Quidel Triage® TOX Drug Screen, 94600

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

Device Facts

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

Intended Use

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

Device Story

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

Clinical Evidence

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

Technological Characteristics

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

Indications for Use

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

Regulatory Classification

Identification

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

Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Quidel Triage® TOX Drug Screen (K200363)

Submission Summary (Full Text)

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March 11, 2020

Quidel Cardiovascular Inc. Rachael S. Williamson Associate Director, Regulatory Affairs 9975 Summers Ridge Road San Diego, CA 92121

Re: k200363

Trade/Device Name: Quidel Triage® TOX Drug Screen, 94600 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 Dated: February 13, 2020 Received: February 14, 2020

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 (for the indications for use stated in the enclosure) 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 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

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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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Marianela Perez-Torres, M.T., Ph.D. Acting Deputy 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) k200363

Device Name Quidel Triage® TOX Drug Screen, 94600

### Indications for Use (Describe)

The 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.

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

| <div> <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> </div> |
|---------------------------------------------------------------------------------|
| <div> <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> </div> |

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## K200363

#### 1. 510(K) SUMMARY

#### 1.1. Date Prepared:

February 13, 2020

#### Purpose for Submission: 1.2.

Modification to Existing 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: [phone] Fax: [phone]

Rachael S. Williamson (Submission Contact)

#### 1.6. Proprietary and Established Names:

Quidel Triage® TOX Drug Screen, 94600

#### 1.7. Regulatory Information:

Quidel Triage® TOX Drug Screen, 94600:

| Product<br>Code | Classification | Regulatory Section | Panel |
|-----------------|----------------|---------------------------------------------|-----------------|
| DKZ | Class II | 21 CFR 862.3100,<br>Amphetamine test system | Toxicology (91) |

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Image /page/5/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square divided into two sections. The top left section is a gradient of colors, including yellow, green, red, and orange. The bottom right section is blue. The word "QUIDEL" is written in a sans-serif font below the square.

| Product<br>Code | Classification | Regulatory Section | Panel |
|-----------------|----------------|-------------------------------------------------------------------|-----------------|
| LAF | Class II | 21 CFR 862.3610,<br>Methamphetamine test<br>system | Toxicology (91) |
| DIS | Class II | 21 CFR 862.3150,<br>Barbiturate test system | Toxicology (91) |
| JXM | Class II | 21 CFR 862.3170,<br>Benzodiazepine test system | Toxicology (91) |
| JXO | Class II | 21 CFR 862.3250, Cocaine<br>and cocaine metabolite test<br>system | Toxicology (91) |
| DJR | Class II | 21 CFR 862.3260,<br>Methadone test system | Toxicology (91) |
| DJG | Class II | 21 CFR 862.3650, Opiate<br>test system | Toxicology (91) |
| LDJ | Class II | 21 CFR 862.3870,<br>Cannabinoid test system | Toxicology (91) |
| LFG | Class II | 21 CFR 862.3910, Tricyclic<br>antidepressant drugs test<br>system | Toxicology (91) |

#### 1.8. Intended 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 |

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| Abbreviation | Analyte | Calibrator | Cutoff |
|--------------|---------------------------|-------------------------|------------|
| 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 method must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.

#### 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.

#### 1.10. Substantial Equivalence Information:

- 1. Predicate Device Name:
Quidel Triage TOX Drug Screen, 94600

- 2. Predicate 510(k) Number:
K182719, Quidel Triage TOX Drug Screen, 94600

- 3. Comparison with Predicate:

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Image /page/7/Picture/0 description: The image shows the logo for Quidel. The logo features a square with rounded corners, divided into four sections. The top left section is a gradient of colors, including yellow, green, and red. The bottom right section is blue. The word "QUIDEL" is written in a sans-serif font below the square.

| Item | Cleared Device | | Modified Device | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------------------|------------|
| Features | Quidel Triage TOX Drug Screen, 94600 | | Quidel Triage TOX Drug Screen, 94600 | |
| Intended Use | The Quidel Triage TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage MeterPro for the qualitative determination of the presence of drug and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations.<br>The threshold concentrations are provided below: | | Same | |
| | Abbreviation | Analyte | Calibrator | Cutoff |
| | AMP | Amphetamines | d-Amphetamine | 500 ng/mL |
| | mAMP | Methamphetamines | d-Methamphetamine | 500ng/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<br>Antidepressants | Desipramine | 1000 ng/mL |
| This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectroscopy (GC/MS), Liquid Chromatography/Mass Spectroscopy/Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. | | | | |

