Predicate Devices

K130082, K161714, K173963, K151395, K043242, K973547

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on fluorescence immunoassay technology and a fluorescence instrument for reading results based on predefined threshold concentrations. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.

Therapeutic

No
This device is an in vitro diagnostic (IVD) device used for the qualitative detection of drugs and/or metabolites in human urine. It is explicitly stated that this test provides only a preliminary test result and does not treat or alleviate a disease or condition.

Diagnostic

Yes
The device is described as a "fluorescence immunoassay for the qualitative determination of the presence of drugs and/or metabolites in human urine," which is a diagnostic purpose to identify specific substances in a biological sample.

SaMD (Software as a Medical Device)

No

The device is a fluorescence immunoassay test strip used in conjunction with a physical instrument (Quidel Triage® MeterPro) to measure results. It is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Quidel Triage® TOX Drug Screen, 94600 is indeed an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is for the "qualitative determination of the presence of drugs and/or metabolites in human urine". This involves testing a sample taken from the human body in vitro (outside the body).
Device Description: The device is a "single use test device" that analyzes a human urine sample.
Performance Studies: The performance studies involve testing human urine specimens and comparing the results to reference methods.

Therefore, the Quidel Triage® TOX Drug Screen, 94600 fits the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Quidel Triage® TOX Drug Screen, 94600:

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
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 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.

Quidel Triage® MeterPro:

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.

Product codes (comma separated list FDA assigned to the subject device)

DKZ, LAF, DIS, JXM, JXO, DJR, DJG, LDJ, LFG, KHO

Device Description

Quidel Triage® TOX Drug Screen, 94600:

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 contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result.

Quidel Triage® MeterPro:

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.

The Quidel Triage MeterPro uses a laser as a light source. 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. The more energy the fluorescent dye gives off, the stronger the signal.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 (3) study sites. Three (3) operators conducted the testing at each study site. Each operator was assigned one test device lot and five (5) Triage MeterPro instruments to conduct the testing. Each operator tested ten (10) samples each day of testing. The ten (10) samples were run in duplicate two (2) times per day for twenty (20) days at each clinical site. Each device was read on one (1) Triage MeterPro. There were approximately seven hundred twenty (720) results 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.

Results are presented in tables showing sample concentration (ng/mL), % of cutoff, n, # Neg, # Pos for AMP, mAMP, BAR, BZO, COC, EDDP, OPI, THC, and TCA.

b. Linearity/Assay Reportable Range: Not applicable. These devices are intended for qualitative use only.

c. Traceability, Stability, Expected Values
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℃ to 8℃). Real time stability studies are ongoing.
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℃ to 24℃). Room temperature stability studies are ongoing.
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 and within four (4) days when stored refrigerated. No more than a single freeze/thaw cycle is recommended.

d. Detection Limit: See assay cutoff characterization data in Section 15.13.1.f.

e. Analytical Specificity:
Cross-reactivity was tested by spiking drug metabolites and other compounds into human urine samples using nine (9) lots of Quidel Triage TOX Drug Screen, 94600 Test Devices. Results are summarized in tables for each analyte showing results positive at (ng/mL) and % cross-reactivity for various compounds.
Exogenous Interference: Potential interference from exogenous compounds was tested by spiking listed compounds into treated drug-free urine containing target drug concentrations at 50% below and 50% above the threshold cutoff level. Table shows Interfering Substance and Concentration.
Endogenous Interference: Potential interference from endogenous compounds was tested by spiking listed compounds into drug-free urine containing target drug concentrations at 50% below and 50% above the threshold cutoff level. Table shows Interfering Substance and Concentration.

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. 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. No excessive interference was observed, but increasing urine pH levels at the top of the validated range could impact positive control sample results for the TCA assay.

Operating Temperature: The effect of operating temperature for each analyte was evaluated by testing positive and negative samples at temperatures ranging from 16℃ to 30℃ (61°F to 86°F). The Quidel Triage TOX Drug Screen, 94600 was validated for an operating temperature range from 18℃ to 28℃ (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 (RH) ranging from ≤ 10 %RH to 85 %RH. The Quidel Triage TOX Drug Screen, 94600 was validated for an operating relative humidity (RH) range from 10 %RH to 85 %RH.

f. Assay cut-off: Each analyte for the cutoff characterization study was tested at 0, 25%, 50%, 75%, 100%, +125%, +150%, +175% and +200% of the specific cutoff. Testing was performed using 3 lots of Quidel Triage TOX Drug Screen, 94600 Test Devices and by 3 operators. Results are summarized in tables showing concentration, % of cutoff, and Results #Neg/#Pos for each analyte (AMP, mAMP, BAR, BZO, COC, EDDP, OPI, THC, TCA).

Comparison studies:
a. Method comparison with reference method: A method comparison study was conducted using unaltered urine specimens and comparing results from the Quidel Triage TOX Drug Screen, 94600 to a reference method (GC/MS or LC-MS/MS). Results are summarized in tables for each drug showing distribution of negative and positive results based on reference method values (negative, near threshold negative, near threshold positive, positive). Discordant sample resolution details are provided for each drug, including specimen ID, result (False Negative/Positive), drug/metabolite detected, and GC/MS or LC/MS/MS value (ng/mL), and in some cases, isomeric composition breakdown.

b. Method comparison with reference method: Not applicable. These devices are for use with human urine samples only.

