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.

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.

AI/ML Overview

The provided document describes the Quidel Triage® TOX Drug Screen, 94600 and the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine. The acceptance criteria and the study results are detailed in the "Performance Characteristics" section (1.13) and "Comparison studies" section (1.13.2.a).

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for each analyte are based on the percentage of positive and negative results at concentrations around the cutoff, as shown in the "Precision/Reproducibility" data in section 1.13.1.a and "Assay cut-off" in section 1.13.1.f. The primary performance metric from the method comparison study (1.13.2.a) is the agreement between the Quidel Triage TOX Drug Screen, 94600 and GC/MS or LC-MS/MS values, particularly for specimens near the threshold and outside the threshold.

Below is a summary table, combining data from the precision/reproducibility testing (1.13.1.a) and the method comparison study (1.13.2.a). For the precision/reproducibility, a high percentage of correct results (e.g., all negative below -75% of cutoff, all positive above +50% of cutoff) would be considered acceptance. For method comparison, "agreement" is implicitly the acceptance criteria, with discordant results requiring explanation.

Analyte (Cutoff)	Performance Criteria (e.g., Precision/Reproducibility: Expected % agreement)	Reported Device Performance (Precision/Reproducibility)	Reported Device Performance (Method Comparison: Agreement with GC/MS/LC-MS/MS, excluding discordant resolved cases)
AMP (500 ng/mL)	At -75% and below: 100% Neg; At +50% and above: 100% Pos	- Neg Control (0%): 720/720 Neg (100%) - 126 ng/mL (-75%): 720/720 Neg (100%) - 760 ng/mL (+50%): 720/720 Pos (100%) - 522 ng/mL (Cutoff): 50 Neg/669 Pos (89.5% Pos)	Out of 220 samples: - Negative (<50% of threshold): 99/99 Neg (100%) - Near Threshold Negative (within 50% below threshold): 11/11 Neg (100%) - Near Threshold Positive (within 50% above threshold): 2 Neg/8 Pos (80% Pos) - Positive (>150% of threshold): 2 Neg/98 Pos (98% Pos) (Discordant results acknowledged and explained related to isomeric cross-reactivity.)
mAMP (500 ng/mL)	At -75% and below: 100% Neg; At +50% and above: 100% Pos	- Neg Control (0%): 720/720 Neg (100%) - 250 ng/mL (-50%): 720/720 Neg (100%) - 742 ng/mL (+50%): 720/720 Pos (100%) - 529 ng/mL (Cutoff): 281 Neg/431 Pos (60.0% Pos)	Out of 218 samples: - Negative (<50% of threshold): 99/99 Neg (100%) - Near Threshold Negative (within 50% below threshold): 5 Neg/5 Pos (50% Pos) - Near Threshold Positive (within 50% above threshold): 5 Neg/6 Pos (54.5% Pos) - Positive (>150% of threshold): 7 Neg/91 Pos (92.9% Pos) (Discordant results acknowledged, with some attributed to isomeric differences in cross-reactivity.)
BAR (200 ng/mL)	At -75% and below: 100% Neg; At +50% and above: 100% Pos	- Neg Control (0%): 720/720 Neg (100%) - 53 ng/mL (-75%): 736/736 Neg (100%) - 306 ng/mL (+50%): 719/719 Pos (100%) - 192 ng/mL (Cutoff): 111 Neg/605 Pos (84.5% Pos)	Out of 218 samples: - Negative (<50% of threshold): 99/99 Neg (100%) - Near Threshold Negative (within 50% below threshold): 3 Neg/8 Pos (72.7% Pos) - Near Threshold Positive (within 50% above threshold): 0 Neg/11 Pos (100% Pos) - Positive (>150% of threshold): 0 Neg/97 Pos (100% Pos) (Discordant results acknowledged and explained.)
BZO (200 ng/mL)	At -75% and below: 100% Neg; At +50% and above: 100% Pos	- Neg Control (0%): 720/720 Neg (100%) - 58 ng/mL (-75%): 704/704 Neg (100%) - 306 ng/mL (+50%): 720/720 Pos (100%) - 219 ng/mL (Cutoff): 318 Neg/402 Pos (55.9% Pos)	Out of 221 samples: - Negative (<50% of threshold): 99/99 Neg (100%) - Near Threshold Negative (within 50% below threshold): 1 Neg/10 Pos (90.9% Pos) - Near Threshold Positive (within 50% above threshold): 1 Neg/10 Pos (90.9% Pos) - Positive (>150% of threshold): 0 Neg/99 Pos (100% Pos) (Discordant results acknowledged and explained.)
