WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)

K131232 · Guangzhou Wondfo Biotech Co., Ltd. · DJR · May 31, 2013 · Clinical Toxicology

Device Facts

• Record ID: K131232
• Device Name: WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DJR · Clinical Toxicology
• Decision Date: May 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

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 Story

Lateral flow immunochromatographic assay for qualitative detection of Methadone or Morphine in human urine; utilizes competitive binding principle. Device consists of absorbent end, monoclonal antibody-dye conjugate, and pre-coated membrane with drug-protein conjugates. Urine sample migrates via capillary action; analyte below cut-off binds to immobilized drug-protein conjugate in test region (colored line = negative); analyte above cut-off binds to antibody-dye conjugate (no line = positive). Available in Dip Card or Cup formats. Used in clinical/laboratory settings by professional staff. Provides preliminary results to assist clinical decision-making; requires confirmatory testing via GC/MS. Benefits include rapid screening for drug presence.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (25 days, two runs/day) and method comparison against GC/MS using 80 clinical samples. Results demonstrated concordance with GC/MS. Interference and specificity tested against numerous physiological/pathological compounds; no interference observed. Stability confirmed for 18 months at 4-30°C.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials: monoclonal antibody-dye conjugate, gold chloride, drug-protein conjugates, anti-mouse IgG polyclonal antibody. Formats: Dip Card and Cup. Standalone device; no energy source required. Visual readout.

Indications for Use

Indicated for qualitative detection of Methadone (200 ng/mL) or Morphine (100 ng/mL) in human urine. Intended for prescription use only; not for point-of-care use. Provides preliminary results requiring GC/MS confirmation.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

{0}------------------------------------------------

#### 510(k) SUMMARY

MAY 3 1 2013

1. Date:

May 29, 2013

2. Submitter:

3. 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: [phone] Fax: [phone] Email:[e-mail]

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

Classification:

| Product<br>Code | CFR # | Panel |
|-----------------|-------------------------------------------|------------|
| DJR | 21 CFR, 862.3620 Methadone Test<br>System | Toxicology |
| DJG | 21 CFR, 862.3640 Morphine Test<br>System | Toxicology |

- 5. Predicate Devices:
- K050394

Medtox Diagnostics Sure-Screen

1

- 6. 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.

- 8. 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 -<br>K050394 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>Methadone in human urine. For<br>prescription use. | Same (but the<br>number of drugs<br>detected is<br>different) |
| Calibrator | Methadone | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative to indicate positive or negative<br>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

| Item | Device | Predicate - K050394 |
|--------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>Morphine in human urine. For<br>prescription use. | Same(but the number<br>of drugs detected is<br>different) |

{2}------------------------------------------------

| Item | Device | Predicate - K050394 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Calibrator | Morphine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative to indicate positive or<br>negative result | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 100 ng/mL | Same |
| Configurations | Cup, Dip Card | Cup |

#### 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%<br>Cut-Off | -75%<br>Cut-Off | -50%<br>Cut-Off | -25%<br>Cut-Off | Cut-Off | +25%<br>Cut-Off | +50%<br>Cut-Off | +75%<br>Cut-Off | +100%<br>Cut-Off |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| MTD 200 | | | | | | | | | |
| LOT<br>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<br>W1570902 <br>CU2 | | 50-10+ 20-10+ | 50-10+ | 50-10+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT<br>W1570903<br>CU2 | 50-10+ | 50-10+ | 50-10+ 50-10+ | | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

## MOP 100

| Result | -100%<br>Cut-Off | -75%<br>Cut-Off | -50%<br>Cut-Off | -25%<br>Cut-Off | Cut-Off | +25%<br>Cut-Off | +50%<br>Cut-Off | +75%<br>Cut-Off | +100%<br>Cut-Off |
|------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| LOT<br>W1670901<br>CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT<br>W1670902<br>CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT<br>W1670903<br>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<br>MTD 200 | -100%<br>Cut-Off | -75%<br>Cut-Off | -50%<br>Cut-Off | -25%<br>Cut-Off | Cut-Off | +25%<br>Cut-Off | +50%<br>Cut-Off | +75%<br>Cut-Off | +100%<br>Cut-Off |
|----------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| LOT<br>W1570901<br>P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT<br>W1570902<br>P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT<br>W1570903<br>P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

## MOP 100

| Result<br>MOR 100 | -100%<br>Cut-Off | -75%<br>Cut-Off | -50%<br>Cut-Off | -25%<br>Cut-Off | Cut-Off | +25%<br>Cut-Off | +50%<br>Cut-Off | +75%<br>Cut-Off | +100%<br>Cut-Off |
|----------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| LOT<br>W1670901<br>P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT<br>W1670902<br>P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT<br>W1670903<br>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<br>(ng/mL) |
|------------------------------------------|------------|--------------------|
| Wondfo Methadone Urine Test (MTD<br>200) | Methadone | 200 |
| Wondfo Morphine Urine Test (MOP<br>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.

| Acetaminophen | Erythromycin | Oxymetazoline |
|------------------------|--------------------------------------------------|---------------------------------------------------|
| Acetophenetidin | β-Estradiol | Papaverine |
| N-Acetylprocainamide | Estrone-3-sulfate | Penicillin-G |
| Acetylsalicylic acid | Ethyl-p-aminobenzoate | Pentazocine hydrochloride |
| Aminopyrine | Fenoprofen | Pentobarbital |
| Amitryptyline | Furosemide | Perphenazine |
| Amobarbital | Gentisic acid | Phencyclidine |
| Amoxicillin | Hemoglobin | Phenelzine |
| Ampicillin | Hydralazine | Phenobarbital |
| L-Ascorbic acid | Hydrochlorothiazide | Phentermine |
| DL-Amphetamine sulfate | Hydrocodone | Trans-2-phenylcyclo-propyl<br>amine hydrochloride |
| Apomorphine | Hydrocortisone | L-Phenylephrine |
| Aspartame | O-Hydroxyhippuric acid | β-Phenylethylamine |
| Atropine | p-Hydroxyamphetamine | Phenylpropanolamine |
| Benzilic acid | p-Hydroxymethamphetamine | Prednisolone |
| Benzoic acid | 3-Hydroxytyramine | Prednisone |
| Benzoylecgonine | Ibuprofen | Procaine |
| Benzphetamine | Imipramine | Promazine |
| Bilirubin | Iproniazid | Promethazine |
| (±) - Brompheniramine | (±) - Isoproterenol | DL-Propranolol |
| Caffeine | Isoxsuprine | D-Propoxyphene |
| Cannabidiol | Ketamine | D-Pseudoephedrine |
| Cannabinol | Ketoprofen | Quinacrine |
| Chloralhydrate | Labetalol | Quinidine |
| Chloramphenicol | Levorphanol | Quinine |
| Chlorothiazide | Loperamide | Ranitidine |
| (±) - Chlorpheniramine | Mephentermine | Salicylic acid |
| Chlorpromazine | Maprotiline | Secobarbital |
| Chlorquine | Meperidine | Serotonin |
| Cholesterol | Meprobamate | Sulfamethazine |
| Clomipramine | Methamphetamine | Sulindac |
| Clonidine | Methoxyphenamine | Tetracycline |
| Cocaethylene | (±)-3,4-Methylenedioxy-amphetamine hydrochloride | Tetrahydrocortisone, 3-acetate |
| Cocaine hydrochloride | Morphine-3-B-D glucuronide | Tetrahydrozoline |
| Codeine | Morphine Sulfate | Thebaine |
| Cortisone | Nalidixic acid | Thiamine |
| (-) Cotinine | Naloxone | Thioridazine |
| Creatinine | Naltrexone | DL-Tyrosine |
| Deoxycorticosterone | Naproxen | Tolbutamide |
| Dextromethorphan | Niacinamide | Triamterene |
| Diazepam | Nifedipine | Trifluoperazine |
| Diclofenac | Norcodein | Trimethoprim |
| Diflunisal | Norethindrone | Trimipramine |
| Digoxin | D-Norpropoxyphene | Tryptamine |
| Diphenhydramine | Noscapine | DL-Tryptophan |
| Ecgonine hydrochloride | DL-Octopamine | Tyramine |
| Ecgonine methyl ester | Oxalic acid | Uric acid |
| (-) - Ψ-Ephedrine | Oxazepam | Verapamil |
| [1R,2S] (-) Ephedrine | Oxolinic acid | Zomepirac |
| (L) - Epinephrine | Oxycodone | |

MTD 200

{5}------------------------------------------------

and the comments of the country

.

and the contraction of the comments of the country of

:

.

.

.

:

. . . . .

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

MOP 100

| 4-Acetamidophenol | Ecgonine methylester | Oxolinic acid |
|------------------------|-------------------------------------------|-------------------------------------------|
| Acetophenetidin | (-) -Y -Ephedrine | Oxymetazoline |
| N-Acetylprocainamide | Erythromycin | Papaverine |
| Acetylsalicylic acid | B-Estradiol | Penicillin-G |
| Aminopyrine | Estrone-3-sulfate | Pentazocine |
| Amitryptyline | Ethyl-p-aminobenzoate | Pentobarbital |
| Amobarbital | Fenoprofen | Perphenazine |
| Amoxicillin | Furosemide | Phencyclidine |
| Ampicillin | Gentisic acid | Phenelzine |
| Ascorbic acid | Hemoglobin | Phenobarbital |
| D,L-Amphetamine | Hydralazine | Phentermine |
| Apomorphine | Hydrochlorothiazide | L-Phenylephrine |
| Aspartame | Hydrocortisone | β-Phenylethylamine |
| Atropine | O-Hydroxyhippuric acid | Phenylpropanolamine |
| Benzilic acid / | p-Hydroxy methamphetamine | Prednisone |
| Benzoic acid | 3-Hydroxytyramine | D,L-Propanolol |
| Benzoylecgonine | Ibuprofen | D-Propoxyphene |
| Benzphetamine | Imipramine | D-Pseudoephedrine |
| Bilirubin (±) | Iproniazid | Quinidine |
| Brompheniramine | Isoproterenol | Quinine |
| Caffeine | Isoxsuprine | Ranitidine |
| Cannabidiol | Ketamine | Salicylic acid |
| Chloralhydrate | Ketoprofen | Secobarbital |
| Chloramphenicol | Labetalol | Serotonin<br>(5-Hydroxytyramine) |
| Chlordiazepoxide | Loperamide | Sulfamethazine |
| Chlorothiazide | Maprotiline | Sulindac |
| (±) Chlorpheniramine | Meperidine | Temazepam |
| Chlorpromazine | Meprobamate | Tetracycline |
| Chlorquine | Methadone | Tetrahydrocortisone,<br>3 Acetate |
| Cholesterol | Methoxyphenamine | Tetrahydrocortisone3<br>(β-D glucuronide) |
| Clomipramine | (+) 3,4-Methylenedioxy-amphetamine | Tetrahydrozoline |
| Clonidine | (+)3,4-Methylenedioxy-methamphetamin<br>e | Thiamine |
| Cocaine hydrochloride | Nalidixic acid | Thioridazine |
| Cortisone | Nalorphine | D, L-Tyrosine |
| (-) Cotinine | Naloxone | Tolbutamide |
| Creatinine | Naltrexone | Triamterene |
| Deoxycorticosterone | Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Trimethoprim |
| Diazepam | Nifedipine | Trimipramine |
| Diclofenac | Norethindrone | Tryptamine |
| Diflunisal | D-Norpropoxyphene | D, L-Tryptophan |
| Digoxin | Noscapine | Tyramine |
| Diphenhydramine | D,L-Octopamine | Uric acid |
| Doxylamine | Oxalic acid | Verapamil |
| Ecgonine hydrochloride | Oxazepam | Zomepirac |

・

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

ﺎ

:

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)<br>(Methadone, Cut-off=200 ng/mL) | Minimum Concentration<br>Required to Obtain a<br>Positive Result (ng/mL) | %<br>Cross-Reactivity |
| Methadone | 200 | 100 |
| Doxylamine | 40,000 | 0.5 |
| | MOP 100 | |
| MOR(Morphine) | Minimum Concentration | % |
| (Morphine, Cut-off=100 ng/mL) | Required to Obtain a | Cross-Reactivity |

{9}------------------------------------------------

| | Positive Result (ng/mL) | |
|----------------------------|-------------------------|------|
| Morphine | 100 | 100 |
| Codeine | 100 | 100 |
| Ethylmorphine | 200 | 50 |
| Hydrocodone | 400 | 25 |
| Hydromorphine | 200 | 50 |
| Levorphanol | 5000 | 2.0 |
| σ-Monoacetylmorphine | 200 | 50 |
| Morphine 3-β-D-glucuronide | 200 | 50 |
| Norcodeine | 500 | 20 |
| Normorphone | 5000 | 2.0 |
| Oxycodone | 1000 | 10 |
| Oxymorphine | 1000 | 10 |
| Procaine | 100000 | <1.0 |
| Thebaine | 5000 | 2.0 |

f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, the urine samples, with 1.000~1.035 specific 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 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. The results are presented in the table below:

#### MTD 200:

| 11 | H 1 | | 1<br>11<br>ormat |
|----|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | |

| | Wondfo Result | Drug-free | Low Negative<br>by GC/MS<br>(Less than<br>-50%) | Near Cut-Off<br>Negative by<br>GC/MS<br>(Between -50%<br>and Cut-Off) | Near Cut-Off<br>Positive by<br>GC/MS<br>(Between the<br>Cut-Off and<br>+50%) | High Positive<br>by GC/MS<br>(Greater than<br>+50%) |
|----------|---------------|-----------|-------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 15 | 25 |
| | Negative | 10 | 13 | 15 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 15 | 25 |

{10}------------------------------------------------

| | Negative | 10 | 13 | 15 | 0 | 0 |
|----------|----------|----|----|----|----|----|
| Viewer C | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 13 | 16 | 0 | 0 |

Dip Card Format

| Wondfo Result | Drug-free | Low Negative by GC/MS<br>(Less than -50%) | Near Cut-Off Negative by GC/MS<br>(Between -50% and Cut-Off) | Near Cut-Off Positive by GC/MS<br>(Between the Cut-Off and +50%) | High Positive by GC/MS<br>(Greater than +50%) | |
|---------------|-----------|-------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------|----|
| Viewer A | Positive | 0 | 0 | 1 | 15 | 25 |
| | Negative | 10 | 13 | 16 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 15 | 25 |
| | Negative | 10 | 13 | 15 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 15 | 25 |
| | Negative | 10 | 13 | 15 | 0 | 0 |

# Discordant Results of MTD 200

| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Result |
|----------|---------------|--------------|-----------------------------|
| Viewer A | MTD2061 | I 86 | Positive |
| Viewer A | MTD2063 | 192 | Positive |
| Viewer B | MTD2061 | 186 | Positive |
| Viewer B | MTD2063 | 192 | Positive |
| Viewer C | MTD2063 | 192 | Positive |

r

| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | MTD2061 | 186 | Positive |
| Viewer B | MTD2061 | 186 | Positive |
| Viewer B | MTD2063 | 192 | Positive |
| Viewer C | MTD2061 | 186 | Positive |
| Viewer C | MTD2063 | 192 | Positive |

11

{11}------------------------------------------------

# Cup Format

| | Wondfo Result | Drug-free | Low Negative<br>by GC/MS<br>(Less than<br>-50%) | Near Cut-Off<br>Negative by<br>GC/MS<br>(Between -50%<br>and Cut-Off) | Near Cut-Off<br>Positive by<br>GC/MS<br>(Between the<br>Cut-Off and<br>+50%) | High Positive<br>by GC/MS<br>(Greater than<br>+50%) |
|----------|---------------|-----------|-------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 28 | 12 |
| | Negative | 10 | 16 | 12 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 28 | 12 |
| | Negative | 10 | 16 | 11 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 28 | 12 |
| | Negative | 10 | 16 | 12 | 0 | 0 |

Dip Card Format

| | Wondfo Result | Drug-free | Low Negative<br>by GC/MS<br>(Less than<br>-50%) | Near Cut-Off<br>Negative by<br>GC/MS<br>(Between -50%,<br>and Cut-Off) | Near Cut-Off<br>Positive by<br>GC/MS<br>(Between the<br>Cut-Off and<br>+50%) | High Positive<br>by GC/MS<br>(Greater than<br>+50%) |
|----------|---------------|-----------|-------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 3 | 28 | 12 |
| | Negative | 10 | 16 | 11 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 28 | 12 |
| | Negative | 10 | 16 | 12 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 28 | 12 |
| | Negative | 10 | 16 | 11 | 0 | 0 |

# Discordant Results of MOP 100

| Viewer | Sample Number GC/MS Result | Cup Format<br>Viewer Result |
|--------|------------------------------|-----------------------------|
| | | |

:

{12}------------------------------------------------

| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Result |
|----------|---------------|--------------|-----------------------------|
| Viewer A | OPI1061 | 98 | Positive |
| Viewer A | OPI1215 | 97 | Positive |
| Viewer B | OPI1063 | 95 | Positive |
| Viewer B | OPI1061 | 98 | Positive |
| Viewer B | OPI1215 | 97 | Positive |
| Viewer C | OPI1064 | 93 | Positive |
| Viewer C | OPI1061 | 98 | Positive |

| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | OPI1064 | 93 | Positive |
| Viewer A | OPI1061 | 98 | Positive |
| Viewer A | OPI1215 | 97 | Positive |
| Viewer B | OPI1063 | 95 | Positive |
| Viewer B | OPI1215 | 97 | Positive |
| Viewer C | OPI1062 | 94 | Positive |
| Viewer C | OPI1065 | 94 | Positive |
| Viewer C | OPI1063 | 95 | Positive |

- 3. Clinical Studies ﻟﻘﺮﺭ ﺍﻟﻤﺮﺍﺟﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ
Not applicable

## 11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that Wondfo Methadone Urine Test (MTD 200), and Wondfo Morphine . Urine Test (MOP 100) are substantially equivalent to the predicate.

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2013 ,

Guangzhou Wondfo Biotech Co., Ltd. C/O Mr. Joe Shia LSI International Inc. 504 East Diamond Ave. Suite F GAITHERSBURG MD 20878

Re: K131232

Trade/Device Name: Wondfo Methadone Urine Test (MTD 200) Wondfo Morphine Urine Test (MOP 100) Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: II · Product Code: DJR, DJG Dated: April 26, 2013 Received: May 06, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{14}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportaProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

.

Sincerely yours,

Carol C. Benson -S for

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

Enclosure

{15}------------------------------------------------

# Indications for Use

#### 510(k) Number (if known): K131232

### Device Name: Wondfo Methadone Urine Test (MTD 200) Wondfo Morphine Urine Test (MOP 100)

Indications for Use:

#### Wondfo Methadone Urine Test (MTD 200)

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.

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 Johnson=lyless=5
2013.05.31 10:04:45:304:00

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k131232

{16}------------------------------------------------

# Indications for Use

### 510(k) Number (if known): K131232

### Device Name: Wondfo Methadone Urine Test (MTD 200) Wondfo Morphine Urine Test (MOP 100)

Indications for Use:

#### Wondfo Morphine Urine Test (MOP 100)

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.

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 Johnson​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k131232