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.
Clinical cut-off: Not applicable.
Expected values/Reference range: Not applicable.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not provided explicitly, but can be inferred from the "Comparison studies: Method comparison with reference method" tables. For example, for AMP at 500 ng/mL cutoff, 99 true negatives and 98 true positives for values >150% of threshold.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K130082, K161714, K173963, K151395, K043242, K973547

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
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.(b)
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).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 19, 2019

Quidel Cardiovascular Inc. Rachael Williamson Senior Manager, Regulatory Affairs 9975 Summers Ridge Road San Diego, CA 92121

Re: K182719

Trade/Device Name: Quidel Triage® TOX Drug Screen, 94600 Quidel Triage® MeterPro Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, LAF, DIS, JXM, JXO, DJR, DJG, LDJ, LFG, KHO Dated: June 13, 2019 Received: June 14, 2019

Dear Rachael Williamson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K182719

Device Name

Quidel Triage® TOX Drug Screen, 94600 Quidel Triage® MeterPro

Indications for Use (Describe)

Quidel Triage® TOX Drug Screen, 94600:

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
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 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.

Quidel Triage® MeterPro:

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K182719

1. 510(K) SUMMARY

1.1. Date Prepared:

June 18, 2019

1.2. Purpose for Submission:

New device

1.3. Measurand:

Amphetamine, Methamphetamine, Barbiturates, Benzodiazepines, Cocaine, EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine), Opiates, Cannabinoids, Tricyclic Antidepressants

1.4. Type of Test:

Qualitative, lateral flow immunofluorescence

1.5. Applicant:

Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, California 92121 Telephone: 858-302-0334 Fax: 858-805-8622

Rachael S. Williamson (Submission Contact)

1.6. Proprietary and Established Names:

Quidel Triage® TOX Drug Screen, 94600 Quidel Triage® MeterPro

Regulatory Information: 1.7.

Quidel Triage® TOX Drug Screen, 94600:

| Product

Code	Classification	Regulatory Section	Panel
DKZ	Class II	21 CFR 862.3100,
Amphetamine test system	Toxicology (91)

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| Product

Code	Classification	Regulatory Section
LAF	Class II	21 CFR 862.3610,
Methamphetamine test
system	Toxicology (91)
DIS	Class II	21 CFR 862.3150,
Barbiturate test system	Toxicology (91)
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 862.3260,
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)

Quidel Triage® MeterPro:

Product Code	Classification	Regulatory Section
KHO	Class I	21 CFR 862.2560, Fluorometer for
clinical use	Clinical
Chemistry

Intended Use: 1.8.

Quidel Triage® TOX Drug Screen, 94600:

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

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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
OPI	Opiates	Morphine	300 ng/mL
THC	Cannabinoids	11-nor-9-carboxy- $\Delta$ -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 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.

Quidel Triage® MeterPro:

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.

1.9. Device Description:

Quidel Triage® TOX Drug Screen, 94600:

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 contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result.

Quidel Triage® MeterPro:

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.

The Quidel Triage MeterPro uses a laser as a light source. 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. The more energy the fluorescent dye gives off, the stronger the signal.

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Image /page/7/Picture/0 description: The image features the logo for QuidelOrtho Corporation. The logo consists of a square shape with a smaller square cut out of the lower right corner. The larger square is filled with a gradient of colors, transitioning from green and yellow on the left to red and orange at the top, and blue and purple on the right. Below the square is the word "QUIDEL" in a bold, sans-serif font.

1.10. Substantial Equivalence Information:

1. Predicate Device Name:
  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
1. Predicate 510(k) Number:
  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
1. Comparison with Predicate:

Quidel Triage® TOX Drug Screen, 94600:

Assays: Amphetamines (AMP), Methamphetamines (mAMP), Cocaine (COC), Opiates (OPI), and Cannabinoids (THC)

Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	GenPrime Drugs of Abuse
(DOA) Reader System
(K130082)
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

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Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	GenPrime Drugs of Abuse
(DOA) Reader System
(K130082)
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	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	GenPrime Drugs of Abuse
(DOA) Reader System
(K130082)
Analyte Cutoffs
(ng/mL)	BAR = 200
BZO = 200
EDDP = 100
TCA = 1000

MTD, OXY, PCP are not panel
assays and have no associated
analyte cutoffs. | BAR = 300 (OS Cup)
MTD = 300 (SK Cup)
MOP = 2000 (SK Cup)
PCP = 25 (SK Cup)

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Differences
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	GenPrime Drugs of Abuse
(DOA) Reader System
(K130082)
Test Time and Timing
Method	Operator adds sample to test
device and operates
the
instrument.	Operator manually times test
development for 5 minutes and
then operates the instrument.
Measurement Method	Scans the single-use test
device to measure signals.	Scans the single-use test device
to detect a signal.
Time to Results	Result interpretation occurs in
approximately 15 minutes.	Results interpretation must
occur between 5 and 60
minutes following specimen
application
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. If connected, the
MeterPro can transmit results
to the laboratory or hospital
information system.	Outputs "presumptive
positive", “negative”, and
"invalid" test results on a
graphic user interface
displayed on a computer screen
and automatically stores results
along with test information.
Operator has ability to print
and/or export results.

