Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro
Device Facts
| Record ID | K182719 |
|---|---|
| Device Name | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro |
| Applicant | Quidel Cardiovascular, Inc. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Jun 19, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
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: [Table of analytes/cutoffs]. This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.
Device Story
Single-use lateral flow fluorescence immunoassay cassette; used with Quidel Triage MeterPro. Input: human urine sample applied to test device. Principle: competitive immunoassay; monoclonal antibody conjugates compete with drug in sample for binding sites; fluorescence inversely proportional to analyte concentration. Meter uses laser diode excitation and silicon photodiode detection. Output: qualitative 'POS' or 'NEG' result displayed on LCD or printed. Used in lab or point-of-care settings by clinicians. Results stored in meter memory; optional transmission to LIS/HIS. Provides preliminary results requiring confirmatory testing (GC/MS, LC-MS/MS). Benefits: rapid, portable screening for drug presence to aid clinical decision-making.
Clinical Evidence
No clinical trials performed. Analytical performance established via bench testing. Precision/reproducibility evaluated at three POC sites (N=~720 per sample). Method comparison conducted against GC/MS or LC-MS/MS reference methods using clinical urine specimens. Performance characterized by cutoff studies and cross-reactivity/interference testing.
Technological Characteristics
Lateral flow competitive fluorescence immunoassay. Components: murine monoclonal antibodies, fluorescently labeled antibodies/metabolites, solid phase, stabilizers. MeterPro: portable fluorescence instrument, laser light source, LCD, elastomer keypads. Connectivity: serial ports for LIS/HIS transmission. Power: 100-240 VAC or 4 AA batteries. Storage: 2-8°C. Validated operating range: 18-28°C, 10-85% RH.
Indications for Use
Indicated for qualitative detection of drugs/metabolites in human urine at or above specified threshold concentrations. Intended for use by professionals in laboratory or point-of-care settings for preliminary screening. Not for semi-quantitative determination.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- GenPrime Drugs of Abuse (DOA) Reader System (k130082)
- Immunalysis Barbiturates Urine Enzyme Immunoassay (k161714)
- DRI Benzodiazepine Assay (k173963)
- Immunalysis EDDP Specific Urine Enzyme Immunoassay (k151395)
- Biosite Incorporated Triage TOX Drug Screen (k043242)
- Biosite Incorporated Triage Meter (k973547)
Related Devices
- K200363 — Quidel Triage® TOX Drug Screen, 94600 · Quidel Cardiovascular, Inc. · Mar 11, 2020
- K162395 — MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup · Mp Biomedicals, LLC · Jun 2, 2017
Submission Summary (Full Text)
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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:
The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below:
| Abbreviation | Analyte | Calibrator | Cutoff |
|--------------|---------------------------|-------------------------|------------|
| AMP | Amphetamines | d-Amphetamine | 500 ng/mL |
| mAMP | Methamphetamines | d-Methamphetamine | 500 ng/mL |
| BAR | Barbiturates | Butalbital | 200 ng/mL |
| BZO | Benzodiazepines | Temazepam | 200 ng/mL |
| COC | Cocaine | Benzoylecgonine | 150 ng/mL |
| EDDP | Methadone Metabolite | EDDP | 100 ng/mL |
| OPI | Opiates | Morphine | 300 ng/mL |
| THC | Cannabinoids | 11-nor-9-carboxy-Δ9-THC | 50 ng/mL |
| TCA | Tricyclic Antidepressants | Desipramine | 1000 ng/mL |
This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.
Quidel Triage® MeterPro:
The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# K182719
#### 1. 510(K) SUMMARY
#### 1.1. Date Prepared:
June 18, 2019
#### 1.2. Purpose for Submission:
New device
#### 1.3. Measurand:
Amphetamine, Methamphetamine, Barbiturates, Benzodiazepines, Cocaine, EDDP (2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine), Opiates, Cannabinoids, Tricyclic Antidepressants
#### 1.4. Type of Test:
Qualitative, lateral flow immunofluorescence
#### 1.5. Applicant:
Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego, California 92121 Telephone: 858-302-0334 Fax: 858-805-8622
Rachael S. Williamson (Submission Contact)
#### 1.6. Proprietary and Established Names:
Quidel Triage® TOX Drug Screen, 94600 Quidel Triage® MeterPro
#### Regulatory Information: 1.7.
Quidel Triage® TOX Drug Screen, 94600:
| Product<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/9 description: The image features the logo for QuidelOrtho Corporation. The logo consists of a square shape divided into two sections. The larger section is a gradient of colors, transitioning from red to yellow to green to blue. The smaller section is a darker shade of blue. Below the square is the word "QUIDEL" in a simple, sans-serif font.
