WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)

K122961 · Guangzhou Wondfo Biotech Co., Ltd. · DKZ · Dec 21, 2012 · Clinical Toxicology

Device Facts

• Record ID: K122961
• Device Name: WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

Wondfo Amphetamine Urine Test (AMP 300): Wondfo Amphetamine Urine Test (AMP 300) is an immunochromatographic assay for the qualitative determination of d-Amphetamine in human urine at a cutoff concentration 300 ng/mL. The test is available in a Dip Card format and a Cup format. It 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 Methamphetamine Urine Test (MET 500): Wondfo Methamphetamine Urine Test (MET 500) is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a cutoff concentration 500 ng/mL. The test is available in a Dip Card format and a Cup format. It 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 Story

Lateral flow immunochromatographic assay; detects d-Amphetamine or D(+)-Methamphetamine in human urine. Input: urine specimen; capillary action draws sample across nitrocellulose membrane coated with drug-protein conjugate and anti-mouse IgG. Principle: competitive binding; free drug in sample competes with immobilized drug-protein conjugate for limited antibody-dye conjugate. Output: visual colored lines in Test (T) and Control (C) regions. Negative result: colored line in T region; Positive result: absence of T line. Used in clinical/laboratory settings; operated by laboratory personnel. Provides preliminary screening results; requires confirmatory testing via GC/MS for clinical decision-making.

Clinical Evidence

Bench testing only. Performance evaluated using 80 clinical urine samples compared to GC/MS reference method. AMP 300: 100% positive agreement, 96.7-97.5% negative agreement. MET 500: 100% positive agreement, 95-96.7% negative agreement. Precision, cross-reactivity, and interference studies (pH, specific gravity) performed across three lots.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Components: conjugate pad with colloidal gold anti-drug antibodies, nitrocellulose membrane with drug-protein conjugate (T-line) and goat anti-mouse IgG (C-line). Formats: Cup and Dip Card. Storage: 4-30°C. No electronic components or software.

Indications for Use

Indicated for qualitative determination of d-Amphetamine (300 ng/mL cutoff) or D(+)-Methamphetamine (500 ng/mL cutoff) in human urine. For prescription use only; not for point-of-care use. Requires confirmatory testing (GC/MS preferred).

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

• ACON® AMP 300 One Step Amphetamine Test Strip, ACON® AMP 300 One Step Amphetamine Test Device (k041822)
• ACON® mAMP-500 One Step Methamphetamine Test Strip, ACON® mAMP-500 One Step Methamphetamine Test Device (k033299)

Submission Summary (Full Text)

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K122961

# TABLE 4

# SUMMARY

DEC 2 1 2012

1. Date:

2. Submitter:

November 1, 2012

Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641 012-86-20-32296069

3. Name of 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 Amphetamine Urine Test (AMP 300) Wondfo Methamphetamine Urine Test (MET 500)

Classification: All are Class II medical devices with the following various product codes with Code of Federal Requlation references:

| Product Code | CFR # |
|--------------|------------------|
| DKZ | 21 CFR, 862.3100 |
| LAF | 21 CFR, 862.3610 |

#### 5. Predicate Devices:

- 1. K041822
- Acon Laboratories, Inc.

ACON® AMP 300 One Step Amphetamine Test Strip, ACON® AMP 300 One Step Amphetarmine Test Device

#### 2. K033299

Acon Laboratories, Inc.

ACON® mAMP-500 One Step Methamphetamine Test Strip, ACON® mAMP-500 One Step Methamphetamine Test Device

#### 6. Intended Use:

Wondfo Amphetamine Urine Test (AMP 300) and Wondfo Methamphetamine Urine Test (MET 500) are intended for the qualitative determination of d-Amphetamine and D(+)-Methamphetamine (target analyte) at the specific cut-off concentration in human urine. This product is only intended for prescription use and is not intended for point-of-care use. For in vitro diagnostic use only.

#### 7. Device Description:

Assay Principle: Immunochromatograph assay for Amphetamine and Methamphetamine Urine Test using a lateral flow, one step system for the qualitative detection of d-Amphetamine and D(+)-Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.

