Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
Device Facts
| Record ID | K182719 |
|---|---|
| Device Name | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro |
| Applicant | Quidel Cardiovascular, Inc. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Jun 19, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| 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: [Table of analytes/cutoffs]. 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 method 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. The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.
Device Story
Single-use lateral flow fluorescence immunoassay cassette; used with Quidel Triage MeterPro. Input: human urine sample applied to test device. Principle: competitive immunoassay; monoclonal antibody conjugates compete with drug in sample for binding sites; fluorescence inversely proportional to analyte concentration. Meter uses laser diode excitation and silicon photodiode detection. Output: qualitative 'POS' or 'NEG' result displayed on LCD or printed. Used in lab or point-of-care settings by clinicians. Results stored in meter memory; optional transmission to LIS/HIS. Provides preliminary results requiring confirmatory testing (GC/MS, LC-MS/MS). Benefits: rapid, portable screening for drug presence to aid clinical decision-making.
Clinical Evidence
No clinical trials performed. Analytical performance established via bench testing. Precision/reproducibility evaluated at three POC sites (N=~720 per sample). Method comparison conducted against GC/MS or LC-MS/MS reference methods using clinical urine specimens. Performance characterized by cutoff studies and cross-reactivity/interference testing.
Technological Characteristics
Lateral flow competitive fluorescence immunoassay. Components: murine monoclonal antibodies, fluorescently labeled antibodies/metabolites, solid phase, stabilizers. MeterPro: portable fluorescence instrument, laser light source, LCD, elastomer keypads. Connectivity: serial ports for LIS/HIS transmission. Power: 100-240 VAC or 4 AA batteries. Storage: 2-8°C. Validated operating range: 18-28°C, 10-85% RH.
Indications for Use
Indicated for qualitative detection of drugs/metabolites in human urine at or above specified threshold concentrations. Intended for use by professionals in laboratory or point-of-care settings for preliminary screening. Not for semi-quantitative determination.
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
- GenPrime Drugs of Abuse (DOA) Reader System (k130082)
- Immunalysis Barbiturates Urine Enzyme Immunoassay (k161714)
- DRI Benzodiazepine Assay (k173963)
- Immunalysis EDDP Specific Urine Enzyme Immunoassay (k151395)
- Biosite Incorporated Triage TOX Drug Screen (k043242)
- Biosite Incorporated Triage Meter (k973547)
Related Devices
- K200363 — Quidel Triage® TOX Drug Screen, 94600 · Quidel Cardiovascular, Inc. · Mar 11, 2020
- K162395 — MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup · Mp Biomedicals, LLC · Jun 2, 2017
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k182719
B. Purpose for Submission:
New Device
C. Measurand:
Amphetamine, Methamphetamine, Barbiturates, Benzodiazepines, Cocaine, EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine), Opiates, Cannabinoids, Tricyclic Antidepressants
D. Type of Test:
Qualitative, lateral flow immunofluorescence
E. Applicant:
Quidel Cardiovascular Inc.
F. Proprietary and Established Names:
Quidel Triage® TOX Drug Screen, 94600
Quidel Triage® MeterPro
G. Regulatory Information:
| Product Code | Classification | Regulatory Section | Panel |
| --- | --- | --- | --- |
| DKZ | Class II | 21 CFR 862.3100, Amphetamine test system | Toxicology (91) |
| LAF | Class II | 21 CFR 862.3610, Methamphetamine test system | Toxicology (91) |
| DIS | Class II | 21 CFR 862.3150, Barbiturate test system | Toxicology (91) |
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| Product Code | Classification | Regulatory Section | Panel |
| --- | --- | --- | --- |
| JXM | Class II | 21 CFR 862.3170, Benzodiazepine test system | Toxicology (91) |
| JXO | Class II | 21 CFR 862.3250, Cocaine and cocaine metabolite test system | Toxicology (91) |
| DJR | Class II | 21 CFR 862.3620, Methadone test system | Toxicology (91) |
| DJG | Class II | 21 CFR 862.3650, Opiate test system | Toxicology (91) |
| LDJ | Class II | 21 CFR 862.3870, Cannabinoid test system | Toxicology (91) |
| LFG | Class II | 21 CFR 862.3910, Tricyclic antidepressant drugs test system | Toxicology (91) |
| KHO | Class I | 21 CFR 862.2560, Fluorometer for clinical use | Chemistry (75) |
## H. Intended Use:
1. Intended use(s):
See Indication(s) for use below.
2. Indication(s) 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:
| Abbreviation | Analyte | Calibrator | Cutoff |
| --- | --- | --- | --- |
| AMP | Amphetamines | d-Amphetamine | 500 ng/mL |
| mAMP | Methamphetamines | d-Methamphetamine | 500 ng/mL |
| BAR | Barbiturates | Butalbital | 200 ng/mL |
| BZO | Benzodiazepines | Temazepam | 200 ng/mL |
| COC | Cocaine | Benzoylecgonine | 150 ng/mL |
| EDDP | Methadone Metabolite | EDDP | 100 ng/mL |
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| Abbreviation | Analyte | Calibrator | Cutoff |
| --- | --- | --- | --- |
| OPI | Opiates | Morphine | 300 ng/mL |
| THC | Cannabinoids | 11-nor-9-carboxy-Δ⁹-THC | 50 ng/mL |
| TCA | Tricyclic Antidepressants | Desipramine | 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 method 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.
The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.
3. Special conditions for use statement(s):
For prescription use only.
4. Special instrument requirements:
Quidel Triage® MeterPro
I. Device Description:
The Quidel Triage® TOX Drug Screen, 94600 is a single use test device, and is used in conjunction with the Quidel Triage® MeterPro. The device is a competitive-based lateral flow fluorescence immunoassay and contains murine monoclonal antibody conjugates (depending on the test analyte) and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers.
The Quidel Triage® TOX Drug Screen, 94600 is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are factory calibrated and are used to determine a negative result or a presumptive positive result for the presence of the major urinary metabolites of the following substances in human urine: amphetamine (AMP), methamphetamine (mAMP), barbiturates (BAR), benzodiazepines (BZO), cocaine (COC), methadone metabolite, (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine), (EDDP), opiates (OPI), cannabinoid (THC), and tricyclic antidepressants (TCA).
The Quidel Triage TOX Drug Screen, 94600 Test is provided as a kit that contains 25 test devices, 25 transfer pipettes, one reagent CODE CHIP Module and 2 printer paper rolls. The test device is individually wrapped for one time use only.
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Quidel Triage® MeterPro, and Quidel Triage TOX Drug Screen, 94600 Control 1 and 2 are needed but not provided with the kit.
The Quidel Triage® MeterPro is a portable fluorescence instrument. It uses a laser diode as the excitation light source and a silicon photodiode as the light detector for the reaction. Light from the laser hits a test device that has been inserted in the meter. This causes the fluorescent dye in the test device to give off energy, and this fluorescence is captured by the light detector. The amount of fluorescence produced directly correlates with analyte concentrations in an analyte-specific manner. Results are displayed on a liquid crystal display or hard copies can be printed via the internal printer.
