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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the Wondfo Methamphetamine Urine Test (MET 300) and Wondfo Oxazepam Urine Test (BZO 200), based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria for drug testing devices like these are typically based on the accurate classification of samples relative to a defined cut-off concentration. While explicit "acceptance criteria" percentages are not directly stated in the document, the precision and comparison studies demonstrate the device's ability to correctly identify samples around the cut-off.

The reported performance indicates that:

For concentrations below -25% Cut-Off, all samples were reported as Negative.
For concentrations at and above +25% Cut-Off, all samples were reported as Positive.

This suggests an implied acceptance criterion of 100% agreement for samples sufficiently far from the cut-off. For samples at the cut-off, a high percentage of positive results is expected, though not necessarily 100% due to inherent variability allowed around the cut-off.

Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Wondfo MET 300 Reported Performance (Cup/Dip Card)	Wondfo BZO 200 Reported Performance (Cup/Dip Card)
Precision	100% agreement for samples at/below -25% from cut-off. 100% agreement for samples at/above +25% from cut-off. High agreement for samples at cut-off.	Cup:-100% to -25% Cut-off: 50-/0+ (100% Neg)At Cut-off: 45-47+/3-5- (90-94% Pos)+25% to +100% Cut-off: 50+/0- (100% Pos)Dip Card:-100% to -25% Cut-off: 50-/0+ (100% Neg)At Cut-off: 44-45+/5-6- (88-90% Pos)+25% to +100% Cut-off: 50+/0- (100% Pos)	Cup:-100% to -25% Cut-off: 50-/0+ (100% Neg)At Cut-off: 46-47+/3-4- (92-94% Pos)+25% to +100% Cut-off: 50+/0- (100% Pos)Dip Card:-100% to -25% Cut-off: 50-/0+ (100% Neg)At Cut-off: 45-46+/4-5- (90-92% Pos)+25% to +100% Cut-off: 50+/0- (100% Pos)
Cut-off Verification	All positive at and above +25% Cut-off. All negative at and below -25% Cut-off.	All positive at and above +25% Cut-off. All negative at and below -25% Cut-off.	All positive at and above +25% Cut-off. All negative at and below -25% Cut-off.
Interference	No interference from common substances at 100 µg/mL.	Compounds listed show no interference at 100 µg/mL.	Compounds listed show no interference at 100 µg/mL.
Specificity	Demonstrate cross-reactivity profiles.	D(+)-Methamphetamine: 100%. Other amphetamines/substances show varying degrees of cross-reactivity.	Oxazepam: 100%. Other benzodiazepines/substances show varying degrees of cross-reactivity.
Urine Gravity/pH Effect	No effect on results when urine gravity is 1.000-1.035 or pH is 4-9.	All positive at and above +25% Cut-Off, all negative at and below -25% Cut-Off within specified ranges.	All positive at and above +25% Cut-Off, all negative at and below -25% Cut-Off within specified ranges.
Method Comparison	Good agreement with GC/MS across different concentration ranges.	Agreements shown in tables (performance varies slightly per viewer and format). For example, Viewer A (Cup) for MET 300 showed 0 false positives for drug-free, low negative, and high positive samples. Some discrepancies near cut-off.	Agreements shown in tables (performance varies slightly per viewer and format). For example, Viewer A (Cup) for BZO 200 showed 0 false positives for drug-free, low negative, and high positive samples. Some discrepancies near cut-off.

