ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD
Device Facts
| Record ID | K131110 |
|---|---|
| Device Name | ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD |
| Applicant | Co-Innovation Biotech Co., Ltd. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Jan 15, 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 |
|---|---|---|---|---|---|
| K131110 · Jan 15, 2014 | ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD | Co-Innovation Biotech Co., Ltd. | Clinical urine specimens | Clinical urine specimens were analyzed by GC/MS and the subject devices to establish accuracy, sensitivity, and specificity of the drug test systems. | Clinical accuracy study; Urine specimens; GC/MS comparison |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Clinical Accuracy Study; Retrospective comparison of device results against GC/MS analysis of clinical urine specimens. | Clinical urine specimens; Sample Size: 165-186 specimens per drug for single-drug tests; 80 specimens per drug for multi-drug tests | GC/MS analysis | Accuracy, sensitivity, and specificity relative to GC/MS |
Indications for Use
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations: Marijuana (THC) 50 ng/mL, Cocaine (COC) 300 ng/mL, Amphetamine (AMP) 1000 ng/mL, Methamphetamine (MET) 1000 ng/mL, Morphine 2000 (MOP) 2000 ng/mL. The tests contain two formats: 1) Test Cup, 2) Test Dipcard. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use. These tests provide only a preliminary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipcard Insert, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Device Story
Lateral flow chromatographic immunoassay; detects drugs of abuse in human urine. Input: urine sample; capillary action draws sample across membrane pre-coated with drug-protein conjugates. Principle: competitive binding; drug in sample competes with drug-protein conjugate for limited antibody-dye conjugate binding sites. Output: visual colored bands in test (T) and control (C) regions. Negative result: colored band in T region (no drug or below cutoff); positive result: no band in T region (drug at or above cutoff). Used in clinical settings; operated by healthcare professionals. Provides preliminary results; requires GC/MS confirmation for clinical decision-making.
Clinical Evidence
Bench testing only. Precision/reproducibility studies conducted at 3 hospitals (N=60 per lot) using spiked urine samples confirmed by GC/MS. Method comparison studies performed on 165-186 clinical samples per drug format compared against GC/MS reference method. Analytical specificity evaluated via cross-reactivity testing with structurally similar compounds and interference testing with endogenous/exogenous substances. No clinical studies performed.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Formats: Test Cup and Test Dipcard. Storage: 4-30°C. Qualitative visual readout. No electronic components or software.
Indications for Use
Indicated for qualitative detection of drugs and drug metabolites (Amphetamine, Cocaine, Marijuana, Methamphetamine, Morphine) in human urine at specified cut-off levels. Intended for prescription use in clinical laboratories only. Not for point-of-care use.
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 Cards (k091588)
- UCP Home™ Drug Screening Test Cup (k091588)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k131110
B. Purpose for Submission:
New devices
C. Measurand:
Amphetamine, Methamphetamine, Cocaine, Cannabinoid, Morphine
D. Type of Test:
Qualitative lateral flow chromatographic competitive binding immunoassay
E. Applicant:
Co-Innovation Biotech Co., Ltd.
F. Proprietary and Established Names:
One-Step Single/Multi-drug Test Cup
One-Step Single/Multi-drug Test Dipcard
G. Regulatory Information:
1. Regulation section:
| Regulation | Name | Classification | Product Code | Panel |
| --- | --- | --- | --- | --- |
| 21 § 862.3100 | Amphetamine test system | II | DKZ | Toxicology (91) |
| 21 § 862.3610 | Methamphetamine test system | II | DJC | Toxicology (91) |
| 21 § 862.3640 | Morphine test system | II | DKN | Toxicology (91) |
| 21 § 862.3870 | Cannabinoid test system | II | LDJ | Toxicology (91) |
| 21 § 862.3250 | Cocaine and cocaine metabolite test system | II | DIO | Toxicology (91) |
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H. Intended Use:
1. Intended use(s):
See Indications for use below.
2. Indication(s) for use:
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations:
| Test | Calibrator | Cut-off level |
| --- | --- | --- |
| Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Amphetamine (AMP) | D-Amphetamine | 1000 ng/mL |
| Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL |
| Morphine 2000 (MOP) | Morphine | 2000 ng/mL |
The tests contain two formats: 1) Test Cup, 2) Test Dipcard. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. They are intended for prescription use.
