CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD
Device Facts
| Record ID | K111322 |
|---|---|
| Device Name | CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD |
| Applicant | Chemtron Biotech, Inc. |
| Product Code | JXM · Clinical Toxicology |
| Decision Date | Sep 14, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3170 |
| Device Class | Class 2 |
Indications for Use
The Chemtrue® test device is intended for the qualitative detection of drugs of abuse, for in vitro diagnostic use and for prescription use ONLY. The test provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
Device Story
Rapid lateral flow immunoassay for qualitative detection of drugs of abuse in human urine; utilizes competitive binding between rabbit monoclonal antibodies and drug-labeled conjugate; visual readout of test lines; absence of line indicates positive result; presence of line indicates negative result; internal process control confirms sample volume and wicking; intended for prescription use in clinical settings; provides preliminary results requiring confirmation by GC/MS or LC/MS; aids healthcare providers in identifying potential drug use; benefits include rapid screening for clinical decision-making.
Clinical Evidence
Clinical performance evaluated via method comparison study against GC/MS reference method. Samples with concentrations above cut-off were presumptive positive; below were negative. Results showed high agreement: BZO (98.5% overall), BAR (98.4% overall), MDMA (98% overall), MTD (99% overall), OPI/MOR (100% overall), and OXY (99.1% overall).
Technological Characteristics
One-step lateral flow competitive immunoassay. Components: plastic holder, test strips with drug-protein conjugate, anti-drug antibody-colloidal gold conjugate pads. Detection via visual color band formation. Storage: 2-30°C. No electronic components or software.
Indications for Use
Indicated for qualitative detection of up to six drugs (Benzodiazepines, Barbiturates, Ecstasy, Methadone, Opiates, Oxycodone) in human urine. For prescription use only; not for point-of-care or OTC use. Requires confirmatory testing via GC/MS or LC/MS.
Regulatory Classification
Identification
A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). A benzodiazepine 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
- ACON, One Step Drug Screen Test Card For Single and Multi Drug Screen Test Cards (k061718)
Related Devices
- K121339 — CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/CASSETTE TESTS · Chemtron Biotech, Inc. · May 17, 2012
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number:
k111322
B. Purpose for Submission:
New device
C. Measurand:
Benzodiazepines, Barbiturates, Ecstasy, Methadone, Opiates and Oxycodone
D. Type of Test:
Qualitative immunoassay
E. Applicant:
Chemtron Biotech, Inc.
F. Proprietary and Established Names:
Chemtrue Single/Multi-Panel Drug Screen Cassette and Dip Card Tests
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JXM | II | 862.3170 Benzodiazepine test system | 91, Toxicology |
| DIS | II | 862.3150 Barbiturate test system | 91, Toxicology |
| DJC | II | 862.6310 Methamphetamine test system | 91, Toxicology |
| DJR | II | 862.3620 Methadone test system | 91, Toxicology |
| DJG | II | 862.3650 Opiate test system | 91, Toxicology |
H. Intended Use:
1. Intended use(s):
See indication for use below
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2. Indication(s) for use:
The Chemtron Biotech, Inc.'s Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and the calibrators used for these drugs are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff |
| --- | --- | --- | --- |
| Benzodiazepines | BZO | Oxazepam | 300 ng/mL |
| Barbiturates | BAR | Secobarbital/ Pentobarbital | 300 ng/mL |
| Ecstasy | MDMA/ XTC | d,l-Methylenedioxyethamphetamine | 500 ng/mL |
| Methadone | MTD | Methadone | 300 ng/mL |
| Opiates | OPI/MOR | Morphine | 2000 ng/mL |
| Oxycodone | OXY | Oxycodone | 100 ng/mL |
The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for in vitro diagnostic and prescription use ONLY. They are not intended for point-of-care settings or over the counter use. These assays provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory methods.
Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
3. Special conditions for use statement(s):
In vitro diagnostic use, prescription use only
Not for point-of-care or over the counter use
4. Special instrument requirements:
Not applicable, as the devices are visually-read single-use devices.
I. Device Description:
The devices are for use in human urine. The Chemtrue Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are single-test test strips. The Chemtrue Single/Multi-Panel Drug Screen Cassette and Dip Card Tests contain test cassettes and package inserts (instructions for use).
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J. Substantial Equivalence Information:
1. Predicate device name(s):
ACON, One Step Drug Screen Test Card For Single and Multi Drug Screen Test Cards
2. Predicate K number(s):
k061718
3. Comparison with predicate:
| Item | Device | Predicate |
| --- | --- | --- |
| Intended use | Qualitative detection of drugs-of-abuse in urine for prescription and In Vitro Diagnostic Use ONLY | Same |
| Test Principle | One-Step lateral flow competitive immunoassay | Same |
| Specimen | Urine | Same |
| Cutoff | Benzodiazepines 300 ng/mL
Barbiturates 300 ng/mL
Ecstasy (MDMA) 500 mg/dL
Methadone 300 ng/ml
Opiates (Morphine) 2000 ng/mL
Oxycodone 100 ng/mL | Same |
| Read time | 5 minutes | Same |
| Storage | 2-30 °C (36-86 F) | Same |
| Time to read results | Do not read after 8 minutes | Results remain stable for up to 4 hours after test initiation |
K. Standard/Guidance Document Referenced (if applicable):
None were referenced
L. Test Principle:
Chemtron Biotech’s Chemtrue Single/Multi-Panel Drug Screen Cassette and Dip Card Tests employs lateral flow immunochromatographic technology.
Benzodiazepine, Barbiturates, Ecstasy, Methadone, Opiates and Oxycodone are detected in human urine by competitive binding between rabbit monoclonal
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antibodies to one of its respective drug and drug-labeled conjugate (containing a chromagen). Binding of the drug in the sample causes the absence of a line at the test area, i.e., a positive result. When drug is not present in the sample, the drug-labeled conjugate binds at the test line, resulting in formation of a line, i.e., a negative result. The absence or presence of the line is determined visually by the operator.
The device also has an internal process control (goat monoclonal anti-rabbit IgG) which indicates that an adequate volume of sample has been added and that the immunochromatographic strip is intact.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Dip Card
| Drug | Concentration Tested | Operator1/Lot One | Operator 2/Lot Two | Operator 3/Lot Three | Total |
| --- | --- | --- | --- | --- | --- |
| | | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| BZO | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 9/1 | 9/1 | 9/1 | 27/3 |
| | Cutoff | 6/4 | 4/6 | 6/4 | 16/14 |
| | +25% | 1/9 | 2/8 | 1/9 | 4/26 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
| BAR | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 9/1 | 9/1 | 9/1 | 27/3 |
| | Cutoff | 5/5 | 5/5 | 7/3 | 17/13 |
| | +25% | 2/8 | 2/8 | 1/9 | 5/25 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
| MDMA | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 10/0 | 9/1 | 10/0 | 29/1 |
| | Cutoff | 6/4 | 7/3 | 6/4 | 19/11 |
| | +25% | 1/9 | 0/10 | 1/9 | 2/28 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
| MTD | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 10/0 | 10/0 | 10/0 | 30/0 |
| | Cutoff | 7/3 | 4/6 | 2/8 | 13/17 |
| | +25% | 1/9 | 1/9 | 0/10 | 2/28 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