# J. Substantial Equivalence Information:
1. Predicate device name(s):
GenPrime Drugs of Abuse (DOA) Reader System
Immunalysis Barbiturates Urine Enzyme Immunoassay
DRI Benzodiazepine Assay
Immunalysis EDDP Specific Urine Enzyme Immunoassay
Biosite Incorporated Triage TOX Drug Screen
Biosite Incorporated Triage Meter
2. Predicate 510(k) number(s):
k130082, GenPrime Drugs of Abuse (DOA) Reader System
k161714, Immunalysis Barbiturates Urine Enzyme Immunoassay
k173963, DRI Benzodiazepine Assay
k151395, Immunalysis EDDP Specific Urine Enzyme Immunoassay
k043242, Biosite Incorporated Triage® TOX Drug Screen
k973547, Biosite Incorporated Triage® Meter
3. Comparison with predicate:
Quidel Triage® TOX Drug Screen, 94600:
Assays: Amphetamines (AMP), Methamphetamines (mAMP), Cocaine (COC), Opiates (OPI), and Cannabinoids (THC)
| Similarities | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | GenPrime Drugs of Abuse (DOA) Reader System (K130082) (Predicate Device) |
| Intended Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Intended Population | Prescription use | Same |
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| Similarities | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | GenPrime Drugs of Abuse (DOA) Reader System (K130082) (Predicate Device) |
| Assay Type | Competitive assay where concentration of drug is inversely related to the signal detected by the instrument. | Same |
| System Procedure | Sample is added to a single use test device which is then read by the instrument. The instrument is designed to read multiple assays at the same time. | Same |
| Specimen Type | Human urine | Same |
| Single-use Test Device | Yes | Same |
| Analyte Cutoffs (ng/mL) | AMP = 500 mAMP = 500 COC = 150 OPI = 300 THC = 50 | AMP = 500 (OS Cup; SK Cup) MET = 500 (OS Cup; SK Cup) COC = 150 (OS Cup) MOP = 300 (SK Cup) THC = 50 (OS Cup; SK Cup) |
| Differences | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | GenPrime Drugs of Abuse (DOA) Reader System (K130082) (Predicate Device) |
| Test Device Reader | Quidel Triage® MeterPro | GenPrime DOA Reader |
| Analyte Cutoffs (ng/mL) | BAR = 200 BZO = 200 EDDP = 100 TCA = 1000 | BAR = 300 (OS Cup) MTD = 300 (SK Cup) MOP = 2000 (SK Cup) PCP = 25 (SK Cup) |
| | MTD, OXY, PCP are not panel assays and have no associated analyte cutoffs. | BZO, EDDP, and TCA are not panel assays and have no associated cutoff. |
| Test Device Format | Cassette | Cup |
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Assay: Barbiturates (BAR)
| Similarities | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | ImmunalysisBarbiturates Urine Enzyme Immunoassay (K161714) (Predicate Device) |
| Intended Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Specimen Type | Human urine | Same |
| Storage | 2-8°C | Same |
| Measured Analyte | BAR | Same |
| Analyte Cutoff (ng/mL) | BAR = 200 | Same |
| Differences | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | ImmunalysisBarbiturates Urine Enzyme Immunoassay (K161714) (Predicate Device) |
| Antibody Type | Mouse monoclonal antibodies | Recombinant and monoclonal antibodies |
Assay: Benzodiazepines (BZO)
| Similarities | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | DRI Benzodiazepine Assay (K173963) (Predicate Device) |
| Intended Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Specimen Type | Human urine | Same |
| Storage | 2-8°C | Same |
| Analyte Cutoff (ng/mL) | BZO = 200 | Same |
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| Differences | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | DRI Benzodiazepine Assay (K173963) (Predicate Device) |
| Antibody Type | Mouse monoclonal antibodies | Polyclonal sheep antibody |
Assay: 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)
| Similarities | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | Immunalysis EDDP Specific Urine Enzyme Immunoassay (K151395) (Predicate Device) |
| Intended Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Specimen Type | Human urine | Same |
| Storage | 2-8°C | Same |
| Assay calibrated | EDDP | Same |
| Measured Analyte | EDDP | Same |
| Analyte Cutoff (ng/mL) | EDDP = 100 | Same |
| Differences | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | Immunalysis EDDP Specific Urine Enzyme Immunoassay (K151395) (Predicate Device) |
| Antibody Type | Mouse monoclonal antibodies | Recombinant fab antibodies |
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Assay: Tricyclic Antidepressants (TCA)
| Similarities | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | Triage® TOX Drug Screen (K043242) (Predicate Device) |
| Intended Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Assay Type | Competitive assay, where concentration of drug is inversely related to the signal detected by the instrument. | Same |
| Specimen Type | Human urine | Same |
| Storage | 2-8°C | Same |
| Detection method | Measures fluorescence of discreet measurement zones for each assay. | Same |
| Assay calibrated | Desipramine | Same |
| Measured Analyte | TCA | Same |
| Analyte Cutoff (ng/mL) | TCA = 1000 | Same |
| Differences | | |
| --- | --- | --- |
| Item | Quidel Triage® TOX Drug Screen, 94600 (Proposed Device) | Triage® TOX Drug Screen (K043242) (Predicate Device) |
| Analytes | Amphetamines, Methamphetamines, Barbiturates, Benzodiazepines, Cocaine, Methadone Metabolite, Opiates, Cannabinoids (THC), and Tricyclic Antidepressants | Acetaminophen, Amphetamines, Methamphetamines, Barbiturates, Benzodiazepines, Cocaine, Opiates, Phencyclidine, THC, and Tricyclic Antidepressants |
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Quidel Triage MeterPro:
| Similarities | | |
| --- | --- | --- |
| Item | Quidel Triage® MeterPro (Proposed Device) | Triage Meter (K973547) (Predicate Device) |
| Intended Use | Fluorometer for the measurement of fluorescence in various assay systems. | Same |
| Device Class | Class I | Same |
| Power supply | 100-240 VAC, self-switching, or with 4 AA batteries | Same |
| Max. Voltage of ext. power supply | 20 V | Same |
| Electrostatic protection to serial port | 8 / 15 kV | Same |
| Number of serial ports | 2 (by use of adapter) | Same |
| Printer | Integrated | Same |
| Sample ID | Manual input or external hand-held barcode scanner | Same |
| Barcode | Integrated barcode on each test device with lot specific information | Same |
| Time to result | Approximately 15 – 20 minutes | Same |
| Output | Outputs are “POS” if the result is at or above the threshold concentration or “NEG” if the result is below the threshold concentration. The operator has the option to print the results. | Same |
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| Differences | | |
| --- | --- | --- |
| Item | Quidel Triage® MeterPro (Proposed Device) | Triage Meter (K973547) (Predicate Device) |
| Top meter housing | New top meter housing mold to provide a larger liquid crystal display (LCD) and two elastomer keypads | Small LCD with one single membrane keyboard |
| Output | If connected, the MeterPro can transmit results to the laboratory or hospital information system. | The Triage Meter does not have capability to transmit results to the laboratory or hospital information system. |
# K. Standard/Guidance Document Referenced (if applicable):
None referenced.
# L. Test Principle:
The Quidel Triage TOX Drug Screen, 94600 is a competitive fluorescence immunoassay which contains all the reagents necessary for the qualitative detection, relative to an assigned threshold value, of the major urinary metabolites of the following substances in human urine: amphetamine (AMP), methamphetamine (mAMP), barbiturates (BAR), benzodiazepines (BZO), cocaine (COC), methadone/methadone metabolite (EDDP), opiates (OPI), tetrahydrocannabinol (THC), and tricyclic antidepressants (TCA).
The tests use monoclonal antibodies against 9 targeted drugs or metabolites in the patient urine sample. The tests utilize a competitive immunoassay format in which the fluorescence results are inversely proportional to the analyte concentration. If the assay spot concentration is less than the assay-specific threshold then the result will be reported as positive. If the assay spot concentration is equal to or greater than the test-specific threshold then the result will be reported as negative.
The tests contain positive on-board test device controls. Before calculating whether the test is positive or negative for each assay spot, the algorithm checks to ensure that the acceptance criteria for the on-board test device controls have been met. If any have not been met, the assay result is reported as invalid.
The test procedure involves the addition of a urine specimen to the sample port on the Test Device. After addition of the specimen, the urine passes through a filter. The specimen reacts with fluorescent antibody conjugates or with fluorescent drug conjugates and flows through the Test Device by capillary action. The presence of drug or drug metabolite in the urine specimen prevents binding of the fluorescent conjugates to the solid phase on the detection zone. Excess urine washes the unbound fluorescent conjugates from the detection
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lane into a waste reservoir.