These tests provide only a preliminary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipcard Insert, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
3. Special conditions for use statement(s):
These assays are intended for prescription use only.
4. Special instrument requirements:
Not applicable; these are visually read, single use devices.
I. Device Description:
The One Step Single/Multi-drug devices have 2 formats—a dipcard and a test cup.
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The formats can accommodate a single drug test or a combination of the five drugs of abuse in k131110. The One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Amphetamine, Cocaines, Marijuana, Methamphetamine, Morphine and their metabolites at specific cutoffs (see Indications for Use). The devices are individually packaged in pouches which are opened as needed by the user.
## J. Substantial Equivalence Information:
1. Predicate device name(s):
UCP Home™ Drug Screening Test Cards
UCP Home™ Drug Screening Test Cup
2. Predicate K number(s):
k091588
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device (k131110) | Predicate (k091588) |
| Indication for use | Qualitative detection of drugs-of-abuse in urine | Same |
| Specimen | Urine | Same |
| Cutoff | Cocaine: 300 ng/mL
Methamphetamine: 1000 ng/mL
Amphetamine: 1000 ng/mL
Marijuana: 50 ng/mL | Same |
| Read time | 5 minutes | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay based on the principle of antigen antibody immunochemistry | Same |
| Configuration | Dipcard and Cup | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Users | Prescription Use | Over the Counter |
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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | | (OTC)
Use and Prescription
Use |
| Storage | 4 - 30 °C | 2 - 30 °C |
| Morphine cutoff | 2000 ng/mL | 300 ng/mL |
## K. Standard/Guidance Document Referenced (if applicable):
None listed.
## L. Test Principle:
The One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are competitive immunoassays that are used to screen for the presence of Amphetamine, Cocaine, Methamphetamine, Morphine and Marijuana in urine using monoclonal antibodies. It is a chromatographic absorbent device in which Amphetamine, Cocaine, Methamphetamine, Morphine and/or Marijuana competitively combine to a limited number of antibody-dye conjugate binding sites.
When the absorbent end of the test device is immersed into the urine sample, the urine is absorbed into the device by capillary action. The urine mixes with the antibody-dye conjugate, and flows across the pre-coated membrane, in which Amphetamine, Cocaine, Methamphetamine, Morphine and/or Marijuana antigen is coated respectively. When the drug levels are at or above the cutoffs, the drugs in the sample bind to the antibody-dye conjugate preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Regions (T) of the device. This prevents the development of a distinct colored band in the test region (T), indicating a positive result for each drug.
When the drug levels are zero or below the cutoffs, antibody-dye conjugate binds to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored band in the test region (T) which indicates a negative result. To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Precision studies were performed at 3 hospitals, by two individuals per site. Samples were analyzed in 3 runs per day over 10 non-consecutive days using 3 lots each of Dipcard and Test Cup (N=60 per lot). Drug free urine samples were spiked for each assay at ±75% cutoff, ±50% cutoff, ±25%
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cutoff ,cutoff and high positive. All urine concentrations were confirmed by GC/MS. A negative sample was also included in each precision study. Results are summarized below for each lot and device.
