AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
Device Facts
| Record ID | K201630 |
|---|---|
| Device Name | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests |
| Applicant | Assure Tech. (Hangzhou) Co, Ltd. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Aug 12, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine. Methadone, EDDP. Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of. [Table omitted] Configuration of the AssureTech DOA Dipstick Screen Panel Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine. Methadone, EDDP. Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of. [Table omitted] Configuration of the AssureTech Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
Device Story
Single-use in vitro diagnostic devices (dipstick panels or integrated cups) for qualitative detection of drugs of abuse in human urine; utilizes competitive binding, lateral flow immunochromatographic assay principle. Urine sample migrates via capillary action; target drugs below cutoff allow antibody-coated particles to bind immobilized drug-conjugate, forming visible colored test line. If drug exceeds cutoff, binding sites saturate, preventing test line formation. Control line indicates proper test performance. Used in clinical settings; operated by healthcare professionals. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits include rapid, simultaneous screening for multiple analytes.
Clinical Evidence
Bench testing only. Performance validated via precision studies across three POC sites using spiked samples confirmed by LC/MS. Method comparison studies performed on 80 clinical samples per drug (40 positive/40 negative) compared against LC/MS. Interference and specificity testing confirmed no cross-reactivity or matrix effects.
Technological Characteristics
Lateral flow immunochromatographic assay; qualitative. Components: monoclonal antibody-dye conjugate, gold chloride, drug-protein conjugates, anti-mouse IgG. Formats: dipstick panel or integrated cup. Sample: human urine. Principle: competitive binding. Shelf-life: 24 months.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse (6-MAM, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, Methadone, EDDP, Nortriptyline, d-Propoxyphene) in human urine. Intended for prescription use as a preliminary screening tool; requires confirmatory testing via GC/MS or LC/MS.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate 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
- AssureTech Panel Dip Tests and AssureTech Quick Cup Tests (K181768)
- Advin Biotech ATTEST Drug Screen Cup and ATTEST Drug Screen Dip Card (K182123)
Related Devices
- K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card · Safecare Biotech (Hangzhou) Co., Ltd. · May 27, 2020
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test · Assure Tech. (Hangzhou) Co, Ltd. · May 2, 2017
- K163704 — Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card · Healgen Scientific,, LLC · Aug 2, 2017
- K182654 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card · Safecare Biotech (Hangzhou) Co., Ltd. · Nov 19, 2018
- K243996 — AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup · Assure Tech., LLC · Feb 7, 2025
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY
I Background Information:
A 510(k) Number
K201630
B Applicant
Assure Tech (Hangzhou) Co., Ltd.
C Proprietary and Established Names
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJG | Class II | 21 CFR 862.3650 - Opiate Test System | TX - Clinical Toxicology |
| DKZ | Class II | 21 CFR 862.3100 - Amphetamine test system | TX - Clinical Toxicology |
| LDJ | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
| DIO | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| LAF | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
| JXM | Class II | 21 CFR 862.3170 - Benzodiazepine test system | TX - Clinical Toxicology |
| DIS | Class II | 21 CFR 862.3150 - Barbiturate test system | TX - Clinical Toxicology |
| LCM | Unclassified | | |
| DJR | Class II | 21 CFR 862.3620 - Methadone test system | TX - Clinical Toxicology |
| LFG | Class II | 21 CFR 862.3910 - Tricyclic antidepressant drugs test system | TX - Clinical Toxicology |
| JXN | Class II | 21 CFR 862.3700 - Propoxyphene test system | TX - Clinical Toxicology |
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II Submission/Device Overview:
A Purpose for Submission:
New device
B Measurand:
6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene
C Type of Test:
Qualitative lateral flow immunoassay
III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
AssureTech DOA Dipstick Screen Panel Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
| --- | --- |
| 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Marijuana | 20 ng/mL |
| Methamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
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Configuration of the AssureTech DOA Dipstick Screen Panel Tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
AssureTech DOA Integrated Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
| --- | --- |
| 6-Monoacetylmorphine | 10 ng/mL |
| Amphetamine | 500 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 150 ng/mL |
| Marijuana | 20 ng/mL |
| Methamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL |
| Oxycodone | 100 ng/mL |
| Secobarbital | 300 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methylenedioxy-methamphetamine | 500 ng/mL |
| Phencyclidine | 25 ng/mL |
| Methadone | 300 ng/mL |
| EDDP | 300 ng/mL |
| Nortriptyline | 1000 ng/mL |
| d-Propoxyphene | 300 ng/mL |
Configuration of the AssureTech DOA Integrated Cup Tests can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test
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results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
## D Special Instrument Requirements:
Not applicable
## IV Device/System Characteristics:
### A Device Description:
The device is available in a cup and dip card format. With the cup format, the test strips are integrated into the cup provided and the urine sample is collected directly into the cup containing the strips. With the dip card format, the urine is collected into a clean, dry container (not included) and the dip card is dipped into the urine that has been collected. Both formats use the same test strips.