COC (150 ng/mL)	At -75% and below: 100% Neg; At +50% and above: 100% Pos	- Neg Control (0%): 720/720 Neg (100%) - 76 ng/mL (-50%): 719/719 Neg (100%) - 218 ng/mL (+50%): 736/736 Pos (100%) - 157 ng/mL (Cutoff): 26 Neg/694 Pos (96.4% Pos)	Out of 220 samples: - Negative (<50% of threshold): 99/99 Neg (100%) - Near Threshold Negative (within 50% below threshold): 5 Neg/6 Pos (54.5% Pos) - Near Threshold Positive (within 50% above threshold): 0 Neg/11 Pos (100% Pos) - Positive (>150% of threshold): 0 Neg/99 Pos (100% Pos) (Discordant results acknowledged and explained.)
EDDP (100 ng/mL)	At -75% and below: 100% Neg; At +50% and above: 100% Pos	- Neg Control (0%): 720/720 Neg (100%) - 29 ng/mL (-75%): 720/720 Neg (100%) - 143 ng/mL (+50%): 716/716 Pos (100%) - 111 ng/mL (Cutoff): 126 Neg/594 Pos (82.5% Pos)	Out of 220 samples: - Negative (<50% of threshold): 99/99 Neg (100%) - Near Threshold Negative (within 50% below threshold): 9 Neg/1 Pos (10.0% Pos) - Near Threshold Positive (within 50% above threshold): 2 Neg/10 Pos (83.3% Pos) - Positive (>150% of threshold): 0 Neg/98 Pos (100% Pos) (Discordant results acknowledged and explained.)
OPI (300 ng/mL)	At -75% and below: 100% Neg; At +50% and above: 100% Pos	- Neg Control (0%): 720/720 Neg (100%) - 165 ng/mL (-50%): 722/722 Neg (100%) - 480 ng/mL (+50%): 720/720 Pos (100%) - 344 ng/mL (Cutoff): 197 Neg/507 Pos (72.0% Pos)	Out of 220 samples: - Negative (<50% of threshold): 99/99 Neg (100%) - Near Threshold Negative (within 50% below threshold): 2 Neg/8 Pos (80% Pos) - Near Threshold Positive (within 50% above threshold): 0 Neg/11 Pos (100% Pos) - Positive (>150% of threshold): 1 Neg/98 Pos (99.0% Pos) (Some discordant results explained by secondary reference testing.)
THC (50 ng/mL)	At -75% and below: 100% Neg; At +50% and above: 100% Pos	- Neg Control (0%): 720/720 Neg (100%) - 12 ng/mL (-75%): 716/716 Neg (100%) - 78 ng/mL (+50%): 4 Neg/700 Pos (99.4% Pos) - 54 ng/mL (Cutoff): 163 Neg/559 Pos (77.4% Pos)	Out of 221 samples: - Negative (<50% of threshold): 99/99 Neg (100%) - Near Threshold Negative (within 50% below threshold): 10 Neg/1 Pos (9.1% Pos) - Near Threshold Positive (within 50% above threshold): 3 Neg/8 Pos (72.7% Pos) - Positive (>150% of threshold): 0 Neg/99 Pos (100% Pos) (Discordant results acknowledged and explained.)
TCA (1000 ng/mL)	At -75% and below: 100% Neg; At +50% and above: 100% Pos	- Neg Control (0%): 720/720 Neg (100%) - 498 ng/mL (-50%): 719/719 Neg (100%) - 1577 ng/mL (+50%): 1 Neg/719 Pos (99.9% Pos) - 996 ng/mL (Cutoff): 218 Neg/518 Pos (70.4% Pos)	Out of 220 samples: - Negative (<50% of threshold): 98/98 Neg (100%) - Near Threshold Negative (within 50% below threshold): 1 Neg/10 Pos (90.9% Pos) - Near Threshold Positive (within 50% above threshold): 0 Neg/11 Pos (100% Pos) - Positive (>150% of threshold): 1 Neg/95 Pos (99% Pos) (Some discordant results explained by data entry errors or pH interference.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Precision/Reproducibility Test Set:
- For each of the 9 analytes, 720-736 samples were tested for each concentration point (0 to +100% of cutoff, plus negative control). This means for each analyte, n=720-736 replicates were performed at each concentration.
- Data provenance: Not explicitly stated, but the submission is for the FDA in the US. The study involved "three (3) study sites" which implies data collection within a controlled, prospective study setting, most likely in the US, given the FDA submission. The samples were "blinded and randomized" prior to testing.
Method Comparison Test Set:
- The total number of samples for each analyte in the method comparison study with GC/MS or LC-MS/MS varies slightly per analyte but is around 220 samples (e.g., for AMP, 99+11+2+98+0+0+8 = 218 specimens + 2 discordant cases).
- Data provenance: The samples were described as "unaltered urine specimens," implying they were clinical samples. The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the use of "patient specimens" strongly suggests prospective collection for the purpose of the study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