Single test Dipcard:
| Drug test | Approximate concentration of sample (ng/mL) | Number of determinations per lot | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| AMP (cutoff 1000 ng/mL) | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 250 | 60 | 60/0 | 60/0 | 60/0 |
| | 500 | 60 | 60/0 | 60/0 | 60/0 |
| | 750 | 60 | 50/10 | 52/8 | 48/12 |
| | 1000 | 60 | 26/34 | 28/32 | 28/32 |
| | 1250 | 60 | 12/48 | 6/54 | 10/50 |
| | 1500 | 60 | 4/56 | 4/56 | 6/54 |
| | 1750 | 60 | 0/60 | 0/60 | 0/60 |
| | 2000 | 60 | 0/60 | 0/60 | 0/60 |
| COC (cutoff 300 ng/mL) | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 75 | 60 | 60/0 | 60/0 | 60/0 |
| | 150 | 60 | 60/0 | 60/0 | 60/0 |
| | 225 | 60 | 56/4 | 58/2 | 54/6 |
| | 300 | 60 | 24/36 | 22/38 | 24/36 |
| | 375 | 60 | 6/54 | 4/56 | 8/52 |
| | 450 | 60 | 0/60 | 2/58 | 2/58 |
| | 525 | 60 | 0/60 | 0/60 | 0/60 |
| | 600 | 60 | 0/60 | 0/60 | 0/60 |
| THC (cutoff 50 ng/mL) | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 12.5 | 60 | 60/0 | 60/0 | 60/0 |
| | 25.0 | 60 | 60/0 | 60/0 | 60/0 |
| | 37.5 | 60 | 56/4 | 52/8 | 58/2 |
| | 50.0 | 60 | 24/36 | 22/38 | 26/34 |
| | 62.5 | 60 | 12/48 | 6/54 | 10/50 |
| | 75.0 | 60 | 2/58 | 0/60 | 2/58 |
| | 87.5 | 60 | 0/60 | 0/60 | 0/60 |
| | 100.0 | 60 | 0/60 | 0/60 | 0/60 |
| MET (cutoff 1000 ng/mL) | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 250 | 60 | 60/0 | 60/0 | 60/0 |
| | 500 | 60 | 60/0 | 60/0 | 60/0 |
| | 750 | 60 | 58/2 | 54/6 | 58/2 |
| | 1000 | 60 | 28/32 | 26/34 | 24/36 |
| | 1250 | 60 | 6/54 | 8/52 | 6/54 |
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Multi-drug Test Dipcard:
| Drug test | Approximate concentration of sample (ng/mL) | Number of determinations per lot | Result (Negative/Positive) |
| --- | --- | --- | --- |
| Lot 1 | Lot 2 | Lot 3 |
| 0 | 60/0 | 60/0 | 60/0 |
| AMP | 0 | 60 | 60/0 | 60/0 | 60/0 |
| 250 | 60 | 60/0 | 60/0 | 60/0 |
| 500 | 60 | 60/0 | 60/0 | 60/0 |
| 1000 | 60 | 60/0 | 56/4 | 60/0 |
| 1500 | 60 | 52/8 | 50/10 | 56/4 |
| 2000 | 60 | 20/40 | 16/44 | 16/44 |
| 2500 | 60 | 4/56 | 2/58 | 8/52 |
| 3000 | 60 | 0/60 | 0/60 | 0/60 |
| 3500 | 60 | 0/60 | 0/60 | 0/60 |
| 4000 | 60 | 0/60 | 0/60 | 0/60 |
| Drug test | Approximate concentration of sample (ng/mL) | Number of determinations per lot | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| AMP | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 250 | 60 | 60/0 | 60/0 | 60/0 |
| | 500 | 60 | 60/0 | 60/0 | 60/0 |
| | 750 | 60 | 54/6 | 50/10 | 52/8 |
| | 1000 | 60 | 26/34 | 28/32 | 26/34 |
| | 1250 | 60 | 4/56 | 8/52 | 6/54 |
| | 1500 | 60 | 2/58 | 4/56 | 4/56 |
| | 1750 | 60 | 0/60 | 0/60 | 0/60 |
| | 2000 | 60 | 0/60 | 0/60 | 0/60 |
| COC | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 75 | 60 | 60/0 | 60/0 | 60/0 |
| | 150 | 60 | 60/0 | 60/0 | 60/0 |
| | 225 | 60 | 58/2 | 56/4 | 56/4 |
| | 300 | 60 | 22/38 | 24/36 | 24/36 |
| | 375 | 60 | 4/56 | 2/58 | 6/54 |
| | 450 | 60 | 0/60 | 2/58 | 2/58 |
| | 525 | 60 | 0/60 | 0/60 | 0/60 |
| | 600 | 60 | 0/60 | 0/60 | 0/60 |
| THC | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 12.5 | 60 | 60/0 | 60/0 | 60/0 |
| | 25.0 | 60 | 60/0 | 60/0 | 60/0 |
| | 37.5 | 60 | 52/8 | 54/6 | 54/6 |
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Single Test Cup
