UCP MULTI-DRUG TEST KEY CUPS
Device Facts
| Record ID | K132812 |
|---|---|
| Device Name | UCP MULTI-DRUG TEST KEY CUPS |
| Applicant | Ucp Biosciences, Inc. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Mar 6, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K132812 · Mar 6, 2014 | UCP MULTI-DRUG TEST KEY CUPS | Ucp Biosciences, Inc. | Clinical urine samples from reference laboratories | Clinical urine samples were used to evaluate the accuracy of the device by comparing performance against predicate devices and reference methods (GC/MS or HPLC). | Accuracy study; Clinical urine samples; Reference laboratory data |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Retrospective comparison study using clinical urine samples | Clinical urine samples (drug negative and drug positive); Sample Size: 80 clinical urine samples per drug test | Predicate devices (k130463) and reference methods (GC/MS or HPLC) | Agreement between candidate device and predicate/reference methods |
Indications for Use
The UCP Multi-Drug Test Key Cups are rapid tests for preliminary detection of the following drugs in human urine: Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressant. The test configuration comes with a single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. The second step is to send preliminary positive samples for confirmation testing by GCMS. The test is not intended to distinguish between prescription use or abuse of the following drugs: Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants. There are no uniformly recognized cutoff concentration levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propxyphene, Tricyclic Antidepressant in urine. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. For Over-The-Counter (OTC) use For In Vitro Diagnostics only
Device Story
UCP Multi-Drug Test Key Cups are lateral flow immunochromatographic assays for qualitative drug screening in human urine. Device utilizes key-activated mechanism to initiate testing. Input: human urine sample. Principle: competitive binding; drug-specific antibodies on nitrocellulose strips compete with drug-conjugates for binding sites. Output: visual colored lines in test region (negative result) or absence of line (positive result). Used by OTC consumers for preliminary screening; positive results require laboratory confirmation via GC/MS. Includes collection cup, transport bag, and ID labels for lab submission. Benefits: provides rapid, preliminary information regarding presence of drugs of abuse to facilitate further clinical or professional decision-making.
Clinical Evidence
Bench testing only. Precision/reproducibility studies performed using spiked urine samples across 3 lots. Analytical specificity (cross-reactivity) and interference testing conducted. Method comparison study against GC/MS using 80 clinical samples showed high agreement. Lay user study (n=115) confirmed ability of non-professionals to interpret results correctly (99.1% accuracy).
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Form factor: test cup with key-activated mechanism. Qualitative visual readout. No electronic components or software algorithms. In vitro diagnostic use.
Indications for Use
Indicated for preliminary detection of drugs of abuse in human urine for OTC and prescription use. Target drugs: Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiates 2000, Oxycodone, Phencyclidine, Propoxyphene, Tricyclic Antidepressants. Not intended to distinguish between prescription use and abuse.
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
- UCP Home™ Drug Screening Test Cups (k130463)
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k132812
B. Purpose for Submission:
New Device
C. Measurand:
Amphetamine (d-amphetamine), Barbiturates (secobarbital), Benzodiazepines (oxazepam), Buprenorphine (buprenorphine), Cocaine (benzoylecgonine), Methamphetamine (d-methamphetamine), Methylenedioxymethamphetamine (MDMA), Methadone (methadone), Opiate 2000 (morphine), Morphine 300 (morphine), Oxycodone (oxycodone), Phencyclidine (phencyclidine), Propoxyphene (propoxyphene), Cannabinoids (THC) (delta-9-THC-COOH) and Tricyclic Antidepressants (nortriptyline).