The following cutoff values are being incorporated into the Quidel Triage® TOX Drug Screen, 94600 Test Device. The cutoff values have been modified to accommodate changes in the calibrator used to manufacture the Test Device for barbiturates and benzodiazepines. In addition, the proposed predicates are identified for the EDDP and TCA assays. The tables below provide the similarities and differences with the selected predicates.

Assay: Barbiturates (BAR)

Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	Immunalysis
Barbiturates
Urine Enzyme Immunoassay
(K161714)
Intended Use	For the qualitative
determination of drugs of
abuse in human urine.	Same

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Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	Immunalysis Barbiturates
Urine Enzyme Immunoassay
(K161714)
Specimen Type	Human urine	Same
Storage	2-8°C	Same
Measured Analyte	BAR	Same
Analyte Cutoff
(ng/mL)	BAR = 200	Same

Differences
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	Immunalysis Barbiturates
Urine Enzyme Immunoassay
(K161714)
Intended Use	Not intended for semi-
quantitative determination of
the presence of Barbiturates in
human urine.	For the semi-quantitative
determination of the presence
of Barbiturates in human
urine.
Assay Type	Competitive
assay, where
concentration of drug is
inversely related to the signal
detected by the instrument.	Enzyme immunoassay
Antibody Type	Mouse monoclonal antibodies	Recombinant and monoclonal
antibodies

Assay: Benzodiazepines (BZO)

Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	DRI Benzodiazepine Assay
(K173963)
Intended Use	For the qualitative
determination of drugs of
abuse in human urine.	Same
Specimen Type	Human urine	Same
Storage	2-8°C	Same

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Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	DRI Benzodiazepine Assay
(K173963)
Analyte Cutoff
(ng/mL)	BZO = 200	Same

Differences
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	DRI Benzodiazepine Assay
(K173963)
Intended Use	Not intended for semi-
quantitative determination of
the presence of
benzodiazepines and their
metabolites in human urine.	For the semi-quantitative
determination of the presence
of benzodiazepines and their
metabolites in human urine.
Assay Type	Competitive assay, where
concentration of drug is
inversely related to the signal
detected by the instrument.	Homogenous enzyme
immunoassay
Antibody Type	Mouse monoclonal antibodies	Polyclonal sheep antibody

Assay: 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)

Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	Immunalysis EDDP Specific
Urine Enzyme Immunoassay
(K151395)
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

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Differences
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	Immunalysis EDDP Specific
Urine Enzyme Immunoassay
(K151395)
Intended Use	Not intended for semi-
quantitative determination of
the presence of EDDP in
human urine.	For the semi-quantitative
determination of the presence
of EDDP in human urine.
Assay Type	Competitive assay, where
concentration of drug is
inversely related to the signal
detected by the instrument.	Homogenous enzyme
immunoassay
Antibody Type	Mouse monoclonal antibodies	Recombinant fab antibodies
Analyte Cutoffs
(ng/mL)	Not intended to have cutoffs
available at 300 ng/mL and
1000 ng/mL	EDDP = 300 and 1000

Assay: Tricyclic Antidepressants (TCA)

Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	Triage® TOX Drug Screen
(K043242)
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

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Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	Triage® TOX Drug Screen
(K043242)
Measured Analyte	TCA	Same
Analyte Cutoff
(ng/mL)	TCA = 1000	Same

Differences
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX Drug
Screen, 94600 (Proposed)	Triage® TOX Drug Screen
(K043242)
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

Quidel Triage® MeterPro:

Last, the proposed predicate for the Quidel Triage MeterPro is its predecessor the Triage Meter cleared under K973547.

Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® MeterPro (Proposed)	Triage Meter (K973547)
Device 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

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Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® MeterPro
(Proposed)	Triage Meter (K973547)
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

Differences
Item	Proposed Device	Predicate Device
Features	Quidel Triage®
MeterPro
(Proposed)	Predicate Device
Regulation	21 CFR 862.2560	21 CFR 862.2560 (KHO)
21 CFR 862.5680 (DDR)
21 CFR 862.1215 (JHX)
21 CFR 862.1215 (MMI)
Product Code	KHO	KHO, DDR, JHX, MMI
Sample Type	Whole blood, plasma or urine	Whole blood or plasma
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

1.11. Standard/Guidance Document Referenced:

None referenced.

1.12. Test Principle:

The Quidel Triage TOX Drug Screen, 94600 is a test device utilizing the standard Triage technology. It 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 for 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).

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The Test Device contains:

Murine monoclonal antibodies against 9 targeted drugs or metabolites
Fluorescently labeled antibodies ●
Fluorescently labeled metabolites
Solid phase
Stabilizers

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 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 results are displayed on the Quidel Triage MeterPro screen in about 15 minutes. 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.

1.13. Performance Characteristics:

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 (3) study sites. Three (3) operators conducted the testing at each study site. Each operator was assigned one test device lot and five (5) Triage MeterPro instruments to conduct the testing. Each operator tested ten (10) samples each day of testing. The ten (10) samples were run in duplicate two (2) times per day for twenty (20) days at each clinical site. Each device was read on one (1) Triage MeterPro. There were approximately seven hundred twenty (720) results 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.

| Sample
Concentration

(ng/mL)	% of Cutoff	n	# Neg	# Pos
AMP (500 ng/mL)

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| Sample
Concentration

(ng/mL)	% of Cutoff	n	# Neg	# Pos
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
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

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| Sample
Concentration

(ng/mL)	% of Cutoff	n	# Neg	# Pos
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
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
Sample
Concentration
(ng/mL)	% of Cutoff	n	# Neg	# Pos
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

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℃ to 8℃). Real time stability studies are ongoing and shelf life will be extended based upon data meeting the acceptance criteria.

