WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)

• K Number: K131754
• Device Name: WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
• Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
• Date Cleared: 2013-07-31 ( 47 days)
• Product Code: DIO LDJ
• Regulation Number: 862.3250

Intended Use

Wondfo Cocaine Urine Test (COC 100) is an immunochromatographic assay for the qualitative determination of Benzoylecgonine 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. Wondfo Cannabinoids Urine Test (THC 40) is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 40 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

Immunochromatograph assays for Cocaine and Cannabinoids Urine Tests use a lateral flow, for the for step system qualitative detection of Benzoylecgonine and one 11-nor-A9-THC-9-COOH (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.

Predicate Devices

K050394

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies describe a standard immunochromatographic assay, which is a chemical reaction-based test, not a software-based or image-processing system that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts in the document.

Therapeutic

No
This device is an immunochromatographic assay for the qualitative determination of substances (Benzoylecgonine and 11-nor-A9-THC-9-COOH) in human urine, providing preliminary diagnostic test results rather than therapeutic intervention.

Diagnostic

Yes

The device is an "immunochromatographic assay for the qualitative determination of Benzoylecgonine in human urine" and "11-nor-A9-THC-9-COOH in human urine." It is used to detect the presence of substances in a biological sample to aid in diagnosis or screening.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an immunochromatographic assay available in Dip Card and Cup formats, which are physical hardware components used for testing urine samples.

IVD (In Vitro Diagnostic)

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 Benzoylecgonine in human urine" and "qualitative determination of 11-nor-A9-THC-9-COOH in human urine". This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about a physiological state (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.
• Performance Studies: The document describes various performance studies conducted on the device using human urine samples, including precision, cut-off determination, interference testing, specificity testing, and comparison studies with clinical samples. These are typical studies performed to validate the performance of an IVD.
• 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.

The fact that it's for "prescription use" and "not intended for point-of-care use" further supports its classification as an IVD, as many IVDs are intended for use in a laboratory or clinical setting under the supervision of healthcare professionals.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Wondfo Cocaine Urine Test (COC 100) is an immunochromatographic assay for the qualitative determination of Benzoylecgonine 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.

Wondfo Cannabinoids Urine Test (THC 40) is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 40 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)

DIO, LDJ

Device Description

Immunochromatograph assays for Cocaine and Cannabinoids Urine Tests use a lateral flow, for the for step system qualitative detection of Benzoylecgonine and one 11-nor-A9-THC-9-COOH (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 For each concentration, tests were performed two runs per day for 25 sample testing. days.

**b. Linearity**: Not applicable

**c. Stability**: Stable at 4-30 degrees C for 18 months based on the accelerated stability study at 50 degrees C and real time stability determination at both 4 degrees C and 30 degrees C.

**d. Cut-off**: Total 150 samples equally distributed at concentrations of -50% 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 cocaine and cannabinoids.

**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. Compounds that show no interference at a concentration of 100 µg/mL are summarized. No differences observed 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. Compounds that produced positive results are listed. No differences observed for both Dip Card and Cup formats.

**g. Effect of Urine Specified Gravity and Urine pH**: To investigate the effect of urine specified gravity and urine pH, the urine samples, with 1.000~1.035 specified gravity or urine samples with pH 4~9 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. There were no differences observed for both Dip Card and Cup formats.

2. Comparison Studies
The method comparison for the Wondfo Cocaine Urine Test (COC100), Wondfo Cannabinoids Urine Test (THC40) 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

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).

Summary

0

K 131757

510(k) SUMMARY

1. Date:	July 28, 2013	JUL 3 1 2013
2. Submitter:	Guangzhou Wondfo Biotech Co., Ltd.
South China University of Technology
Guangzhou, P.R. China 510641
3. Contact person:	Joe Shia
LSI International Inc.
504 East Diamond Ave., Suite F
Gaithersburg, MD 20878
Telephone: [phone]
Fax: [phone]
Email: [e-mail]

• 4. Device Name: Wondfo Cocaine Urine Test (COC100) Wondfo Cannabinoids Urine Test (THC40)
     Classification:

Product Code	CFR #	Panel
DIO	21 CFR, 862.3250 Cocaine Test System	Toxicology
LDJ	21 CFR, 862.3870 Cannabinoid Test System	Toxicology

• 5. Predicate Devices:
     K050394

Medtox Diagnostics Sure-Screen

6. Intended Use

Wondfo Cocaine Urine Test (COC 100) is an immunochromatographic assay for the qualitative determination of Benzoylecgonine 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.

Wondfo Cannabinoids Urine Test (THC 40) is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 40 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

1

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

Immunochromatograph assays for Cocaine and Cannabinoids Urine Tests use a lateral flow, for the for step system qualitative detection of Benzoylecgonine and one 11-nor-A9-THC-9-COOH (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.

8. Substantial Equivalence Information

A summary comparison of features of the Wondfo Cocaine Urine Test (COC 100) and Wondfo Cannabinoids Urine Test (THC 40) and the predicate devices is provided in Table 1 & Table 2.