| 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) |
Quidel Triage® MeterPro:
| Product Code | Classification | Regulatory Section | Panel |
|--------------|----------------|--------------------------------------------------|-----------------------|
| KHO | Class I | 21 CFR 862.2560, Fluorometer for<br>clinical use | Clinical<br>Chemistry |
#### Intended Use: 1.8.
## Quidel Triage® TOX Drug Screen, 94600:
The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or
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Image /page/6/Picture/0 description: The image shows the logo for Quidel. The logo features a square with rounded corners that is divided into two sections. The top section is a gradient of colors, including yellow, orange, red, purple, and blue. The bottom section is a solid blue color. Below the square is the word "QUIDEL" in a sans-serif font.
metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below:
| Abbreviation | Analyte | Calibrator | Cutoff |
|--------------|---------------------------|---------------------------------|------------|
| AMP | Amphetamines | d-Amphetamine | 500 ng/mL |
| mAMP | Methamphetamines | d-Methamphetamine | 500 ng/mL |
| BAR | Barbiturates | Butalbital | 200 ng/mL |
| BZO | Benzodiazepines | Temazepam | 200 ng/mL |
| COC | Cocaine | Benzoylecgonine | 150 ng/mL |
| EDDP | Methadone Metabolite | EDDP | 100 ng/mL |
| OPI | Opiates | Morphine | 300 ng/mL |
| THC | Cannabinoids | 11-nor-9-carboxy- $\Delta$ -THC | 50 ng/mL |
| TCA | Tricyclic Antidepressants | Desipramine | 1000 ng/mL |
This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.
## Quidel Triage® MeterPro:
The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.
#### 1.9. Device Description:
## Quidel Triage® TOX Drug Screen, 94600:
The Quidel Triage® TOX Drug Screen, 94600 is a single use test device and is used in conjunction with the Quidel Triage® MeterPro. The device contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result.
### Quidel Triage® MeterPro:
The Quidel Triage MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage MeterPro can be used in a laboratory or in a point-of-care setting.
The Quidel Triage MeterPro uses a laser as a light source. Light from the laser hits a test device that has been inserted in the meter. This causes the fluorescent dye in the test device to give off energy. The more energy the fluorescent dye gives off, the stronger the signal.
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Image /page/7/Picture/0 description: The image features the logo for QuidelOrtho Corporation. The logo consists of a square shape with a smaller square cut out of the lower right corner. The larger square is filled with a gradient of colors, transitioning from green and yellow on the left to red and orange at the top, and blue and purple on the right. Below the square is the word "QUIDEL" in a bold, sans-serif font.
#### 1.10. Substantial Equivalence Information:
- 1. Predicate Device Name:
GenPrime Drugs of Abuse (DOA) Reader System Immunalysis Barbiturates Urine Enzyme Immunoassay DRI Benzodiazepine Assay Immunalysis EDDP Specific Urine Enzyme Immunoassay Biosite Incorporated Triage TOX Drug Screen Biosite Incorporated Triage Meter
- 2. 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
- 3. Comparison with Predicate:
## Quidel Triage® TOX Drug Screen, 94600:
Assays: Amphetamines (AMP), Methamphetamines (mAMP), Cocaine (COC), Opiates (OPI), and Cannabinoids (THC)
| Similarities | | |
|--------------|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | GenPrime Drugs of Abuse<br>(DOA) Reader System<br>(K130082) |
| Intended Use | For the qualitative<br>determination of drugs of<br>abuse in human urine. | Same |
| Assay Type | Competitive assay, where<br>concentration of drug is<br>inversely related to the signal<br>detected by the instrument. | Same |
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Image /page/8/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with a gradient of colors, including red, orange, yellow, green, blue, and purple. The word "QUIDEL" is written in a sans-serif font below the square.