| OPI | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
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| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| --- | --- | --- | --- | --- | --- |
| | -25% | 10/0 | 10/0 | 10/0 | 30/0 |
| | Cutoff | 7/3 | 8/2 | 8/2 | 23/7 |
| | +25% | 2/8 | 0/10 | 1/9 | 3/27 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
| OXY | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 9/1 | 10/0 | 10/0 | 29/1 |
| | Cutoff | 4/6 | 7/3 | 5/5 | 16/14 |
| | +25% | 0/10 | 2/8 | 1/9 | 27/3 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
Cassette
| Drug | Concentration Tested | Operator1/Lot One | Operator 2/Lot Two | Operator 3/Lot Three | Total |
| --- | --- | --- | --- | --- | --- |
| | | Neg/Pos | Neg/Pos | Neg/Pos | Neg/Pos |
| BZO | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 9/1 | 9/1 | 9/1 | 27/3 |
| | Cutoff | 6/4 | 6/4 | 5/5 | 17/13 |
| | +25% | 2/8 | 2/8 | 1/9 | 5/25 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
| BAR | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 9/1 | 9/1 | 10/0 | 28/2 |
| | Cutoff | 5/5 | 5/5 | 6/4 | 16/14 |
| | +25% | 3/7 | 2/8 | 2/8 | 7/23 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
| MDMA | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 9/1 | 9/1 | 10/0 | 28/2 |
| | Cutoff | 5/5 | 5/5 | 6/4 | 16/14 |
| | +25% | 2/8 | 0/10 | 1/9 | 3/27 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
| MTD | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 10/0 | 8/2 | 10/0 | 28/2 |
| | Cutoff | 4/6 | 4/6 | 6/4 | 14/16 |
| | +25% | 0/10 | 1/9 | 0/10 | 1/29 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
| OPI | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 10/0 | 10/0 | 10/0 | 30/0 |
| | Cutoff | 3/7 | 7/3 | 6/4 | 16/14 |
| | +25% | 2/8 | 2/8 | 1/9 | 5/25 |
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| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
| --- | --- | --- | --- | --- | --- |
| OXY | Negative | 10/0 | 10/0 | 10/0 | 30/0 |
| | -50% | 10/0 | 10/0 | 10/0 | 30/0 |
| | -25% | 8/2 | 10/0 | 10/0 | 28/2 |
| | Cutoff | 5/5 | 3/7 | 4/6 | 12/18 |
| | +25% | 0/10 | 1/9 | 0/10 | 1/29 |
| | +50% | 0/10 | 0/10 | 0/10 | 0/30 |
b. Linearity/assay reportable range:
Not applicable, the device is intended for qualitative use
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
This device has internal process controls. A colored line appearing in the control region confirms sufficient sample volume and adequate membrane wicking. Users are informed that the test is invalid if a line fails to appear in the control region.
Control materials are not supplied with this device; however it is good laboratory practice to confirm the test procedure and to verify proper test performance. Users should follow all applicable guidelines for testing QC materials.
Stability:
Accelerated studies have been conducted. Protocols and acceptance criteria were described and found to be acceptable. The manufacturer claims the following expiration date:
When stored at 2–30 °C product is stable until expiration date which is 24 months.
Real time studies have been conducted and are on-going.
Read time stability was performed for Chemtrue Single/Multi-Panel Drug Screen Dip Card and Cassette. A drug-free urine was spiked with the appropriate drug at 50% cutoff, 150% cutoff, as well as a negative urine was used to perform the study. All samples were analyzed fifteen times at each concentration with three lots of test strips at 1-5 minute intervals from 1-20 minutes. Data supports the recommended read time of 5 minutes for each device.
d. Detection limit:
See Precision/Reproducibility section in M 1.a above.