The Test Device is inserted into the Quidel Triage® MeterPro. The Quidel Triage® MeterPro is programmed to perform the analysis after the specimen has reacted with the reagents in the Test Device. The analysis is based on the amount of fluorescence the Quidel Triage® MeterPro detects within a measurement zone on the Test Device. The positive or negative results are displayed on the Quidel Triage® MeterPro screen at a specified time after the addition of specimen. All results are stored in the Quidel Triage MeterPro memory to display or print when needed. If connected, the Quidel Triage® MeterPro can transmit results to the laboratory or hospital information system.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Each analyte for the precision study was tested at the following concentrations, as percentages of the cutoffs: A negative control, drug free, 25%, 50%, 75%, cutoff, 125%, 150%, 175%, and 200%. The panels were blinded and randomized prior to testing. Testing was performed at three representative point of care (POC) sites using three device lots and 45 meters. Three operators conducted the testing at each POC site. Each operator was assigned one test device lot and five Triage MeterPro instruments to conduct the testing. Each operator tested ten samples each day of testing. The ten samples were run in duplicate two times per day for twenty days at each clinical site. Each device was read on one Triage MeterPro. There were approximately 720 results (N=4x20x9) per sample. The test results were interpreted as positive (POS) or negative (NEG) for each individual assay based on the assay specific cut-off concentration values. The results of the testing are summarized as follow for the test device.
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| Actual Drug Concentration (ng/mL) | Target Drug Levels (% of Cutoff) | Number of Replicates (N) | Number of Negative Results | Number of Positive Results |
| --- | --- | --- | --- | --- |
| | | | | |
| **AMP (500 ng/mL)** | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 720 | 720 | 0 |
| 126 | -75 | 720 | 720 | 0 |
| 281 | -50 | 716 | 712 | 4 |
| 395 | -25 | 720 | 694 | 26 |
| 522 | Cutoff | 719 | 50 | 669 |
| 650 | +25 | 722 | 2 | 720 |
| 760 | +50 | 720 | 0 | 720 |
| 884 | +75 | 704 | 0 | 704 |
| 991 | +100 | 736 | 0 | 736 |
| **mAMP (500 ng/mL)** | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 736 | 736 | 0 |
| 130 | -75 | 720 | 720 | 0 |
| 250 | -50 | 720 | 720 | 0 |
| 366 | -25 | 716 | 697 | 19 |
| 529 | Cutoff | 720 | 281 | 431 |
| 652 | +25 | 719 | 12 | 707 |
| 742 | +50 | 722 | 2 | 720 |
| 872 | +75 | 720 | 0 | 720 |
| 961 | +100 | 704 | 0 | 704 |
| **BAR (200 ng/mL)** | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 704 | 704 | 0 |
| 53 | -75 | 736 | 736 | 0 |
| 108 | -50 | 720 | 719 | 1 |
| 156 | -25 | 720 | 689 | 31 |
| 192 | Cutoff | 716 | 111 | 605 |
| 233 | +25 | 720 | 3 | 717 |
| 306 | +50 | 719 | 0 | 719 |
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| 355 | +75 | 722 | 0 | 722 |
| --- | --- | --- | --- | --- |
| 406 | +100 | 720 | 0 | 720 |
| BZO (200 ng/mL) | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 720 | 720 | 0 |
| 58 | -75 | 704 | 704 | 0 |
| 107 | -50 | 736 | 735 | 1 |
| 166 | -25 | 720 | 626 | 94 |
| 219 | Cutoff | 720 | 318 | 402 |
| 259 | +25 | 716 | 9 | 707 |
| 306 | +50 | 720 | 0 | 720 |
| 378 | +75 | 719 | 0 | 719 |
| 399 | +100 | 722 | 0 | 722 |
| COC (150 ng/mL) | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 716 | 716 | 0 |
| 41 | -75 | 720 | 720 | 0 |
| 76 | -50 | 719 | 719 | 0 |
| 119 | -25 | 722 | 519 | 203 |
| 157 | Cutoff | 720 | 26 | 694 |
| 185 | +25 | 704 | 0 | 704 |
| 218 | +50 | 736 | 0 | 736 |
| 267 | +75 | 720 | 0 | 720 |
| 300 | +100 | 720 | 0 | 720 |
| EDDP (100 ng/mL) | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 722 | 722 | 0 |
| 29 | -75 | 720 | 720 | 0 |
| 52 | -50 | 704 | 702 | 2 |
| 85 | -25 | 736 | 645 | 91 |
| 111 | Cutoff | 720 | 126 | 594 |
| 136 | +25 | 720 | 5 | 715 |
| 143 | +50 | 716 | 0 | 716 |
| 174 | +75 | 720 | 0 | 720 |
| 204 | +100 | 719 | 0 | 719 |
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| OPI (300 ng/mL) | | | | |
| --- | --- | --- | --- | --- |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 720 | 720 | 0 |
| 87 | -75 | 719 | 719 | 0 |
| 165 | -50 | 722 | 722 | 0 |
| 231 | -25 | 720 | 715 | 5 |
| 344 | Cutoff | 704 | 197 | 507 |
| 426 | +25 | 736 | 5 | 731 |
| 480 | +50 | 720 | 0 | 720 |
| 548 | +75 | 720 | 0 | 720 |
| 589 | +100 | 716 | 0 | 716 |
| THC (50 ng/mL) | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 720 | 720 | 0 |
| 12 | -75 | 716 | 716 | 0 |
| 26 | -50 | 720 | 717 | 3 |
| 39 | -25 | 719 | 676 | 43 |
| 54 | Cutoff | 722 | 163 | 559 |
| 65 | +25 | 720 | 1 | 719 |
| 78 | +50 | 704 | 4 | 700 |
| 91 | +75 | 736 | 1 | 735 |
| 103 | +100 | 720 | 0 | 720 |
| TCA (1,000 ng/mL) | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 719 | 719 | 0 |
| 236 | -75 | 722 | 722 | 0 |
| 498 | -50 | 720 | 719 | 1 |
| 741 | -25 | 704 | 618 | 86 |
| 996 | Cutoff | 736 | 218 | 518 |
| 1,395 | +25 | 720 | 5 | 715 |
| 1,577 | +50 | 720 | 1 | 719 |
| 1,716 | +75 | 716 | 0 | 716 |
| 2,195 | +100 | 720 | 0 | 720 |
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b. Linearity/assay reportable range:
Not applicable. These devices are intended for qualitative use only.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
**Quidel Triage TOX Drug Screen, 94600**
**Cold Storage Stability**
A shelf-life stability study of the test was performed and the results showed that devices are stable for 3 months when stored in cold storage (2°C to 8°C). Real time stability studies are ongoing and shelf life will be extended based upon data meeting the acceptance criteria.
**Room Temperature Stability**
A shelf-life stability study of the test was performed and the results showed that devices are stable for 14 days when stored at room temperature (20°C to 24°C). Room temperature stability studies are ongoing and shelf life will be extended based upon data meeting the acceptance criteria.
**Patient Sample Handling Stability**
A patient sample handling stability study of the test was performed and patient sample results were found to be stable when used within 36 hours of sample collection at room temperature (20°C to 24°C) and within four days when stored refrigerated (2°C to 8°C). No more than a single freeze/thaw cycle is recommended.
d. Detection limit:
See assay cutoff characterization data in Section M.1.a, above, and M.1.f., below, for device performance around the claimed cutoff concentrations.
e. Analytical specificity:
**Analytical Specificity**
To test cross-reactivity, drug metabolites and other compounds that may be present in human urine samples were tested using nine lots of Quidel Triage TOX Drug Screen, 94600 Test Devices. The following is a summary of the cross-reactivity study. The individual assays are calibrated against the compounds marked with an asterisk (*).