| Drug test | Approximate concentration of sample (ng/mL) | Number of determinations per lot | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| AMP | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 250 | 60 | 60/0 | 60/0 | 60/0 |
| | 500 | 60 | 60/0 | 60/0 | 60/0 |
| | 750 | 60 | 56/4 | 58/2 | 56/4 |
| | 1000 | 60 | 24/36 | 22/38 | 26/34 |
| | 1250 | 60 | 4/56 | 2/58 | 4/56 |
| | 1500 | 60 | 2/58 | 0/60 | 2/58 |
| | 1750 | 60 | 0/60 | 0/60 | 0/60 |
| | 2000 | 60 | 0/60 | 0/60 | 0/60 |
| MOP | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 500 | 60 | 60/0 | 60/0 | 60/0 |
| | 1000 | 60 | 60/0 | 60/0 | 58/2 |
| | 1500 | 60 | 54/6 | 56/4 | 52/8 |
| | 2000 | 60 | 18/42 | 14/46 | 16/44 |
| | 2500 | 60 | 2/58 | 2/58 | 4/56 |
| | 3000 | 60 | 0/60 | 0/60 | 0/60 |
| | 3500 | 60 | 0/60 | 0/60 | 0/60 |
| | 4000 | 60 | 0/60 | 0/60 | 0/60 |
| 50.0 | 60 | 24/36 | 24/36 | 26/34 |
| --- | --- | --- | --- | --- |
| 62.5 | 60 | 10/50 | 6/54 | 8/52 |
| 75.0 | 60 | 2/58 | 0/60 | 0/60 |
| 87.5 | 60 | 0/60 | 0/60 | 0/60 |
| 100.0 | 60 | 0/60 | 0/60 | 0/60 |
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| | 75 | 60 | 60/0 | 60/0 | 60/0 |
| --- | --- | --- | --- | --- | --- |
| | 150 | 60 | 60/0 | 60/0 | 60/0 |
| | 225 | 60 | 56/4 | 56/4 | 58/2 |
| | 300 | 60 | 22/38 | 24/36 | 24/36 |
| | 375 | 60 | 4/56 | 4/56 | 6/54 |
| | 450 | 60 | 0/60 | 0/60 | 2/58 |
| | 525 | 60 | 0/60 | 0/60 | 0/60 |
| | 600 | 60 | 0/60 | 0/60 | 0/60 |
| THC | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 12.5 | 60 | 60/0 | 60/0 | 60/0 |
| | 25.0 | 60 | 60/0 | 60/0 | 60/0 |
| | 37.5 | 60 | 54/6 | 58/2 | 56/4 |
| | 50.0 | 60 | 28/32 | 22/38 | 24/36 |
| | 62.5 | 60 | 10/50 | 6/54 | 10/50 |
| | 75.0 | 60 | 0/60 | 4/56 | 4/56 |
| | 87.5 | 60 | 0/60 | 0/60 | 0/60 |
| | 100.0 | 60 | 0/60 | 0/60 | 0/60 |
| MET | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 250 | 60 | 60/0 | 60/0 | 60/0 |
| | 500 | 60 | 60/0 | 60/0 | 60/0 |
| | 750 | 60 | 56/4 | 56/4 | 58/2 |
| | 1000 | 60 | 24/36 | 26/34 | 22/38 |
| | 1250 | 60 | 6/54 | 10/50 | 8/52 |
| | 1500 | 60 | 0/60 | 2/58 | 0/60 |
| | 1750 | 60 | 0/60 | 0/60 | 0/60 |
| | 2000 | 60 | 0/60 | 0/60 | 0/60 |
| MOP | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 500 | 60 | 60/0 | 60/0 | 60/0 |
| | 1000 | 60 | 60/0 | 60/0 | 58/2 |
| | 1500 | 60 | 54/6 | 52/8 | 50/10 |
| | 2000 | 60 | 18/42 | 20/40 | 16/44 |
| | 2500 | 60 | 2/58 | 4/56 | 6/54 |
| | 3000 | 60 | 0/60 | 0/60 | 0/60 |
| | 3500 | 60 | 0/60 | 0/60 | 0/60 |
| | 4000 | 60 | 0/60 | 0/60 | 0/60 |
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Multi-test Cup
| Drug test | Approximate concentration of sample (ng/mL) | Number of determinations per lot | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| AMP | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 250 | 60 | 60/0 | 60/0 | 60/0 |
| | 500 | 60 | 60/0 | 60/0 | 60/0 |
| | 750 | 60 | 52/8 | 54/6 | 54/6 |
| | 1000 | 60 | 26/34 | 24/36 | 28/32 |
| | 1250 | 60 | 6/54 | 8/52 | 6/54 |
| | 1500 | 60 | 4/56 | 2/58 | 2/58 |
| | 1750 | 60 | 0/60 | 0/60 | 0/60 |
| | 2000 | 60 | 0/60 | 0/60 | 0/60 |
| COC | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 75 | 60 | 60/0 | 60/0 | 60/0 |
| | 150 | 60 | 60/0 | 60/0 | 60/0 |
| | 225 | 60 | 56/4 | 54/6 | 58/2 |
| | 300 | 60 | 22/38 | 24/36 | 22/38 |
| | 375 | 60 | 6/54 | 8/52 | 4/56 |