| Similarities | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | GenPrime Drugs of Abuse<br>(DOA) Reader System<br>(K130082) |
| System Procedure | Sample is added to a single<br>use test device which is then<br>read by the instrument. The<br>instrument is designed to read<br>multiple assays at the same<br>time. | Same |
| Specimen Type | Human urine | Same |
| Single-use Test Device | Yes | Same |
| Analyte Cutoffs<br>(ng/mL) | AMP = 500<br>mAMP = 500<br>COC = 150<br>OPI = 300<br>THC = 50 | AMP = 500 (OS Cup; SK Cup)<br>MET = 500 (OS Cup; SK Cup)<br>COC = 150 (OS Cup)<br>MOP = 300 (SK Cup)<br>THC = 50 (OS Cup; SK Cup) |
| Differences | | |
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | GenPrime Drugs of Abuse<br>(DOA) Reader System<br>(K130082) |
| Analyte Cutoffs<br>(ng/mL) | BAR = 200<br>BZO = 200<br>EDDP = 100<br>TCA = 1000<br><br>MTD, OXY, PCP are not panel<br>assays and have no associated<br>analyte cutoffs. | BAR = 300 (OS Cup)<br>MTD = 300 (SK Cup)<br>MOP = 2000 (SK Cup)<br>PCP = 25 (SK Cup)<br><br>BZO, EDDP, and TCA are not<br>panel assays and have no<br>associated cutoff |
| Test Device Format | Cassette | Cup |
| Storage | 2-8°C | 2-30°C |
| Detection method | Measures fluorescence of<br>discreet measurement zones<br>for each assay. | Measures density of visible<br>lines against background on<br>single-use test device. |
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Image /page/9/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square shape with rounded corners, divided into four quadrants. The upper-left quadrant displays a gradient of colors resembling a rainbow, while the other three quadrants are various shades of blue. Below the square is the word "QUIDEL" in a simple, sans-serif font.
| Differences | | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | GenPrime Drugs of Abuse<br>(DOA) Reader System<br>(K130082) |
| Test Time and Timing<br>Method | Operator adds sample to test<br>device and operates<br>the<br>instrument. | Operator manually times test<br>development for 5 minutes and<br>then operates the instrument. |
| Measurement Method | Scans the single-use test<br>device to measure signals. | Scans the single-use test device<br>to detect a signal. |
| Time to Results | Result interpretation occurs in<br>approximately 15 minutes. | Results interpretation must<br>occur between 5 and 60<br>minutes following specimen<br>application |
| Output | Outputs are "POS" if the result<br>is at or above the threshold<br>concentration or "NEG" if the<br>result is below the threshold<br>concentration. The operator<br>has the option to print the<br>results. If connected, the<br>MeterPro can transmit results<br>to the laboratory or hospital<br>information system. | Outputs "presumptive<br>positive", “negative”, and<br>"invalid" test results on a<br>graphic user interface<br>displayed on a computer screen<br>and automatically stores results<br>along with test information.<br>Operator has ability to print<br>and/or export results. |
The following cutoff values are being incorporated into the Quidel Triage® TOX Drug Screen, 94600 Test Device. The cutoff values have been modified to accommodate changes in the calibrator used to manufacture the Test Device for barbiturates and benzodiazepines. In addition, the proposed predicates are identified for the EDDP and TCA assays. The tables below provide the similarities and differences with the selected predicates.
## Assay: Barbiturates (BAR)
| Similarities | | |
|--------------|---------------------------------------------------------------------------|----------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | Immunalysis<br>Barbiturates<br>Urine Enzyme Immunoassay<br>(K161714) |
| Intended Use | For the qualitative<br>determination of drugs of<br>abuse in human urine. | Same |
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Image /page/10/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a stylized square with a gradient of colors, including red, orange, yellow, green, blue, and purple. Below the square is the word "QUIDEL" in a sans-serif font.