| AMP
(Cutoff = 500 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| 3,4-Methylenedioxyamphetamine
(MDA) | 1,850 | 27.0 |
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| AMP
(Cutoff = 500 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| 3,4-
Methylenedioxyethylamphetamine
(MDEA) | >200,000 | 0.0 |
| 3,4-
Methylenedioxymethamphetamine
(MDMA) | >200,000 | 0.0 |
| d,l-1-(3,4-
Methylenedioxyphenyl)-2-
Butanamine (BDB) | 1,500 | 33.3 |
| d,l-Amphetamine | 1,000 | 50.0 |
| d,l-Phenylpropanolamine | >200,000 | 0.0 |
| d-Ephedrine | >200,000 | 0.0 |
| d-Amphetamine* | 500 | 100.0 |
| d-Pseudoephedrine | >200,000 | 0.0 |
| l-Amphetamine | 3,000 | 16.7 |
| l-Ephedrine | >200,000 | 0.0 |
| Phentermine | >200,000 | 0.0 |
| p-Methoxyamphetamine (PMA) | 1,750 | 28.6 |
| Tyramine | 95,000 | 0.5 |
| β-Phenylethylamine | 30,000 | 1.7 |
| p-Chloroamphetamine (PCA) | 2,000 | 25.0 |
| p-Hydroxyamphetamine | 3,500 | 14.3 |
| mAMP
(Cutoff = 500 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| 3,4-Methylenedioxyamphetamine
(MDA) | >200,000 | 0.0 |
| 3,4-
Methylenedioxyethylamphetamine
(MDEA) | 2,300 | 21.7 |
| 3,4-
Methylenedioxymethamphetamine
(MDMA) | 750 | 66.7 |
| Benzodioxazolybutanamine
(BDB) | 25,000 | 2.0 |
16
{16}
| mAMP
(Cutoff = 500 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| d,l-Methyl-1(3,4-
Methylenedioxyphenyl)2-
Butanamine (MBDB) | 500 | 100.0 |
| d-Methamphetamine* | 500 | 100.0 |
| d-Amphetamine | >200,000 | 0.0 |
| d-Ephedrine | >150,000 | 0.0 |
| Ethylamphetamine | 7,000 | 7.1 |
| Fenfluramine | 5,000 | 10.0 |
| l-Amphetamine | >200,000 | 0.0 |
| l-Ephedrine | >200,000 | 0.0 |
| l-Methamphetamine | >200,000 | 0.0 |
| Isometheptine | 50,000 | 1.0 |
| Mephentermine | 25,000 | 2.0 |
| p-Methoxyamphetamine (PMA) | >200,000 | 0.0 |
| p-Methoxymethamphetamine
(PMMA) | 2,200 | 22.7 |
| Propylamphetamine | >200,000 | 0.0 |
| p-Hydroxymethamphetamine | 1,000 | 50.0 |
| BAR
(Cutoff = 200 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| Allobarbital | 300 | 66.7 |
| Alphenal | 400 | 50.0 |
| Amobarbital | 250 | 80.0 |
| Aprobarbital | 300 | 66.7 |
| Barbital | 300 | 66.7 |
| Butabarbital | 200 | 100.0 |
| Butalbital* | 200 | 100.0 |
| Butethal | 100 | 200.0 |
| Cyclopentobarbital | 200 | 100.0 |
| Hexobarbital | 90,000 | 0.2 |
| Mephobarbital | 3,000 | 6.7 |
| Phenallymal | 400 | 50.0 |
| Pentobarbital | 500 | 40.0 |
{17}
| BAR
(Cutoff = 200 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| Phenobarbital | 230 | 87.0 |
| Secobarbital | 700 | 28.6 |
| Thiopental | 80,000 | 0.3 |
| BZO
(Cutoff = 200 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| Alprazolam | 100 | 200.0 |
| Alprazolam, -OH | 150 | 133.3 |
| Bromazepam | 750 | 26.7 |
| Chlordiazepoxide | 8,000 | 2.5 |
| Clobazam | 750 | 26.7 |
| Clonazepam | 650 | 30.8 |
| Clonazepam, 7-amino | 26,000 | 0.8 |
| Clorazepate | 1,200 | 16.7 |
| Delorazepam | 350 | 57.1 |
| Demoxepam | 10,000 | 2.0 |
| Desalkylflurazepam | 200 | 100.0 |
| Diazepam | 125 | 160.0 |
| Estazolam | 400 | 50.0 |
| Flunitrazepam | 200 | 100.0 |
| Flunitrazepam, 7-amino | 6,000 | 3.3 |
| Flurazepam | 80 | 250.0 |
| Halazepam | 250 | 80 |
| Lorazepam | 200 | 100.0 |
| Lorazepam glucuronide | 300 | 66.7 |
| Lormetazepam | 100 | 200.0 |
| Medazepam | 9,000 | 2.2 |
| Midazolam | 200 | 100.0 |
| Nitrazepam | 2,600 | 7.7 |
| Nitrazepam, 7-amino | >150,000 | 0.0 |
| Norchlordiazepoxide | 7,000 | 2.9 |
| Nordiazepam | 1,100 | 18.2 |
| Oxazepam | 2,500 | 8.0 |
| Oxazepam glucuronide | 1,250 | 16.0 |
{18}
| BZO
(Cutoff = 200 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| Prazepam | 350 | 57.1 |
| Temazepam* | 200 | 100.0 |
| Temazepam glucuronide | 300 | 66.7 |
| Triazolam | 100 | 200.0 |
| COC
(Cutoff = 150 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| Benzoylecgonine* | 150 | 100.0 |
| Cocaethylene | >200,000 | 0.0 |
| Cocaine | 50,000 | 0.3 |
| Ecgonine | >200,000 | 0.0 |
| Ecgonine methyl ester | >200,000 | 0.0 |
| Hydroxybenzoylecgonine, m- | 400 | 37.5 |
| Norcocaine | >200,000 | 0.0 |
| EDDP
(Cutoff = 100 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| EDDP* | 100 | 100.0 |
| EMDP | 40,000 | 0.3 |
| l-methadone | 160,000 | 0.1 |
| d-methadone | >200,000 | 0.0 |
| d/l-methadone | >200,000 | 0.0 |
| l-β-Acetylmethadol (LAAM) | >200,000 | 0.0 |
| l-iso-methadone | >100,000 | 0.0 |
| OPI
(Cutoff = 300 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| 6-Acetylcodeine | 200 | 150.0 |
| 6-Acetylmorphine | 200 | 150.0 |
| Buprenorphine | >40,000 | 0.0 |
| Codeine | 300 | 100.0 |
| Diacetylmorphine | 200 | 150.0 |
| Dihydrocodeine | 120 | 250.0 |
19
{19}
| OPI
(Cutoff = 300 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| Ethylmorphine | 300 | 100.0 |
| Hydrocodone | 700 | 42.9 |
| Hydromorphone | 1,100 | 27.3 |
| Levorphanol | 25,000 | 1.2 |
| Morphine* | 300 | 100.0 |
| Morphine 3- glucuronide | 300 | 100.0 |
| Nalorphine | 3,000 | 10.0 |
| Naloxone | >230,000 | 0.0 |
| Naltrexone | >200,000 | 0.0 |
| Nor-Buprenorphine | >200,000 | 0.0 |
| Norcodeine | >200,000 | 0.0 |
| Normorphine | >300,000 | 0.0 |
| Oxycodone | 50,000 | 0.6 |
| Oxymorphone | 100,000 | 0.3 |
| Thebaine | 35,000 | 0.9 |
| THC
(Cutoff = 50 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| 11-nor-9 carboxy-Δ⁹-THC* | 50 | 100.0 |
| 11-nor- Δ⁸-THC-COOH | 100 | 50 |
| 11-nor-9 carboxy-Δ⁹-THC-glucuronide | 17,000 | 0.3 |
| Cannabidiol | >200,000 | 0.0 |
| Cannabinol, Δ⁸- | 3,000 | 1.7 |
| Cannabinol, Δ⁹- | 3,000 | 1.7 |
| Tetrahydrocannabinol | 3,000 | 1.7 |
| (+/-) 11-hydroxy- Δ⁹-THC | 1,500 | 3.3 |
| TCA
(Cutoff = 1,000 ng/mL) | Results
Positive at
(ng/mL) | % Cross-
Reactivity |
| --- | --- | --- |
| Amitriptyline | 600 | 166.7 |
| Amitryptyline metabolite | 300 | 333.3 |
| Chlorpromazine | >400,000 | 0.0 |
| Chlorprothixene | 40,000 | 2.5 |
{20}
21
| TCA (Cutoff = 1,000 ng/mL) | Results Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Clomipramine | 10,000 | 10.0 |
| Cyclobenzaprine | 1,400 | 71.4 |
| Desipramine* | 1,000 | 100.0 |
| Doxepin | 1,300 | 76.9 |
| Imipramine | 600 | 166.7 |
| Maprotiline | 240,000 | 0.4 |
| Nordoxepin | 1,500 | 66.7 |
| Nortriptyline | 900 | 111.1 |
| Perphenazine | 175,000 | 0.6 |
| Phenothiazine | 280,000 | 0.4 |
| Promazine | 35,000 | 2.9 |
| Promethazine | >200,000 | 0.0 |
| Protriptyline | 2,500 | 40.0 |
| Thiothixene | >100,000 | 0.0 |
| Trimeprazine | 83,500 | 1.2 |
| Trimipramine | 3,800 | 26.3 |
## Cross Reactivity and Interference Testing of Non-Structurally Related Pharmaceutical Compounds
Potential interference from pharmaceutical compounds were tested by spiking the potentially interfering pharmaceutical compound at a concentration of $100\ \mu\mathrm{g/mL}$ into drug-free urine containing the target drug concentrations at $50\%$ below and $50\%$ above the threshold cutoff level. The following compounds, arranged in alphabetical order, were found not to cross react when tested at concentration up to at least $100\ \mu\mathrm{g/mL}$. For the pharmaceutical compounds where interference was observed, the highest concentration that did not cause interference is indicated in the table below, along with the assay in which it interfered.