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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℃ to 24℃). 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 and within four (4) days when stored refrigerated. No more than a single freeze/thaw cycle is recommended.

d. Detection Limit:
See assay cutoff characterization data in Section 15.13.1.f. below for assay performance around the claimed cutoff concentrations.
e. Analytical Specificity:
To test cross-reactivity, drug metabolites and other compounds that may be present in human urine samples were tested using nine (9) 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 |
| 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 |

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| AMP
(Cutoff = 500 ng/mL) | Results
Positive
at
(ng/mL) | % Cross-Reactivity |
|-----------------------------|--------------------------------------|--------------------|
| d-Pseudoephedrine | >200,000 | 0.0 |
| l-Amphetamine | 3,000 | 16.7 |
| l-Ephedrine | >200,000 | 0.0 |
| Phentermine | >200,000 | 0.0 |
| p-Chloroamphetamine (PCA) | 2,000 | 25.0 |
| p-Hydroxyamphetamine | 3,500 | 14.3 |
| p-Methoxyamphetamine (PMA) | 1,750 | 28.6 |
| Tyramine | 95,000 | 0.5 |
| β-phenylethylamine | 30,000 | 1.7 |

| 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 |
| d, l -1-(3,4-Methylenedioxyphenyl)-2-Butanamine (BDB) | 25,000 | 2.0 |
| 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 |
| Isometheptene | 50,000 | 1.0 |
| Mephentermine | 25,000 | 2.0 |
| p-Hydroxymethamphetamine | 1,000 | 50.0 |
| p-Methoxyamphetamine (PMA) | >200,000 | 0.0 |
| p-Methoxymethamphetamine (PMMA) | 2,200 | 22.7 |
| Propylamphetamine | >200,000 | 0.0 |

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| 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 |
| Phenallylmal | 400 | 50.0 |
| Pentobarbital | 500 | 40.0 |
| 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 |

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| BZO
(Cutoff = 200 ng/mL) | Results
Positive
at
(ng/mL) | %
Cross-
Reactivity |
|-----------------------------|---- | Diazepam | 125 | Estazolam | 400 | Flunitrazepam | 200 | Flunitrazepam, 7-amino | 6,000 | Flurazepam | 80 | Halazepam | 250 | Lorazepam | 200 | Lorazepam glucuronide | 300 | Lormetazepam | 100 | Medazepam | 9,000 | Midazolam | 200 | Nitrazepam | 2,600 | Nitrazepam, 7-amino | >150,000 | Norchlordiazepoxide | 7,000 | Nordiazepam | 1,100 | Oxazepam | 2,500 | Oxazepam glucuronide | 1,250 | Prazepam | 350 | Temazepam* | 200 | Temazepam glucuronide | 300 | Triazolam | 100 ----------------------------------|---------------------------|
| 160.0 |
| 50.0 |
| 100.0 |
| 3.3 |
| 250.0 |
| 80.0 |
| 100.0 |
| 66.7 |
| 200.0 |
| 2.2 |
| 100.0 |
| 7.7 |
| 0.0 |
| 2.9 |
| 18.2 |
| 8.0 |
| 16.0 |
| 57.1 |
| 100.0 |
| 66.7 |
| 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 |
| m-Hydroxybenzoylecgonine | 400 | 37.5 |
| Norcocaine | >200,000 | 0.0 |

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| EDDP
(Cutoff = 100 ng/mL) | Results
Positive at
(ng/mL) | %
Cross-
Reactivity |
|------------------------------|-----------------------------------|---------------------------|
| EDDP* | 100 | 100.0 |
| EMDP | 40,000 | 0.3 |
| l-iso-methadone | >100,000 | 0.0 |
| 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 |

| 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 |
| 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 |
| Norbuprenorphine | >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 |

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| THC
(Cutoff = 50 ng/mL) | Results
Positive at
(ng/mL) | %
Cross-
Reactivity |
|-------------------------------------|-----------------------------------|---------------------------|
| (+/-) 11-hydroxy- Δ9-ΤΗC | 1,500 | 3.3 |
| 11-nor- Δ8-THC-COOH | 100 | 50.0 |
| 11-nor-9 carboxy-Δ9-THC* | 50 | 100.0 |
| 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 |

| TCA
(Cutoff = 1,000 ng/mL) | Results
Positive
at
(ng/mL) | %
Cross-
Reactivity |
|-------------------------------|--------------------------------------|---------------------------|
| Amitriptyline | 600 | 166.7 |
| Amitriptyline metabolite | 300 | 333.3 |
| Chlorpromazine | >400,000 | 0.0 |
| Chlorprothixene | 40,000 | 2.5 |
| 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% |

25

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Cross-reactivity

Potential interference from pharmaceutical compounds was tested by spiking the listed compounds at a concentration of 100 µg/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 concentrations up to at least 100 µg/mL. For the pharmaceutical compounds where interference was observed, the highest concentration that did not cause interference is indicated along with the assay in which it interfered.