| Similarities | | |
|---------------------------|-----------------------------------------------------|-------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | Immunalysis Barbiturates<br>Urine Enzyme Immunoassay<br>(K161714) |
| Specimen Type | Human urine | Same |
| Storage | 2-8°C | Same |
| Measured Analyte | BAR | Same |
| Analyte Cutoff<br>(ng/mL) | BAR = 200 | Same |
| Differences | | |
|---------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | Immunalysis Barbiturates<br>Urine Enzyme Immunoassay<br>(K161714) |
| Intended Use | Not intended for semi-<br>quantitative determination of<br>the presence of Barbiturates in<br>human urine. | For the semi-quantitative<br>determination of the presence<br>of Barbiturates in human<br>urine. |
| Assay Type | Competitive<br>assay, where<br>concentration of drug is<br>inversely related to the signal<br>detected by the instrument. | Enzyme immunoassay |
| Antibody Type | Mouse monoclonal antibodies | Recombinant and monoclonal<br>antibodies |
## Assay: Benzodiazepines (BZO)
| Similarities | | |
|---------------|---------------------------------------------------------------------------|---------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | DRI Benzodiazepine Assay<br>(K173963) |
| Intended Use | For the qualitative<br>determination of drugs of<br>abuse in human urine. | Same |
| Specimen Type | Human urine | Same |
| Storage | 2-8°C | Same |
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Image /page/11/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape divided into two sections. The left section is a gradient of colors, including red, orange, yellow, green, blue, and purple. The right section is a solid blue color. Below the square is the word "QUIDEL" in a sans-serif font.
| Similarities | | | |
|---------------------------|-----------------------------------------------------|---------------------------------------|--|
| Item | Proposed Device | Predicate Device | |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | DRI Benzodiazepine Assay<br>(K173963) | |
| Analyte Cutoff<br>(ng/mL) | BZO = 200 | Same | |
| Differences | | |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | DRI Benzodiazepine Assay<br>(K173963) |
| Intended Use | Not intended for semi-<br>quantitative determination of<br>the presence of<br>benzodiazepines and their<br>metabolites in human urine. | For the semi-quantitative<br>determination of the presence<br>of benzodiazepines and their<br>metabolites in human urine. |
| Assay Type | Competitive assay, where<br>concentration of drug is<br>inversely related to the signal<br>detected by the instrument. | Homogenous enzyme<br>immunoassay |
| Antibody Type | Mouse monoclonal antibodies | Polyclonal sheep antibody |
## Assay: 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)
| Similarities | | |
|---------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | Immunalysis EDDP Specific<br>Urine Enzyme Immunoassay<br>(K151395) |
| Intended Use | For the qualitative<br>determination of drugs of<br>abuse in human urine. | Same |
| Specimen Type | Human urine | Same |
| Storage | 2-8°C | Same |
| Assay calibrated | EDDP | Same |
| Measured Analyte | EDDP | Same |
| Analyte Cutoff<br>(ng/mL) | EDDP = 100 | Same |
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Image /page/12/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square shape divided into two parts. The upper left part is a gradient of colors, including red, orange, yellow, green, blue, and purple. The lower right part is a solid blue color. Below the square is the word "QUIDEL" in a sans-serif font.
| Differences | | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | Immunalysis EDDP Specific<br>Urine Enzyme Immunoassay<br>(K151395) |
| Intended Use | Not intended for semi-<br>quantitative determination of<br>the presence of EDDP in<br>human urine. | For the semi-quantitative<br>determination of the presence<br>of EDDP in human urine. |
| Assay Type | Competitive assay, where<br>concentration of drug is<br>inversely related to the signal<br>detected by the instrument. | Homogenous enzyme<br>immunoassay |
| Antibody Type | Mouse monoclonal antibodies | Recombinant fab antibodies |
| Analyte Cutoffs<br>(ng/mL) | Not intended to have cutoffs<br>available at 300 ng/mL and<br>1000 ng/mL | EDDP = 300 and 1000 |
## Assay: Tricyclic Antidepressants (TCA)
| Similarities | | |
|------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | Triage® TOX Drug Screen<br>(K043242) |
| Intended Use | For the qualitative<br>determination of drugs of<br>abuse in human urine. | Same |
| Assay Type | Competitive assay, where<br>concentration of drug is<br>inversely related to the signal<br>detected by the instrument. | Same |
| Specimen Type | Human urine | Same |
| Storage | 2-8°C | Same |
| Detection method | Measures fluorescence of<br>discreet measurement zones<br>for each assay. | Same |
| Assay calibrated | Desipramine | Same |
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Image /page/13/Picture/0 description: The image features the logo of Quidel. The logo consists of a square divided into two parts. The left part is a gradient of colors, while the right part is a dark blue color. Below the square is the word "QUIDEL" in a sans-serif font.