For the Precision/Reproducibility study, the ground truth was established by the prepared concentrations of the analytes (e.g., negative control, 25%, 50%, 75%, cutoff, 125%, 150%, 175%, and 200% of cutoff). This does not involve human experts establishing ground truth for individual samples, but rather analytical controls.
For the Method Comparison study, the ground truth was established by a "reference method," specifically GC/MS or LC-MS/MS values. These are analytical methods considered the gold standard for drug confirmation and quantification. This does not involve human experts establishing ground truth for each case, but rather the laboratory performing these reference methods. No specific number or qualifications of experts operating these reference instruments are mentioned, as the results of these instruments are considered the objective ground truth.

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

For the Precision/Reproducibility study, no adjudication method is explicitly described as the results are based on measured values against known concentrations.
For the Method Comparison study, particularly for discordant results between the device and the reference method, an adjudication process did occur. In some cases, explanations are provided for the discordance (e.g., isomeric cross-reactivity for AMP and mAMP, the presence of multiple metabolites for BZO and OPI, pH interference for TCA, or data entry errors). For OPI, one discordant case (Specimen ID 572644) was sent to a "second reference testing laboratory" for reconfirmation, which then aligned with the device's negative result. This indicates a form of secondary confirmation/adjudication by an additional reference lab for specific discordant cases, rather than a typical 2+1 or 3+1 expert consensus model for image/clinical interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This document describes an in vitro diagnostic (IVD) device that performs qualitative drug screening using a fluorescence immunoassay and a meter (Quidel Triage® MeterPro). It is not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or clinical data. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable to this device.

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

The Quidel Triage® TOX Drug Screen, 94600 with the Quidel Triage® MeterPro functions as a standalone device in terms of producing a "POS" or "NEG" result for each drug assay. The meter reads the test device and provides a direct qualitative result. While the meter requires a human operator to insert the device and, if desired, print or transmit results, the interpretation of the fluorescence signal into a positive or negative drug screen result is entirely performed by the instrument's programming, which is equivalent to an "algorithm only" performance. The performance data presented in the precision/reproducibility and method comparison studies directly reflect this standalone performance.

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

For the analytical performance studies (precision/reproducibility, analytical specificity, cutoff characterization), the ground truth was established by known prepared concentrations of drugs/metabolites or spiking experiments.
For the method comparison study, the ground truth was established by Gas Chromatography / Mass Spectroscopy (GC/MS) or Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) values. These are analytical "gold standard" methods.

8. The sample size for the training set

The document describes a 510(k) submission for a new IVD device and presents validation studies. It does not explicitly mention a "training set" in the context of machine learning or AI models. The studies are designed to demonstrate the analytical performance and substantial equivalence of the device to existing predicate devices. Therefore, a specific training set sample size is not applicable/not provided in this type of submission. The performance data is from a test/validation set.

9. How the ground truth for the training set was established

As a "training set" is not explicitly referenced in the context of AI/machine learning development, the method of establishing its ground truth is not applicable/not provided. The ground truth for the validation studies (test sets) was established via known concentrations of analytes and reference methods (GC/MS, LC-MS/MS) as detailed above.

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

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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

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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:

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

Quidel Triage® MeterPro:

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:

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

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ProductCode	Classification	Regulatory Section	Panel
LAF	Class II	21 CFR 862.3610,Methamphetamine testsystem	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, Cocaineand cocaine metabolite testsystem	Toxicology (91)
DJR	Class II	21 CFR 862.3260,Methadone test system	Toxicology (91)
DJG	Class II	21 CFR 862.3650, Opiatetest system	Toxicology (91)
LDJ	Class II	21 CFR 862.3870,Cannabinoid test system	Toxicology (91)
LFG	Class II	21 CFR 862.3910, Tricyclicantidepressant drugs testsystem	Toxicology (91)

Quidel Triage® MeterPro:

Product Code	Classification	Regulatory Section	Panel
KHO	Class I	21 CFR 862.2560, Fluorometer forclinical use	ClinicalChemistry

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

Quidel Triage® MeterPro:

1.9. Device Description:

Quidel Triage® TOX Drug Screen, 94600:

Quidel Triage® MeterPro:

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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 DrugScreen, 94600 (Proposed)	GenPrime Drugs of Abuse(DOA) Reader System(K130082)
Intended Use	For the qualitativedetermination of drugs ofabuse in human urine.	Same
Assay Type	Competitive assay, whereconcentration of drug isinversely related to the signaldetected by the instrument.	Same

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Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX DrugScreen, 94600 (Proposed)	GenPrime Drugs of Abuse(DOA) Reader System(K130082)
System Procedure	Sample is added to a singleuse test device which is thenread by the instrument. Theinstrument is designed to readmultiple assays at the sametime.	Same
Specimen Type	Human urine	Same
Single-use Test Device	Yes	Same
Analyte Cutoffs(ng/mL)	AMP = 500mAMP = 500COC = 150OPI = 300THC = 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 DrugScreen, 94600 (Proposed)	GenPrime Drugs of Abuse(DOA) Reader System(K130082)
Analyte Cutoffs(ng/mL)	BAR = 200BZO = 200EDDP = 100TCA = 1000MTD, OXY, PCP are not panelassays and have no associatedanalyte cutoffs.	BAR = 300 (OS Cup)MTD = 300 (SK Cup)MOP = 2000 (SK Cup)PCP = 25 (SK Cup)BZO, EDDP, and TCA are notpanel assays and have noassociated cutoff
Test Device Format	Cassette	Cup
Storage	2-8°C	2-30°C
Detection method	Measures fluorescence ofdiscreet measurement zonesfor each assay.	Measures density of visiblelines against background onsingle-use test device.

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Differences
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX DrugScreen, 94600 (Proposed)	GenPrime Drugs of Abuse(DOA) Reader System(K130082)
Test Time and TimingMethod	Operator adds sample to testdevice and operatestheinstrument.	Operator manually times testdevelopment for 5 minutes andthen operates the instrument.
Measurement Method	Scans the single-use testdevice to measure signals.	Scans the single-use test deviceto detect a signal.
Time to Results	Result interpretation occurs inapproximately 15 minutes.	Results interpretation mustoccur between 5 and 60minutes following specimenapplication
Output	Outputs are "POS" if the resultis at or above the thresholdconcentration or "NEG" if theresult is below the thresholdconcentration. The operatorhas the option to print theresults. If connected, theMeterPro can transmit resultsto the laboratory or hospitalinformation system.	Outputs "presumptivepositive", “negative”, and"invalid" test results on agraphic user interfacedisplayed on a computer screenand automatically stores resultsalong with test information.Operator has ability to printand/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 DrugScreen, 94600 (Proposed)	ImmunalysisBarbituratesUrine Enzyme Immunoassay(K161714)
Intended Use	For the qualitativedetermination of drugs ofabuse in human urine.	Same

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Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX DrugScreen, 94600 (Proposed)	Immunalysis BarbituratesUrine 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 DrugScreen, 94600 (Proposed)	Immunalysis BarbituratesUrine Enzyme Immunoassay(K161714)
Intended Use	Not intended for semi-quantitative determination ofthe presence of Barbiturates inhuman urine.	For the semi-quantitativedetermination of the presenceof Barbiturates in humanurine.
Assay Type	Competitiveassay, whereconcentration of drug isinversely related to the signaldetected by the instrument.	Enzyme immunoassay
Antibody Type	Mouse monoclonal antibodies	Recombinant and monoclonalantibodies

Assay: Benzodiazepines (BZO)

Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX DrugScreen, 94600 (Proposed)	DRI Benzodiazepine Assay(K173963)
Intended Use	For the qualitativedetermination of drugs ofabuse 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 DrugScreen, 94600 (Proposed)	DRI Benzodiazepine Assay(K173963)
Analyte Cutoff(ng/mL)	BZO = 200	Same