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Image /page/8/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 upper left section is a gradient of colors, including yellow, orange, red, green, and blue. The lower right section is a solid dark blue color. Below the square is the word "QUIDEL" in a sans-serif font.

| Item | Cleared Device | Modified Device |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Quidel Triage TOX Drug Screen, 94600 | Quidel Triage TOX Drug Screen, 94600 |
| Assay Type | Competitive assay, where concentration of drug is inversely related to the signal detected by the instrument. | Same |
| System Procedure | Sample is added to a single use test device which is then read by the instrument. The instrument measures fluorescence of discreet measurement zones for each assay. The instrument is designed to read multiple assays at the same time. | Same |
| Storage | 2-8°C | Same |
| Specimen Type | Human urine | Same |
| Single-use Test Device | Yes | Same |
| Analyte Cutoffs<br>(ng/mL) | AMP = 500<br>mAMP = 500<br>BAR = 200<br>BZO = 200<br>COC = 150<br><br> | EDDP = 100<br>OPI = 300<br>THC = 50<br>TCA = 1,000<br>Same |
| Specificity Table | The four (4) additional compounds identified for the modified device were not included in the original 510(k) submission. | Four (4) additional compounds added to the Specificity Tables in the package insert.<br><br>BAR Specificity Table<br>• Metharbital<br>• p-Hydroxyphenobarbital<br>• Talbutal<br><br>BZO Specificity Table<br>• Alprazolam glucuronide-OH |

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Image /page/9/Picture/0 description: The image is a logo for Quidel. The logo features a square with rounded corners, filled with a gradient of colors from red to blue. A smaller, solid blue square is in the bottom right corner of the larger square. The word "QUIDEL" is written in a sans-serif font below the square.

#### 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).

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.

#### Performance Characteristics: 1.13.

- 1. Analytical Performance
- Precision/Reproducibility: a.

Not applicable. This parameter was assessed under K182719.

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Image /page/10/Picture/0 description: The image features the logo of Quidel. The logo consists of a square shape with a smaller square cut out from the bottom right corner. The larger square is filled with a mosaic of colors, including red, orange, yellow, green, and blue. The smaller square is filled with a mosaic of blue colors. Below the square is the word "QUIDEL" in a sans-serif font.

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

- Traceability, Stability, Expected Values c.
Not applicable. This parameter was assessed under K182719.

- d. Detection Limit:
Not applicable. This parameter was assessed under K182719.

- e. Analytical Specificity:
To test cross-reactivity, drug metabolites and other compounds that may be present in human urine samples were tested on Quidel Triage TOX Drug Screen, 94600 Test Devices. The following is a summary of the cross-reactivity study for four (4) additional compounds that were tested and analyzed in the same manner as the other compounds assessed under K182719.

| BAR<br>(Cutoff = 200 ng/mL) | Results<br>Positive at<br>(ng/mL) | % Cross-<br>Reactivity |
|-----------------------------|-----------------------------------|------------------------|
| Metharbital | 1,000 | 20.0 |
| p-Hydroxyphenobarbital | 700 | 28.6 |
| Talbutal | 200 | 100.0 |

| BZO<br>(Cutoff = 200 ng/mL) | Results<br>Positive at<br>(ng/mL) | % Cross-<br>Reactivity |
|-----------------------------|-----------------------------------|------------------------|
| Alprazolam glucuronide-OH | 1500 | 13.3 |

- f. Assay cut-off:
Not applicable. This parameter was assessed under K182719.

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

Not applicable. This parameter was assessed under K182719.

- b. Matrix comparison:

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Image /page/11/Picture/0 description: The image features the logo for Quidel. The logo consists of a square shape with rounded corners, divided into four sections. The top left section is a gradient of colors, including yellow, green, blue, and red. The bottom right section is a blue color. Below the square is the word "QUIDEL" in a sans-serif font.

Not applicable. These devices are for use with human urine samples only.

- 3. Clinical studies:
- Clinical sensitivity: a.

Not applicable.

- Clinical specificity: b.
Not applicable.

- c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.

- Clinical cut-off: 4.
Not applicable.

- 5. Expected values/Reference range:
Not applicable.

#### 1.14. Conclusion:

The additional analytical specificity testing conducted for the Quidel Triage TOX Drug Screen, 94600 demonstrates the device remains substantially equivalent with the previously cleared Quidel Triage TOX Drug Screen, 94600 (K182719).