| Similarities | | |
|---------------------------|-----------------------------------------------------|--------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | Triage® TOX Drug Screen<br>(K043242) |
| Measured Analyte | TCA | Same |
| Analyte Cutoff<br>(ng/mL) | TCA = 1000 | Same |
| Differences | | |
|-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® TOX Drug<br>Screen, 94600 (Proposed) | Triage® TOX Drug Screen<br>(K043242) |
| Analytes | Amphetamines,<br>Methamphetamines,<br>Barbiturates,<br>Benzodiazepines, Cocaine,<br>Methadone Metabolite,<br>Opiates, Cannabinoids (THC),<br>and Tricyclic Antidepressants | Acetaminophen,<br>Amphetamines,<br>Methamphetamines,<br>Barbiturates, Benzodiazepines,<br>Cocaine, Opiates,<br>Phencyclidine, THC, and<br>Tricyclic Antidepressants |
## Quidel Triage® MeterPro:
Last, the proposed predicate for the Quidel Triage MeterPro is its predecessor the Triage Meter cleared under K973547.
| Similarities | | |
|-----------------------------------------|-----------------------------------------------------|------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® MeterPro (Proposed) | Triage Meter (K973547) |
| Device Class | I | Same |
| Power supply | 100-240 VAC, self-switching, or with 4 AA batteries | Same |
| Max. Voltage of ext. power supply | 20 V | Same |
| Electrostatic protection to serial port | 8 / 15 kV | Same |
| Number of serial ports | 2 (by use of adapter) | Same |
| Printer | Integrated | Same |
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Image /page/14/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with a smaller square cut out of the bottom right corner. The larger square is filled with a gradient of colors, including red, orange, yellow, green, blue, and purple. Below the square is the word "QUIDEL" in a sans-serif font.
| Similarities | | |
|----------------|----------------------------------------------------------------------------|------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage® MeterPro<br>(Proposed) | Triage Meter (K973547) |
| Sample ID | Manual input or external<br>hand-held barcode scanner | Same |
| Barcode | Integrated barcode on each<br>test device with lot specific<br>information | Same |
| Time to result | Approximately 15 – 20<br>minutes | Same |
| Differences | | |
|-------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Item | Proposed Device | Predicate Device |
| Features | Quidel Triage®<br>MeterPro<br>(Proposed) | Predicate Device |
| Regulation | 21 CFR 862.2560 | 21 CFR 862.2560 (KHO)<br>21 CFR 862.5680 (DDR)<br>21 CFR 862.1215 (JHX)<br>21 CFR 862.1215 (MMI) |
| Product Code | KHO | KHO, DDR, JHX, MMI |
| Sample Type | Whole blood, plasma or urine | Whole blood or plasma |
| Top meter housing | New top meter housing mold<br>to provide a larger liquid<br>crystal display (LCD) and two<br>elastomer keypads | Small LCD with one single<br>membrane keyboard |
#### 1.11. Standard/Guidance Document Referenced:
None referenced.
#### 1.12. Test Principle:
The Quidel Triage TOX Drug Screen, 94600 is a test device utilizing the standard Triage technology. It is a competitive fluorescence immunoassay which contains all the reagents necessary for the qualitative detection, relative to an assigned threshold value, of the major urinary metabolites for the following substances in human urine: amphetamine (AMP), methamphetamine (mAMP), barbiturates (BAR), benzodiazepines (BZO), cocaine (COC), methadone/methadone metabolite (EDDP), opiates (OPI), tetrahydrocannabinol (THC), and tricyclic antidepressants (TCA).
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The Test Device contains:
- Murine monoclonal antibodies against 9 targeted drugs or metabolites
- Fluorescently labeled antibodies ●
- Fluorescently labeled metabolites
- Solid phase
- Stabilizers
The test procedure involves the addition of a urine specimen to the sample port on the Test Device. After addition of the specimen, the urine passes through a filter. The specimen reacts with fluorescent antibody conjugates or with fluorescent drug conjugates and flows through the Test Device by capillary action. The presence of drug or drug metabolite in the urine specimen prevents binding of the fluorescent conjugates to the solid phase on the detection zone. Excess urine washes the unbound fluorescent conjugates from the detection lane into a waste reservoir.
