K Number
K131232
Device Name
WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
Date Cleared
2013-05-31

(30 days)

Product Code
Regulation Number
862.3620
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wondfo Methadone Urine Test (MTD 200) is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 200 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. Wondfo Morphine Urine Test (MOP 100) is an immunochromatographic assay for the qualitative determination of Morphine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Device Description
Immunochromatographic assays for Methadone and Morphine Urine Tests use a lateral flow, one step system for the qualitative detection of Methadone and Morphine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.
More Information

Not Found

No
The device is a simple immunochromatographic assay (lateral flow test) for qualitative detection of substances in urine. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The performance studies describe standard analytical and clinical validation methods for such tests.

No.
The device is an immunochromatographic assay for the qualitative determination of Methadone and Morphine in human urine, used for diagnostic purposes (drug screening), not for treating or preventing disease.

Yes

The device is an immunochromatographic assay for the qualitative determination of Methadone and Morphine in human urine, which is used to detect the presence of substances in the body for diagnostic purposes.

No

The device is described as an immunochromatographic assay in Dip Card and Cup formats, which are physical hardware components used for chemical testing of urine samples. The description details the biological and chemical components of the test, not software.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the device is for the "qualitative determination of Methadone in human urine" and "qualitative determination of Morphine in human urine". This indicates that the test is performed in vitro (outside the body) on a biological sample (urine) to provide information about a person's health status (presence of drugs).
  • Device Description: The description details an "immunochromatographic assay," which is a common type of in vitro diagnostic test. It describes the components used to detect the target analytes in the urine sample.
  • Anatomical Site: The sample is "human urine," which is a biological specimen collected from the body for analysis in vitro.
  • Performance Studies: The document describes various performance studies (Analytical Performance, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and Urine pH, Comparison Studies) conducted to evaluate the device's ability to accurately detect the target analytes in urine. These types of studies are standard for validating IVD devices.
  • Predicate Device: The mention of a "Predicate Device(s)" with a K number (K050394) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.

While the document mentions it's for "prescription use" and "not intended for point-of-care use," and that it provides "preliminary test results" requiring confirmation, these are characteristics of the device's intended use and limitations, not factors that negate its classification as an IVD. The core function is an in vitro test on a biological sample to provide diagnostic information.

N/A

Intended Use / Indications for Use

Wondfo Methadone Urine Test (MTD 200) is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 200 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Wondfo Morphine Urine Test (MOP 100) is an immunochromatographic assay for the qualitative determination of Morphine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Product codes (comma separated list FDA assigned to the subject device)

DJR, DJG

Device Description

Immunochromatographic assays for Methadone and Morphine Urine Tests use a lateral flow, one step system for the qualitative detection of Methadone and Morphine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

This product is only intended for prescription use and is not intended for point-of-care use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

  1. Analytical Performance
    a. Precision: Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled by the person who prepared the samples and that person did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days.
    b. Linearity: Not applicable, this is a visually read device.
    c. Stability: Stable at 4-30℃ for 18 months based on the accelerated stability study at 50°C and real time stability determination at both 4°C and 30°C.
    d. Cut-off: Total of 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for both methadone and morphine.
    e. Interference: Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% below and 25% above Cut-Off level respectively. These urine samples were tested using three batches of each device for both Dip Card and Cup formats.
    f. Specificity: To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for both Dip Card and Cup formats.
    g. Effect of Urine Specific Gravity and Urine pH: To investigate the effect of urine specific gravity and urine pH, the urine samples, with 1.0001.035 specific gravity or urine samples with pH 49 were spiked with target drugs at 25% below and 25% above Cut-Off level, respectively. These samples were tested using three batches of each device for both Dip Card and Cup formats. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off.

  2. Comparison Studies
    The method comparison for the Wondfo Methadone Urine Test (MTD200), Wondfo Morphine Urine Test (MOP100) was performed in-house with three laboratory assistants. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K050394

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 862.3620 Methadone test system.

(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).