| 5-(4-Hydroxyphenyl)-5-
phenylhydantoin
Acetaminophen | Doxepin (0.65 µg/mL; TCA)
Dronabinol (1 µg/mL; THC) | O-
desmethylvenlafaxine
d,l-Octopamine |
|------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Acetophenetidin
Acetopromazine
(maleate salt) | Droperidol
Duloxetine | Ofloxacin
Olanzapine |
| Amantadine
Amoxicillin
Ampicillin | Efavirenz
L-Epinephrine
Fenfluramine (2 µg/mL; AMP and mAMP) | Oxalic Acid
Oxaprozin
Pantoprazole |
| Aspirin (acetylsalicylic acid)
Atenolol
Atorvastatin | Fenproporex
Flunitrazepam (0.2 µg/mL; BZO)
Fluoxetine | Papaverine
Pentazocine
Pericyazine |
| Benzocaine
Benzphetamine
Benzydamine | Gamma-Hydroxybutyrate
Glutethimide (10 µg/mL; BAR)
Haloperidol | Phenelzine
Phenethylamine (2-Phenylethylamine) (6 µg/mL; AMP)
Phenmetrazine (37.5 µg/mL; TCA) |
| Buprenorphine
Benztropine Mesylate
Bupropion | Ibuprofen
Ketamine
Ketorolac Tromethamine | Phentermine
Phenylephrine
Phenylpropanolamine |
| Butyrophenone
Carbamazepine
Chlorpheniramine | Labetalol
Levofloxacin
Levorphanol (12.5 µg/mL; OPI) | Promethazine
d/l -Propranolol
d-Pseudoephedrine (50 µg/mL; THC) |
| Cimetidine
Citalopram | Meperidine
Meprobamate | Quetiapine
Quinacrine (50 µg/mL; THC) |

26

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Clobenzorex	Mesoridazine Besylate	Quinine
Clomipramine
(5 $ µg $ /mL; TCA)	Methaqualone	Ranitidine
Clonidine	Methoxyphenamine	Rifampin
Cotinine [I-Cotinine]	Methylphenidate	Ritodrine
Cyproheptadine	Nalbuphine	Selegiline
Dexamphetamine
(0.4 $ µg $ /mL; AMP)	Nalmefene	Sertraline
Dextromethorphan	Naloxone	Thioridazine
Dextrorphan Tartrate	Naltrexone	Tramadol
Dimethylamine	Naproxen
[(S)-6-
Methoxy-α-methyl-2
Naphthaleneacetic acid]	Tranylcypromine
Diphenhydramine	N-desmethylvenlafaxine	Trimethobenzamide
Dopamine	Niacinamide	Tyramine (25 $ µg $ /mL; AMP)
Dothiepin (0.7 $ µg $ /mL; TCA)	Nicotine	Verapamil
Doxylamine Succinate	Norpseudoephedrine
(25 $ µg $ /mL; AMP)	Zolpidem

Exogenous Interference

Potential interference from exogenous compounds was tested by spiking the listed compounds 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

27

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Interfering Substance	Concentration
Scopolamine	62.5 $\mu$ g/mL

Endogenous Interference

Potential interference from endogenous compounds was tested by spiking the listed compounds 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

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. The Quidel Triage TOX Drug Screen, 94600 has been validated with specimens that have a pH range of 4.0 -9.0, and no excessive interference was observed for each of the assays. In the case of the TCA assay, there was evidence that increasing urine pH levels at the top of the validated range could have an impact on positive control sample results as the assay cutoff of 1,000 ng/mL was approached. 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℃ to 30℃ (61°F to 86°F). Even though reasonable performance was found for the whole temperature range, non-conformance beyond the set specifications was observed for the cocaine, methamphetamine and opiate assays at the extremes of the temperature range. The Quidel Triage TOX Drug Screen, 94600 has been validated for an operating temperature range from 18℃ to 28℃ (64°F to 82°F).

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Operating Humidity

The effect of operating humidity for each analyte was evaluated by testing positive and negative samples at relative humidities (RH) ranging from ≤ 10 %RH to 85 %RH. The Quidel Triage TOX Drug Screen, 94600 was validated for an operating relative humidity (RH) range from 10 %RH to 85 %RH and met the specifications set for all 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. The results are summarized as follows for each analyte.

Amphetamine (AMP) 500 ng/mL
Concentration
(ng/mL)	% of cutoff	Results
#Neg/#Pos
Negative
Control	0%	315/0
0	0%	315/0
125	25%	315/0
250	50%	315/0
375	75%	313/2
500	100%	49/266
625	125%	1/314
750	150%	0/315
875	175%	0/315
1000	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
125	25%	315/0
250	50%	315/0
375	75%	312/3
500	100%	127/188

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Methamphetamine (mAMP) 500 ng/mL
625	125%	11/304
750	150%	2/313
875	175%	0/315
1000	200%	0/315

Barbiturates (BAR) 200 ng/mL
Concentration
(ng/mL)	% of cutoff	Results
#Neg/#Pos
Negative Control	0%	315/0
0	0%	315/0
50	25%	315/0
100	50%	315/0
150	75%	309/6
200	100%	78/237
250	125%	1/314
300	150%	1/314
350	175%	0/315
400	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
50	25%	315/0
100	50%	315/0
150	75%	296/19
200	100%	242/73
250	125%	3/312
300	150%	0/315
350	175%	0/315
400	200%	0/315

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Image /page/30/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, divided into two sections. The top and left sections of the square are filled with a gradient of colors, including red, orange, yellow, green, blue, and purple. The bottom right section of the square is filled with a solid blue color. Below the square is the word "QUIDEL" in a sans-serif font.