The Test Device is inserted into the Quidel Triage MeterPro. The Quidel Triage MeterPro is programmed to perform the analysis after the specimen has reacted with the reagents in the Test Device. The analysis is based on the amount of fluorescence the Quidel Triage MeterPro detects within a measurement zone on the Test Device. The positive results are displayed on the Quidel Triage MeterPro screen in about 15 minutes. All results are stored in the Quidel Triage MeterPro memory to display or print when needed. If connected, the Quidel Triage MeterPro can transmit results to the laboratory or hospital information system.
#### 1.13. Performance Characteristics:
- 1. Analytical Performance
- a. Precision/Reproducibility:
Each analyte for the precision study was tested at the following concentrations, as percentages of the cutoffs: A negative control, drug free, 25%, 50%, 75%, cutoff, 125%, 150%, 175%, and 200%. The panels were blinded and randomized prior to testing. Testing was performed at three (3) study sites. Three (3) operators conducted the testing at each study site. Each operator was assigned one test device lot and five (5) Triage MeterPro instruments to conduct the testing. Each operator tested ten (10) samples each day of testing. The ten (10) samples were run in duplicate two (2) times per day for twenty (20) days at each clinical site. Each device was read on one (1) Triage MeterPro. There were approximately seven hundred twenty (720) results per sample. The test results were interpreted as positive (POS) or negative (NEG) for each individual assay based on the assay specific cut-off concentration values. The results of the testing are summarized as follow for the test device.
| Sample<br>Concentration<br>(ng/mL) | % of Cutoff | n | # Neg | # Pos |
|------------------------------------|-------------|---|-------|-------|
| AMP (500 ng/mL) | | | | |
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Image /page/16/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square divided into two sections. The top left section is a gradient of colors, including yellow, orange, red, green, and blue. The bottom right section is a solid dark blue color. Below the square is the word "QUIDEL" in a sans-serif font.
| Sample<br>Concentration<br>(ng/mL) | % of Cutoff | n | # Neg | # Pos | | |
|------------------------------------|-------------|-----|-------|-------|--|--|
| Negative Control | 0 | 720 | 720 | 0 | | |
| 0 | 0 | 720 | 720 | 0 | | |
| 126 | -75 | 720 | 720 | 0 | | |
| 281 | -50 | 716 | 712 | 4 | | |
| 395 | -25 | 720 | 694 | 26 | | |
| 522 | Cutoff | 719 | 50 | 669 | | |
| 650 | +25 | 722 | 2 | 720 | | |
| 760 | +50 | 720 | 0 | 720 | | |
| 884 | +75 | 704 | 0 | 704 | | |
| 991 | +100 | 736 | 0 | 736 | | |
| mAMP (500 ng/mL) | | | | | | |
| Negative Control | 0 | 720 | 720 | 0 | | |
| 0 | 0 | 736 | 736 | 0 | | |
| 130 | -75 | 720 | 720 | 0 | | |
| 250 | -50 | 720 | 720 | 0 | | |
| 366 | -25 | 716 | 697 | 19 | | |
| 529 | Cutoff | 720 | 281 | 431 | | |
| 652 | +25 | 719 | 12 | 707 | | |
| 742 | +50 | 722 | 2 | 720 | | |
| 872 | +75 | 720 | 0 | 720 | | |
| 961 | +100 | 704 | 0 | 704 | | |
| BAR (200 ng/mL) | | | | | | |
| Negative Control | 0 | 720 | 720 | 0 | | |
| 0 | 0 | 704 | 704 | 0 | | |
| 53 | -75 | 736 | 736 | 0 | | |
| 108 | -50 | 720 | 719 | 1 | | |
| 156 | -25 | 720 | 689 | 31 | | |
| 192 | Cutoff | 716 | 111 | 605 | | |
| 233 | +25 | 720 | 3 | 717 | | |
| 306 | +50 | 719 | 0 | 719 | | |
| 355 | +75 | 722 | 0 | 722 | | |
| 406 | +100 | 720 | 0 | 720 | | |
| BZO (200 ng/mL) | | | | | | |
| Negative Control | 0 | 720 | 720 | 0 | | |
| 0 | 0 | 720 | 720 | 0 | | |
| 58 | -75 | 704 | 704 | 0 | | |
| 107 | -50 | 736 | 735 | 1 | | |
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| Sample<br>Concentration<br>(ng/mL) | % of Cutoff | n | # Neg | # Pos |
|------------------------------------|-------------|-----|-------|-------|
| 166 | -25 | 720 | 626 | 94 |
| 219 | Cutoff | 720 | 318 | 402 |
| 259 | +25 | 716 | 9 | 707 |
| 306 | +50 | 720 | 0 | 720 |
| 378 | +75 | 719 | 0 | 719 |
| 399 | +100 | 722 | 0 | 722 |
| COC (150 ng/mL) | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 716 | 716 | 0 |
| 41 | -75 | 720 | 720 | 0 |
| 76 | -50 | 719 | 719 | 0 |
| 119 | -25 | 722 | 519 | 203 |
| 157 | Cutoff | 720 | 26 | 694 |
| 185 | +25 | 704 | 0 | 704 |
| 218 | +50 | 736 | 0 | 736 |
| 267 | +75 | 720 | 0 | 720 |
| 300 | +100 | 720 | 0 | 720 |
| EDDP (100 ng/mL) | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 722 | 722 | 0 |
| 29 | -75 | 720 | 720 | 0 |
| 52 | -50 | 704 | 702 | 2 |
| 85 | -25 | 736 | 645 | 91 |
| 111 | Cutoff | 720 | 126 | 594 |
| 136 | +25 | 720 | 5 | 715 |
| 143 | +50 | 716 | 0 | 716 |
| 174 | +75 | 720 | 0 | 720 |
| 204 | +100 | 719 | 0 | 719 |
| OPI (300 ng/mL) | | | | |
| Negative Control | 0 | 720 | 720 | 0 |
| 0 | 0 | 720 | 720 | 0 |
| 87 | -75 | 719 | 719 | 0 |
| 165 | -50 | 722 | 722 | 0 |
| 231 | -25 | 720 | 715 | 5 |
| 344 | Cutoff | 704 | 197 | 507 |
| 426 | +25 | 736 | 5 | 731 |
| 480 | +50 | 720 | 0 | 720 |
| Sample<br>Concentration<br>(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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Image /page/18/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square divided into two sections. The top left section is a gradient of colors, including yellow, orange, red, green, and blue. The bottom right section is a solid dark blue color. 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.
- 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<br>(Cutoff = 500 ng/mL) | Results<br>Positive<br>at<br>(ng/mL) | % Cross-Reactivity |
|------------------------------------------------------------------|--------------------------------------|--------------------|
| 3,4-Methylenedioxyamphetamine<br>(MDA) | 1,850 | 27.0 |
| 3,4-<br>Methylenedioxyethylamphetamine<br>(MDEA) | >200,000 | 0.0 |
| 3,4-<br>Methylenedioxymethamphetamine<br>(MDMA) | >200,000 | 0.0 |
| d, <i>l</i> -1-(3,4-Methylenedioxyphenyl)-<br>2-Butanamine (BDB) | 1,500 | 33.3 |
| d, <i>l</i> -Amphetamine | 1,000 | 50.0 |
| d, <i>l</i> -Phenylpropanolamine | >200,000 | 0.0 |
| d-Ephedrine | >200,000 | 0.0 |
| d-Amphetamine* | 500 | 100.0 |
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| AMP<br>(Cutoff = 500 ng/mL) | Results<br>Positive<br>at<br>(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<br>(Cutoff = 500 ng/mL) | Results<br>Positive at<br>(ng/mL) | %<br>Cross-<br>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, <i>l</i> -1-(3,4-Methylenedioxyphenyl)-2-Butanamine (BDB) | 25,000 | 2.0 |
| d, <i>l</i> -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 |
| <i>l</i> -Amphetamine | >200,000 | 0.0 |
| <i>l</i> -Ephedrine | >200,000 | 0.0 |
| <i>l</i> -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<br>(Cutoff = 200 ng/mL) | Results<br>Positive<br>at<br>(ng/mL) | %<br>Cross-<br>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<br>(Cutoff = 200 ng/mL) | Results<br>Positive at<br>(ng/mL) | %<br>Cross-<br>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<br>(Cutoff = 200 ng/mL) | Results<br>Positive<br>at<br>(ng/mL) | %<br>Cross-<br>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<br>(Cutoff = 150 ng/mL) | Results<br>Positive at<br>(ng/mL) | %<br>Cross-<br>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<br>(Cutoff = 100 ng/mL) | Results<br>Positive at<br>(ng/mL) | %<br>Cross-<br>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…