| Acetaminophen | Dronabinol (1 μg/mL; THC) | Olanzapine |
| --- | --- | --- |
| Acetophenetidin | Droperidol | Oxalic Acid |
| Acetopromazine (maleate salt) | Duloxetine | Oxaprozin |
| Amantadine | Efavirenz | Pantoprazole |
| Amoxicillin | L-Epinephrine | Papaverine |
| Ampicillin | Fenfluramine (2 μg/mL; AMP and mAMP) | Pentazocine |
| Aspirin (salicyluric | Flunitrazepam (0.2 | Pericyazine |
{21}
| acid) | μg/mL; BZO) | |
| --- | --- | --- |
| Atenolol | Fluoxetine | Phenelzine |
| Atorvastatin | Gamma-Hydroxybutyrate | Phenethylamine (2-Phenylethylamine) (6 μg/mL; AMP) |
| Benzocaine | Glutethimide (10 μg/mL; BAR) | Phenmetrazine (37.5 μg/mL; TCA) |
| Benzydamine | Haloperidol | Phentermine |
| Buprenorphine | Ibuprofen | Phenylephrine |
| Benztropine Methane | Ketamine | Phenylhydantoin, d/1-5(p-hydroxyphenyl)-5- |
| Bupropion | Ketorolac Tromethamine | Phenylpropanolamin e |
| Butyrophenone | Labetalol | Promethazine |
| Carbamazepine | Levofloxacin | Propranolol, d/l |
| Chlorpheniramine | Levorphanol (18.75 μg/mL; OPI) | d-Pseudoephedrine (50 μg/mL; THC) |
| Chlorpromazine | Meperidine | Quetiapine |
| Cimetidine | Mesoridazine Besylate | Quinacrine (50 μg/mL; THC) |
| Citalopram | Methaqualone | Quinine |
| Clomipramine (5 μg/mL; TCA) | Methoxyphenamine | Ranitidine |
| Clonidine | Methylphenidate | Rifampin |
| Cotinine [1-Cotinine] | Nalbuphine | Ritodrine |
| Cyproheptadine | Naloxone | Selegiline |
| Dexamphetamine (0.4 μg/mL; AMP) | Naltrexone | Sertraline |
| Dextromethorphan | Naproxen [(S)-6-Methoxy-α-methyl-2 Naphthaleneacetic acid] | Thioridazine |
| Dextrorphan Tartrate | N-desmethylvenlafaxine | Tramadol |
| Dimethylamine | Niacinamide | Tranylcypromine |
| Diphenhydramine | Nicotine | Trimethobenzamide |
| Dopamine | Norpseudoephedrine (25 μg/mL; AMP) | Tyramine (25 μg/mL; AMP) |
| Dothiepin (0.7 μg/mL; TCA) | O-desmethylvenlafaxine | Verapamil |
| Doxylamine Succinate | d,l-Octopamine | Zolpidem |
| Doxepin (0.65 μg/mL; TCA) | Ofloxacin | Benzphetamine |
| Clobenzorex | Fenproporex | Meprobamate |
| Nalmefene | | |
{22}
# Interference from Exogenous Compounds
Potential interference from exogenous compounds were tested by spiking the potentially interfering compound into treated drug-free urine containing the target drug concentrations at $50\%$ below and $50\%$ above the threshold cutoff level. The following exogenous compounds were found not to interfere with test results when tested up to the concentrations identified in the table below.
| Interfering Substance | Concentration |
| --- | --- |
| Acetaminophen | 1 mg/mL |
| Acetone | 5 mg/mL |
| Acetylsalicylic Acid | 1 mg/mL |
| Ascorbic Acid | 15 mg/mL |
| Caffeine | 0.125 mg/mL |
| Ethanol | 5 mg/mL |
| Fluoxetine | 0.5 mg/mL |
| Hippuric Acid | 10 μg/mL |
| Ibuprofen | 0.75 mg/mL |
| Ketamine | 25 mg/mL |
| Oxalic Acid | 7 mg/mL |
| Riboflavin | 75 μg/mL |
| Scopalamine | 62.5 μg/mL |
# Interference from Endogenous Compounds
Potential interference from endogenous compounds were tested by spiking the potentially interfering compound into drug-free urine containing the target drug concentrations at $50\%$ below and $50\%$ above the threshold cutoff level. The following endogenous compounds were found not to interfere with test results when tested up to the concentrations identified in the table below.
| Interfering Substance | Concentration |
| --- | --- |
| Bilirubin | 2.5 μg/mL |
| Creatinine | 2.5 mg/mL |
| Dextrose | 20 mg/mL |
| Gamma Globulin | 5 mg/mL |
| Hemoglobin | 1.2 mg/mL |
| Human Serum Albumin | 5 mg/mL |
| Sodium Chloride | 30 mg/mL |
| Urea | 30 mg/mL |
{23}
24
# Specific gravity and pH
The effect of specific gravity for each analyte was evaluated by testing positive and negative samples at specific gravities ranging from 1.003 to 1.030 g/mL. No interference was observed for all specific gravities tested.
The effect of pH for each analyte was evaluated by testing positive and negative samples over a range of pH levels of 4.0 to 9.0. Within the pH range of 4.0 to 9.0 acceptable results were observed with the samples tested. However, a low level of interference was noted with the TCA assay as the pH increased which could impact results which are above the threshold of 1,000 ng/mL. Specimens tested outside of the validated pH range of 4.0 to 9.0 may yield inaccurate results.
The sponsor has included the following statement under ‘Warnings and Precautions’ section of the labeling:
“The Quidel Triage TOX Drug Screen, 94600 has been validated with specimens that have a pH range of 4.0 – 9.0 acceptable results were observed with the samples tested. However, a low level of interference was noted with the TCA assay as the pH increased which could impact results which are above the threshold of 1,000 ng/mL. Specimens tested outside of the validated pH range may yield inaccurate results.”
# Operating Temperature
The effect of operating temperature for each analyte was evaluated by testing positive and negative samples at temperatures ranging from 16°C to 30°C (61°F to 86°F). Based on the study results, the Quidel Triage TOX Drug Screen, 94600 is validated for an operating temperature range from 18°C to 28°C (64°F to 82°F).
# Operating Humidity
The effect of operating humidity for each analyte was evaluated by testing positive and negative samples at relative humidities (R.H.) ranging from ≤ 10 %R.H. to 85 %RH. The Quidel Triage TOX Drug Screen, 94600 is validated for an operating relative humidity (R.H.) range from 10 %R.H. to 85 %R.H. for all analyte assays.