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e. Analytical specificity:
Cross-reactivity was established by spiking structurally related compounds into drug-free urine and diluting each to obtain various concentrations. Results are expressed as a minimum concentration of metabolite or compound required to produce a response approximately equivalent to the cutoff concentration of the assay. Testing was performed on both devices (dip card and cassette). Both devices produced similar results. The percent cross-reactivity of those compounds are presented below:
Structurally related:
Benzodiazepines
| Substances | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Oxazepam | 300 | 100 |
| Alprazolam | 3000 | 100 |
| Alpha-Hydroxyalprazolam | 100 | 300 |
| Bromazepam | 500 | 60 |
| Chlordiazepoxide | 2,500 | 12 |
| Clobazam | 200 | 150 |
| Clonazepam | 10,000 | 3 |
| Clorazepate | 350 | 85.7 |
| Desalkylflurazepam | 65 | 462 |
| Diazepam | 200 | 150 |
| Estazolam | 500 | 60 |
| Flunitrazepam | 375 | 80 |
| Flurazepam | 90 | 333 |
| Lorazepam | 600 | 50 |
| Lormetazepam | 7,500 | 4 |
| Midazolam | 900 | 33.3 |
| Nitrazepam | 200 | 150 |
| Nordiazepam | 150 | 200 |
| Sertraline | | |
| Temazepam | 350 | 85.7 |
| Triazolam | 1,000 | 30 |
Barbiturates
| Substances | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Secobarbital | 300 | 100 |
| Pentobarbital | 300 | 100 |
| Alphenal | 500 | 60 |
| Amobarbital | 400 | 75 |
| Aprobarbital | 350 | 85.7 |
| Barbital | 5,000 | 6 |
| Butabarbital Butisol | 250 | 120 |
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| Butalbital | 3,000 | 10 |
| --- | --- | --- |
| Cyclopentobarbital | 750 | 40 |
| Phenobarbital | 250 | 120 |
Ecstasy (MDMA)
| Substances | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| D,1 (3,4)-Methylenedioxymethamphetamine (MDMA) | 500 | 100 |
| 3,4-Methylenedioxyamphetamine (MDA) | 15,000 | 3.3 |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 1,000 | 50 |
| d-Methamphetamine | 100,000 | 0.5 |
Methadone
| Substances | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Methadone | 300 | 100 |
| Doxylamine | 100,000 | 0.3 |
| EDDP | 100,000 | 0.3 |
| Pheniramine | 100,000 | 0.3 |
Opiates
| Substances | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Morphine | 2000 | 100 |
| Codeine | 2000 | 100 |
| 6-Acetylmorphine | 1500 | 133.3 |
| Diacetyl morphine (Heroin) | 2000 | 100 |
| Ethylmorphine | 1500 | 133.3 |
| Hydrocodone | 50,000 | 4 |
| Hydromorphone | 50,000 | 4 |
| Norcodeine | 100,000 | 2 |
| Normorphine | 100,000 | 2 |
| Oxycodone | 100,000 | 2 |
| Oxymorphone | 100,000 | 2 |
| Paracetamol | 100,000 | 2 |
| Thebaine | 100,000 | 2 |
Oxycodone
| Substances | Concentration (ng/mL) | % Cross-reactivity |
| --- | --- | --- |
| Oxycodone | 100 | 100 |
| Codeine | 100,000 | 0.1 |
| Hydrocodone | 100,000 | 0.1 |
| Oxymorphone | 100,000 | 0.1 |
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# Structurally un-related:
