Wondfo Methadone Urine Test (MTD 200) is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 200 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Wondfo Morphine Urine Test (MOP 100) is an immunochromatographic assay for the qualitative determination of Morphine in human urine at a Cut-Off concentration of 100 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Device Description

Immunochromatographic assays for Methadone and Morphine Urine Tests use a lateral flow, one step system for the qualitative detection of Methadone and Morphine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

AI/ML Overview

Here's a summary of the acceptance criteria and study details for the Wondfo Methadone Urine Test (MTD200) and Wondfo Morphine Urine Test (MOP100), based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "sensitivity must be >X%"). Instead, the precision study demonstrates performance at various concentrations relative to the cut-off, and the comparison study evaluates agreement with GC/MS. The implied acceptance criteria are that the device should accurately classify samples at and above the cut-off as positive, and samples below the cut-off as negative, with high consistency.

Wondfo Methadone Urine Test (MTD200)

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Precision	Consistent results across multiple runs and lots.	Cup Format: At -100% to -25% cut-off, all 50 tests per lot were negative. At +25% to +100% cut-off, all 50 tests per lot were positive. At the cut-off, 45-46 out of 50 tests were positive (some variability within 3 lots).Dip Card Format: Similar results, with 45-47 out of 50 tests positive at the cut-off.
Cut-off Verification	Accurate measurement at specified cut-off.	All samples at and above +25% Cut-off were positive. All samples at and below -25% Cut-off were negative. Verified cut-off for Methadone: 200 ng/mL.
Interference	No interference from common substances at specified concentrations.	Many common substances (listed in the document) showed no interference at 100 ug/mL when spiked into drug-free urine and urine with target drugs at ±25% cut-off. No differences between Dip Card and Cup formats.
Specificity (Cross-Reactivity)	Minimal cross-reactivity with structurally similar compounds.	Methadone: Doxylamine showed 0.5% cross-reactivity at 40,000 ng/mL (i.e., 40,000 ng/mL of Doxylamine produced a positive result, equivalent to 200 ng/mL Methadone).
Effect of Specific Gravity & pH	Stable performance across physiological ranges.	Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off, for urine specific gravity 1.000~~1.035 and pH 4~~9. No differences between Dip Card and Cup formats.
Method Comparison (vs. GC/MS)	High agreement with GC/MS, especially near the cut-off.	Cup Format (Viewer A, B, C): Out of 80 clinical samples (40 negative, 40 positive), no false positives in drug-free or low negative GC/MS samples. Few false negatives in "Near Cut-Off Negative" samples (e.g., Viewer A: 2 negatives out of 17 near cut-off negatives were called positive by Wondfo; meaning Wondfo correctly identified 15/17. Discordant results for Viewer A: MTD2061 (186 ng/mL) and MTD2063 (192 ng/mL) were positive by Wondfo but are below 200ng/mL cut-off by GC/MS, so these are false positives for a 200ng/mL cut-off. This is not explicitly highlighted as a failure criterion.
		Dip Card Format (Viewer A, B, C): Similar pattern to Cup format. Discordant results also noted for samples just below the cut-off.

Wondfo Morphine Urine Test (MOP100)

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Precision	Consistent results across multiple runs and lots.	Cup Format: At -100% to -25% cut-off, all 50 tests per lot were negative. At +25% to +100% cut-off, all 50 tests per lot were positive. At the cut-off, 45-46 out of 50 tests were positive.Dip Card Format: Similar results, with 45-49 out of 50 tests positive at the cut-off.
Cut-off Verification	Accurate measurement at specified cut-off.	All samples at and above +25% Cut-off were positive. All samples at and below -25% Cut-off were negative. Verified cut-off for Morphine: 100 ng/mL.
Interference	No interference from common substances at specified concentrations.	Many common substances (listed in the document) showed no interference at 100 ug/mL when spiked into drug-free urine and urine with target drugs at ±25% cut-off. No differences between Dip Card and Cup formats.
Specificity (Cross-Reactivity)	Minimal cross-reactivity with structurally similar compounds.	Morphine: - Codeine: 100% cross-reactivity (100 ng/mL)- Ethylmorphine: 50% cross-reactivity (200 ng/mL)- Hydrocodone: 25% cross-reactivity (400 ng/mL)- Hydromorphine: 50% cross-reactivity (200 ng/mL)- Levorphanol: 2.0% cross-reactivity (5000 ng/mL)- σ-Monoacetylmorphine: 50% cross-reactivity (200 ng/mL)- Morphine 3-β-D-glucuronide: 50% cross-reactivity (200 ng/mL)- Norcodeine: 20% cross-reactivity (500 ng/mL)- Normorphine: 2.0% cross-reactivity (5000 ng/mL)- Oxycodone: 10% cross-reactivity (1000 ng/mL)- Oxymorphine: 10% cross-reactivity (1000 ng/mL)- Procaine: <1.0% cross-reactivity (100,000 ng/mL)- Thebaine: 2.0% cross-reactivity (5000 ng/mL)
Effect of Specific Gravity & pH	Stable performance across physiological ranges.	Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off, for urine specific gravity 1.000~~1.035 and pH 4~~9. No differences between Dip Card and Cup formats.
Method Comparison (vs. GC/MS)	High agreement with GC/MS, especially near the cut-off.	Cup Format (Viewer A, B, C): Out of 80 clinical samples (40 negative, 40 positive), no false positives in drug-free or low negative GC/MS samples. Few false negatives in "Near Cut-Off Negative" samples (<4 per viewer). Discordant results: Multiple samples with GC/MS results just below the 100 ng/mL cut-off (e.g., 98, 97, 95 ng/mL) were reported as positive by the Wondfo device (false positives relative to the stated cut-off). This is not explicitly highlighted as a failure criterion.
		Dip Card Format (Viewer A, B, C): Similar pattern to Cup format, with discordant results for samples close to the cut-off.