The sponsor has included the following statement in the device labeling under the ‘Warnings and Precautions’ section:
“Optimal results will be achieved by performing testing at temperatures between 18°C to 28°C (64°F to 82°F) and between a relative humidity (RH) range of 10 %RH to 85 %RH. Specimens tested outside of the validated temperature range may yield inaccurate results particularly for the cocaine, methamphetamines and opiates assays.”
## f. Assay cut-off:
Each analyte for the cutoff characterization study was tested at the following concentrations: 0, 25%, 50%, 75%, 100%, +125%, +150%, +175% and +200% of the specific cutoff for each drug assay. Testing was performed using 3 lots of Quidel Triage TOX Drug Screen, 94600 Test Devices and was performed by 3 operators
{24}
over four days. Each test sample was run on 105 test devices per device lot for a total of 315 results per sample. For each test device lot, 40 unique meters were used to complete all test measurements. Combined results from three test device lots for each drug test is summarized below.
| Amphetamine (AMP) 500 ng/mL | | |
| --- | --- | --- |
| Concentration (ng/mL) | % of cutoff | Results #Neg/#Pos |
| Negative Control | 0% | 315/0 |
| 0 | 0% | 315/0 |
| 126 | 25% | 315/0 |
| 281 | 50% | 315/0 |
| 395 | 75% | 313/2 |
| 522 | 100% | 49/266 |
| 650 | 125% | 1/314 |
| 760 | 150% | 0/315 |
| 884 | 175% | 0/315 |
| 991 | 200% | 0/315 |
| Methamphetamine (mAMP) 500 ng/mL | | |
| --- | --- | --- |
| Concentration (ng/mL) | % of cutoff | Results #Neg/#Pos |
| Negative Control | 0% | 315/0 |
| 0 | 0% | 315/0 |
| 130 | 25% | 315/0 |
| 250 | 50% | 315/0 |
| 366 | 75% | 312/3 |
| 529 | 100% | 127/188 |
| 652 | 125% | 11/304 |
| 742 | 150% | 2/313 |
| 872 | 175% | 0/315 |
| 961 | 200% | 0/315 |
{25}
| Barbiturates (BAR) 200 ng/mL | | |
| --- | --- | --- |
| Concentration (ng/mL) | % of cutoff | Results #Neg/#Pos |
| Negative Control | 0% | 315/0 |
| 0 | 0% | 315/0 |
| 53 | 25% | 315/0 |
| 108 | 50% | 315/0 |
| 156 | 75% | 309/6 |
| 192 | 100% | 78/237 |
| 233 | 125% | 1/314 |
| 306 | 150% | 1/314 |
| 355 | 175% | 0/315 |
| 406 | 200% | 0/315 |
| Benzodiazepines (BZO) 200 ng/mL | | |
| --- | --- | --- |
| Concentration (ng/mL) | % of cutoff | Results #Neg/#Pos |
| Negative Control | 0% | 315/0 |
| 0 | 0% | 315/0 |
| 58 | 25% | 315/0 |
| 107 | 50% | 315/0 |
| 166 | 75% | 296/19 |
| 219 | 100% | 242/73 |
| 259 | 125% | 3/312 |
| 306 | 150% | 0/315 |
| 378 | 175% | 0/315 |
| 399 | 200% | 0/315 |
| Cocaine (COC) 150 ng/mL | | |
| --- | --- | --- |
| Concentration (ng/mL) | % of cutoff | Results #Neg/#Pos |
| Negative Control | 0% | 315/0 |
| 0 | 0% | 315/0 |
| 41 | 25% | 315/0 |
| 76 | 50% | 315/0 |
{26}
| Cocaine (COC) 150 ng/mL | | |
| --- | --- | --- |
| 119 | 75% | 279/36 |
| 157 | 100% | 10/305 |
| 185 | 125% | 1/314 |
| 218 | 150% | 0/315 |
| 267 | 175% | 0/315 |
| 300 | 200% | 0/315 |
| Methadone Metabolite (EDDP) 100 ng/mL | | |
| --- | --- | --- |
| Concentration (ng/mL) | % of cutoff | Results #Neg/#Pos |
| Negative Control | 0% | 315/0 |
| 0 | 0% | 315/0 |
| 29 | 25% | 315/0 |
| 52 | 50% | 315/0 |
| 85 | 75% | 315/0 |
| 111 | 100% | 115/200 |
| 136 | 125% | 11/304 |
| 143 | 150% | 0/315 |
| 174 | 175% | 0/315 |
| 204 | 200% | 0/315 |
| Opiates (OPI) 300 ng/mL | | |
| --- | --- | --- |
| Concentration (ng/mL) | % of cutoff | Results #Neg/#Pos |
| Negative Control | 0% | 315/0 |
| 0 | 0% | 315/0 |
| 87 | 25% | 315/0 |
| 165 | 50% | 315/0 |
| 231 | 75% | 315/0 |
| 344 | 100% | 132/183 |
| 426 | 125% | 1/314 |
| 480 | 150% | 0/315 |
| 548 | 175% | 0/315 |
| 589 | 200% | 0/315 |
{27}
| Cannabinoids (THC) 50 ng/mL | | |
| --- | --- | --- |
| Concentration (ng/mL) | % of cutoff | Results #Neg/#Pos |
| Negative Control | 0% | 315/0 |
| 0 | 0% | 315/0 |
| 12 | 25% | 315/0 |
| 26 | 50% | 315/0 |
| 39 | 75% | 295/20 |
| 54 | 100% | 20/295 |
| 65 | 125% | 0/315 |
| 78 | 150% | 0/315 |
| 91 | 175% | 0/315 |
| 103 | 200% | 0/315 |
| Tricyclic Antidepressants (TCA) 1000 ng/mL | | |
| --- | --- | --- |
| Concentration (ng/mL) | % of cutoff | Results #Neg/#Pos |
| Negative Control | 0% | 315/0 |
| 0 | 0% | 315/0 |
| 236 | 25% | 315/0 |
| 498 | 50% | 315/0 |
| 741 | 75% | 300/15 |
| 996 | 100% | 161/154 |
| 1,395 | 125% | 5/310 |
| 1,577 | 150% | 1/314 |
| 1,716 | 175% | 0/315 |
| 2,195 | 200% | 0/315 |
2. Comparison studies:
a. Method comparison with predicate device:
A method comparison study was conducted using unaltered urine specimens tested on the Quidel Triage TOX Drug Screen, 94600 and compared to results from a chemically-specific quantitative comparator method. Results are summarized below.
Quidel Triage TOX Drug Screen, 94600 Test Results vs GC/MS or LC-MS/MS
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Values
| | | Reference Method Result by GC/MS or LC-MS/MS Value | | | |
| --- | --- | --- | --- | --- | --- |
| DRUG | Quidel Triage TOX Drug Screen, 94600 | Negative (<50% of threshold) | Near Threshold Negative (within 50% below threshold) | Near Threshold Positive (within 50% above threshold) | Positive (>150% of threshold) |
| AMP (500) | Negative | 99 | 11 | \(2^a\) | \(2^b\) |
| | Positive | 0 | 0 | 8 | 98 |
| mAMP (500) | Negative | 99 | 5 | \(5^d\) | \(7^e\) |
| | Positive | 0 | \(5^c\) | 6 | 91 |
| BAR (200) | Negative | 99 | 3 | 0 | 0 |
| | Positive | 0 | \(8^f\) | 11 | 97 |
| BZO (200) | Negative | 99 | 1 | \(1^h\) | 0 |
| | Positive | 0 | \(10^g\) | 10 | 99 |
| COC (150) | Negative | 99 | 5 | 0 | 0 |
| | Positive | 0 | \(6^i\) | 11 | 99 |
| EDDP (100) | Negative | 99 | 9 | \(2^j\) | 0 |
| | Positive | 0 | \(1^k\) | 10 | 98 |
| OPI (300) | Negative | 99 | 2 | 0 | \(1^m\) |
| | Positive | 0 | \(8^l\) | 11 | 98 |
| THC (50) | Negative | 99 | 10 | \(3^o\) | 0 |
| | Positive | 0 | \(1^n\) | 8 | 99 |
| TCA (1,000) | Negative | 98 | 1 | 0 | \(1^r\) |
| | Positive | \(1^p\) | \(10^q\) | 11 | 95 |
Discordant Results - Resolution
| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| AMP | 500 | 569740a | False Negative | Amphetamine | 697 |
| AMP | 500 | 575202a | False Negative | Amphetamine | 745 |
| AMP | 500 | 570964b | False Negative | Amphetamine | 1003 |
| AMP | 500 | 572667b | False Negative | Amphetamine | 1359 |
{29}
a These two patient specimens were read negative despite a near threshold positive results by the reference method.