| | 450 | 60 | 0/60 | 2/58 | 0/60 |
| | 525 | 60 | 0/60 | 0/60 | 0/60 |
| | 600 | 60 | 0/60 | 0/60 | 0/60 |
| THC | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 12.5 | 60 | 60/0 | 60/0 | 60/0 |
| | 25.0 | 60 | 60/0 | 60/0 | 60/0 |
| | 37.5 | 60 | 58/2 | 54/6 | 56/4 |
| | 50.0 | 60 | 22/38 | 28/32 | 26/34 |
| | 62.5 | 60 | 6/54 | 10/50 | 6/54 |
| | 75.0 | 60 | 0/60 | 4/56 | 2/58 |
| | 87.5 | 60 | 0/60 | 0/60 | 0/60 |
| | 100.0 | 60 | 0/60 | 0/60 | 0/60 |
| MET | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 250 | 60 | 60/0 | 60/0 | 60/0 |
| | 500 | 60 | 60/0 | 60/0 | 60/0 |
| | 750 | 60 | 54/6 | 56/4 | 54/6 |
| | 1000 | 60 | 26/34 | 24/36 | 24/36 |
| | 1250 | 60 | 8/52 | 6/54 | 6/54 |
| | 1500 | 60 | 2/58 | 0/60 | 0/60 |
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| | 1750 | 60 | 0/60 | 0/60 | 0/60 |
| --- | --- | --- | --- | --- | --- |
| | 2000 | 60 | 0/60 | 0/60 | 0/60 |
| MOP | 0 | 60 | 60/0 | 60/0 | 60/0 |
| | 500 | 60 | 60/0 | 60/0 | 60/0 |
| | 1000 | 60 | 58/2 | 60/0 | 60/0 |
| | 1500 | 60 | 50/10 | 54/6 | 52/8 |
| | 2000 | 60 | 16/44 | 14/46 | 14/46 |
| | 2500 | 60 | 6/54 | 2/58 | 4/56 |
| | 3000 | 60 | 0/60 | 0/60 | 0/60 |
| | 3500 | 60 | 0/60 | 0/60 | 0/60 |
| | 4000 | 60 | 0/60 | 0/60 | 0/60 |
b. Linearity/assay reportable range:
Not applicable. The tests are for qualitative use.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Control Materials
External control materials are not supplied with this device; however, this device has internal process controls. A colored line appearing in the control region reflects that sufficient sample volume was applied and that adequate membrane wicking occurred. Users are informed that the test is invalid if a line fails to appear in the control region. The sponsor states in the labeling when external QC materials should be tested.
Accelerated and real time studies have been conducted. Protocols and acceptance criteria were described and found to be acceptable for both devices. The manufacturer claims the following expiration date: closed pouch stability is for 2 years after manufacturing when stored at 4 -30° °C. Open pouch stability is 1.5 hours.
d. Detection limit:
Not applicable. The device is intended for qualitative use.
e. Analytical specificity:
Cross reactivity with structurally similar compounds was tested for each device. Each compound was spiked into drug-free urine to 100 mcg/mL. Each sample was tested in 5 replicates. If any positive result was observed, the compounds were further sequentially diluted to different concentrations and tested in quintuplicate to determine the lowest interference concentration that produces a positive result. 2 lots of dipcard and one lot of test cups were used for the study.
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Results were:
## Amphetamine
| Compound | Quantity equivalent to cutoff (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| d-Amphetamine | 1000 | 100% |
| l-Amphetamine | 50000 | 2% |
| d,l-Amphetamine | 2500 | 40% |
| 3,4-methylenedioxyamphetamine (MDA) | 2000 | 50% |
The compounds (d-methamphetamine, l-methamphetamine, 3,4-Methylenedioxymethamphetamine(MDMA), Methylenedioxyethylamphetamine(MDEA) showed no cross-reactivity in the assay at a concentration of 100 mcg/mL.