0

510(k) SUMMARY

MAY 3 1 2013

  1. Date:

May 29, 2013

  1. Submitter:

  2. Contact person:

Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641

Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6213 Email:shiajl@yahoo.com

    1. Device Name:
      Wondfo Methadone Urine Test (MTD200) Wondfo Morphine Urine Test (MOP100)

Classification:

| Product

CodeCFR #Panel
DJR21 CFR, 862.3620 Methadone Test
SystemToxicology
DJG21 CFR, 862.3640 Morphine Test
SystemToxicology

Medtox Diagnostics Sure-Screen

1

    1. Intended Use
      Wondfo Methadone Urine Test (MTD 200) is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 200 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Wondfo Morphine Urine Test (MOP 100) is an immunochromatographic assay for the qualitative determination of Morphine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use.

1

1

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

7. Device Description

Immunochromatographic assays for Methadone and Morphine Urine Tests use a lateral flow, one step system for the qualitative detection of Methadone and Morphine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

    1. Substantial Equivalence Information
      A summary comparison of features of the Wondfo Methadone Urine Test (MTD 200) and Wondfo Morphine Urine Test (MOP 100) and the predicate device is provided in Table 1 & Table 2.

| Item | Device | Predicate -
K050394 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Indication(s)
for Use | For the qualitative determination of
Methadone in human urine. For
prescription use. | Same (but the
number of drugs
detected is
different) |
| Calibrator | Methadone | Same |
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry. | Same |
| Type of Test | Qualitative to indicate positive or negative
result | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 200 ng/mL | Same |
| Configurations | Cup, Dip Card | Cup |

Table 1: Features Comparison of Wondfo Methadone Urine Test (MTD 200) and
the Predicate Devices

Table 2: Features Comparison of Wondfo Morphine Urine Test (MOP 100) and the Predicate Devices

ItemDevicePredicate - K050394
Indication(s)
for UseFor the qualitative determination of
Morphine in human urine. For
prescription use.Same(but the number
of drugs detected is
different)

2

ItemDevicePredicate - K050394
CalibratorMorphineSame
MethodologyCompetitive binding, lateral flow
immunochromatographic assays based
on the principle of antigen antibody
immunochemistry.Same
Type of TestQualitative to indicate positive or
negative resultSame
Specimen TypeHuman UrineSame
Cut-Off Values100 ng/mLSame
ConfigurationsCup, Dip CardCup

9. Test Principle

It is a rapid test for the qualitative detection of Methadone and Morphine in urine samples. It is a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a urine sample, the urine is absorbed into the device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane. At analyte concentration below the target cut off, antibody-dye conjugates bind to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored test line that indicates a negative result. When analyte concentration is above the cutoff, analyte molecules bind to the antibody-dye conjugate, preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. No colored band shows in the test region, indicating a potentially positive result.

10. Performance Characteristics

    1. Analytical Performance
    • a.Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled by the person who prepared the samples and that person did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following table.

Cup Format

MTD 200

| Result | -100%
Cut-Off | -75%
Cut-Off | -50%
Cut-Off | -25%
Cut-Off | Cut-Off | +25%
Cut-Off | +50%
Cut-Off | +75%
Cut-Off | +100%
Cut-Off |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| MTD 200 | | | | | | | | | |
| LOT
W1570901 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

3

~ Result -100% -75% -50% -25% Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Of
CU2
LOT
W1570902
CU250-10+ 20-10+50-10+50-10+44+/6-50+/0-50+/0-50+/0-50+/0-
LOT
W1570903
CU250-10+50-10+50-10+ 50-10+46+/4-50+/0-50+/0-50+/0-50+/0-

MOP 100

| Result | -100%
Cut-Off | -75%
Cut-Off | -50%
Cut-Off | -25%
Cut-Off | Cut-Off | +25%
Cut-Off | +50%
Cut-Off | +75%
Cut-Off | +100%
Cut-Off |
|------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| LOT
W1670901
CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT
W1670902
CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT
W1670903
CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Dip Card Format