b These two patient specimens were read negative despite a high positive result. The Quidel Triage TOX Drug Screen, 94600 has 100.0% cross reactivity to the d-amphetamine isomer and 16.7% cross-reactivity to the l-amphetamine isomer, resulting in negative screening results even with amphetamine levels above the cutoff concentration of 500 ng/mL by the reference method. A specimen with high levels of the l-amphetamine isomer may be associated with prescription use of medications containing amphetamines or compounds that metabolize to amphetamines. A summary of the results for the patient specimens containing both isomers is presented in the table below. After adjudication, Specimen ID 570964 would be classified as "near threshold" negative and would not be classified as a discordant result. Specimen ID 572667 would be classified as a "near threshold" positive patient specimen (within 10.8% of the assay threshold).
| Specimen ID | Quidel Triage TOX Drug Screen, 94600 AMP Assay Cutoff (ng/mL) | Initial Value determined by LC-MS/MS (ng/mL) | Initial Quidel Triage TOX Drug Screen, 94600 AMP Assay Result | Isomeric Composition (%) | | Isomeric Abundance (ng/mL) | | Effective Amphetamine (ng/mL) * | Adjudicated Quidel Triage TOX Drug Screen, 94600 AMP Assay Result |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | | % d-Amphetamine | % l-Amphetamine | d-Amphetamine | l-Amphetamine | | |
| 570964b | 500 | 1003 | False Negative | 35.3 | 64.7 | 354 | 649 | 463 | Negative |
| 572667b | 500 | 1359 | False Negative | 28.9 | 71.1 | 393 | 966 | 554 | False Negative |
| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| mAMP | 500 | 578510c | False Positive | Methamphetamine | 325 |
| mAMP | 500 | 579777c | False Positive | Methamphetamine | 402 |
| mAMP | 500 | 579705c | False Positive | Methamphetamine | 445 |
| mAMP | 500 | 579727c | False Positive | Methamphetamine | 490 |
| mAMP | 500 | 579806c | False Positive | Methamphetamine | 495 |
| mAMP | 500 | 586313d | False Negative | Methamphetamine | 535 |
| mAMP | 500 | 586273d | False Negative | Methamphetamine | 555 |
| mAMP | 500 | 579791d | False Negative | Methamphetamine | 588 |
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| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| mAMP | 500 | 586280d | False Negative | Methamphetamine | 633 |
| mAMP | 500 | 586293d | False Negative | Methamphetamine | 673 |
| mAMP | 500 | 586276e | False Negative | Methamphetamine | 831 |
| mAMP | 500 | 586269e | False Negative | Methamphetamine | 937 |
| mAMP | 500 | 586264e | False Negative | Methamphetamine | 940 |
| mAMP | 500 | 586282e | False Negative | Methamphetamine | 984 |
| mAMP | 500 | 586275e | False Negative | Methamphetamine | 990 |
| mAMP | 500 | 586300e | False Negative | Methamphetamine | 1028 |
| mAMP | 500 | 579757e | False Negative | Methamphetamine | 1568 |
${}^{c}$ Patient specimens with Specimen IDs 578510, 579777, 579705, 579727, and 579806 were found to be positive despite a near threshold negative result.
${}^{d}$ Patient specimens with Specimen IDs 586313, 586723, 579791, 586280 and 586293 were found to be negative despite a near threshold positive result.
e Patient specimens with Specimen IDs 586276, 586269, 586264, 586282, 586275, 586300, and 579757 were found to be negative despite a high positive result. The specimens contained both the d-methamphetamine and l-methamphetamine isomers. The initial LC-MS/MS reference method was unable to distinguish between the two enantiomeric forms. The Quidel Triage TOX Drug Screen, 94600 has $100.0\%$ cross-reactivity to the d-methamphetamine isomer and $0.0\%$ cross-reactivity to the l-methamphetamine isomer, resulting in negative screening results even with methamphetamine levels above the cutoff concentration of $500~\mathrm{ng / mL}$ . A specimen with high levels of the l-methamphetamine isomer may be associated with prescription use of medications that contain methamphetamine or compounds that metabolize into methamphetamines. A summary of the results for the patient specimens containing both isomers is presented in the table below. After adjudication, Specimen IDs 586282, 586275 and 586300 were found to be negative despite a near threshold positive result (all within $8.6\%$ of the assay threshold).
| mAMP Specimen ID | Reference Laboratory 1 LC-MS/MS Confirmatory Value (ng/mL) | Quidel Triage TOX Drug Screen, 94600 Threshold Concentration (ng/mL) | Quidel Triage TOX Drug Screen, 94600 Result | Reference Laboratory 2 Results | | Adjudicated Quidel Triage TOX Drug Screen, 94600 Result |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | % d-Isomer | Concentration d-Isomer (ng/mL) | |
| 586276e | 831 | 500 | False Negative | 52.3 | 434.6 | Negative |
| 586269e | 937 | 500 | False Negative | 52.8 | 494.7 | Negative |
| 586264e | 940 | 500 | False Negative | 52.9 | 497.3 | Negative |
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| 586282e | 984 | 500 | False Negative | 52.2 | 513.6 | False Negative |
| --- | --- | --- | --- | --- | --- | --- |
| 586275e | 990 | 500 | False Negative | 52.3 | 517.8 | False Negative |
| 586300e | 1028 | 500 | False Negative | 52.8 | 542.8 | False Negative |
| 579757e | 1568 | 500 | False Negative | 19.9 | 312.0 | Negative |
| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| BAR | 200 | 582858f | False Positive | Phenobarbital | 120 |
| BAR | 200 | 575082f | False Positive | Phenobarbital | 172 |
| BAR | 200 | 575081f | False Positive | Butalbital | 150 |
| BAR | 200 | 575079f | False Positive | Butalbital | 151 |
| BAR | 200 | 586932f | False Positive | Amobarbital | 164 |
| BAR | 200 | 575085f | False Positive | Butalbital | 165 |
| BAR | 200 | 575084f | False Positive | Phenobarbital | 210 |
| BAR | 200 | 575095f | False Positive | Butalbital | 197 |
Patient specimens with Specimen IDs 582858, 575082, 575081, 575079, 586932, 575085, 575084, and 575095 were found to be positive despite a near threshold negative result.
| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| BZO | 200 | 586239g | False Positive | Alprazolam-OH | 79 |
| BZO | 200 | 586234g | False Positive | Alprazolam-OH | 80 |
| BZO | 200 | 586235g | False Positive | Alprazolam-OH | 86 |
| BZO | 200 | 582865g | False Positive | 7-aminoclonazepam | 293 |
| | | | | Lorazepam | 53 |
| | | | | Oxazepam | 379 |
| BZO | 200 | 570784g | False Positive | 7-aminoclonazepam | 1134 |
| | | | | Nordiazepam | 63 |
| | | | | Oxazepam | 124 |
| | | | | Temazepam | 90 |
| BZO | 200 | 569935g | False Positive | Nordiazepam | 68 |
| | | | | Oxazepam | 244 |
| BZO | 200 | 570783g | False Positive | 7-aminoclonazepam | 1134 |
| | | | | Nordiazepam | 63 |
| BZO | 200 | 570782g | False Positive | 7-aminoclonazepam | 1134 |
| | | | | Nordiazepam | 68 |
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| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| | | | | Temazepam | 93 |
| BZO | 200 | 585873g | False Positive | Alprazolam-OH | 105 |
| | | | | 7-aminoclonazepam | 2500 |
| BZO | 200 | 570860g | False Positive | Nordiazepam | 83 |
| | | | | Oxazepam | 218 |
| | | | | Temazepam | 126 |
| BZO | 200 | 570941g | False Positive | Alprazolam-OH | 126 |
| BZO | 200 | 578527g | False Positive | Alprazolam-OH | 129 |
| | | | | 7-aminoclonazepam | 146 |
| BZO | 200 | 578563h | False Negative | Lorazepam | 214 |
g Patient specimens with Specimen IDs 586239, 586234, 586235, 582865, 570784, 569935, 585873, 570860, 570941, and 578527 were found to be positive despite a near threshold negative result.