## Cocaine
| Compound | Quantity equivalent to cutoff(ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Benzoylecgonine | 300 | 100% |
| Cocaine | 800 | 37.5% |
| Cocaethylene | 12500 | 2.4% |
| Ecgonine HCl | 35000 | 0.9% |
## Methamphetamine
| Compound | Quantity equivalent to cutoff(ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| d-Methamphetamine | 1000 | 100% |
| l-Methamphetamine | 8000 | 12.5% |
| p-hydroxymethamphetamine | 30000 | 3.3% |
| 3,4-methylenedioxymethamphetamine (MDMA) | 2000 | 50% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 50000 | 2% |
## Morphine
| Compound | Quantity equivalent to cutoff(ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Morphine | 2000 | 100% |
| Codeine | 2000 | 100% |
| Hydrocodone | 15000 | 13.3% |
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The compounds oxycodone and oxymorphone showed no cross-reactivity in the assay at a concentration of $100\mathrm{mcg / mL}$ .
THC
| Compound | Quantity equivalent to cutoff(ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| 11-nor-Δ9-THC-9-COOH | 10.5 | 100% |
| 11-nor-Δ8-THC-9-COOH | 50 | 100% |
| Δ9-THC | 15000 | 0.3% |
| Δ8-THC | 10000 | 0.5% |
| Cannabidiol | 20000 | 0.3% |
| Cannabinol | >100000 | Not detected |
Each device was evaluated for interference from pH. Drug-free urine was adjusted to $\pm 50\%$ cutoffs which were confirmed by GCMS or LCMS. 2 lots of dipcards, one lot of test cup tested were used for the study. pH was tested at 3, 4, 5, 6, 7, 8, 9. No interference was observed from pH for Amphetamine, Morphine, Methamphetamine, Cocaine or THC.
Each device was evaluated for interference from specific gravity. Drug-free urine was adjusted to $\pm 50\%$ cutoffs which were confirmed by GCMS or LCMS.. 2 lots of dipcards, one lot of test cup tested were used for the study. SG was tested at 1.003, 1.010, 1.020, 1.030, 1.040 No interference was observed from specific gravity for Amphetamine, Morphine, Methamphetamine, Cocaine or THC.
Interference from structurally unrelated, or endogenous compounds was evaluated by spiking $100\mathrm{mcg / mL}$ into urine containing amphetamine, cocaine, methamphetamine, morphine, or THC at $\pm 50\%$ of cutoff, confirmed by GCMS or LCMS. Two lots of dipcards and one lot of test cups were used in the studies. The following compounds showed no interference in the presence of Amphetamine, Morphine, Methamphetamine, Cocaine or THC.
| Acetaminophen | β-Estradiol | Norethindrone |
| --- | --- | --- |
| Acetophenetidin | Estrone-3-sulfate | Noscapine |
| Amoxicillin | Ethyl-p-aminobenzoate | d, l-Octopamine |
| Ampicillin | Erythromycin | Oxalic acid |
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| Aspirin | Fenoprofen | Oxolinic acid |
| --- | --- | --- |
| Atenolol | Flucloxacillin | Oxymetazoline |
| Atorvastatin | Fluoxetine | Oxytetracycline |
| Azlocillin | Furosemide | Papaverine |
| Benzilic acid | Gentisic acid | Penicillin-G |
| Benzylpencillin | Hemoglobin | Pentazocine |
| Benzoic acid | Hydralazine | Perphenazine |
| Bilirubin | Hydrochlorothiazide | Phenelzine |
| Benzydamine | Hyrocortisone | Prednosolone |
| Caffeine | o-Hydroxyhippuric acid | Prednisone |
| Carbamazepine | p-Hydroxytyramine | d, l-Propanolol |
| Cephalexin | Ibuprofen | d, l-Pseudoephedrine |
| Chloralhydrate | Indomehtacin | Quinacrine |
| Chloramphenicol | Iproniazid | Quinine |
| Chlorthiazide | d, l-Isoproterenol | Quinidine |
| Chlorpheniramine | Isoxsuprine | Ranitidine |
| d, l-Chlorpromazine | Ketamine | Salicylic acid |
| Cholesterol | Ketoprofen | Serotinin |
| Clonidine | Labetalol | Sulfamethazine |
| Cimetidine | Lisinopril | Sulindac |
| Citalopram | Loperamide | Tetracycline |
| Cortisone | Meperidine | Tetrahydrozoline |
| Creatinine | Meprobamate | Thiamine |
| Deoxycorticosterone | Methoxyphenamine | Thioridazine |
| Dexamethasone | Methylphenidate | d, l-Thyroxine |
| Dextromethorphan | Nadolol | Tolbutamine |
| Diclofenac | Nalidixic acid | Tolbutamide |
| Diflunisal | Naproxin | Trifluoperaxine |
| Digoxin | Nicinamide | Tryptamine |
| Diphenhydramine | Nicotine | Uric acid |
| Ephedrine | Nifedipine | Verapamil |
| | | Zomepirac |
f. Assay cut-off:
The cut-off characterization study results can be found in the precision section of this summary.