Table 1: Features Comparison of Wondfo Cocaine Urine Test (COC 100) and the Predicate Devices

| Item | Device | Predicate -
K050394 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Indication(s) for
Use | For the qualitative determination of
Benzoylecgonine in human urine. For
prescription use. | Same (but the
number of drugs
detected is different) |
| Calibrator | Benzoylecgonine | 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 | 100 ng/mL | Same |
| Configurations | Cup, Dip Card | Cup |

Table 2: Features Comparison of Wondfo Cannabinoids Urine Test (THC 40) and the Predicate Devices

Item	Device	Predicate - K050394
Indication(s) for
Use	For the qualitative determination of
11-nor-Δ9-THC-9-COOH in human urine.	Same (but the number
of drugs detected is
different)
Calibrator	11-nor-Δ9-THC-9-COOH	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody	Same

2

Item	Device	Predicate - K050394
	immunochemistry.
Type of Test	Qualitative to indicate positive or negative
result	Same
Specimen Type	Human Urine	Same
Cut-Off Values	40 ng/mL	Same
Configurations	Cup, Dip Card	Cup

9. Test Principle

It is a rapid test for the qualitative detection of Benzoylecgonine and

11-nor-A9-THC-9-COOH 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 For each concentration, tests were performed two runs per day for 25 sample testing. days. The results obtained are summarized in the following table.

Cup Format

| COC 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 W1070901CU2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1070902CU2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1070903CU2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

الي سال ا
		Result -100%	-75%	-50%	-25%	Cut-Off	+25%	+50%	+75%	+100%
ITHC 40			Cut-Off Cut-Off Cut-Off Cut-Off							Cut-Off Cut-Off Cut-Off Cut-Off
LOT W1970901CU2		50-10+	50-10+	50-10+	50-10+	45+/5-	, 50+/0-	50+/0-	50+/0-	50+/0-
LOT W1970902CU2		50-10+	50-10+	50-10+	50-10+	45+/5-	50+/0-	50+/0-	50+/0-	50+/0-

THE AD.

3

| | 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 |
|---------------------------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| THC 40
LOT W1970903CU2 | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Dip Card Format

| COC 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 W1070901P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1070902P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1070903P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| THC 40: | | | | | | | | | | |
| THC 40 | 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 W1970901P | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1970902P | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1970903P | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

COC 100:

b. Linearity

Not applicable

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

• d. Cut-off
  Total 150 samples equally distributed at concentrations of -50% 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 cocaine and cannabinoids. The following cut-off values for the test devices have been verified.

Test	Calibrator	Cut-off (ng/mL)
Wondfo Cocaine Urine Test (COC 100)	Benzoylecgonine	100
Wondfo Cannabinoids Urine Test (THC 40)	11-nor-Δ9-THC-9-COOH	40

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.

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

Acetominophen	Estrone-3-sulfate	Papaverine
Acetophenetidin	Ethyl-p-aminobenzoate	Penicillin-G
N-Acetylprocainamide	Fenoprofen	Pentobarbital
Acetylsalicylic acid	Furosemide	Perphenazine
Aminopyrine	Gentisic acid	Phencyclidine
Amitriptyline	Hemoglobin	Phenelzine
Amobarbital	Hydralazine	Phenobarbital
Amoxicillin	Hydrochlorothiazide	Phentermine
Ampicillin	Hydrocodone	L-Phenylephrine
L-Ascorbic acid	Hydrocortisone	β-Phenylethylamine
DL-Amphetamine Sulfate	O-Hydroxyhippuric acid	Phenylpropanolamine
Apomorphine	p-Hydroxymethamphetamine	Prednisolone
Aspartame	3-Hydroxytyramine	Prednisone
Atropine	Ibuprofen	Procaine
Benzilic acid	Imipramine	Promazine
Benzoic acid	Iproniazid	Promethazine
Benzphetamine	(±) - Isoproterenol	DL-Propranolol
Bilirubin	Isoxsuprine	D-Propoxyphene
(±) -Brompheniramine	Ketamine	D-Pseudoephedrine
Caffeine	Ketoprofen	Quinidine
Cannabidiol	Labetalol	Quinine
Cannabinol	Levorphanol	Ranitidine
Chloralhydrate	Loperamide	Salicylic acid
Chloramphenicol	Maprotiline	Secobarbital
Chlordiazepoxide	Meperidine	Serotonin
Chlorothiazide	Meprobamate	Sulfamethazine
(±) -Chlorpheniramine	Methadone	Sulindac
Chlorpromazine	Methoxyphenamine	Temazepam
Chlorquine	(±)-3,4-Methylene
dioxyamphetamine	Tetracycline
Cholesterol	hydrochloride(±)-3,4-Methylene-
dioxymethamphetamine
hydrochloride	Tetrahydrocortisone, 3-Acetate
Clomipramine	Morphine-3-B-D glucuronide	Tetrahydrocortisone 3-(β-D
glucuronide)
Clonidine	Morphine Sulfate	Tetrahydrozoline
Codeine	Nalidixic acid	Thebaine
Cortisone	Naloxone	Thiamine
(-) Cotinine	Naltrexone	Thioridazine
Creatinine	Naproxen	DL-Tyrosine
Deoxycorticosterone	Niacinamide	Tolbutamide
Dextromethorphan	Nifedipine	Triamterene
Diazepam	Norcodein	Trifluoperazine
Diclofenac	Norethindrone	Trimethoprim
Diflunisal	D-Norpropoxyphene	Trimipramine
Digoxin	Noscapine	Tryptamine
Diphenhydramine	DL-Octopamine	DL-Tryptophan
Doxylamine	Oxalic acid	Tyramine
Ecgonine methylester	Oxazepam	Uric acid
(-) - Ψ-Ephedrine	Oxolinic acid	Verapamil
Erythromycin	Oxycodone	Zomepirac
ß-Estradiol	Oxymetazoline