D. Type of Test:
Qualitative immunochromatographic assay
E. Applicant:
UCP Biosciences, Inc
F. Proprietary and Established Names
UCP Multi-Drug Test Key Cups
G. Regulatory Information:
| Product | Classificatie | Regulation Section | Panel |
| --- | --- | --- | --- |
| DKZ | Class II | 21 CFR 862.3100 Amphetamine test system | 91 (Toxicology) |
| DIS | Class II | 21 CFR 862.3150 Barbiturate test system | 91 (Toxicology) |
| JXM | Class II | 21 CFR 862.3170 Benzodiazepine test system | 91 (Toxicology) |
| JXN | Class II | 21 CFR 862.3700 Propoxyphene Test System | 91 (Toxicology) |
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| DIO | Class II | 21 CFR 862.3250 Cocaine and cocaine metabolite test system | 91 (Toxicology) |
| --- | --- | --- | --- |
| DJC | Class II | 21 CFR 862.3610 Methamphetamine test system | 91 (Toxicology) |
| DJR | Class II | 21 CFR 862.3620 Methadone test system | 91 (Toxicology) |
| DJG | Class II | 21 CFR 862.3650 Opiate test system. | 91 (Toxicology) |
| LCM | Class II | Unclassified, Enzyme immunoassay, phencyclidine | 91 (Toxicology) |
| LDJ | Class II | 21 CFR 862.3870 Cannabinoid test system | 91 (Toxicology) |
| LFG | Class II | 21 CFR 862.3910 Tricyclic antidepressant drugs test system | 91 (Toxicology) |
## H. Intended Use:
1. Intended Use(s):
See indications for use below.
2. Indication(s) for use:
The UCP Multi-Drug Test Key Cups are rapid tests for preliminary detection of the following drugs in human urine:
| Test | Calibrated to | Cut-off |
| --- | --- | --- |
| Amphetamine | D-Amphetamine | 1000 ng/mL |
| Barbiturates | Secobarbital | 300 ng/mL |
| Benzodiazepines | Oxazepam | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | Delta-9-THC-COOH | 50 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Methamphetamine | D-Methamphetamine | 1000 ng/mL |
| MDMA | MDMA | 500 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Opiates 2000 | Morphine | 2000 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
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| Phencyclidine | Phencyclidine | 25 ng/mL |
| --- | --- | --- |
| Propoxyphene | Propoxyphene | 300 ng/mL |
| Tricyclic Antidepressant | Nortriptyline | 1000 ng/mL |
The test configuration comes with a single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers with information concerning the presence or absence of the above stated drugs in a urine sample. The second step is to send preliminary positive samples for confirmation testing by GCMS. The test is not intended to distinguish between prescription use or abuse of the following drugs: Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants.
There are no uniformly recognized cutoff concentration levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressant in urine.
Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated.
3. Special conditions for use statement(s):
The OTC test can contain various combinations of drugs including either the morphine 300 cutoff or the opiates 2000 cutoff.
4. Special instrument requirements:
Not applicable; the device is a visually-read single use device.
I. Device Description:
The UCP Multi-Drug Test Key Cups are capable of measuring the 14 drugs listed in the intended use at one time. The UCP Multi-Drug Test Key Cups can measure up to three drugs per strip. The test is activated by a key. The test includes user instructions, collection cups, transportation bag with absorbent pad, mailing box and identification labels with personal identification number to be used when sending preliminary positive urine specimens to the laboratory for confirmation.
J. Substantial Equivalence Information:
1. Predicate device names(s)
UCP Home Drug Screening Test Cups
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2. Predicate K number(s):
k130463
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device | Predicate (k130463) |
| Intended Use | Same | Qualitative and preliminary detection of drugs in human urine |
| Methodology | Same | Lateral flow immunochromatographic |
| Type of assay | Same | Qualitative |
| Matrix | Same | Urine |
| Cutoff | Same | Amphetamine: 1000 ng/mL |
| | Same | Barbiturates: 300 ng/mL |
| | Same | Benzodiazepines: 300 ng/mL |
| | Same | Buprenorphine: 10 ng/mL |
| | Same | Cocaine: 300 ng/mL |
| | Same | Cannabinoids (THC): 50 ng/mL |
| | Same | Methadone: 300 ng/mL |
| | Same | Methamphetamine: 1000 ng/mL |
| | Same | MDMA: 500 ng/mL |
| | Same | Morphine: 300 ng/mL |
| | Same | Opiate: 2000 ng/mL |
| | Same | Oxycodone: 100 ng/mL |
| | Same | Phencyclidine: 25 ng/mL |
| | Same | Propoxyphene: 300 ng/mL |
| | Same | Tricyclic Antidepressants: 1000 ng/mL |
| Endpoint | Same | Colored lines |
| Differences | | |
| --- | --- | --- |
| Item | Candidate | Predicate |
| Sample Application | Key-activated | Direct |
K. Standard/Guidance Document Referenced (if applicable):
None referenced.