### B Principle of Operation:
Immunochromatographic assays of AssureTech DOA Dipstick Screen Panel and the DOA Integrated Cup Tests use a lateral flow, one step system for the qualitative detection of 6-Monoacetylmorphine, Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and d-Propoxyphene (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes. When the absorb end is immersed into the urine specimen, the urine is absorbed into the device by capillary action, mixes with the antibody-dye conjugate, and flows across the pre-coated membrane. When sample drug levels are zero or below the target cut-off (the detection sensitivity of the test), antibody-dye conjugate binds to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored Test line that, regardless of its intensity, indicates a negative result. When sample drug levels are at or above the target Cut-Off, the free drug in the sample binds to the antibody-dye conjugate preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a potentially positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly because of the antibody-dye conjugate binding to anti-mouse IgG immobilized in the Control Region (C) of the device.
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V Substantial Equivalence Information:
A Predicate Device Name(s):
AssureTech Panel Dip Tests, AssureTech Quick Cup Tests, ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
B Predicate 510(k) Number(s):
K181768, K182123
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K201630 | K181768 |
| --- | --- | --- |
| Device Trade Name | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Same, with the addition of 6-MAM | For the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, EDDP, Nortriptyline and Propoxyphene in human urine. |
| General Device Characteristic Differences | | |
| Number of analytes | 16 | 15 |
| Cutoff (THC) | 20 ng/mL | 50 ng/mL |
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| Device & Predicate Device(s): | K201630 | K182123 |
| --- | --- | --- |
| Device Trade Name | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Same, different analytes | For the qualitative detection of 6-Acetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital and THC-COOH in human urine |
| General Device Characteristic Differences | | |
| Number of analytes | 16 | 20 |
VI Standards/Guidance Documents Referenced:
None referenced.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
Nine sample pools were prepared by spiking target drugs in drug-free urine samples. Each percentage is % cut-off corresponding to each target drug in each of the nine drug mix samples. The number under drug abbreviation is cut-off value of the drug.
Each sample pools were further aliquoted into 180 individual containers (total 1620 aliquots, 90 aliquots per spiked sample for each test format). All aliquots were blinded labeled by the person who prepared the samples and didn't take part in the sample testing. Drug concentrations of the
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sample pools were confirmed by LC/MS/MS. These concentrations were blinded to test operators.
This was a multi-center study to validate the cutoff and precision of the AssureTech DOA Dipstick Screen Screen Panel Tests and the AssureTech DOA Integrated Cup Tests. The three sites represent the intended use settings of the product. Each study site had one test operator for each format to test these samples over a 10-day period. Each operator tested and interpreted 270 specimens over the course of ten days (27 specimens per day, 3 lots $\times$ 9 concentrations). Each operator could only test one device format, i.e., the person who tested the cup did not test the panel dip.
Results are summarized below:
AssureTech DOA Integrated Cup Tests
| CUP | 6-MAM | | | AMP | | | BAR | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 24+/6- | 23+/7- | 23+/7- | 23+/7- | 24+/6- | 26+/4- | 28+/2- | 26+/4- | 28+/2- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| | BUP | | | BZO | | | COC | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 28+/2- | 27+/3- | 27+/3- | 28+/2- | 28+/2- | 29+/1- | 23+/7- | 26+/4- | 24+/6- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
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| | EDDP | | | MDMA | | | MET | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 24+/6- | 24+/6- | 25+/5- | 23+/7- | 22+/8- | 22+/8- | 23+/7- | 27+/3- | 23+/7- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| | MOR | | | MTD | | | OXY | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 22+/8- | 24+/6- | 23+/7- | 26+/4- | 27+/3- | 27+/3- | 27+/3- | 28+/2- | 28+/2- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| | PCP | | | PPX | | | TCA | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 25+/5- | 25+/5- | 24+/6- | 25+/5- | 27+/3- | 25+/5- | 24+/6- | 25+/5- | 23+/7- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