Differences
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX DrugScreen, 94600 (Proposed)	DRI Benzodiazepine Assay(K173963)
Intended Use	Not intended for semi-quantitative determination ofthe presence ofbenzodiazepines and theirmetabolites in human urine.	For the semi-quantitativedetermination of the presenceof benzodiazepines and theirmetabolites in human urine.
Assay Type	Competitive assay, whereconcentration of drug isinversely related to the signaldetected by the instrument.	Homogenous enzymeimmunoassay
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 DrugScreen, 94600 (Proposed)	Immunalysis EDDP SpecificUrine Enzyme Immunoassay(K151395)
Intended Use	For the qualitativedetermination of drugs ofabuse 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 DrugScreen, 94600 (Proposed)	Immunalysis EDDP SpecificUrine Enzyme Immunoassay(K151395)
Intended Use	Not intended for semi-quantitative determination ofthe presence of EDDP inhuman urine.	For the semi-quantitativedetermination of the presenceof EDDP in human urine.
Assay Type	Competitive assay, whereconcentration of drug isinversely related to the signaldetected by the instrument.	Homogenous enzymeimmunoassay
Antibody Type	Mouse monoclonal antibodies	Recombinant fab antibodies
Analyte Cutoffs(ng/mL)	Not intended to have cutoffsavailable at 300 ng/mL and1000 ng/mL	EDDP = 300 and 1000

Assay: Tricyclic Antidepressants (TCA)

Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX DrugScreen, 94600 (Proposed)	Triage® TOX Drug Screen(K043242)
Intended Use	For the qualitativedetermination of drugs ofabuse in human urine.	Same
Assay Type	Competitive assay, whereconcentration of drug isinversely related to the signaldetected by the instrument.	Same
Specimen Type	Human urine	Same
Storage	2-8°C	Same
Detection method	Measures fluorescence ofdiscreet measurement zonesfor each assay.	Same
Assay calibrated	Desipramine	Same

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Similarities
Item	Proposed Device	Predicate Device
Features	Quidel Triage® TOX DrugScreen, 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 DrugScreen, 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, andTricyclic 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 externalhand-held barcode scanner	Same
Barcode	Integrated barcode on eachtest device with lot specificinformation	Same
Time to result	Approximately 15 – 20minutes	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 moldto provide a larger liquidcrystal display (LCD) and twoelastomer keypads	Small LCD with one singlemembrane 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.

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

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SampleConcentration(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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SampleConcentration(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
SampleConcentration(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)	ResultsPositiveat(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)	ResultsPositiveat(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)	ResultsPositive 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)	ResultsPositiveat(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)	ResultsPositive 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)	ResultsPositiveat(ng/mL)	%Cross-Reactivity
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	80.0
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
Prazepam	350	57.1
Temazepam*	200	100.0
Temazepam glucuronide	300	66.7
Triazolam	100	200.0

COC(Cutoff = 150 ng/mL)	ResultsPositive 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)	ResultsPositive 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)	ResultsPositiveat(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)	ResultsPositive 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)	ResultsPositiveat(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%

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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-phenylhydantoinAcetaminophen	Doxepin (0.65 µg/mL; TCA)Dronabinol (1 µg/mL; THC)	O-desmethylvenlafaxined,l-Octopamine
AcetophenetidinAcetopromazine(maleate salt)	DroperidolDuloxetine	OfloxacinOlanzapine
AmantadineAmoxicillinAmpicillin	EfavirenzL-EpinephrineFenfluramine (2 µg/mL; AMP and mAMP)	Oxalic AcidOxaprozinPantoprazole
Aspirin (acetylsalicylic acid)AtenololAtorvastatin	FenproporexFlunitrazepam (0.2 µg/mL; BZO)Fluoxetine	PapaverinePentazocinePericyazine
BenzocaineBenzphetamineBenzydamine	Gamma-HydroxybutyrateGlutethimide (10 µg/mL; BAR)Haloperidol	PhenelzinePhenethylamine (2-Phenylethylamine) (6 µg/mL; AMP)Phenmetrazine (37.5 µg/mL; TCA)
BuprenorphineBenztropine MesylateBupropion	IbuprofenKetamineKetorolac Tromethamine	PhenterminePhenylephrinePhenylpropanolamine
ButyrophenoneCarbamazepineChlorpheniramine	LabetalolLevofloxacinLevorphanol (12.5 µg/mL; OPI)	Promethazined/l -Propranolold-Pseudoephedrine (50 µg/mL; THC)
CimetidineCitalopram	MeperidineMeprobamate	QuetiapineQuinacrine (50 µg/mL; THC)

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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-2Naphthaleneacetic 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

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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
NegativeControl	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
NegativeControl	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
NegativeControl	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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Cocaine (COC) 150 ng/mL
Concentration(ng/mL)	% of cutoff	Results#Neg/#Pos
NegativeControl	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
NegativeControl	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
NegativeControl	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
NegativeControl	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 (<50% of threshold)	Near Threshold Negative (within 50% below threshold)	Near Threshold Positive (within 50% above threshold)	Positive (>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)	SpecimenID	Quidel Triage TOX DS 94600Result (POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (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).