Cocaine (COC) 150 ng/mL
Concentration
(ng/mL)	% of cutoff	Results
#Neg/#Pos
Negative
Control	0%	315/0
0	0%	315/0
37.5	25%	315/0
75	50%	315/0
112.5	75%	279/36
150	100%	10/305
187.5	125%	1/314
225	150%	0/315
262.5	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
25	25%	315/0
50	50%	315/0
75	75%	315/0
100	100%	115/200
125	125%	11/304
150	150%	0/315
175	175%	0/315
200	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
75	25%	315/0
150	50%	315/0

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Opiates (OPI) 300 ng/mL
225	75%	315/0
300	100%	132/183
375	125%	1/314
450	150%	0/315
525	175%	0/315
600	200%	0/315

Cannabinoids (THC) 50 ng/mL
Concentration
(ng/mL)	% of cutoff	Results
#Neg/#Pos
Negative
Control	0%	315/0
0	0%	315/0
12.5	25%	315/0
25	50%	315/0
37.5	75%	295/20
50	100%	20/295
62.5	125%	0/315
75	150%	0/315
87.5	175%	0/315
100	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
250	25%	315/0
500	50%	315/0
750	75%	300/15
1000	100%	161/154
1250	125%	5/310
1500	150%	1/314
1750	175%	0/315
2000	200%	0/315

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1. Comparison studies:
- Method comparison with reference method: a.

A method comparison study was conducted using unaltered urine specimens and comparing results from the Quidel Triage TOX Drug Screen, 94600 to a reference method. Results are summarized below.

Quidel Triage TOX Drug Screen, 94600 Test Results vs GC/MS or LC-MS/MS Values

| AMP

(Cutoff = 500 ng/mL)
	Reference Method Result by GC/MS or LC-MS/MS Value
Drug	Quidel Triage TOX Drug Screen, 94600	Negative (150% of threshold)
AMP	Negative	99	11	2a	2b
	Positive	0	0	8	98

3 Patient specimens with Specimen IDs 569740 and 575202 were found to be negative despite a near threshold positive result

b Patient specimens with Specimen IDs 570964 and 572667 were found to be negative despite a high 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) |
|-------|-------------------------|----------------|------------------------------------------------|-----------------------------|------------------------------------|
| 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 |

Discordant sample resolution

b 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. A specimen with high levels of the Iamphetamine 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).

33

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| | Quidel
Triage
TOX | Initial
Value | Initial
Quidel
Triage | Isomeric
Composition (%) | | Isomeric
Abundance
(ng/mL) | | | Adjudicated |
|----------------|---------------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------|-----------------------------|-------------------------|----------------------------------|-----------------------|------------------------------------------|-------------------------------------------------------------------|
| Specimen
ID | Drug
Screen,
94600
AMP
Assay
Cutoff
(ng/mL) | deter-
mined
by
LC-
MS/MS
(ng/mL) | TOX
Drug
Screen,
94600
AMP
Assay
Result | % d-
Amphe
tamine | % /-
Amphe
tamine | d-
Amphe
tamine | /-
Amphe
tamine | Effective
Amphet
amine
(ng/mL)* | Quidel Triage
TOX Drug
Screen, 94600
AMP Assay
Result |
| 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 |

| mAMP

(Cutoff = 500 ng/mL)		Reference Method Result by GC/MS or LC-MS/MS Value
Drug	Quidel Triage TOX Drug Screen, 94600	Negative (150% of threshold)
mAMP	Negative	99	5	5d	7e
	Positive	0	5c	6	91

← 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

° Patient specimens with Specimen IDs 586276, 586264, 586282, 586275, 586300, and 579757 were found to be negative despite a high positive result

Discordant sample 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) |
|-------|-------------------------|----------------|---------------------------------------------------|-----------------------------|------------------------------------|
| 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 |

34

Image /page/34/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square divided into four quadrants, each filled with a different color gradient. The top-left quadrant transitions from red to yellow, the top-right quadrant is green, the bottom-left quadrant is blue, and the bottom-right quadrant is a darker shade of blue. Below the square is the word "QUIDEL" in a sans-serif font.

| 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 |

e The specimens contained both the d-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 I-methamphetamine isomer, resulting in negative screening results even with methamphetamine levels above the cutoff concentration of 500 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).

| | 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 |
|----------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------------------------------------|------------|--------------------------------------|----------------|------------------------------------------------------------------|
| Specimen
ID | | | | % d-Isomer | Concentration
d-Isomer
(ng/mL) | | |
| 586276° | 831 | 500 | False Negative | 52.3 | 434.6 | Negative | |
| 586269° | 937 | 500 | False Negative | 52.8 | 494.7 | Negative | |
| 586264° | 940 | 500 | False Negative | 52.9 | 497.3 | Negative | |
| 586282° | 984 | 500 | False Negative | 52.2 | 513.6 | False Negative | |
| 586275° | 990 | 500 | False Negative | 52.3 | 517.8 | False Negative | |
| 586300° | 1028 | 500 | False Negative | 52.8 | 542.8 | False Negative | |
| 579757° | 1568 | 500 | False Negative | 19.9 | 312.0 | Negative | |