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L. Test Principle:
The UCP Multi-Drug Test Key Cups employ lateral flow immunochromatographic technology based on the principle of competitive binding. If the sample does not contain the drugs (or if they are present in concentrations below the cutoff level) binding sites of antibody coated particles in the device will not be saturated. The antibody-coated particles will then be captured by immobilized colloidal gold-labeled drug-specific conjugate and a colored line will appear in the test line region. The colored line will not form if the sample contains drug in excess of the cutoff level because the drug will saturate all the binding sites of the drug specific antibody. Each strip in the device is composed of nitrocellulose and contains the test line with mouse monoclonal antibodies specific to each drug. The test strips also contain a procedural control line region containing a goat polyclonal antibody against gold-protein conjugate to indicate that the sample has migrated properly on the test strip.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Precision studies were performed using drug-free urine spiked to the following concentrations: negative (0%), 50% below the cutoff, 25% below the cutoff, 25% above the cutoff, and 50% above the cutoff for each analyte. Sample concentrations were confirmed by GC/MS. The samples were aliquoted, coded, randomized and masked. Each specimen, at each concentration analyte, was tested on a total of sixty (60) test devices from three different lots by three operators within 10 to 20 non-consecutive days. The results are displayed in the tables below. Also see section 2.b., below, for additional results obtained by the intended user that include results for high positive and low negative concentrations.
Amphetamine
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 1/19 | 95 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
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| Lot 3 | Negative | 20 | 20/0 | 100 |
| --- | --- | --- | --- | --- |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
## Barbiturates
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 1/19 | 95 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 2/18 | 90 |
| | +50% | 20 | 0/20 | 100 |
## Benzodiazepines
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 19/1 | 95 |
| | +25% | 20 | 0/20 | 100 |
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Buprenorphine
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 19/1 | 95 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
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Cocaine
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 2/18 | 90 |
| | +50% | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 1/19 | 95 |
| | +50% | 20 | 0/20 | 100 |
Marijuana (THC)
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 1/19 | 95 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
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| Lot 3 | Negative | 20 | 20/0 | 100 |
| --- | --- | --- | --- | --- |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 1/19 | 95 |
| | +50% | 20 | 0/20 | 100 |
## Methadone
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
## Methamphetamine
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
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| Lot 2 | Negative | 20 | 20/0 | 100 |
| --- | --- | --- | --- | --- |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 2/18 | 90 |
| | +50% | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
MDMA
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
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Morphine
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 2/18 | 90 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 1/19 | 95 |
| | +50% | 20 | 0/20 | 100 |
Opiates 2000
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 18/2 | 90 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
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| Lot 3 | Negative | 20 | 20/0 | 100 |
| --- | --- | --- | --- | --- |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 19/1 | 95 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
## Oxycodone
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25 | 20 | 0/20 | 100 |
| | +50 | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 19/1 | 95 |
| | +25 | 20 | 0/20 | 100 |
| | +50 | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25 | 20 | 0/20 | 100 |
| | +50 | 20 | 0/20 | 100 |
## Phencyclidine
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 18/2 | 90 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
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| Lot 2 | Negative | 20 | 20/0 | 100 |
| --- | --- | --- | --- | --- |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 19/1 | 95 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
## Propoxyphene
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 18/2 | 90 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 19/1 | 95 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
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Tricyclic Antidepressants
| | Concentration of sample (ng/mL) | Number of determinations | Results #Neg/#Pos | Precision (%) |
| --- | --- | --- | --- | --- |
| Lot 1 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
| Lot 2 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 1/19 | 95 |
| | +50% | 20 | 0/20 | 100 |
| Lot 3 | Negative | 20 | 20/0 | 100 |
| | -50% | 20 | 20/0 | 100 |
| | -25% | 20 | 20/0 | 100 |
| | +25% | 20 | 0/20 | 100 |
| | +50% | 20 | 0/20 | 100 |
b. Linearity/assay reportable range:
Not applicable; the device is intended for qualitative use.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
External control standards are not supplied with this device. For prescription use, the sponsor provides instruction for testing QC materials.
Stability:
The sponsor’s stability protocols and acceptance criteria were reviewed and found acceptable. The information supports that UCP Multi-Drug Test Key Cups unopened stability is 18 months. Real time stability testing is ongoing. (Instructions note that opened tests should be used immediately.)
d. Detection limit:
Analytical performance of the device around the cutoff is described in Section a. (Precision/Reproducibility) above.