COC 100

4

and the comments of the comments of the comments of

:

·

5

• .

Deoxycorticosterone

4-Acetamidophenol	Estrone-3-sulfate	Penicillin-G
Acetophenetidin	Ethyl-p-aminobenzoate	Pentazocine
N-Acetylprocainamide	Fenoprofen	Pentobarbital
Acetylsalicylic acid	Furosemide	Perphenazine
Aminopyrine	Gentisic acid	Phencyclidine
Amitryptyline	Hemoglobin	Phenelzine
Amobarbital	Hydralazine	Phenobarbital
Amoxicillin	Hydrochlorothiazide	Phentermine
Ampicillin	Hydrocodone	L-Phenylephrine
Ascorbic acid	Hydrocortisone	β-Phenylethlamine
D,L-Amphetamine	O-Hydroxyhippuric acid	β-Phenyllethylamine
L-Amphetamine	3-Hydroxytyramine	Phenylpropanolamine
Apomorphine	Ibuprofen	Prednisolone
Aspartame	Imipramine	Prednisone
Atropine	Iproniazid	Procaine
Benzilic acid	(-) Isoproterenol	Promazine
Benzoic acid	Isoxsuprine	Promethazine
Benzoylecgonine	Ketamine	D,L-Propanolol
Benzphetamine	Ketoprofen	D-Propoxyphene
Bilirubin	Labetalol	D-Pseudoephedrine
Brompheniramine	Levorphanol	Quinidine
Caffeine	Loperamide	Quinine
Chloralhydrate	Maprotiline	Ranitidine
Chloramphenicol	Meprobamate	Salicylic acid
Chlordiazepoxide	Methadone	Secobarbital
Chlorothiazide	Methoxyphenamine	Serotonin (5-Hydroxytyramine)
(±) Chlorpheniramine	(+)3,4-Methylenedioxyamphetamine	Sulfamethazine
Chlorpromazine	(+)3,4-Methylenedioxymethampheta
mine	Sulindac
Chlorquine	Methylphenidate	Temazepam
Cholesterol	Methyprylon	Tetracycline
Clomipramine	Morphine-3-β-Dglucuronide	Tetrahydrocortisone, 3 Acetate
Clonidine	Nalorphine	Tetrahydrocortisone3
(5-Dglucuronide)
Cocaine hydrochloride	Naloxone	Tetrahydrozoline
Codeine	Nalidixic acid	Thebaine
Cortisone	Naltrexone	Thiamine
(-) Cotinine	Naproxen	Thioridazine
Creatinine	Niacinamide	D,L-Thyroxine

Nifedipine

.

Tolbutamine

.

6

Dextromethorphan	Norcodein	Triamterene
Diazepam	Norethindrone	Trifluoperazine
Diclofenac	D-Norpropoxyphene	Trimethoprim
Diflunisal	Noscapine	Trimipramine
Digoxin	D,L-Octopamine	Tryptamine
Diphenhydramine	Oxalic acid	D, L-Tryptophan
Doxylamine	Oxazepam	Tyramine
Ecgonine hydrochloride	Oxolinic acid	PrD, L-Tyrosine
Ecgonine methylester	Oxycodone	Uric acid
(-) Y Ephedrine	Oxymetazoline	Verapamil
Erythromycin	p-Hydroxymethamphetamine	Zomepirac
β-Estradiol	Papaverine

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. Compounds that produced positive results are listed below. There are no differences observed for both Dip Card and Cup formats.

COC 100
COC(Cocaine)
(Benzoylecgonine, Cut-off=100 ng/mL)	Minimum Concentration
Required to Obtain a Positive
Result (ng/mL)	% Cross-Reactivity
Benzoylecgonine	100	100%
Cocaine HCI	250	40.0%
Cocaethylene	4000	2.5%
Ecgonine	10000	1%

THC 40
--------	--

| THC(11-nor-Δ9-THC-9-COOH)
(11-nor-Δ9-THC-9-COOH, Cut-off=40 ng/mL) | Minimum Concentration
Required to Obtain a Positive
Result (ng/mL) | % Cross-Reactivity |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------|
| 11-nor-Δ9-THC-9-COOH | 40 | 100% |
| 11-nor-Δ8-THC-9-COOH | 20 | 200% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 2000 | 2% |
| Δ 8-Tetrahydrocannabinol | 6000 |