35

Image /page/35/Picture/0 description: The image features the logo for QuidelOrtho Corporation. The logo consists of a square shape with a gradient of colors, including red, orange, yellow, green, blue, and purple. The square is partially filled, with a section missing from the lower right corner. Below the square is the word "QUIDEL" in a sans-serif font.

| BAR

(Cutoff = 200 ng/mL)
Drug	Quidel Triage
TOX Drug
Screen, 94600	Negative
(150% of
threshold)
BAR	Negative	99	3	0	0
	Positive	0	8f	11	97

' Patient specimens with Specimen IDs 582858, 575082, 575079, 586932, 575085, 575084, and 575095 were found to be positive despite a near threshold negative result

Discordant sample 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) |
|-------|----------------------------|----------------|------------------------------------------------|-----------------------------|------------------------------------|
| 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 |

BZO

(Cutoff = 200 ng/mL)
		Reference Method Result by GC/MS or LC-MS/MS Value
Drug	Quidel Triage
TOX Drug
Screen, 94600	Negative
(150% of
threshold)
BZO	Negative	99	1	1h	0
	Positive	0	10g	10	99

8 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

36

Image /page/36/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a stylized square divided into two sections. The larger section is a gradient of colors, transitioning from red and orange at the top left to green and yellow in the middle, and blue and purple at the top right. The smaller section is a solid blue color. Below the square is the word "QUIDEL" in a modern, sans-serif font.

Discordant sample 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) |
|-------|-------------------------|----------------|------------------------------------------------|-----------------------------|------------------------------------|
| BZO | 200 | 586239g | False Positive | Alprazolam-OH | 79 |
| BZO | 200 | 586234g | False Positive | Alprazolam-OH | 80 |
| BZO | 200 | 586235g | False Positive | Alprazolam-OH | 86 |
| | | | | 7-aminoclonazepam | 293 |
| BZO | 200 | 582865g | False Positive | Lorazepam | 53 |
| | | | | Oxazepam | 379 |
| | | | | 7-aminoclonazepam | 1134 |
| BZO | 200 | 570784g | False Positive | Nordiazepam | 63 |
| | | | | Oxazepam | 124 |
| | | | | Temazepam | 90 |
| BZO | 200 | 569935g | False Positive | Nordiazepam | 68 |
| | | | | Oxazepam | 244 |
| | | | | 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 |

| COC

(Cutoff = 150 ng/mL)
		Reference Method Result by GC/MS or LC-MS/MS Value
Drug	Quidel Triage
TOX Drug
Screen, 94600	Negative
(150% of
threshold)
COC	Negative	99	5	0	0
	Positive	0	6i	11	99

¹ Patient specimens with Specimen IDs 569915, 579796, 579821, 569790, 570955 and 577368 were found to be positive despite a near threshold negative result

37

Image /page/37/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a stylized square divided into four quadrants, each filled with a different color gradient. The top-left quadrant transitions from red to orange, the top-right quadrant from orange to yellow, the bottom-left quadrant from green to blue, and the bottom-right quadrant is a solid blue. Below the square is the word "QUIDEL" in a sans-serif font.

Discordant sample 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) |
|-------|-------------------------|----------------|------------------------------------------------|-----------------------------|------------------------------------|
| COC | 150 | 569915 | COC False Positive | Benzoylecgonine | 113 |
| COC | 150 | 579796 | False Positive | Benzoylecgonine | 126 |
| COC | 150 | 579821 | False Positive | Benzoylecgonine | 128 |
| COC | 150 | 569790 | False Positive | Benzoylecgonine | 129 |
| COC | 150 | 570955 | False Positive | Benzoylecgonine | 144 |
| COC | 150 | 577368 | False Positive | Benzoylecgonine | 144 |

| EDDP

(Cutoff = 100 ng/mL)
Reference Method Result by GC/MS or LC-MS/MS Value
Drug	Quidel Triage
TOX Drug
Screen, 94600	Negative
(150% of
threshold)
EDDP	Negative	99	9	2i	0
	Positive	0	1k	10	98

أ Patient specimen with Specimen ID 572444 was found to be positive despite a near threshold negative result

Patient specimens with Specimen IDs 572432 and 572426 were found to be negative a near threshold positive result

Discordant sample 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) |
|-------|-------------------------|----------------|------------------------------------------------|-----------------------------|------------------------------------|
| EDDP | 100 | 572444j | False Positive | EDDP | 76 |
| EDDP | 100 | 572432k | False Negative | EDDP | 100 |
| EDDP | 100 | 572426k | False Negative | EDDP | 110 |

| OPI

(Cutoff = 300 ng/mL)
		Reference Method Result by GC/MS or LC-MS/MS Value
Drug	Quidel Triage
TOX Drug
Screen, 94600	Negative
(150% of
threshold)
OPI	Negative	99	2	0	1m

38

Image /page/38/Picture/0 description: The image features the logo for Quidel. The logo consists of a square divided into four quadrants, each filled with a different color gradient. The top-left quadrant transitions from red to orange to yellow, the top-right quadrant transitions from yellow to green, the bottom-left quadrant transitions from green to blue, and the bottom-right quadrant transitions from blue to purple. Below the square is the word "QUIDEL" in a simple, sans-serif font.