MTD 200

| Result
MTD 200 | -100%
Cut-Off | -75%
Cut-Off | -50%
Cut-Off | -25%
Cut-Off | Cut-Off | +25%
Cut-Off | +50%
Cut-Off | +75%
Cut-Off | +100%
Cut-Off |
|----------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| LOT
W1570901
P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT
W1570902
P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT
W1570903
P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

MOP 100

| Result
MOR 100 | -100%
Cut-Off | -75%
Cut-Off | -50%
Cut-Off | -25%
Cut-Off | Cut-Off | +25%
Cut-Off | +50%
Cut-Off | +75%
Cut-Off | +100%
Cut-Off |
|----------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| LOT
W1670901
P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT
W1670902
P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT
W1670903
P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

b. Linearity

Not applicable, this is a visually read device

c.Stability

Stable at 4-30℃ for 18 months based on the accelerated stability study at 50°C and real time stability determination at both 4°C and 30°C.

4

Cut-off

Total of 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for both methadone and morphine. The following cut-off values for the test devices have been verified.

| Test | Calibrator | Cut-off
(ng/mL) |
|------------------------------------------|------------|--------------------|
| Wondfo Methadone Urine Test (MTD
200) | Methadone | 200 |
| Wondfo Morphine Urine Test (MOP
100) | Morphine | 100 |

d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% below and 25% above Cut-Off level respectively. These urine samples were tested using three batches of each device for both Dip Card and Cup formats.

Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. There were no differences observed for both Dip Card and Cup formats.

AcetaminophenErythromycinOxymetazoline
Acetophenetidinβ-EstradiolPapaverine
N-AcetylprocainamideEstrone-3-sulfatePenicillin-G
Acetylsalicylic acidEthyl-p-aminobenzoatePentazocine hydrochloride
AminopyrineFenoprofenPentobarbital
AmitryptylineFurosemidePerphenazine
AmobarbitalGentisic acidPhencyclidine
AmoxicillinHemoglobinPhenelzine
AmpicillinHydralazinePhenobarbital
L-Ascorbic acidHydrochlorothiazidePhentermine
DL-Amphetamine sulfateHydrocodoneTrans-2-phenylcyclo-propyl
amine hydrochloride
ApomorphineHydrocortisoneL-Phenylephrine
AspartameO-Hydroxyhippuric acidβ-Phenylethylamine
Atropinep-HydroxyamphetaminePhenylpropanolamine
Benzilic acidp-HydroxymethamphetaminePrednisolone
Benzoic acid3-HydroxytyraminePrednisone
BenzoylecgonineIbuprofenProcaine
BenzphetamineImipraminePromazine
BilirubinIproniazidPromethazine
(±) - Brompheniramine(±) - IsoproterenolDL-Propranolol
CaffeineIsoxsuprineD-Propoxyphene
CannabidiolKetamineD-Pseudoephedrine
CannabinolKetoprofenQuinacrine
ChloralhydrateLabetalolQuinidine
ChloramphenicolLevorphanolQuinine
ChlorothiazideLoperamideRanitidine
(±) - ChlorpheniramineMephentermineSalicylic acid
ChlorpromazineMaprotilineSecobarbital
ChlorquineMeperidineSerotonin
CholesterolMeprobamateSulfamethazine
ClomipramineMethamphetamineSulindac
ClonidineMethoxyphenamineTetracycline
Cocaethylene(±)-3,4-Methylenedioxy-amphetamine hydrochlorideTetrahydrocortisone, 3-acetate
Cocaine hydrochlorideMorphine-3-B-D glucuronideTetrahydrozoline
CodeineMorphine SulfateThebaine
CortisoneNalidixic acidThiamine
(-) CotinineNaloxoneThioridazine
CreatinineNaltrexoneDL-Tyrosine
DeoxycorticosteroneNaproxenTolbutamide
DextromethorphanNiacinamideTriamterene
DiazepamNifedipineTrifluoperazine
DiclofenacNorcodeinTrimethoprim
DiflunisalNorethindroneTrimipramine
DigoxinD-NorpropoxypheneTryptamine
DiphenhydramineNoscapineDL-Tryptophan
Ecgonine hydrochlorideDL-OctopamineTyramine
Ecgonine methyl esterOxalic acidUric acid
(-) - Ψ-EphedrineOxazepamVerapamil
[1R,2S] (-) EphedrineOxolinic acidZomepirac
(L) - EpinephrineOxycodone

MTD 200

5

and the comments of the country

.

and the contraction of the comments of the country of

:

.