#### 8. Substantial Equivalence Information

A summary comparison of the features of the Wondfo Amphetamine Urine Test (AMP 300) and Wondfo Methamphetamine Urine Test (MET 500) and the predicate devices is provided in the Table 2.

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## Table 1: Features Comparison of Wondfo Amphetamine Urine Test (AMP 300) and the Predicate Devices

| Item | Device | Predicate - K041822 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Indication(s) for Use | For the qualitative determination of Amphetamine in human urine. | Same |
| Calibrator | d-Amphetamine | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Type of Test | Immunoassay principles that rely on antigen-antibody interactions to indicate positive or negative result | Same |
| Specimen Type | Human Urine | Same |
| Cut Off Values | 300 ng/mL | Same |
| Configurations | Cup, Dip Card | Strip, Device |
| Intended Use | Prescription Use and not for point-of-care use | Prescription Use and for point-of-care use |

## Table 2: Features Comparison of Wondfo Methamphetamine Urine Test (MET 500) and the Predicate Devices

| Item | Device | Predicate - K033299 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Indication(s) for Use | For the qualitative determination of D(+)-<br>Methamphetamine in human urine. | Same |
| Calibrator | D(+)-Methamphetamine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody immunochemistry. | Same |
| Type of Test | Immunoassay principles that rely on antigen-<br>antibody interactions to indicate positive or<br>negative result | Same |
| Specimen Type | Human Urine | Same |
| Cut Off Values | 500 ng/mL | Same |
| Configurations | Cup, Dip Card | Strip, Device |
| Intended Use | Prescription Use and not for point-of-care use | Prescription Use and for<br>point-of-care use |

# 9. Standard/Guidance Document Reference

- Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man. Biomedical Publications, Davis, CA, . 1982.
- Ellenhorn, M.J. and Barceloux, D. G Medical Toxicology. Elservier Science Publishing Company, Inc., . New York, 1988
- Gilman, A. G., and Goodman, L. S. The Pharmacological Fluids, in Martin WR(ed): Drug Addiction I, . New York, Spring - Verlag, 1977.
- Harvey, R.A., Champe, P.C. Lippincotts Illustrated Reviews. Pharmacology. 91-95, 1992. .
- Hawwks RL, CN Chiang, Urine Testing for drugs of Abuse. National Institute for Drug Abuse (NIDA), . Research Monography 73, 1986

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- . Hofmann F.E., A Handbook on Drug and Alcohol Abuse: The Biomedical Aspects, New York, Oxford University Press, 1983.
- McBay, A. J. Clin. Chem. 33,33B-40B, 1987 .

# 10. Test Principle

Wondfo Amphetamine Urine Test (AMP 300) and Wondfo Methamphetamine Urine Test (MET 500) are a one-step lateral flow immunoassay containing a conjugate pad with colloidal gold with anti-drug antibodies, a nitrocellulose membrane, with a test line (T) and a control line (C). The T line is coated with drug-protein conjugate and the C line is coated with goat anti-mouse IgG polyclonal antibodies. The test is a competitive binding immunoassay in which drugs in a urine sample compete with immobilized drug conjugate for limited labeled antibody binding sites. When a sufficient amount of sample is applied, the sample migrates through the test device by capillary action.

If the concentration of drug is below the cutoff level, the anti-drug antibodies in the colloidal gold particles will bind to the drug antigens coated in the test zone producing a band which indicates a negative result. If the drug concentration is at the cutoff level or higher no band will form in the test zone (test line T) indicating a preliminary positive. A band should form in the control region reqardless of the presence of drug or metabolite in the sample.

#### 11. Performance Characteristics

#### 11.1. Analytical Performance

- a. Precision
Precision studies were carried out for samples with concentrations of -100%cut off, -50%cut off, -25%cut off, +25%cut off, +50%cut off , +75%cut off and +100%cut off. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following table.

#### Cup Format

| AMP 300: | | | | | | | | | |
|-----------------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|--------|
| Result | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>Cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off | |
| AMP 300 | | | | | | | | | |
| LOT W0770901CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W0770902CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W0770903CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

ARD 200

| | | | | MET 500: | | | | | |
|-----------------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|--------|
| Result | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>Cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off | |
| MET 500 | | | | | | | | | |
| LOT W1170901CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1170902CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1170903CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### Dip Card Format

| AMP 300: | | | | | | | | | |
|---------------|---------------|--------------|--------------|--------------|---------|--------------|--------------|--------------|---------------|
| 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 |
| AMP 300 | | | | | | | | | |
| LOT W0770901P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W0770902P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W0770903P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### MET 500:

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| Result | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|-----------------|-----------------|-----------------|-----------------|------------------|
| MET 500 | | | | | | | | |
| LOT W1170901P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1170902P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- |
| LOT W1170903P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- |

#### b. Linearity

Not applicable

# c. Stability

Stable for 18 months when stored at 4 to 30 ℃

#### d. Cut-off

| Test | Calibrator | Cut-off (ng/mL) |
|---------------------------------------------|----------------------|-----------------|
| Wondfo Amphetamine Urine Test (AMP 300) | d-Amphetamine | 300 |
| Wondfo Methamphetamine Urine Test (MET 500) | D(+)-Methamphetamine | 500 |

' .

#### e. Interference

Compounds that show no interference at a concentration of 100 µg/mL are summarized in the following tables.

| AMP 300 | | |
|-----------------------|-------------------------|---------------------|
| 4-Acetamidophenol | (-) Y Ephedrine | Penicillin-G |
| Acetophenetidin | Erythromycin | Pentazocaine |
| N-Acetylprocainamide | B-Estradiol | Pentobarbital |
| Acetylsalicylic acid | Estrone-3-sulfate | Perphenazine |
| Aminopyrine | Ethyl-p-aminobenzoate | Phencyclidine |
| Amitryptyline | Fenfluramine | Phenelzine |
| Amobarbital | Fenoprofen | Phendimetrazine |
| Amoxicillin | Furosemide | Phenobarbital |
| Ampicillin | Gentisic acid | Phetoin |
| Ascorbic acid | Hemoglobin | L-Phenylephrine |
| Apomorphine | Hydralazine | ẞ-Phenylethlamine |
| Aspartame | Hydrochlorothiazide | Phenylpropanolamine |
| Atropine | Hydrocodone | Prednisolone |
| Benzilic acid | Hydrocortisone | Prednisone |
| Benzoic acid | O-Hydroxyhippuric acid | Procaine |
| Benzoylecgonine | 3-Hydroxytyramine | Promazine |
| Bilirubin | Ibuprofen | Promethazine |
| Brompheniramine | Imipramine | D,L-Propanolol |
| Caffeine | (-) Isoproterenol | Propiomazine |
| Cannabidiol | Isoxsuprine | D-Propoxyphene |
| Cannabinol | Ketamine | Quinidine |
| Chloralhydrate | Ketoprofen | Quinine |
| Chloramphenicol | Labetalol | Ranitidine |
| Chlordiazepoxide | Levorphanol | Salicylic acid |
| Chlorothiazide | Loperamide | Secobarbital |
| (±) Chlorpheniramine | Maprotiline | Serotonin |
| Chlorpromazine | Meperidine | Sulfamethazine |
| Chlorquine | Meprobamate | Sulindac |
| Cholesterol | Methadone | Temazepam |
| Clomipramine | Methylphenidate | Tetracycline |
| Clonidine | Morphine-3-Dglucuronide | Tetrahydrocortisone |
| Cocaine hydrochloride | Nalidixic acid | Tetrahydrozoline |
| Codeine | Naloxone | Δ9-THC-COOH |
| Cortisone | Naltrexone | Thebaine |
| (-) Cotinine | Naproxen | Thiamine |
| Creatinine | Niacinamide | Thioridazine |
| Deoxycorticosterone | Nifedipine | D,L-Thyroxine |

·

AMP 300

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| Dextromethorphan | Norcodeine | Tolbutamine |
|------------------------|-------------------|-----------------|
| Diazepam | Norethindrone | Triamterene |
| Diclofenac | D-Norpropoxyphene | Trifluoperazine |
| Diflunisal | Noscapine | Trimethoprim |
| Digoxin | D,L-Octopamine | Trimipramine |
| Diphenhydramine | Oxalic acid | Tryptamine |
| Doxylamine | Oxazepam | D, L-Tyrosine |
| Ecgonine hydrochloride | Oxolinic acid | Uric acid |
| Ecgonine methylester | Oxycodone | Verapamil |
| (IR,2S)-(-)-Ephedrine | Oxymetazoline | Zomepirac |
| L-Ephedrine | Papaverine | |

# MET 500

.

| Acetamidophen | Gentisic acid | Oxycodone |
|------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Acetophenetidin | Glucuronide | Oxymetazoline |
| N-Acetylprocainamide | Glutethimide | Papaverine |
| Acetylsalicylate | Guaifenesin | Penicillin-G |
| Aminopyrine | Hippuric acid | Pentazocine |
| Amitryptyline | Hydralazine | Pentobarbital |
| Amobarbital | Hydrochlorothiazide | Perphenazine |
| Amoxicillin | Hydrocodone | Phencyclidine |
| Ampicillin | Hydrocortisone | Phenelzine |
| Apomorphine | O-Hydroxyhippuric acid | Phenobarbital |
| Aspartame | 3-Hydroxytyramine | Prednisolone |
| Atropine | Ibuprofen | Phenylpropanolamine |
| Benzilic acid | Imipramine | Prednisone |
| Benzoic acid | (-) Isoproterenol | Procaine |
| Benzoylecgonine | Isoxsuprine | Promazine |
| Butabartital | Ketamine | Promethazine |
| Cannabidiol | Ketoprofen | D,L-Propanolol |
| Chloralhydrate | Labetalol | D-Propoxyphene |
| Chloramphenicol | Levorphanol | D-Pseudoephedrine |
| Chlordiazepoxide | Loperamide | Quinidine |
| Chlorothiazide | Loxapine succinate | Quinine |
| Chlorpromazine | Maprotiline | Ranitidine |
| Cholesterol | Meperidine | Salicylic acid |
| Clomipramine | Meprobamate | Secobarbital |
| Clonidine | Methadone | Serotonin (5- Hydroxytyramine) |
| Cocaine hydrochloride | Methaqualone | Sulfamethazine |
| Codeine | Methylphenidal | Sulindac |
| Cortisone | Methyprylon | Temazepam |
| (-) Cotinine | Morphine-3- <span style="text-transform: lowercase;"> β</span> -Dglucuronide | Tetracycline |
| Creatinine | Nalidixic acid | Tetrahydrocortisone, 3-Acetate |
| Deoxycorticosterone | Nalorphine | Tetrahydrocortisone 3 ( <span style="text-transform: lowercase;"> β</span> -D glucuronide) |
| Dextromethorphan | Naloxone | Tetrahydrozoline |
| Diazepam | Naltrexone | Thebaine |
| Diclofenac | Naproxen | Thiamine |
| Diflunisal | Niacinamide | Thioridazine |
| Digoxin | Nifedipine | Tolbutamine |
| Diphenhydramine | Norcodein | Triamterene |
| Doxylamine | Norethindrone | Trifluoperazine |
| Ecgonine hydrochloride | Noroxymorphone | Trimethoprim |
| Ecgonine methyl ester | D-Norpropoxyphene | Trimipramine |
| Erythromycin | Noscapine | D, L-Tryptophan |
| β-Estradiol | Nylidrin | Tyramine |
| Estrone-3-sulfate | D, L-Octopamine | D, L-Tyrosine |
| Ethyl-p-aminobenzoate | Oxalic acid | Uric acid |
| Fenoprofen | Oxazepam | Verapamil |

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#### f. Specificity

To test the specificity, target drug, drug metabolites and other components that are likely to be present in urine samples were tested. Compounds that produced positive results with the test when tested at levels equal to or greater than the concentrations listed below. Percent cross reactivity of a compound is calculated by dividing the cutoff concentration by the minimum concentration required to obtain a positive result and the multiplying by 100%.

| AMP 300 | | |
|-------------------------------------------------------|--------------------------------------------------------------------------|--------------------|
| AMP(Amphetamine)<br>(d-Amphetamine, Cutoff=300 ng/mL) | Minimum concentration<br>required to obtain a positive<br>result (ng/mL) | % Cross-Reactivity |
| d-Amphetamine | 300 | 100% |
| I-Amphetamine | 17500 | 1.7% |
| dl-Amphetamine | 850 | 35.3% |
| (+/-) 3,4-methylenedioxyamphetamine (MDA) | 1000 | 30.0% |
| Phentermine | 1000 | 30.0% |
| β -Phenylethylamine | 100000 | 0.3% |
| Tyramine | 100000 | 0.3% |
| p-Hydroxynorephedrine | 100000 | 0.3% |
| Phenylpropanolamine | >100,000 | Not detected |
| (±)Phenylpropanolamine | >100,000 | Not detected |
| p-Hydroxyamphetamine | 100,000 | 0.3% |
| d/I-Norephedrine | 100,000 | 0.3% |
| d-Methamphetamine | >100,000 | Not detected |
| I-Methamphetamine | >100,000 | Not detected |
| (+/-)3,4-Methylenedioxyethylamphetamine<br>(MDE) | >100,000 | Not detected |
| (+/-)3,4-Methylenedioxymethamphetamine<br>(MDMA) | >100,000 | Not detected |
| Benzphetamine | >100,000 | Not detected |
| Ephedrine | >100,000 | Not detected |
| I-Ephedrine | >100,000 | Not detected |
| I-Epinephrine | >100,000 | Not detected |
| d/I-Epinephrine | >100,000 | Not detected |

| MET 500 | | |
|------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------|
| MET(Methamphetamine)<br>(D(+)-Methamphetamine, Cutoff=500 ng/mL) | Minimum concentration<br>required to obtain a positive<br>result (ng/mL) | % Cross-Reactivity |
| D(+)-Methamphetamine | 500 | 100% |
| D-Amphetamine | 50000 | 1.0% |
| Chloroquine | 10000 | 5.0% |
| (+/-)-Ephedrine | 25000 | 2.0% |
| (-)-Methamphetamine | 10000 | 5.0% |
| (+/-)3,4-<br>methylenedioxumethamphetamine(MDMA) | 1000 | 50.0% |
| β-Phenylethylamine | 25000 | 2.0% |
| Trimethobenzamide | 5000 | 10.0% |
| d/l-Amphetamine | 75,000 | 0.7% |
| p-Hydroxymethamphetamine | 15,000 | 3.3% |
| Mephentermine | 25,000 | 2.0% |

{6}------------------------------------------------

| ---------------------------------<br>-----------------<br><br>shedrine | 50.000 | and and the first of the first of the first of the first of the first and the may be<br>C<br>ﻟ |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------------------------------------------------------------------------------------------------|
| -Phenvlephrine<br>BALLER I BE BERE BEAULT<br>------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <br>100 000 | V.VI |

## 11.2. Comparison Studies

The method comparison for the Wondfo Amphetamine Urine Test (AMP 300), Wondfo Methamphetamine Urine Test (MET 500) were performed in-house with three laboratory assistants with relevant experience reading the instructions for use. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples were blind labeled and compared to GC/MS results. The results are presented in the table below:

#### AMP 300:

#### Cup Format

| | Wondfo Result | Drug-free | Low Negative by<br>GC/MS<br>(Less than -50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between -50%<br>and Cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>Cutoff and +50%) | High Positive by<br>GC/MS (Greater<br>than +50%) |
|----------|---------------|-----------|----------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 29 | 11 |
| | Negative | 10 | 17 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 29 | 11 |
| | Negative | 10 | 17 | 12 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 29 | 11 |
| | Negative | 10 | 17 | 12 | 0 | 0 |

#### Dip Card Format

| | Wondfo Result | Drug-free | Low Negative by<br>GC/MS<br>(Less than -50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between -50%<br>and Cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>Cutoff and +50%) | High Positive by<br>GC/MS (Greater<br>than +50%) |
|----------|---------------|-----------|----------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 29 | 11 |
| | Negative | 10 | 17 | 12 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 29 | 11 |
| | Negative | 10 | 17 | 12 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 29 | 11 |
| | Negative | 10 | 17 | 12 | 0 | 0 |

#### Discordant Results of AMP 300

| Viewer | Sample Number | GC/MS Result | Cup Format Viewer Result |
|----------|---------------|--------------|--------------------------|
| Viewer A | AMP3063 | 281 | Positive |
| Viewer A | AMP3216 | 259 | Positive |
| Viewer B | AMP3218 | 287 | Positive |
| Viewer C | AMP3063 | 281 | Positive |

| Viewer | Sample Number | GC/MS Result | Dip Card Format Viewer Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | AMP3218 | 287 | Positive |
| Viewer B | AMP3216 | 259 | Positive |
| Viewer C | AMP3063 | 281 | Positive |

#### MET 500:

Cup Format

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| | Wondfo Result | Drug-free | Low Negative by<br>GC/MS<br>(Less than -50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between -50%<br>and Cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>Cutoff and +50%) | High Positive by<br>GC/MS (Greater<br>than +50%) |
|----------|---------------|-----------|----------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 20 | 20 |
| | Negative | 10 | 15 | 13 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 20 | 20 |
| | Negative | 10 | 15 | 13 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 20 | 20 |
| | Negative | 10 | 15 | 13 | 0 | 0 |

#### Dip Card Format

| Wondfo Result | Drug-free | Low Negative by<br>GC/MS<br>(Less than -50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between -50%<br>and Cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>Cutoff and +50%) | High Positive by<br>GC/MS (Greater<br>than +50%) | |
|---------------|-----------|----------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------|----|
| Viewer A | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 20 | 20 |
| | Negative | 10 | 15 | 13 | 0 | 0 |

#### Discordant Results of MET 500

| Viewer | Sample Number | GC/MS Result | Cup Format Viewer<br>Result |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | MET5061 | 478 | Positive |
| Viewer A | MET5216 | 474 | Positive |
| Viewer B | MET5063 | 499 | Positive |
| Viewer B | MET5215 | 421 | Positive |
| Viewer C | MET5061 | 478 | Positive |
| Viewer C | MET5063 | 499 | Positive |
| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
| Viewer A | MET5063 | 499 | Positive |
| Viewer B | MET5061 | 478 | Positive |
| Viewer C | MET5061 | 478 | Positive |
| Viewer C | MET5063 | 499 | Positive |

#### 11.3. Clinical Studies

Not applicable

# 12. Conclusion

Based on the test principle and performance characteristics of the device, it's concluded that Wondfo Amphetamine Urine Test (AMP 300), Wondfo Methamphetamine Urine Test (MET 500) are substantially equivalent to the predicate devices.

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

# DEPARTMENT OF HEALTH & HUM AN SERVICES

Public Health Service

Food and Drug Administraion 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

# December 21, 2012

Guangzhou Wondfo Biotech Co., Ltd. LSI International Inc. c/o Joe Shia 504 East Diamond Ave. Suite F Gaithersburg, MD 20878

Re: k122961

Trade/Device Name: Wondfo Amphetamine Urine Test (AMP 300) Wondfo Methamphetamine Urine Test (MET 500)

Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: DKZ, LAF Dated: November 8, 2012 Received: November 13, 2012

Dear Mr Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Mr. Joe Shia

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

#### Carol C. Benson for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices In Vitro Diagnosticsand Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K122961

Wondfo Amphetamine Urine Test (AMP 300) Device Name: Wondfo Methamphetamine Urine Test (MET 500)

Indications for Use:

Wondfo Amphetamine Urine Test (AMP 300):

Wondfo Amphetamine Urine Test (AMP 300) is an immunochromatographic assay for the qualitative determination of d-Amphetamine in human urine at a cutoff concentration of 300 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. For in vitro diagnostic use only.

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 Methamphetamine Urine Test (MET 500):

Wondfo Methamphetamine Urine Test (MET 500) is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a cutoff concentration of 500 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. For in vitro diagnostic use only.

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

enise Johnson-Lyles
Division Sign Off

Office of In Vitro Diagnostics and Radiological Health 510(k) 1961

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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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnsonlephs
Division Sign-Off

Office of In Vitro Diagnostics and Radiological Health 510(k) K177961