2. Comparison studies:
a. Method comparison with predicate device:
For all tests formats the sponsor conducted studies on one lot of dipcards and test cups each of 2 hospital labs. One hospital used 1 lot of dipcards, the other lab used 1 lot of test cups. Testing was performed on both devices using
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between 165-186 unaltered clinical samples. All samples were compared to GCMS. Sample identification was masked to the users.
Single Test Dipcards:
| Drug Test | Co-Innovation Result | Drug free by GC/MS analysis | Less than half the cutoff | Near Cutoff Negative (Between 50% below the cutoff and the cutoff) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff) | High Positive (greater than 50% above the cutoff) | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| AMP | + | 0 | 0 | 1 | 10 | 29 | 176 |
| | - | 117 | 7 | 11 | 1 | 0 | |
| COC | + | 0 | 0 | 1 | 9 | 31 | 186 |
| | - | 133 | 0 | 12 | 0 | 0 | |
| THC | + | 0 | 0 | 1 | 12 | 31 | 165 |
| | - | 107 | 4 | 9 | 1 | 0 | |
| MET | + | 0 | 0 | 1 | 17 | 44 | 165 |
| | - | 85 | 4 | 13 | 1 | 0 | |
| MOP | + | 0 | 0 | 2 | 19 | 57 | 165 |
| | - | 67 | 5 | 15 | 0 | 0 | |
Analysis of Discordant Results:
| One Step Single drug Test Dipcard | | | GC/MS Analysis | |
| --- | --- | --- | --- | --- |
| Drug Test | Cutoff (ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| AMP | 1000 | Positive | 867 | Amphetamine |
| AMP | 1000 | Negative | 1175 | Amphetamine |
| COC | 300 | Positive | 172 | Benzoylecgonine |
| MET | 1000 | Positive | 904 | Methamphetamine |
| MET | 1000 | Negative | 1248 | Methamphetamine |
| MOP | 2000 | Positive | 1608 | Morphine |
| MOP | 2000 | Positive | 1875 | Morphine |
| THC | 50 | Positive | 40 | 11-nor-Δ9--THC-9-COOH |
| THC | 50 | Negative | 59 | 11-nor-Δ9--THC-9-COOH |
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Single Test Cup:
| Drug Test | Co-Innovation Result | Drug free by GC/MS analysis | Less than half the cutoff concentration | Near Cutoff Negative (Between 50% below the cutoff and the cutoff) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff ) | High Positive (greater than 50% above the cutoff) | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| AMP | + | 0 | 0 | 1 | 10 | 29 | 176 |
| | - | 117 | 7 | 11 | 1 | 0 | |
| COC | + | 0 | 0 | 1 | 9 | 31 | 186 |
| | - | 133 | 0 | 12 | 0 | 0 | |
| THC | + | 0 | 0 | 1 | 12 | 31 | 165 |
| | - | 107 | 4 | 9 | 1 | 0 | |
| MET | + | 0 | 0 | 1 | 17 | 44 | 165 |
| | - | 85 | 4 | 13 | 1 | 0 | |
| MOP | + | 0 | 0 | 2 | 19 | 57 | 165 |
| | - | 67 | 5 | 15 | 0 | 0 | |
Analysis of Discordant Results:
| One Step Single drug Test Cup | | | GC/MS Analysis | |
| --- | --- | --- | --- | --- |
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration | Drug in Urine |
| AMP | 1000 | Positive | 867 | Amphetamine |
| AMP | 1000 | Negative | 1175 | Amphetamine |
| COC | 300 | Positive | 172 | Benzoylecgonine |
| MET | 1000 | Positive | 904 | Methamphetamine |
| MET | 1000 | Negative | 1248 | Methamphetamine |
| MOP | 2000 | Positive | 1608 | Morphine |
| MOP | 2000 | Positive | 1875 | Morphine |
| THC | 50 | Positive | 40 | 11-nor-Δ9--THC-9-COOH |
| THC | 50 | Negative | 59 | 11-nor-Δ9--THC-9-COOH |
80 clinical urine specimens for each drug were analyzed by GC/MS and by one lot of the corresponding One Step Multi-drug Test Dipcard and one lot of the One Step Multi-drug Test Cups.
