoassay. Qualitative detection of drug analytes in urine. Device form factor and fundamental scientific technology remain consistent with the previously cleared predicate. No changes to materials or energy sources.

Indications for Use

Indicated for the qualitative detection of drugs of abuse in human urine, including amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine/metabolites, methadone, opiates, cannabinoids, and tricyclic antidepressants.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Quidel Triage® TOX Drug Screen (K200363)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

k200363

B Applicant

Quidel Cardiovascular Inc.

C Proprietary and Established Names

Quidel Triage® TOX Drug Screen, 94600

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKZ | Class II | 21 CFR 862.3100 - Amphetamine Test System | TX - Clinical Toxicology |
| LAF | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
| DIS | Class II | 21 CFR 862.3150 - Barbiturate test system | TX - Clinical Toxicology |
| JXM | Class II | 21 CFR 862.3170 - Benzodiazepine test system | TX - Clinical Toxicology |
| JXO | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| DJR | Class II | 21 CFR 862.3620 - Methadone test system | TX - Clinical Toxicology |
| DJG | Class II | 21 CFR 862.3650 - Opiate test system | TX - Clinical Toxicology |
| LDJ | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
| LFG | Class II | 21 CFR 862.3910 - Tricyclic antidepressant drugs test system | TX - Clinical Toxicology |

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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K200363 - Page 2 of 2

# II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

Product labeling to include the percent cross-reactivity of four drug metabolites that may be present in human urine samples, but not previously tested for cross-reactivity:

- Metharbital, p-Hydroxyphenobarbital, and Talbutal for the Barbiturates assay.
- Alprazolam glucuronide-OH for the Benzodiazepines assay.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.