This study was performed by spiking structurally unrelated compounds and endogenous substances at a concentration of $100\mu \mathrm{g / mL}$ into urine samples containing drug at $+/-25\%$ of the respective drug cutoff concentrations. The substances at $100\mu \mathrm{g / mL}$ concentration were also tested at $+/-50\%$ respective drug cutoff concentrations, if a false result was observed at $+/-25\%$ cutoff levels. Testing was performed on both devices (dip card and cassette). The following compounds showed no interference when tested at the $+/-50\%$ drug concentration:
| Acetaminophen | 5,5-Diphenylhydantoin | Oxalic Acid |
| --- | --- | --- |
| Acetylsalicylic Acid | Dopamine | Papaverine |
| Albumin | (-)-ephedrine | Perphenazine |
| Amoxicillin | l-Erythromycin | Phenelzine |
| R-(-)-Apomorphine | Estradiol | L-Phenylephrine |
| L-Ascorbic Acid | Estrone | Phenylethylamine |
| Atropine | Ethanol | Phenylpropanolamine |
| Baclofen | Fenofibrate | Prednisone |
| Benzocaine | Fentanyl | Promazine |
| Benzoic Acid | Fotemustine | Promethazine |
| Bilirubin | Furosemide | D-Propoxyphene |
| Buprenorphine | Gemfibrozil | d,l Propranolol |
| Cannabidiol | Gentisic acid | d-Pseudoephedrine |
| Carisoprodol | Glucose | Pyridoxal-5-phosphate |
| Cholesterol | Guaiacol glyceryl ether | Pyridoxine |
| Chloral hydrate | Hemoglobin | Pyrilamine |
| Chloramphenicol | Hydralazine | Pyrogallol |
| Chlordiazepoxide | Hydrocortisone | Quinidine |
| (+)-Chlorpheniramine | 3-Hydroxytyramine | Quinine |
| Chlorpromazine | (+/-)-Isoproterenol | Quinolinic Acid |
| Chlorprothixene | Ketamine | Riboflavin |
| Clofibrate | Meprobamate | Salicylic Acid |
| Clonidine | Methapyrilene | Sodium Chloride |
| Cortisone | Methylphenidate | Sulfamethazine |
| (-)-Cotinine | Nalidixic Acid | Sulindac |
| Creatine Hydrate | Naloxone | Tetracycline |
| Creatinine | Naltrexone | Tetrahydrozoline |
| Cyclobenzaprine | (+)-Naproxen | Thiamine |
| Cyclodextrin-r | Niacinamide | Thioridazine |
| Cyproheptadine | Nicotinic Acid | Tramadol |
| Deoxycorticosterone | Nifedipine | Trifluoperazine |
| Dextromethorphan | 19-Norethindrone | Tryptamine |
| Diclofenac | Norpropoxyphene | Tyramine |
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| Diflunisal | Nortriptyline | Uric Acid |
| --- | --- | --- |
| 4-Dimethyl-aminoantipyrine | Noscapine | Zomepirac sodium salt |
| Diphenhydramine | Octopamine | |
Evaluation of SG and pH on test results:
To evaluate the effect of pH value on the test results, urine controls at 50%, 75%, 125% and 150% of the cutoff value were used. Each control level was adjusted by either 1N NaOH solution or 1N HCl to the pH levels at 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0 and 8.5. Each test sample was tested in duplicate.
To evaluate the effect of specific gravity, urine controls at +/-25% and +/-50% of the cut-off values were spiked with DI water or sugar to obtain specific gravities of 1.002, 1.010, 1.015, 1.020, 1.025, and 1.030. Each test sample was tested in duplicate.
The testing results demonstrate that varying pH's and specific gravities do not affect urine testing results around each analyte cut-off.
f. Assay cut-off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section, M1.a, above.