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	QuidelTriageTOX	InitialValue	InitialQuidelTriage	IsomericComposition (%)		IsomericAbundance(ng/mL)			Adjudicated
SpecimenID	DrugScreen,94600AMPAssayCutoff(ng/mL)	deter-minedbyLC-MS/MS(ng/mL)	TOXDrugScreen,94600AMPAssayResult	% d-Amphetamine	% /-Amphetamine	d-Amphetamine	/-Amphetamine	EffectiveAmphetamine(ng/mL)*	Quidel TriageTOX DrugScreen, 94600AMP AssayResult
570964b	500	1003	FalseNegative	35.3	64.7	354	649	463	Negative
572667b	500	1359	FalseNegative	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 (<50% of threshold)	Near Threshold Negative (within 50% below threshold)	Near Threshold Positive (within 50% above threshold)	Positive (>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)	SpecimenID	Quidel Triage TOX DS94600 Result(POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (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)	SpecimenID	Quidel Triage TOX DS94600 Result(POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (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).

	ReferenceLaboratory 1LC-MS/MSConfirmatoryValue(ng/mL)	Quidel TriageTOX DrugScreen, 94600ThresholdConcentration(ng/mL)	Quidel TriageTOX DrugScreen, 94600Result		Reference Laboratory 2Results
SpecimenID				% d-Isomer	Concentrationd-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

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BAR(Cutoff = 200 ng/mL)
Drug	Quidel TriageTOX DrugScreen, 94600	Negative(<50% ofthreshold)	Near ThresholdNegative(within 50%below threshold)	Near ThresholdPositive(within 50%above threshold)	Positive(>150% ofthreshold)
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	CutoffValue(ng/mL)	SpecimenID	Quidel Triage TOX DS94600 Result (POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (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 TriageTOX DrugScreen, 94600	Negative(<50% ofthreshold)	Near ThresholdNegative(within 50%below threshold)	Near ThresholdPositive(within 50%above threshold)	Positive(>150% ofthreshold)
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

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Discordant sample resolution

Assay	Cutoff Value(ng/mL)	SpecimenID	Quidel Triage TOX DS94600 Result (POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (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 TriageTOX DrugScreen, 94600	Negative(<50% ofthreshold)	Near ThresholdNegative(within 50%below threshold)	Near ThresholdPositive(within 50%above threshold)	Positive(>150% ofthreshold)
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

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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)	SpecimenID	Quidel Triage TOX DS94600 Result (POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (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 TriageTOX DrugScreen, 94600	Negative(<50% ofthreshold)	Near ThresholdNegative(within 50%below threshold)	Near ThresholdPositive(within 50%above threshold)	Positive(>150% ofthreshold)
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)	SpecimenID	Quidel Triage TOX DS94600 Result (POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (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 TriageTOX DrugScreen, 94600	Negative(<50% ofthreshold)	Near ThresholdNegative(within 50%below threshold)	Near ThresholdPositive(within 50%above threshold)	Positive(>150% ofthreshold)
OPI	Negative	99	2	0	1m

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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)	SpecimenID	Quidel Triage TOX DS94600 Result (POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (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 TriageTOX DrugScreen, 94600	Negative(<50% ofthreshold)	Near ThresholdNegative(within 50%below threshold)	Near ThresholdPositive(within 50%above threshold)	Positive(>150% ofthreshold)
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

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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)	SpecimenID	Quidel Triage TOX DS94600 Result (POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (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 TriageTOX DrugScreen, 94600	Reference Method Result by GC/MS or LC-MS/MS Value
		Negative(<50% ofthreshold)	Near ThresholdNegative(within 50%below threshold)	Near ThresholdPositive(within 50%above threshold)	Positive(>150% ofthreshold)
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)	SpecimenID	Quidel Triage TOX DS94600 Result (POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (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

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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)	SpecimenID	Quidel Triage TOX DS94600 Result (POS/NEG)	Drug/MetaboliteDetected	GC/MS or LC/MS/MSvalue (ng/mL)
TCA	1,000	585879q	False Positive	Desipramine	758
TCA	1,000	582925q	False Positive	AmitriptylineNortriptyline	162599
TCA	1,000	585874q	False Positive	DesipramineDoxepin	608238
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:

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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.

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).