WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
Device Facts
| Record ID | K132630 |
|---|---|
| Device Name | WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) |
| Applicant | Guangzhou Wondfo Biotech Co., Ltd. |
| Product Code | DJC · Clinical Toxicology |
| Decision Date | Sep 27, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
Intended Use
Wondfo Methamphetamine Urine Test (MET 300) is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a Cut-Off 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. 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 Oxazepam Urine Test (BZO 200) is an immunochromatographic assay for the qualitative determination of Oxazepam 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.
Device Story
Lateral flow immunochromatographic assay for qualitative detection of D(+)-Methamphetamine and Oxazepam in human urine. Device formats include Dip Card and Cup. Principle: competitive binding; urine sample migrates via capillary action across membrane pre-coated with drug-protein conjugates; antibody-dye conjugate binds to target analyte if present. Absence of colored test line indicates positive result; presence indicates negative result. Used in clinical settings by professionals; not for point-of-care. Provides preliminary results requiring GC/MS confirmation. Assists healthcare providers in identifying drug presence to inform clinical decision-making.
Clinical Evidence
Bench testing only. Precision studies performed over 25 days with multiple concentrations. Specificity and interference testing conducted with various physiological/pathological compounds. Method comparison study performed in-house using 80 clinical samples (40 positive, 40 negative) compared against GC/MS reference method. Results showed high concordance with GC/MS.
Technological Characteristics
Lateral flow immunochromatographic assay. Components: monoclonal antibody-dye conjugate, gold chloride, drug-protein conjugates, anti-mouse IgG polyclonal antibody. Formats: Dip Card and Cup. Stable at 4-30°C for 18 months. No electronic components or software.
Indications for Use
Indicated for the qualitative detection of D(+)-Methamphetamine (300 ng/mL cutoff) or Oxazepam (200 ng/mL cutoff) in human urine. Intended for prescription use only; not for point-of-care use. Requires confirmatory testing via GC/MS.
Regulatory Classification
Identification
A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Special Controls
*Classification.* Class II (special controls). A methamphetamine 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).
Related Devices
- K161251 — CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests · Hangzhou Clongene Biotech Co., Ltd. · Aug 30, 2016
- K121987 — WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST · Guangzhou Wondfo Biotech Co., Ltd. · Aug 1, 2012
- K122961 — WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) · Guangzhou Wondfo Biotech Co., Ltd. · Dec 21, 2012
Submission Summary (Full Text)
{0}------------------------------------------------
#### 510(k) SUMMARY
| 1. Date: | September 26, 2013 |
|-------------------|--------------------|
| 2. 510(K) Number: | k132630 |
3. Submitter: Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641
4. Contact person:
Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6213 Email:shiajl@yahoo.com
- 5. Device Name: Wondfo Methamphetamine Urine Test (MET 300) Wondfo Oxazepam Urine Test (BZO 200)
Classification: Class II
| Product<br>Code | CFR # | Panel |
|-----------------|------------------------------------------------|------------|
| DJC | 21 CFR 862.3610 Methamphetamine Test<br>System | Toxicology |
| JXM | 21 CFR 862.3170 Benzodiazepine Test<br>System | Toxicology |
- 6. Predicate Devices: K050394
Medtox Diagnostics Sure-Screen
- 7. Intended Use
Wondfo Methamphetamine Urine Test (MET 300) is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a Cut-Off 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.
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.
8
P 2 7 2013
{1}------------------------------------------------
Wondfo Oxazepam Urine Test (BZO 200) is an immunochromatographic assay for the qualitative determination of Oxazepam 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.
## 8. Device Description
Immunochromatographic assays for Methamphetamine and Oxazepam Urine Tests use a lateral flow, one step system for the qualitative detection of D(+)-Methamphetamine and Oxazepam (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. Oxazepam is part of the Benzodiazepine class of drugs of abuse.
#### 9. Substantial Equivalence Information
A summary comparison of features of the Wondfo Methamphetamine Urine Test (MET 300) and Wondfo Oxazepam Urine Test (BZO 200) and the predicate device is provided in Table 1.
## Table 1: Features Comparison of Wondfo Methamphetamine Urine Test (MET300) and Wondfo Oxazepam Urine Test (BZO 200) and the Predicate Device
| Item | Device | Predicate - K050394 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. For<br>prescription use. | Same |
| Calibrator | D(+)-Methamphetamine and<br>Oxazepam | D(+)-Methamphetamine<br>and Nordiazepam |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays<br>based on the principle of antigen<br>antibody immunochemistry. | Same |
| Type of Test | Qualitative to indicate positive or<br>negative result | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL(MET) and<br>200 ng/mL (Oxazepam/BZO) | Same |
| Configurations | Cup, Dip Card | Cup |
{2}------------------------------------------------
## 10. Test Principle
It is a rapid test for the qualitative detection of D(+)-Methamphetamine and Oxazepam 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.
#### 11. 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 tables.
| | 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 |
|------------------|---------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| MET 300 | LOT W1171001<br>CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | LOT W1171002<br>CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | LOT W1171003<br>CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Oxazepam BZO 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 |
| BZO 200 | LOT W0970901<br>CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
50-10+
20-10+
46+/4-
46+/4-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
50+/0-
MET 300
## Cup Format
20-10+
50-10+
W0970903
20-10+
20-10+
50-10+
20-10+
50+/0-
50+/0-
{3}------------------------------------------------
## Dip Card Format
| | 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 |
|---------|-------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| MET 300 | LOT W1171001<br>P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | LOT W1171002<br>P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | LOT W1171003<br>P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Oxazepam BZO 200
| Result | BZO 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 W0970901<br>P | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W0970902<br>P | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W0970903<br>P | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## b. Linearity
Not applicable
c. Stability
The test devices are 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°C and 30°C.
## d. Cut-off
A 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 Methamphetamine and Oxazepam. The following cut-off values for the test devices have been verified.
| Test | Calibrator | Cut-off<br>(ng/mL) |
|------------------------------------------------|----------------------|--------------------|
| Wondfo Methamphetamine Urine Test (MET<br>300) | D(+)-Methamphetamine | 300 |
| Wondfo Oxazepam Urine Test (BZO 200) | Oxazepam | 200 |
e. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine
{4}------------------------------------------------
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.
| 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 |
| Atropinne | 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-β-Dglucuronide | Tetracycline |
| Creatinine | Nalidixic acid | Tetrahydrocortisone, |
| | | 3-Acetate |
| Deoxycorticosterone | Nalorphine | Tetrahydrocortisone |
| | | 3 (β-D glucuronide) |
| Dextromethorphan | Naloxone | Tetrahydrozoline |
| Diazepam | Naltrexone | Thebaine |
| Diclofenac | Naproxen | Thiamine |
MET 300
{5}------------------------------------------------
| 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 |
| Furosemide | Oxolinic acid | Zomepirac |
## Oxazepam BZO 200
| 4-Acetamidophenol | Diphenhydramine | Oxalic acid |
|----------------------|----------------------------|-------------------------------------------|
| Acetophenetidin | Doxylamine | Oxolinic acid |
| N-Acetvprocainamide | Ecaonine dydrochloride | Pentobarbital |
| Acetvsalicylic acid | Ecqonine methylester | Perphenazine |
| Aminopyrine | (-)-Y-Ephedrine | Phencyclidine |
| Amitriptyline | Fenoprofen | Phenelzine |
| Amorbarbital | Furosemide | Phenobarbital |
| Amoxicillin | Gentisic acid | Phentermine |
| Ampicillin | Hemoglobin | L-Phenylephrine |
| 1-Ascorbic Acid | Hydrocortisone | b-Phenylethylamine |
| D.L-Amphetamine | O-Hydroxyhippuric acid | Phenylpropanotamine |
| Apormorphine | p-Hydroxy- methamphetamine | Prednisone |
| Aspartame | 3-Hydroxytyramine | D.L-Propanolol |
| Atropine | Ibuprofen | D-Propoxyphene |
| Benzilic acid | Imipramine | D-Pseudoephedrine |
| Benzoic acid | Iproniazid | Quinine |
| Benzoylecgonine | (±)Isoproterenol | Ranitidine |
| Benzphetamine | Isoxsuprine | Salicylic acid |
| Bilirubin | Ketamine | Secobarbital |
| (±) Chlorpheniramine | Ketoprofen | Serotonin |
| | | (5-Hydroxytyramine) |
| Caffeine | Labetalol | Sertraline |
| Cannabidiol | Loperamide | Sulfamethazine |
| Chloralhydrate | Maprotiline | Sulindac |
| Chloramphenicol | Meperidine | Tetrahydrocortisone, 3 Acetate |
| Chlordiazepoxide | Meprobamate | Tetrahydrocortisone, (b-D<br>glucuronide) |
| Chlorothiazide | Methadone | Tetrahydrozoline |
| (±)Chlorpheniramine | Methoxyphenamine | Thiamine |
| Chlorpromazine | (+) 3,4-Methylenedioxy- | Thioridazine |
. .
{6}------------------------------------------------
| | amphetamine | |
|-----------------------|-------------------------------------------|-----------------|
| Chloroquine | (+)3,4-Methylenedioxy-<br>methamphetamine | D.L-Tyrosine |
| Cholesterol | Nalidixic acid | Tolbutamide |
| Clomipramine | Nalorphine | Triamterene |
| Clonidine | Naloxone | Trifluoperazine |
| Cocaine hydrochloride | Naltrexone | Trimethoprim |
| Cortisone | Naproxen | Tryptamine |
| (-)cotinine | Niacinamide | D.L-Tryptophan |
| Creatinine | Nifedipine | Tyramine |
| Dextromethorphan | Norethindrone | Uric acid |
| Diclofenac | D-Norpropoxyphene | Verapamil |
| Diflunisal | Noscapine | Zomepirac |
| Digoxin | D.L-Octopamine | |
## 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.
| MET(Methamphetamine)<br>(D(+)-Methamphetamine, Cut-off=300 ng/mL) | Minimum<br>Concentration<br>Required to<br>Obtain a<br>Positive Result<br>(ng/mL) | %<br>Cross-Reactivity |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------|
| D(+)-Methamphetamine | 300 | 100% |
| D-Amphetamine | 40,000 | <1% |
| Chloroquine | 8,000 | 3.8% |
| (+/-)-Ephedrine | 20,000 | 1.5% |
| (-)-Methamphetamine | 8,000 | 3.8% |
| (+/-)3,4-methylenedioxumethamphetamine(MDMA) | 800 | 37.5% |
| β-Phenylethylamine | 10,000 | 3% |
| Trimethobenzamide | 3,000 | 10% |
{7}------------------------------------------------
| | Minimum | |
|------------------------------------------------|------------------------------------------------------------------|-----------------------|
| BZO(Oxazepam)<br>(Oxazepam, Cut-off=200 ng/mL) | Concentration<br>Required to Obtain a<br>Positive Result (ng/mL) | %<br>Cross-Reactivity |
| Oxazepam | 200 | 100% |
| Alprazolam | 50 | 400% |
| a-Hydroxyalprazolam | 500 | 40% |
| Bromazepam | 500 | 40% |
| Chlordiazepoxide | 800 | 25% |
| Clonazepam HCl | 400 | 50% |
| Clobazam | 50 | 400% |
| Clonazepam | 400 | 50% |
| Clorazepate dipotassium | 50 | 400% |
| Delorazepam | 500 | 40% |
| Desalkylflurazepam | 200 | 100% |
| Diazepam | 50 | 400% |
| Estazolam | 1000 | 20% |
| Flunitrazepam | 200 | 100% |
| D,L-Lorazepam | 800 | 25% |
| Midazolam | 5000 | 4% |
| Nitrazepam | 50 | 400% |
| Norchlordiazepoxide | 100 | 200% |
| Nordiazepam | 200 | 100% |
| Temazepam | 50 | 400% |
| Triazolam | 500 | 40% |
#### Oxazenam BZO 200
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 Methamphetamine Urine Test (MET 300), Wondfo Oxazepam Urine Test (BZO 200) 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:
{8}------------------------------------------------
MET 300:
| 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 | 21 | 19 |
| | Negative | 10 | 11 | 17 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 21 | 19 |
| | Negative | 10 | 11 | 17 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 21 | 19 |
| | Negative | 10 | 11 | 17 | 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 | 21 | 19 |
| | Negative | 10 | 11 | 16 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 21 | 19 |
| | Negative | 10 | 11 | 17 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 21 | 19 |
| | Negative | 10 | 11 | 16 | 0 | 0 |
# Discordant Results of MET 300
| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Result |
|----------|---------------|--------------|-----------------------------|
| Viewer A | MET3212 | 294 | Positive |
| Viewer A | MET3214 | 293 | Positive |
| Viewer B | MET3212 | 294 | Positive |
| Viewer B | MET3213 | 294 | Positive |
| Viewer C | MET3062 | 281 | Positive |
| Viewer C | MET3213 | 294 | Positive |
| Viewer | Sample Number GC/MS Result | | Dip Card Format<br>Viewer Results |
|----------|------------------------------|-----|-----------------------------------|
| Viewer A | MET3062 | 281 | Positive |
{9}------------------------------------------------
| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | MET3212 | 294 | Positive |
| Viewer A | MET3213 | 294 | Positive |
| Viewer B | MET3212 | 294 | Positive |
| Viewer B | MET3213 | 294 | Positive |
| Viewer C | MET3061 | 280 | Positive |
| Viewer C | MET3062 | 281 | Positive |
| Viewer C | MET3214 | 293 | Positive |
## Oxazepam BZO 200:
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 | 22 | 18 |
| | Negative | 10 | 18 | 10 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 22 | 18 |
| | Negative | 10 | 18 | 11 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 22 | 18 |
| | Negative | 10 | 18 | 11 | 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 | 2 | 22 | 18 |
| | Negative | 10 | 18 | 10 | 0 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 22 | 18 |
| | Negative | 10 | 18 | 10 | 0 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 22 | 18 |
| | Negative | 10 | 18 | 10 | 0 | 0 |
# Discordant Results of Oxazepam BZO 200
| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Result |
|----------|---------------|--------------|-----------------------------|
| Viewer A | BZO2065 | 182 | Positive |
| Viewer A | BZO2063 | 186 | Positive |
{10}------------------------------------------------
| Viewer | Sample Number | GC/MS Result | Cup Format<br>Viewer Result |
|----------|---------------|--------------|-----------------------------|
| Viewer B | BZO2063 | 186 | Positive |
| Viewer C | BZO2062 | 178 | Positive |
| Viewer | Sample Number | GC/MS Result | Dip Card Format<br>Viewer Results |
|----------|---------------|--------------|-----------------------------------|
| Viewer A | BZO2062 | 178 | Positive |
| Viewer A | BZO2063 | 186 | Positive |
| Viewer B | BZO2062 | 178 | Positive |
| Viewer B | BZO2065 | 182 | Positive |
| Viewer C | BZO2063 | 186 | Positive |
| Viewer C | BZO2216 | 171 | Positive |
3. Clinical Studies
Not applicable
## 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 Methamphetamine Urine Test (MET 300) and Wondfo Oxazepam Urine Test (BZO 200) are substantially equivalent to the predicate.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
September 27, 2013
Guangzhou Wondfo Biotech Co., Ltd. c/o Joe Shia 504 East Diamond Ave. Suite F GAITHERSBURG MD 20878
Re: K132630
Trade/Device Name: Wondfo Methamphetamine Urine Test (MET 300) Wondfo Oxazepam Urine Test (BZO 200); Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Il Product Code: DJC, JXM Dated: August 11, 2013
Received: August 22, 2013
Dear Mr. Shia:
We have reviewed your Scction 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 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 Parts 801 and 809); medical device reporting of medical 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.
{12}------------------------------------------------
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.lda.gov/MedicalDevices/Safetv/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincercly yours.
# Courtney H. Lias, Ph.D.
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
{13}------------------------------------------------
## Indications for Use
510(k) Number (if known): k132630
#### Device Name: Wondfo Methamphetamine Urine Test (MET 300) Wondfo Oxazepam Urine Test (BZO 200)
Indications for Use:
.. "
#### Wondfo Methamphetamine Urine Test (MET 300)
Wondfo Methamphetamine Urine Test (MET 300) is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a Cut-Off 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.
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-lyles -S 2013.09.27 12:56:24 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) k132630
{14}------------------------------------------------
# Indications for Use
510(k) Number (if known): k132630
Device Name: Wondfo Methamphetamine Urine Test (MET 300) Wondfo Oxazepam Urine Test (BZO 200)
Indications for Use:
ﮩ . . .
## Wondfo Oxazepam Urine Test (BZO 200)
Wondfo Oxazepam Urine Test (BZO 200) is an immunochromatographic assay for the qualitative determination of Oxazepam 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-lyles -S 2013.09.27 12:56:48 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) k132630