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# e. Analytical specificity:
Cross-reactivity was evaluated by spiking similarly structured compounds into drug free urine. These solutions were tested using 3 lots of the UCP Home Drug Screening Test Cups. Results are expressed as a minimum concentration of compound required to produce a response approximately equivalent to the cutoff concentration of the assay. The percent cross-reactivity of those compounds is presented below.
Amphetamine
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| D-Amphetamine | 1000 | 100% |
| D,L-Amphetamine | 2500 | 40% |
| L-Amphetamine | 50000 | 2% |
| D-Methamphetamine | >100000 | <1% |
| L-Methamphetamine | >100000 | <1% |
| (±)3,4-Methylenedioxyamphetamine (MDA) | 2000 | 50% |
| Ephedrine | >100000 | <1% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | >100000 | <1% |
Methamphetamine
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| (±) Methamphetamine | 2,000 | 50% |
| (+) Methamphetamine | 1000 | 100% |
| (±) 3,4-Methylenedioxymethamphetamine (MDMA) | 2,000 | 50% |
| Ranidine (Zantac) | >100,000 | <1% |
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16
| 3,4-Methylenedioxyamphetamine (MDA) | >100,000 | <1% |
| --- | --- | --- |
| D-Amphetamine | >100,000 | <1% |
| L-Amphetamine | >100,000 | <1% |
| Ephedrine | >100,000 | <1% |
## Barbiturates
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Secobarbital | 300 | 100% |
| Phenobarbital | 2500 | 12% |
| Butalbital | 500 | 60% |
| Pentobarbital | 1500 | 20% |
| Amobarbital | 2500 | 12% |
| Cyclopentobarbital | 500 | 60% |
| Butethal | 800 | 37.5% |
| Barbital | 300 | 100% |
| Butabarbital | 1500 | 20% |
## Benzodiazepines
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Oxazepam | 300 | 100% |
| Alprazolam | 200 | 150% |
| α-Hydroxyalprazolam | 1000 | 30% |
| Bromazepam | 250 | 120% |
| Chlordiazepoxide | 2500 | 12% |
| Clobazam | 100 | 300% |
| Clonazepam | 850 | 35.3% |
| Clorazepate | 250 | 120% |
| Delorazepam | 1600 | 18.8% |
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Buprenorphine
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Buprenorphine | 10 | 100 |
| Norbuprenorphine | 15 | 66.67 |
| Buprenorphine-3-D-glucuronide | 12.5 | 80 |
| Norbuprenorphine-3-D-glucuronide | 175 | 5.71 |
| Morphine-3-D-glucuronide | 100000 | <1% |
| Morphine | >100000 | <1% |
| Oxymorphone | >100000 | <1% |
| Hydromorphone | >100000 | <1% |
Cocaine
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Cocaine | >100000 | <1% |
| Benzoylecgonine | 300 | 100% |
| Ecgonine HCI | 35000 | 0.86% |
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Marijuana
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| 11-nor-Δ⁸-THC-9-COOH | 50 | 100% |
| 11-nor-Δ⁹-THC-9-COOH | 50 | 100% |
| Δ⁸-Tetrahydrocannabinol | 8000 | 0.6% |
| Δ⁹-Tetrahydrocannabinol | 10000 | 0.5% |
| Cannabinol | 10000 | 0.5% |
| Cannabidiol | 100000 | <1% |
Methadone
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Methadone | 300 | 100% |
| (±)2-Ethyl-1,5-dimethy1-3,3-diphenylpyrrolinium | 50000 | 0.6% |
| Doxylamine | 50000 | 0.6% |
MDMA
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| D-Amphetamine | >100000 | <1% |
| L-Methamphetamine | 100000 | <1% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 200 | 250% |
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3,4-Methylenedioxyamphetamine (MDA) 2000 25%
Morphine
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Morphine | 300 | 100% |
| Codeine | 300 | 100% |
| Heroin | 300 | 100% |