.

.

:

. . . . .

6

MOP 100

4-AcetamidophenolEcgonine methylesterOxolinic acid
Acetophenetidin(-) -Y -EphedrineOxymetazoline
N-AcetylprocainamideErythromycinPapaverine
Acetylsalicylic acidB-EstradiolPenicillin-G
AminopyrineEstrone-3-sulfatePentazocine
AmitryptylineEthyl-p-aminobenzoatePentobarbital
AmobarbitalFenoprofenPerphenazine
AmoxicillinFurosemidePhencyclidine
AmpicillinGentisic acidPhenelzine
Ascorbic acidHemoglobinPhenobarbital
D,L-AmphetamineHydralazinePhentermine
ApomorphineHydrochlorothiazideL-Phenylephrine
AspartameHydrocortisoneβ-Phenylethylamine
AtropineO-Hydroxyhippuric acidPhenylpropanolamine
Benzilic acid /p-Hydroxy methamphetaminePrednisone
Benzoic acid3-HydroxytyramineD,L-Propanolol
BenzoylecgonineIbuprofenD-Propoxyphene
BenzphetamineImipramineD-Pseudoephedrine
Bilirubin (±)IproniazidQuinidine
BrompheniramineIsoproterenolQuinine
CaffeineIsoxsuprineRanitidine
CannabidiolKetamineSalicylic acid
ChloralhydrateKetoprofenSecobarbital
ChloramphenicolLabetalolSerotonin
(5-Hydroxytyramine)
ChlordiazepoxideLoperamideSulfamethazine
ChlorothiazideMaprotilineSulindac
(±) ChlorpheniramineMeperidineTemazepam
ChlorpromazineMeprobamateTetracycline
ChlorquineMethadoneTetrahydrocortisone,
3 Acetate
CholesterolMethoxyphenamineTetrahydrocortisone3
(β-D glucuronide)
Clomipramine(+) 3,4-Methylenedioxy-amphetamineTetrahydrozoline
Clonidine(+)3,4-Methylenedioxy-methamphetamin
eThiamine
Cocaine hydrochlorideNalidixic acidThioridazine
CortisoneNalorphineD, L-Tyrosine
(-) CotinineNaloxoneTolbutamide
CreatinineNaltrexoneTriamterene
DeoxycorticosteroneNaproxenTrifluoperazine
DextromethorphanNiacinamideTrimethoprim
DiazepamNifedipineTrimipramine
DiclofenacNorethindroneTryptamine
DiflunisalD-NorpropoxypheneD, L-Tryptophan
DigoxinNoscapineTyramine
DiphenhydramineD,L-OctopamineUric acid
DoxylamineOxalic acidVerapamil
Ecgonine hydrochlorideOxazepamZomepirac

7

i

. .

7

.

. .

ﻬﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

:

8

: ·

.

8

e. Specificity

To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for both Dip Card and Cup formats. Compounds that produced positive results are listed below. There were no differences observed for both Dip Card and Cup formats.

MTD 200
MTD(Methadone)
(Methadone, Cut-off=200 ng/mL)Minimum Concentration
Required to Obtain a
Positive Result (ng/mL)%
Cross-Reactivity
Methadone200100
Doxylamine40,0000.5
MOP 100
MOR(Morphine)Minimum Concentration%
(Morphine, Cut-off=100 ng/mL)Required to Obtain aCross-Reactivity

9

Positive Result (ng/mL)
Morphine100100
Codeine100100
Ethylmorphine20050
Hydrocodone40025
Hydromorphine20050
Levorphanol50002.0
σ-Monoacetylmorphine20050
Morphine 3-β-D-glucuronide20050
Norcodeine50020
Normorphone50002.0
Oxycodone100010
Oxymorphine100010
Procaine100000