Study Details

Sample sizes used for the test set and the data provenance:
- Precision Study: For each drug (MET 300 and BZO 200) and each format (Cup, Dip Card), 8 concentrations were tested (-100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100% of cut-off).
  - Each concentration was tested two runs per day for 25 days across 3 lots of the device. This means for each distinct drug/format (e.g., MET 300 Cup), there were: 8 concentrations x 2 runs/day x 25 days/run x 3 lots = 1200 tests.
  - The exact number of unique "samples" is not explicitly stated beyond "samples prepared by spiking drug in negative samples." It implies contrived samples.
- Cut-off Verification: 150 samples were used (equally distributed at -50%, -25%, Cut-Off, +25%, +50% Cut-Off). These were tested using three different lots of each device by three different operators. (150 samples x 3 lots x 3 operators = 1350 tests per drug)
- Interference Study: "drug-free urine and target drugs urine with concentration at 25% below and 25% above Cut-Off level" were spiked with potential interferents. These were tested using three batches of each device for both Dip Card and Cup formats. The number of unique samples is not specified.
- Specificity Study: Various compounds were tested against three batches of each device for both Dip Card and Cup formats. The number of unique samples is not specified.
- Urine Specific Gravity and pH Effect: Urine samples with varying specific gravity (1.000~~1.035) or pH (4~~9) were spiked at -25% and +25% of Cut-Off. These were tested using three batches of each device for both Dip Card and Cup formats. The number of unique samples is not specified.
- Comparison Studies:
  - MET 300: 80 unaltered clinical samples were used (40 negative and 40 positive). These were tested by three laboratory assistants.
  - BZO 200: 80 unaltered clinical samples were used (40 negative and 40 positive). These were tested by three laboratory assistants.
- Data Provenance: The study was performed "in-house" and used "unaltered clinical samples" for the comparison studies. The country of origin of these clinical samples is not specified, but the submitter is from Guangzhou, P.R. China. The samples were likely retrospective, as they were "blind labeled" and then retrospectively compared to GC/MS results.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth Establishment: For the comparison studies, the ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is considered the "preferred confirmatory method" and is an objective, analytical gold standard rather than expert consensus.
- No "experts" in the clinical sense (e.g., radiologists) were used to establish the ground truth; it was established by chemical analysis.
Adjudication method for the test set:
- For the comparison studies, the Wondfo results from each of the three "viewers" (laboratory assistants) were individually compared to the GC/MS ground truth. There is no mention of an adjudication process among the viewers' interpretations of the Wondfo device to reach a single "device" result; each viewer's interpretation stands separately. The GC/MS results serve as the objective truth against which each viewer's reading of the rapid test is compared.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
- This device is a rapid diagnostic test based on immunochromatography, not an AI-based imaging or interpretive device. Therefore, there is no AI component, and no effect size for human readers with and without AI assistance is applicable or reported.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone (algorithm-only) performance study was not done in the context of AI.
- This is a qualitative rapid diagnostic test where human observation of a colored line determines the result. While the chemical reaction is the "algorithm," the interpretation traditionally involves a human "in-the-loop." The precision studies and cut-off verification can be considered standalone performance in the sense that the device's chemical reactions perform consistently with known spiked concentrations, but the final reading is still noted as being performed by operators/viewers.
The type of ground truth used:
- GC/MS (Gas Chromatography/Mass Spectrometry) was used as the ground truth for confirming drug concentrations in samples for the precision studies, cut-off verification, and method comparison studies. This is a highly accurate and objective analytical method.
The sample size for the training set:
- The document describes performance studies for the device, which are typically analogous to validation or test sets. There is no mention of a "training set" in the context of machine learning or AI, as this is a traditional immunochromatographic assay.
- The document implies that the device (likely the antibodies and reagent concentrations) was developed through an internal R&D process, but no specific dataset labeled as a "training set" with associated size is disclosed here.
How the ground truth for the training set was established:
- As no "training set" for an algorithm is described, this question is not applicable. The components of the assay (antibodies, drug-protein conjugates) would have been developed based on known chemical specificities and binding affinities, likely validated against known concentrations of analytes, but not in the format of a "ground truth for a training set" as it would be for an AI model.

Summary

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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

1. Device Name: Wondfo Methamphetamine Urine Test (MET 300) Wondfo Oxazepam Urine Test (BZO 200)
  Classification: Class II

ProductCode	CFR #	Panel
DJC	21 CFR 862.3610 Methamphetamine TestSystem	Toxicology
JXM	21 CFR 862.3170 Benzodiazepine TestSystem	Toxicology