| Hydrocodone | 2000 | 15% |
| Hydromorphone | 3500 | 8.6% |
| Morphine 3-β-D-glucuronide | 300 | 100% |
| 6-Monoacetylmorphine | 600 | 50% |
| Normorphone | 100000 | <1% |
| Oxycodone | 10000 | 3% |
| Oxymorphone | 50000 | <1% |
| Thebaine | 7000 | 4.3% |
Opiates 2000
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Morphine | 2000 | 100% |
| Codeine | 2000 | 100% |
| Heroin | 2000 | 100% |
| Hydrocodone | 10000 | 20% |
| Hydromorphone | 7000 | 28.6% |
| Morphine 3-β-D-glucuronide | 2000 | 100% |
| 6-Monoacetylmorphine | 5000 | 40% |
| Normorphone | 100000 | 2% |
| Oxycodone | 20000 | 10% |
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| Oxymorphone | 100000 | 2% |
| --- | --- | --- |
| Thebaine | 70000 | 2.9% |
## Oxycodone
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Oxycodone | 100 | 100% |
| Morphine | 50000 | <1% |
| Codeine | 25000 | <1% |
| Morphine 3-β-D-glucuronide | 50000 | <1% |
| Hydrocodone | 1600 | 6.25% |
| Hydromorphone | 15000 | 0.7% |
| Normorphone | 100000 | <1% |
| Oxymorphone | 1500 | 6.7% |
## Phencyclidine
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Phencyclidine | 25 | 100% |
| 4-Hydroxyphencyclidine | 15000 | <1% |
## Propoxyphene
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Propoxyphene | 300 | 100 |
| Norpropoxyphene | 600 | 50 |
| Methadone | 100000 | <1 |
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| 2-ethyl-1,5-dimethyl-3,3-diphenylpyrroline (EDDP) | 100000 | <1 |
| --- | --- | --- |
## Tricyclic Antidepressants
| Compounds | Concentration that yields response approximately equivalent to that of target drug at the cutoff concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Notriptiline | 1000 | 100% |
| Trimipramine | 4500 | 22% |
| Amitriptyline | 1000 | 100% |
| Promazine | 3000 | 33.33% |
| Desipramine | 1000 | 100% |
| Imipramine | 1000 | 100% |
| Clomipramine | 7500 | 13.33% |
| Doxepin | 3000 | 33.33% |
| Maprotiline | 50000 | 2% |
Interference testing for structurally unrelated compounds:
The following structurally unrelated compounds were found not to interfere with UCP Home Drug Screening Test Cups when tested spiked (100 mg/mL) into drug free urine or urine spiked with each drug at ±50%, ±25% of the cut-off values:
Acetaminophen, Acetylsalicylic Acid, Amikacin, Ampicillin, Arterenal, Aspirin, Atropine, Benzoic Acid, Oxalic Acid, Caffeine, Methanol, Ethanol, Lidocaine, Thioridazine, Trifluoperazine, Penicillin-G, Phenylpropanalamine, Ranitidine, Salicylic Acid, Albumin, Bilirubin, Creatine, Hemoglobin, Glucose, Vitamin C (L-Ascorbic Acid), Uric Acid.
Evaluation of Specific Gravity and pH on the test results:
To evaluate the effect of pH value on the test results, negative urine samples were adjusted to pH levels 4.5, 5.0, 6.0, 7.0, 8.0, and 9.0. The samples were then spiked with each drug at ±50%, ±25% of the cut-off values. Testing was performed on 3 lots of UCP Home Drug Screening Test Cups.
To evaluate the effect of specific gravity, the urine samples having specific gravities of 1.005, 1.01, 1.02, 1.025, and 1.030, 1.032, and 1.035 were spiked with each drug at ±50%, ±25% of the cut-off values. Testing was performed on 3 lots of UCP Home
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Drug Screening Test Cups. The testing results demonstrated that the varying pH and specific gravities listed above do not affect urine testing results around each analyte cut-off.
f. Assay cut-off:
Analytical performance of the device around the cutoff is described in Section a. (Precision/Reproducibility) above.