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Multi-test Dipcards:
| Drug Test | Co-Innovation Result | Drug free by GC/MS analysis | Less than half the cutoff | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| AMP | + | 0 | 0 | 1 | 10 | 29 | 80 |
| | - | 25 | 3 | 11 | 1 | 0 | |
| COC | + | 0 | 0 | 1 | 9 | 31 | 80 |
| | - | 27 | 0 | 12 | 0 | 0 | |
| THC | + | 0 | 0 | 1 | 12 | 27 | 80 |
| | - | 26 | 4 | 9 | 1 | 0 | |
| MET | + | 0 | 0 | 1 | 12 | 27 | 80 |
| | - | 24 | 2 | 13 | 1 | 0 | |
| MOP | + | 0 | 0 | 2 | 11 | 29 | 80 |
| | - | 21 | 2 | 15 | 0 | 0 | |
Analysis of Discordant Results:
| One Step Multi-drug Test Dipcard | | | GC/MS Analysis | |
| --- | --- | --- | --- | --- |
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentratio | Drug in Urine |
| AMP | 1000 | Positive | 867 | Amphetamine |
| AMP | 1000 | Negative | 1175 | Amphetamine |
| COC | 300 | Positive | 172 | Benzoylecgonine |
| MET | 1000 | Negative | 1248 | Methamphetamine |
| MOP | 2000 | Positive | 1608 | Morphine |
| MOP | 2000 | Positive | 1875 | Morphine |
| THC | 50 | Positive | 40 | 11-nor-Δ9--THC-9- |
| THC | 50 | Negative | 59 | 11-nor-Δ9--THC-9- |
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Multi-drug Test Cups:
| Drug Test | Co-Innovation Result | Drug free by GC/MS analysis | Less than half the cutoff | Near Cutoff Negative (Between 50% below the cutoff and the cutoff) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff) | High Positive (greater than 50% above the cutoff) | Total |
| --- | --- | --- | --- | --- | --- | --- | --- |
| AMP | + | 0 | 0 | 1 | 10 | 29 | 80 |
| | - | 2 | 3 | 11 | 1 | 0 | |
| COC | + | 0 | 0 | 1 | 9 | 31 | 80 |
| | - | 2 | 0 | 12 | 0 | 0 | |
| THC | + | 0 | 0 | 1 | 12 | 27 | 80 |
| | - | 2 | 4 | 9 | 1 | 0 | |
| MET | + | 0 | 0 | 1 | 12 | 27 | 80 |
| | - | 2 | 2 | 13 | 1 | 0 | |
| MOP | + | 0 | 0 | 2 | 11 | 29 | 80 |
| | - | 2 | 2 | 15 | 0 | 0 | |
Analysis of Discordant Results:
| One Step Multi-drug Test Cup | | | GC/MS Analysis | |
| --- | --- | --- | --- | --- |
| Drug Test | Cutoff(ng/mL) | Test Result | Drug Concentration | Drug in Urine |
| AMP | 1000 | Positive | 867 | Amphetamine |
| AMP | 1000 | Negative | 1175 | Amphetamine |
| COC | 300 | Positive | 172 | Benzoylecgonine |
| MET | 1000 | Positive | 904 | Methamphetamine |
| MET | 1000 | Negative | 1248 | Methamphetamine |
| MOP | 2000 | Positive | 1608 | Morphine |
| MOP | 2000 | Positive | 1875 | Morphine |
| THC | 50 | Positive | 40 | 11-nor-Δ9--THC-9-COOH |
| THC | 50 | Negative | 59 | 11-nor-Δ9--THC-9-COOH |
b. Matrix comparison:
Not applicable. This test is for urine only.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
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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.
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.