2. Comparison studies:
a. Method comparison with predicate device:
The method comparison study was conducted to evaluate the performance of the device for detection of benzodiazepine, barbiturate, MDMA, opiates, methadone and oxycodone, with 2 operators (1 operator/device). In the method comparison study, 203 unaltered clinical samples (85 negative and 118 positive) benzodiazepine, 190 unaltered clinical samples (85 negative and 105 positive) barbiturate, 100 unaltered clinical samples (60 negative and 40 positive) MDMA, 106 unaltered clinical samples (65 negative and 41 positive) opiates, 104 unaltered clinical samples (60 negative and 44 positive) methadone, 106 unaltered clinical samples (59 negative and 47 positive) oxycodone were tested with the proposed devices and compared against the results obtained with GC/MS. The results of the studies are presented below:
Benzodiazepine
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| | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Dip Card | Positive | 0 | 0 | 1 | 35 | 82 | 99.2% |
| | Negative | 43 | 9 | 32 | 1 | 0 | 98.8% |
| Cassette | Positive | 0 | 0 | 1 | 34 | 82 | 98.3% |
| | Negative | 43 | 9 | 32 | 2 | 0 | 98.8% |
Barbiturates
| | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Dip Card | Positive | 0 | 0 | 1 | 42 | 62 | 99.1% |
| | Negative | 43 | 8 | 33 | 1 | 0 | 98.8% |
| Cassette | Positive | 0 | 0 | 1 | 41 | 62 | 98.1% |
| | Negative | 43 | 8 | 33 | 2 | 0 | 98.8% |
MDMA
| | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Dip Card | Positive | 0 | 0 | 1 | 12 | 28 | 97.6% |
| | Negative | 43 | 5 | 11 | 1 | 0 | 98.3% |
| Cassette | Positive | 0 | 0 | 1 | 12 | 28 | 97.6% |
| | Negative | 43 | 5 | 11 | 1 | 0 | 98.3% |
Opiates
| | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Dip Card | Positive | 0 | 0 | 0 | 19 | 22 | 100% |
| | Negative | 43 | 10 | 12 | 0 | 0 | 100% |
| Cassette | Positive | 0 | 0 | 0 | 19 | 22 | 100% |
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| | Negative | 43 | 10 | 12 | 0 | 0 | 100% |
| --- | --- | --- | --- | --- | --- | --- | --- |
Methadone
| | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Dip Card | Positive | 0 | 0 | 1 | 15 | 28 | 97.7% |
| | Negative | 43 | 5 | 11 | 1 | 0 | 98.3% |
| Cassette | Positive | 0 | 0 | 1 | 16 | 28 | 100% |
| | Negative | 43 | 5 | 11 | 0 | 0 | 98.3% |
Oxycodone
| | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) | % Agreement |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Dip Card | Positive | 0 | 0 | 1 | 11 | 36 | 100% |
| | Negative | 43 | 6 | 9 | 0 | 0 | 98.3% |
| Cassette | Positive | 0 | 0 | 1 | 11 | 36 | 100% |
| | Negative | 43 | 6 | 9 | 0 | 0 | 98.3% |
Discordant Tables:
Dip Card
| Cutoff value (ng/mL) | Assay (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) | |
| --- | --- | --- | --- |
| | | Drug/Metabolite | GC/MS value (ng/ml) |
| Benzodiazepine 300 | positive | Oxazepam | 298 |
| Benzodiazepine 300 | negative | Alprazolam | 322 |
| Barbiturate 300 | positive | Pentobarbital | 290 |
| Barbiturate 300 | negative | Pentobarbital | 302 |
| MDMA 500 | positive | MDMA | 498 |
| MDMA 500 | negative | MDMA | 526 |
| Methadone 300 | positive | Methadone | 298 |
| Methadone 300 | negative | Methadone | 334 |
| Oxycodone 100 | positive | Oxycodone | 94 |
Cassette
| Cutoff value (ng/mL) | Assay (POS/NEG) | Drug/Metabolite GC/MS value (ng/mL) |
| --- | --- | --- |
{12}
| | | Drug/Metabolite | GC/MS value (ng/ml) |
| --- | --- | --- | --- |
| Benzodiazepine 300 | positive | Oxazepam | 298 |
| Benzodiazepine 300 | negative | Oxazepam | 303 |
| Benzodiazepine 300 | negative | Alprazolam | 322 |
| Barbiturate 300 | positive | Pentobarbital | 290 |
| Barbiturate 300 | negative | Pentobarbital | 309 |
| Barbiturate 300 | negative | Butalbital | 328 |
| MDMA 500 | positive | MDMA | 498 |
| MDMA 500 | negative | MDMA | 526 |
| Methadone 300 | positive | Methadone | 298 |
| Oxycodone 100 | positive | Oxycodone | 94 |
b. Matrix comparison:
Not applicable. The assay is intended for only one sample matrix, urine
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
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.