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| | THC | | |
| --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 23+/7- | 24+/6- | 24+/6- |
| +25% | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- |
AssureTech DOA Dipstick Screen Panel Tests
| CARD | 6-MAM | | | AMP | | | BAR | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 24+/6 | 23+/7- | 25+/5- | 23+/7- | 23+/7- | 27+/3- | 27+/3- | 27+/3- | 26+/4- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| | BUP | | | BZO | | | COC | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 26+/4- | 26+/4- | 28+/2- | 28+/2- | 28+/2- | 27+/3- | 22+/8- | 25+/5- | 23+/7- |
| +25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
{9}
| | BUP | | | BZO | | | COC | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| +50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| | EDDP | | | MDMA | | | BZO | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 24+/6- | 24+/6- | 24+/6- | 24+/6- | 24+/6- | 22+/8- | 25+/5 | 25+/5- | 24+/6- |
| 25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| 50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| 75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| 100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| | MOR | | | MTD | | | OXY | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 23+/7- | 24+/6- | 25+/5- | 27+/3- | 26+/4- | 26+/4- | 28+/2- | 27+/3- | 28+/2- |
| 25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| 50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
{10}
| | PCP | | | PPX | | | TCA | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 25+/5- | 25+/5- | 24+/6- | 25+/5- | 25+/5- | 26+/4- | 23+/7- | 23+/7- | 24+/6- |
| 25% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| 50% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- | 30+/0- |
| | THC | | |
| --- | --- | --- | --- |
| Drug conc as % of cutoff | Lot 1 | Lot 2 | Lot 3 |
| -100% | 30-/0+ | 30-/0+ | 30-/0+ |
| -75% | 30-/0+ | 30-/0+ | 30-/0+ |
| -50% | 30-/0+ | 30-/0+ | 30-/0+ |
| -25% | 30-/0+ | 30-/0+ | 30-/0+ |
| cutoff | 24+/6- | 22+/8- | 22+/8- |
| 25% | 30+/0- | 30+/0- | 30+/0- |
| 50% | 30+/0- | 30+/0- | 30+/0- |
| +75% | 30+/0- | 30+/0- | 30+/0- |
| +100% | 30+/0- | 30+/0- | 30+/0- |
2. Linearity:
Not applicable, these devices are intended for qualitative use only.
3. Analytical Specificity/Interference:
The sponsor performed specificity and cross-reactivity studies for the 6-Acetylmorphine (6-MAM) and THC strips only. Please refer to k181768 for the specificity and cross-reactivity performance for the remaining assays.
The sponsor performed studies to evaluate whether compounds structurally related to 6-MAM and THC cross-react with the assays. The study used three lots and the testing was performed by trained professionals by following the instructions in the package insert.
Results are summarized below:
{11}
| 6-acetylmorphine (Cut-off=10 ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| 6-acetylmorphine | 10 | 100% |
| Acetylcodeine | >10000 | <0.1% |
| Buprenorphine | >10000 | <0.1% |
| Codeine | >10000 | <0.1% |
| Diacetylmorphine | 1000 | 1% |
| Dihydrocodeine | >10000 | <0.1% |
| Ethylmorphine | >10000 | <0.1% |
| Hydrocodone | >10000 | <0.1% |
| Hydromorphone | 5000 | 0.2% |
| Morphine | 10000 | 0.1% |
| Morphine-3-glucuronide | >10000 | <0.1% |
| Nalorphine | 5000 | 0.2% |
| Thebaine | >20000 | <0.05% |
| Dextromethorphan | >100,000 | <0.01% |
| Heroin | 100,000 | 0.01% |
| Imipramine | >100,000 | <0.01% |
| LAAM (Levacetylmethadol) | >100,000 | <0.01% |
| Levorphanol | >100,000 | <0.01% |
| Meperidine | >100,000 | <0.01% |
| Methadone | >100,000 | <0.01% |
| Mitragynine (kratom) | >20,000 | <0.05% |
| Morphine 6-D-glucuronide | >100,000 | <0.01% |
| Naloxone | >100,000 | <0.01% |
| Naltrexone | >100,000 | <0.01% |
| Naproxen | >100,000 | <0.01% |
| Norbuprenorphine | >10,000 | <0.1% |
| Norbuprenorphine glucuronide | >100,000 | <0.01% |
| Norcodeine | >100,000 | <0.01% |
| Norhydrocodone | >100,000 | <0.01% |
| Normorphine | >100,000 | <0.01% |
| Noroxycodone | >100,000 | <0.01% |
| Noroxymorphone | >100,000 | <0.01% |
| Norpropoxyphene | >100,000 | <0.01% |
| Oxycodone | >100,000 | <0.01% |
| Oxymorphone | >100,000 | <0.01% |
{12}
| 6-acetylmorphine (Cut-off=10 ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Oxymorphone-3β-D-glucuronide | >100,000 | <0.01% |
| Tapentadol HCl | >100,000 | <0.01% |
| Tramadol | >100,000 | <0.01% |
| Marijuana (Cut-off=20 ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| 11-nor-D^{9}-THC-9 COOH | 20 | 100% |
| 11-nor-D^{8}-THC-9 COOH | 20 | 100% |
| Δ^{8}-Tetrahydrocannabinol | >10000 | <0.2% |
| Δ^{9}-Tetrahydrocannabinol | >10000 | <0.2% |
| Cannabinol | >10000 | <0.2% |
To evaluate potential positive or negative interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the claimed analytes at 25% below and 25% above each corresponding cutoff.