2. Comparison studies:
a. Method comparison with predicate device:
The method comparison for UCP Home Drug Screening Test Cups was performed with total 80 (40 negative and 40 positive) unaltered clinical samples by three operators. The samples were masked and device results were compared to GC/MS results. For classes of drugs (e.g. barbiturates, benzodiazepines, tricyclic antidepressants) testing included a minimum of 3 drugs for each class. The results are presented in the table below:
| | | Negative Urine | Near Cutoff Negative by GC/MS (Between - 50% and the cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Total Agreement with GCMS |
| --- | --- | --- | --- | --- | --- | --- |
| Amphetamine | Positive Results | 0 | 0 | 3 | 36 | 98.8% |
| | Negative Results | 36 | 4 | 1 | 0 | |
| Barbiturates | Positive Results | 0 | 1 | 8 | 32 | 98.8% |
| | Negative Results | 32 | 7 | 0 | 0 | |
| Benzodiazepines | Positive Results | 0 | 1 | 7 | 32 | 97.5% |
| | Negative Results | 32 | 7 | 1 | 0 | |
| Buprenorphine | Positive Results | 0 | 1 | 4 | 36 | 98.8% |
| | Negative Results | 36 | 3 | 0 | 0 | |
| Cocaine | Positive Results | 0 | 0 | 8 | 32 | 100% |
| | Negative Results | 29 | 11 | 0 | 0 | |
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| Methadone | Positive Results | 0 | 1 | 4 | 36 | 98.8% |
| --- | --- | --- | --- | --- | --- | --- |
| | Negative Results | 36 | 3 | 0 | 0 | |
| MDMA | Positive Results | 0 | 1 | 3 | 36 | 97.5% |
| | Negative Results | 36 | 3 | 1 | 0 | |
| Methamphetamine | Positive Results | 0 | 0 | 5 | 34 | 98.8% |
| | Negative Results | 34 | 6 | 1 | 0 | |
| Morphine | Positive Results | 0 | 1 | 4 | 36 | 98.8% |
| | Negative Results | 36 | 3 | 0 | 0 | |
| Opiates 2000 | Positive Results | 0 | 2 | 8 | 32 | 97.5% |
| | Negative Results | 33 | 5 | 0 | 0 | |
| Marijuana | Positive Results | 0 | 1 | 3 | 36 | 97.5% |
| | Negative Results | 36 | 3 | 1 | 0 | |
| PCP | Positive Results | 0 | 0 | 3 | 36 | 98.8% |
| | Negative Results | 36 | 4 | 1 | 0 | |
| Oxycodone | Positive Results | 0 | 0 | 4 | 36 | 100% |
| | Negative Results | 36 | 4 | 0 | 0 | |
| Propoxyphene | Positive Results | 0 | 1 | 11 | 29 | 98.8% |
| | Negative Results | 28 | 11 | 0 | 0 | |
| TCA | Positive Results | 0 | 1 | 5 | 34 | 97.5% |
| | Negative Results | 35 | 4 | 1 | 0 | |
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Summary of discordant results shown in the table above:
| Sample Numbers | Drug Test | Cutoff value (ng/mL) | Result (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | |
| --- | --- | --- | --- | --- | --- |
| | | | | Drug /Metabolite | GC/MS value (ng/ml) |
| AMP-42 | Amphetamine | 1000 | Negative | D-Amphetamine | 1215 |
| BAR-39 | Barbiturates | 300 | Positive | Secobarbital | 285 |
| BZO-34 | Benzodiazepines | 300 | Positive | Oxazepam | 289 |
| BZO-45 | Benzodiazepines | 300 | Negative | Diazepam | 209 |
| BUP-40 | Buprenorphine | 10 | Positive | Buprenorphine | 9 |
| MTD-38 | Methadone | 300 | Positive | Methadone | 230 |
| MDMA-40 | MDMA | 500 | Positive | MDMA | 480 |
| MDMA-43 | MDMA | 500 | Negative | MDMA | 525 |
| MET-42 | Methamphetamine | 1000 | Negative | D-Methamphetamine | 1195 |
| MOP-39 | Morphine | 300 | Positive | Morphine | 285 |
| OPI-38 | Opiates 2000 | 2000 | Positive | Codeine | 1952 |
| OPI-39 | Opiates 2000 | 2000 | Positive | Morphine | 1852 |
| THC-40 | THC | 50 | Positive | Delta-9-THC-COOH | 45 |
| THC-42 | THC | 50 | Negative | Delta-9-THC-COOH | 55 |
| PCP-43 | Phencyclidine | 25 | Negative | Phencyclidine | 26 |
| PPX-38 | Propyphene | 300 | Positive | Propoxyphene | 275 |
| TCA-40 | Tricyclic Antidepressant | 1000 | Positive | Nortriptyline | 836 |
| TCA-43 | Tricyclic Antidepressant | 1000 | Negative | Amitriptyline | 1215 |
b. Lay user study:
A lay user study was conducted in three locations with 115 lay persons. Fifty-eight females and fifty-seven males from ages of 18 to 77 years of age, with a range of educational backgrounds participated in the study. None of the participants had experience with a drug testing product.