1. Predicate Devices: K050394
  Medtox Diagnostics Sure-Screen
1. 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.

P 2 7 2013

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8. Device Description

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 ofdrugs of abuse in human urine. Forprescription use.	Same
Calibrator	D(+)-Methamphetamine andOxazepam	D(+)-Methamphetamineand Nordiazepam
Methodology	Competitive binding, lateral flowimmunochromatographic assaysbased on the principle of antigenantibody immunochemistry.	Same
Type of Test	Qualitative to indicate positive ornegative result	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL(MET) and200 ng/mL (Oxazepam/BZO)	Same
Configurations	Cup, Dip Card	Cup

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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%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 W1171001CU2	50-/0+	50-/0+	50-/0+	50-/0+	47+/3-	50+/0-	50+/0-	50+/0-	50+/0-
	LOT W1171002CU2	50-/0+	50-/0+	50-/0+	50-/0+	45+/5-	50+/0-	50+/0-	50+/0-	50+/0-
	LOT W1171003CU2	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 W0970901CU2	50-/0+	50-/0+	50-/0+	50-/0+	46+/4-	50+/0-	50+/0-	50+/0-	50+/0-

50-10+

20-10+

46+/4-

50+/0-

MET 300

Cup Format

20-10+

50-10+

W0970903

20-10+

50-10+

20-10+

50+/0-

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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 W1171001P	50-/0+	50-/0+	50-/0+	50-/0+	44+/6-	50+/0-	50+/0-	50+/0-	50+/0-
	LOT W1171002P	50-/0+	50-/0+	50-/0+	50-/0+	45+/5-	50+/0-	50+/0-	50+/0-	50+/0-
	LOT W1171003P	50-/0+	50-/0+	50-/0+	50-/0+	45+/5-	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
LOT W0970901P	50-/0+	50-/0+	50-/0+	50-/0+	45+/5-	50+/0-	50+/0-	50+/0-	50+/0-
LOT W0970902P	50-/0+	50-/0+	50-/0+	50-/0+	46+/4-	50+/0-	50+/0-	50+/0-	50+/0-
LOT W0970903P	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 (MET300)	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

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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

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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-Dglucuronide)
Chlorothiazide	Methadone	Tetrahydrozoline
(±)Chlorpheniramine	Methoxyphenamine	Thiamine
Chlorpromazine	(+) 3,4-Methylenedioxy-	Thioridazine

. .

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	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)	MinimumConcentrationRequired toObtain aPositive Result(ng/mL)	%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%

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	Minimum
BZO(Oxazepam)(Oxazepam, Cut-off=200 ng/mL)	ConcentrationRequired to Obtain aPositive Result (ng/mL)	%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:

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MET 300:

Cup Format
	Wondfo Result	Drug-free	Low Negativeby GC/MS(Less than-50%)	Near Cut-offNegative byGC/MS(Between -50%and Cut-off)	Near Cut-offPositive byGC/MS(Between theCut-off and+50%)	High Positiveby GC/MS(Greater than+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 Negativeby GC/MS(Less than-50%)	Near Cut-offNegative byGC/MS(Between -50%and Cut-off)	Near Cut-offPositive byGC/MS(Between theCut-off and+50%)	High Positiveby GC/MS(Greater than+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 FormatViewer 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 FormatViewer Results
Viewer A	MET3062	281	Positive

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Viewer	Sample Number	GC/MS Result	Dip Card FormatViewer 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 Negativeby GC/MS(Less than-50%)	Near Cut-offNegative byGC/MS(Between -50%and Cut-off)	Near Cut-offPositive byGC/MS(Between theCut-off and+50%)	High Positiveby GC/MS(Greater than+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 Negativeby GC/MS(Less than-50%)	Near Cut-offNegative byGC/MS(Between -50%and Cut-off)	Near Cut-offPositive byGC/MS(Between theCut-off and+50%)	High Positiveby GC/MS(Greater than+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 FormatViewer Result
Viewer A	BZO2065	182	Positive
Viewer A	BZO2063	186	Positive

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Viewer	Sample Number	GC/MS Result	Cup FormatViewer Result
Viewer B	BZO2063	186	Positive
Viewer C	BZO2062	178	Positive

Viewer	Sample Number	GC/MS Result	Dip Card FormatViewer 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

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.

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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

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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)

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)

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

Regulation Number and Section

§ 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).