Potential interferents were spiked in at a concentration of 100 µg/mL except for albumin at 100 mg/dL and ethanol at 1%.
The following compounds did not cause any positive or negative interference with any of the 16 assays with the candidate device.
Acetaminophen, Acetophenetidin, N-Acetylprocainamide, Acetylsalicylic acid, Albumin (100mg/dL), Aminopyrine, Amoxicillin, Ampicillin, Apomorphine, Ascorbic acid, Aspartame, Atropine, Benzilic acid, Benzoic acid, Bilirubin, Chloral hydrate, Digoxin, Diphenhydramine, Ecgonine methyl ester, β-Estradiol, Erythromycin, Ethanol (1%), Fenoprofen, Furosemide, Gentisic acid, Hemoglobin, Hydralazine, Hydrochlorothiazide, Hydrocortisone, O-Hydroxyhippuric acid, 3-Hydroxytyramine, Ibuprofen, Isoproterenol, Isoxsuprine, Ketamine, Ketoprofen, Labetalol, Loperamide, Meperidine, Meprobamate, Methoxyphenamine, Nalidixic acid, Naloxone, Naltrexone, Naproxen, Niacinamide, Nifedipine, Norethindrone, Noscapine, (±)-Octopamine, Oxalic acid, Oxolinic acid, Oxymetazoline, Papaverine, Penicillin G, Perphenazine, Phenelzine, Prednisone, (±)-Propranolol, Pseudoephedrine, Quinine, Ranitidine, Salicylic acid, Serotonin (5-Hydroxytyramine), Sulfamethazine Sulindac, Tetrahydrocortisone, 3-(β-D glucuronide, Tetrahydrocortisone 3-acetate, Tetrahydrozoline, Thiamine, Thioridazine, Triamterene, Trifluoperazine, Trimethoprim, DL-Tryptophan, Tyramine, DL-Tyrosine, Uric acid, Verapamil, and Zomepirac.
The sponsor also performed studies to evaluate the effect of urine pH and specific gravity on the results. Samples with concentrations of 0 (drug-free), at 25% below and 25% above each corresponding cutoff were adjusted to pH levels of 4, 5, 6, 7, 8, and 9 and at a specific gravity of 1.001, 1.003, 1.005, 1.007, 1.009, 1.010, 1.012, 1.014, 1.015, 1.016, 1.017, 1.020, 1.021, 1.024, 1.025, 1.026, 1.027, 1.029, and 1.030.
{13}
There were no deviations from the expected negative or positive results for either pH or specific gravity.
# 4. Assay Reportable Range:
Not applicable.
# 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The sponsor's stability protocols were reviewed and found to be acceptable. A shelf-life stability of 24 months from the date of manufacture is claimed.
# 6. Detection Limit:
Not applicable.
# 7. Assay Cut-Off:
See section VII.A.1 above for a description of how the device performs around the cutoffs.
# B Comparison Studies:
# 1. Method Comparison with Predicate Device:
Method comparison studies for the AssureTech DOA Dipstick Screen Panel Tests and the AssureTech DOA Integrated Cup Tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below for 6-MAM and THC. Please refer to k181768 for the method comparison performance for the remaining assays.
| Dip 6-MAM | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer 1 | Positive | 0 | 0 | 0 | 15 | 5 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer 2 | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer 3 | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
{14}
| Cup
6-MAM | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer 1 | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer 2 | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer 3 | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Dip
THC | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer 1 | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer 2 | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Viewer 3 | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
| Cup
THC | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer 1 | Positive | 0 | 0 | 0 | 14 | 25 |
| | Negative | 10 | 20 | 10 | 1 | 0 |
| Viewer 2 | Positive | 0 | 0 | 0 | 15 | 25 |
| | Negative | 10 | 20 | 10 | 0 | 0 |
| Viewer 3 | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 20 | 9 | 0 | 0 |
{15}
2. **Matrix Comparison:**
Not applicable. The assays are only intended for use with urine samples.
**C Clinical Studies:**
1. **Clinical Sensitivity:**
Not applicable.
2. **Clinical Specificity:**
Not applicable.
3. **Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):**
Not applicable.
**D Clinical Cut-Off:**
Not applicable.
**E Expected Values/Reference Range:**
Not applicable.
**VIII Proposed Labeling:**
The labeling supports the finding of substantial equivalence for this device.
**IX Conclusion:**
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