	Positive	0	8'	11	98
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

Discordant sample 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) |
|-------|-------------------------|----------------|------------------------------------------------|-----------------------------|------------------------------------|
| OPI | 300 | 572508' | False Positive | Hydrocodone | 353 |
| | | | | Oxycodone | 24859 |
| OPI | 300 | 570415' | False Positive | Oxymorphone | 217 |
| OPI | 300 | 586327' | False Positive | Morphine | 228 |
| OPI | 300 | 582860' | False Positive | Hydrocodone | 469 |
| OPI | 300 | 572488' | False Positive | Morphine | 239 |
| OPI | 300 | 586330' | False Positive | Morphine | 260 |
| OPI | 300 | 582932' | False Positive | Hydrocodone | 488 |
| | | | | Hydromorphone | 67 |
| OPI | 300 | 586329' | False Positive | Morphine | 285 |
| | | | | Morphine | 2097 |
| OPI | 300 | 572644m | False Negative | Oxycodone | 2674 |
| | | | | Oxymorphone | 137 |

™ 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.

| THC

(Cutoff = 50 ng/mL)
Drug	Quidel Triage
TOX Drug
Screen, 94600	Negative
(150% of
threshold)
THC	Negative	99	10	3°	0
	Positive	0	1ⁿ	8	99

ª Patient specimen with Specimen ID 570021 was found to be positive despite a near threshold negative result

0 Patient specimens with Specimen IDs 570366, 575089, and 569400 were found to be negative despite a near threshold positive result

39

Image /page/39/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a stylized square divided into four quadrants. The top-left quadrant is a gradient of colors, including yellow, orange, red, and purple. The bottom-right quadrant is blue. Below the square is the word "QUIDEL" in a sans-serif font.

Discordant sample 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) |
|-------|-------------------------|----------------|------------------------------------------------|----------------------------------|------------------------------------|
| 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-Carboxy-
delta 9-THC | 63 |

| TCA

(Cutoff = 1,000 ng/mL)
Drug	Quidel Triage
TOX Drug
Screen, 94600	Reference Method Result by GC/MS or LC-MS/MS Value
		Negative
(150% of
threshold)
TCA	Negative	98	1	0	1r
	Positive	1p	10q	11	95

م Patient specimen with Specimen ID 586712 was found to be positive despite a high negative result 9 Patient specimens with Specimen IDs 586353, 585878, 582936, 585866, 586232, 585830, 585879, 582925, and 585874 were found to be positive despite a near threshold negative result

「 Patient specimen with Specimen ID 586694 was found to be negative despite a high 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 | 586712p | False Positive | Desipramine | 0 |
| TCA | 1,000 | 586353q | False Positive | Desipramine | 637 |
| TCA | 1,000 | 585878q | False Positive | Desipramine | 639 |
| TCA | 1,000 | 582936q | False Positive | Amitriptyline | 385 |
| TCA | 1,000 | 582936q | False Positive | Nortriptyline | 160 |
| TCA | 1,000 | 572581q | False Positive | Amitriptyline | 149 |
| TCA | 1,000 | 572581q | False Positive | Nortriptyline | 512 |
| TCA | 1,000 | 585866q | False Positive | Desipramine | 680 |
| TCA | 1,000 | 586232q | False Positive | Desipramine | 727 |
| TCA | 1,000 | 585830q | False Positive | Desipramine | 730 |

Discordant sample resolution

40

Image /page/40/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square divided into four quadrants, each filled with a different color gradient. The top-left quadrant is a blend of red, orange, and yellow, while the top-right quadrant transitions from yellow to green. The bottom-left quadrant displays a gradient from green to blue, and the bottom-right quadrant shows a blend of blue, indigo, and violet. Below the square is the word "QUIDEL" in a sans-serif font.

| 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 | 585879q | False Positive | Desipramine | 758 |
| TCA | 1,000 | 582925q | False Positive | Amitriptyline
Nortriptyline | 162
599 |
| TCA | 1,000 | 585874q | False Positive | Desipramine
Doxepin | 608
238 |
| TCA | 1,000 | 586694r | False Negative | Desipramine | 1646 |

P 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).

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 urine8 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 validated with specimens that have a pH range of 4.0 – 9.0, and no excessive interference was observed for each of the assays. In the case of the TCA assay, there was evidence that increasing urine pH levels at the top of the validated range could have an impact on positive control sample results as the assay cutoff of 1,000 ng/mL was approached. Specimens tested outside of the validated pH range may yield inaccurate results.

b. Method comparison with reference method:
Not applicable. These devices are for use with human urine samples only.
1. 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.
1. Clinical cut-off:
  Not applicable.
1. Expected values/Reference range:

41

Image /page/41/Picture/0 description: The image features the logo for Quidel. The logo consists of a square shape with rounded corners, divided into two sections. The larger section displays a gradient of colors, including red, orange, yellow, green, blue, and purple. The smaller section is a solid blue color. Below the square is the word "QUIDEL" in a sans-serif font.

Not applicable.

1.14. Conclusion:

These studies demonstrated the substantial equivalence of the Quidel Triage TOX Drug Screen, 94600 to the 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), Triage® TOX Drug Screen (K043242), and Triage Meter (K973547). Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution.