(36 days)
Not Found
No
The device description and performance studies describe a standard immunochromatographic assay, which relies on chemical reactions and visual interpretation of lines, not AI/ML for analysis or interpretation. There is no mention of AI, ML, or related concepts in the document.
No
Explanation: This device is an in-vitro diagnostic test used to detect the presence of specific substances (methamphetamine and oxazepam) in a patient's urine. It provides preliminary test results and does not describe any therapeutic function.
Yes.
The device is an immunochromatographic assay for the qualitative determination of Methamphetamine and Oxazepam in human urine, which provides preliminary test results for detecting or confirming a disease or condition (drug use).
No
The device is described as an immunochromatographic assay available in Dip Card and Cup formats, which are physical hardware components used for testing urine samples. The description focuses on the chemical and physical aspects of the test, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "qualitative determination of D(+)-Methamphetamine in human urine" and "qualitative determination of Oxazepam in human urine." This indicates that the device is used to test a sample taken from the human body (urine) to provide information about a person's health status (presence of drugs).
- Device Description: The description details an "immunochromatographic assay," which is a common type of in vitro diagnostic test. It describes the components used to detect the target analytes in the urine sample.
- Performance Studies: The document describes various performance studies conducted on the device using human urine samples, including precision, cut-off determination, interference testing, specificity testing, and comparison studies with clinical samples. These are typical studies performed to validate the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K050394 Medtox Diagnostics Sure-Screen) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
The fact that it is "only intended for prescription use and is not intended for point-of-care use" further supports its classification as an IVD, as many IVDs are designed for use in a laboratory or clinical setting under the supervision of healthcare professionals.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DJC, JXM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use and is not intended for point-of-care use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Analytical Performance
a. Precision: Precision studies were carried out for samples with concentrations of -100%cut off, -75%cut off, -50%cut off, -25%cut off, +25%cut off, +50%cut off, +75%cut off and +100%cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled by the person who prepared the samples and that person did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days.
b. Linearity: Not applicable
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.
e. Interference: Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% below and 25% above Cut-Off level respectively. These urine samples were tested using three batches of each device for both Dip Card and Cup formats. Compounds that show no interference at a concentration of 100 µg/mL are summarized in the tables. There are no differences observed for both Dip Card and Cup formats.
f. Specificity: To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for both Dip Card and Cup formats. Compounds that produced positive results are listed. There are no differences observed for both Dip Card and Cup formats.
g. Effect of Urine Specified Gravity and Urine pH: To investigate the effect of urine specified gravity and urine pH, the urine samples, with 1.0001.035 specified gravity or urine samples with pH 49 were spiked with target drugs at 25% below and 25% above Cut-Off level, respectively. These samples were tested using three batches of each device for both Dip Card and Cup formats. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for both Dip Card and Cup formats. - 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3610 Methamphetamine test system.
(a)
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.(b)
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).
0
510(k) SUMMARY
| 1. Date: | September 26, 2013 |
|---|---|
| 2. 510(K) Number: | K132630 |
-
Submitter: Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641
-
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
-
- Device Name: Wondfo Methamphetamine Urine Test (MET 300) Wondfo Oxazepam Urine Test (BZO 200)
Classification: Class II
- Device Name: Wondfo Methamphetamine Urine Test (MET 300) Wondfo Oxazepam Urine Test (BZO 200)
| Product
| Code | CFR # | Panel |
|---|---|---|
| DJC | 21 CFR 862.3610 Methamphetamine Test | |
| System | Toxicology | |
| JXM | 21 CFR 862.3170 Benzodiazepine Test | |
| System | Toxicology |
-
- Predicate Devices: K050394
Medtox Diagnostics Sure-Screen
- Predicate Devices: K050394
-
- 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.
- Intended 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) | ||
| for Use | For the qualitative determination of | |
| drugs of abuse in human urine. For | ||
| prescription use. | Same | |
| Calibrator | D(+)-Methamphetamine and | |
| Oxazepam | D(+)-Methamphetamine | |
| and Nordiazepam | ||
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays | ||
| based on the principle of antigen | ||
| antibody immunochemistry. | Same | |
| Type of Test | Qualitative to indicate positive or | |
| negative result | Same | |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 300 ng/mL(MET) and | |
| 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
-
- 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%
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 |
|------------------|---------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| MET 300 | LOT W1171001
CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 47+/3- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | LOT W1171002
CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | LOT W1171003
CU2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Oxazepam BZO 200 | | | | | | | | | | |
| | Result | -100%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
| BZO 200 | LOT W0970901
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%
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 |
|---------|-------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| MET 300 | LOT W1171001
P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | LOT W1171002
P | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | LOT W1171003
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%
Cut-off | -75%
Cut-off | -50%
Cut-off | -25%
Cut-off | Cut-off | +25%
Cut-off | +50%
Cut-off | +75%
Cut-off | +100%
Cut-off |
|-------------------|---------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| LOT W0970901
P | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 45+/5- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W0970902
P | | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 46+/4- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| LOT W0970903
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
(ng/mL) |
|------------------------------------------------|----------------------|--------------------|
| Wondfo Methamphetamine Urine Test (MET
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 |
| glucuronide) | ||
| Chlorothiazide | Methadone | Tetrahydrozoline |
| (±)Chlorpheniramine | Methoxyphenamine | Thiamine |
| Chlorpromazine | (+) 3,4-Methylenedioxy- | Thioridazine |
. .
6
| amphetamine | ||
|---|---|---|
| Chloroquine | (+)3,4-Methylenedioxy- | |
| 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)
(D(+)-Methamphetamine, Cut-off=300 ng/mL) | Minimum
Concentration
Required to
Obtain a
Positive Result
(ng/mL) | %
Cross-Reactivity |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------|
| D(+)-Methamphetamine | 300 | 100% |
| D-Amphetamine | 40,000 |