Quality control samples for test cups were prepared to contain the following
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levels: cutoff concentration; -50% below the cutoff; -25% below the cutoff; +25% above the cutoff; +50% above the cutoff and +300% above the cutoff for each drug. The drugs used for spiking included D-Amphetamine for amphetamine, secobarbital and cyclopentobarbital for barbiturates, oxazepam and estazolam for benzodiazepines, buprenorphine for buprenorphine, benzylecgonine for cocaine, methadone for methadone, D-methamphetamine for methamphetamine, MDMA for MDMA, morphine for morphine, morphine, heroin and codeine for opiates 2000, oxycodone for oxycodone, Delta-9-THC-COOH for marijuana, PCP for PCP, propoxyphene for propoxyphene, and nortriptyline and amitriptyline for tricyclic antidepressants. All samples (except TCA samples) were verified by GC/MS. TCA samples were verified by HPLC. There were 456 observations. The results are summarized below:
| Drug | Results | Drug Concentration | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | Negative | -50% | -25% | +25% | +50% | +300% |
| AMP | Positive | 0 | 0 | 2 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 2 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 88.9% | 88.9% | 100% | 100% |
| BAR | Positive | 0 | 0 | 3 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 15 | 2 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 83.3% | 88.9% | 100% | 100% |
| BZO | Positive | 0 | 0 | 3 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 15 | 2 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 83.3% | 88.9% | 100% | 100% |
| BUP | Positive | 0 | 0 | 2 | 17 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 1 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 88.9% | 94.4% | 100% | 100% |
| COC | Positive | 0 | 0 | 1 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 17 | 2 | 0 | 0 |
| | Total | 140 | 17 | 18 | 18 | 18 | 17 |
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| | Agreement with GC/MS | 100% | 100% | 94.4% | 88.9% | 100% | 100% |
| --- | --- | --- | --- | --- | --- | --- | --- |
| MTD | Positive | 0 | 0 | 3 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 15 | 2 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 83.3% | 88.9% | 100% | 100% |
| MET | Positive | 0 | 0 | 1 | 17 | 18 | 17 |
| | Negative | 140 | 17 | 17 | 1 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 83.3% | 88.9% | 100% | 100% |
| MDMA | Positive | 0 | 0 | 2 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 2 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 88.9% | 88.9% | 100% | 100% |
| MOP | Positive | 0 | 0 | 1 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 17 | 2 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 94.4% | 88.9% | 100% | 100% |
| OXY | Positive | 0 | 0 | 2 | 17 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 1 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 88.9% | 94.4% | 100% | 100% |
| OPI | Positive | 0 | 0 | 2 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 2 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 88.9% | 88.9% | 100% | 100% |
| PCP | Positive | 0 | 0 | 1 | 17 | 18 | 17 |
| | Negative | 140 | 17 | 17 | 1 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 94.4% | 94.4% | 100% | 100% |
| PPX | Positive | 0 | 0 | 2 | 16 | 18 | 17 |
| | Negative | 140 | 17 | 16 | 2 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 88.9% | 88.9% | 100% | 100% |
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| TCA | Positive | 0 | 0 | 1 | 16 | 18 | 17 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | Negative | 140 | 17 | 17 | 2 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 94.4% | 88.9% | 100% | 100% |
| THC | Positive | 0 | 0 | 3 | 17 | 18 | 17 |
| | Negative | 140 | 17 | 15 | 1 | 0 | 0 |
| | Total Agreement with GC/MS | 140 | 17 | 18 | 18 | 18 | 17 |
| | | 100% | 100% | 83.3% | 94.4% | 100% | 100% |
A Flesh-Kincaid reading analysis was performed on package inserts and the score revealed a reading grade level of 7.
Each participant was given a pre and post-study questionnaire. The pre-study questionnaire collected personal information about each participant. The post-study questionnaire was used to determine if the lay users understood the test instruction and the meaning of the results. Consumers were asked questions about the test, control line, prescription drug and food interference and confirmation of results. The results from the post-questionnaire were acceptable as nearly all of the participants answered the questions correctly (99.1%).
b. Matrix comparison:
Not applicable. The assay is intended for urine samples.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.
4. Clinical cut-off
Not applicable.
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5. Expected values/Reference range:
Not applicable.
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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