h Patient specimen with Specimen ID 578563 was found to be negative despite a near threshold positive result.
| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| COC | 150 | 569915i | COC False Positive | Benzoylecgonine | 113 |
| COC | 150 | 579796i | False Positive | Benzoylecgonine | 126 |
| COC | 150 | 579821i | False Positive | Benzoylecgonine | 128 |
| COC | 150 | 569790i | False Positive | Benzoylecgonine | 129 |
| COC | 150 | 570955i | False Positive | Benzoylecgonine | 144 |
| COC | 150 | 577368i | False Positive | Benzoylecgonine | 144 |
i Patient specimens with Specimen IDs 569915, 579796, 579821, 569790, 570955 and 577368 were found to be positive despite a near threshold negative result.
| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| EDDP | 100 | 572444j | False Positive | EDDP | 76 |
| EDDP | 100 | 572432k | False Negative | EDDP | 100 |
| EDDP | 100 | 572426k | False Negative | EDDP | 110 |
j Patient specimen with Specimen ID 572444 was found to be positive despite a near threshold negative result.
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${}^{k}$ Patient specimens with Specimen IDs 572432 and 572426 were found to be negative despite a near threshold positive result.
| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| OPI | 300 | 5725081 | False Positive | Hydrocodone | 353 |
| OPI | 300 | 5704151 | False Positive | Oxycodone | 24859 |
| | | | | Oxymorphone | 217 |
| OPI | 300 | 5863271 | False Positive | Morphine | 228 |
| OPI | 300 | 5828601 | False Positive | Hydrocodone | 469 |
| OPI | 300 | 5724881 | False Positive | Morphine | 239 |
| OPI | 300 | 5863301 | False Positive | Morphine | 260 |
| OPI | 300 | 5829321 | False Positive | Hydrocodone | 488 |
| | | | | Hydromorphone | 67 |
| OPI | 300 | 5863291 | False Positive | Morphine | 285 |
| OPI | 300 | 572644m | False Negative | Morphine | 2097 |
| | | | | Oxycodone | 2674 |
| | | | | Oxymorphone | 137 |
1 Patient specimens with Specimen IDs 572508, 570415, 586327, 582860, 572488, 586330, 582932 and 586359 were found to be positive despite a near threshold negative result.
Patient specimen with Specimen ID 572644 was found to be negative despite a high positive result. The initial reference testing laboratory result for Specimen ID 572644 was positive for opiates while the Quidel Triage TOX Drug Screen, 94600 OPI assay result was negative. Specimen ID 572644 was sent to a second reference testing laboratory and was confirmed to be negative for opiates. The second result is concordant with the Quidel Triage TOX Drug Screen, 94600 OPI assay result.
| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| THC | 50 | 570021n | False Positive | 11-nor-9-Carboxy-delta 9-THC | 31 |
| THC | 50 | 570366o | False Negative | 11-nor-9-Carboxy-delta 9-THC | 51 |
| THC | 50 | 575089o | False Negative | 11-nor-9-Carboxy-delta 9-THC | 56 |
| THC | 50 | 569400o | False Negative | 11-nor-9- | 63 |
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35
| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| | | | | Carboxy-delta 9-THC | |
${}^{n}$ Patient specimen with Specimen ID 570021 was found to be positive despite a near threshold negative result.
${}^{o}$ Patient specimens with Specimen IDs 570366, 575089, and 569400 were found to be negative despite a near threshold positive result.
| Assay | Cutoff Value (ng/mL) | Specimen ID | Quidel Triage TOX DS 94600 Result (POS/NEG) | Drug/Metabolite Detected | GC/MS or LC/MS/MS value (ng/mL) |
| --- | --- | --- | --- | --- | --- |
| TCA | 1,000 | 586712^{p} | False Positive | Desipramine | 0 |
| TCA | 1,000 | 586353^{q} | False Positive | Desipramine | 637 |
| TCA | 1,000 | 585878^{q} | False Positive | Desipramine | 639 |
| TCA | 1,000 | 582936^{q} | False Positive | Amitriptyline | 385 |
| | | | | Nortriptyline | 160 |
| TCA | 1,000 | 572581^{q} | False Positive | Amitriptyline | 149 |
| | | | | Nortriptyline | 512 |
| TCA | 1,000 | 585866^{q} | False Positive | Desipramine | 680 |
| TCA | 1,000 | 586232^{q} | False Positive | Desipramine | 727 |
| TCA | 1,000 | 585830^{q} | False Positive | Desipramine | 730 |
| TCA | 1,000 | 585879^{q} | False Positive | Desipramine | 758 |
| TCA | 1,000 | 582925^{q} | False Positive | Amitriptyline | 162 |
| | | | | Nortriptyline | 599 |
| TCA | 1,000 | 585874^{q} | False Positive | Desipramine | 608 |
| | | | | Doxepin | 238 |
| TCA | 1,000 | 586694^{r} | False Negative | Desipramine | 1646 |
${}^{p}$ Patient specimen with Specimen ID 586712 was found to be positive despite a high negative result. A data entry error occurred with Specimen ID 586712. This patient specimen was positive for TCA when tested on the Quidel Triage TOX Drug Screen, 94600 and reconfirmed as a near cut-off negative at a secondary reference testing laboratory with value of 864 ng/mL desipramine (within 10.8% of the assay threshold).
${}^{q}$ Patient specimens with Specimen IDs 586353, 585878, 582936, 572581, 585866, 586232, 585830, 585879, 582925, and 585874 were found to be positive despite a near threshold negative result.
${}^{r}$ Patient specimen with Specimen ID 586694 was found to be negative despite a high positive result. Specimen ID 586694 was confirmed to have a pH value of 9.4. A pH value at this level is above the upper limit of the expected range for normal human urine 8 and above the upper limit evaluated for performance on the Quidel Triage TOX Drug Screen, 94600. The Quidel Triage TOX Drug Screen, 94600 has been
{35}
validated with specimens that have a pH range of 4.0 – 9.0 acceptable results were observed with the samples tested. However, a low level of interference was noted with the TCA assay as the pH increased which could impact results which are above the threshold of 1,000 ng/mL. Specimens tested outside of the validated pH range may yield inaccurate results.
b. Matrix comparison:
Not applicable. These devices are for use with human urine samples only.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
Not applicable.
N. Instrument Name:
Quidel Triage® MeterPro
O. System Descriptions:
1. Modes of Operation:
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
Yes ☐ X ☐ or No ☐
Does the applicant’s device transmit data to a computer, webserver, or mobile device
36
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using wireless transmission?
Yes _______ or No ☐ X
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No _______
3. Specimen Identification:
There is no sample identification function with this device. Samples are applied directly to the test device.
4. Specimen Sampling and Handling:
This device is intended to be used with urine samples. The labeling provides instructions for storage of samples.
5. Calibration:
Lot Calibration of the meter is performed using Reagent CODE CHIP Module which is specific to each lot of the test device.
6. Quality Control:
For the meter quality control, the device operator installs the QC Device CODE CHIP Module in the meter. After installation, the operator runs the QC Device every day prior to running the external quality control samples and patient samples to assess the functioning of the meter lasers etc.
The QC Sample CODE CHIP module is lot specific. The operator installs the QC Sample CODE CHIP module in the meter prior to testing of the external QC samples (Control 1 and 2).
The sponsor specifies in the labeling the quality control products that must be used with the device systems.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
Not applicable.
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Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
38