2. Sample Size Used for the Test Set and Data Provenance

Precision Study Test Set:
- For each drug (MTD200, MOP100) and format (Cup, Dip Card): 3 lots x 9 concentrations x 50 tests/concentration = 1350 tests per drug/format.
- Total for Precision Study: 1350 (MTD Cup) + 1350 (MTD Dip) + 1350 (MOP Cup) + 1350 (MOP Dip) = 5400 tests.
- Data Provenance: Samples were prepared by spiking drugs into negative samples. The document states "Each drug concentration was confirmed by GC/MS." Implies prospective preparation in a controlled lab setting, likely within China (country of origin of the submitter).
Cut-off Verification Test Set:
- Total of 150 samples per drug/format (equally distributed at -50%, -25%, Cut-Off, +25%, +50% Cut-Off).
- Tested using three different lots of each device by three different operators.
- Total for Cut-off Verification: 150 (MTD) + 150 (MOP) = 300 samples (at least for the reporting of performance, though the number of individual tests would be 150 samples * 3 lots * 3 operators = 1350 tests per drug if each operator tested each sample with each lot).
- Data Provenance: Samples prepared by spiking drugs in negative samples, confirmed by GC/MS. Controlled lab setting.
Interference Study Test Set:
- For each interfering substance: spiked into drug-free urine and target drug urine (at 25% below and 25% above Cut-Off level).
- Tested using three batches of each device for both Dip Card and Cup formats.
- The exact number of samples (unique urine samples) is not stated, but the number of tests performed would be substantial given the long list of interfering substances.
- Data Provenance: Controlled lab setting.
Specificity (Cross-Reactivity) Test Set:
- Tested "drug metabolites and other components that are likely to interfere."
- Used three batches of each device for both Dip Card and Cup formats.
- Data Provenance: Controlled lab setting.
Effect of Urine Specific Gravity and Urine pH Test Set:
- Urine samples with specific gravity 1.000~~1.035 or pH 4~~9, spiked with target drugs at ±25% Cut-Off level.
- Tested using three batches of each device for both Dip Card and Cup formats.
- Number of samples not explicitly stated but implies a range of samples covering the specified SG and pH range.
- Data Provenance: Controlled lab setting.
Method Comparison Study Test Set:
- 80 unaltered clinical samples per drug (40 negative and 40 positive).
- Total for Method Comparison: 80 (MTD) + 80 (MOP) = 160 clinical samples.
- Data Provenance: "unaltered clinical samples." The country of origin is not explicitly stated, but given the submitter's country, it is likely China. The study is retrospective as the samples were collected and then tested.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For the Precision, Cut-off, Interference, Specificity, and Effect of SG/pH studies, the ground truth was established by GC/MS confirmation of spiked concentrations. This implies a skilled analytical chemist or laboratory technician performed these confirmations.
For the Method Comparison Study, the ground truth was GC/MS results. "GC/MS is the preferred confirmatory method." The qualifications of the personnel performing the GC/MS are not specified beyond this.

4. Adjudication Method for the Test Set

There is no explicit adjudication method described for the interpretation of the Wondfo device results in the method comparison study. The study states "Operators ran 80 ... clinical samples. The samples were blind labeled and compared to GC/MS results."
There were three "laboratory assistants" (referred to as Viewer A, B, C) who presumably interpreted the Wondfo test results. Each viewer's results are reported individually, indicating no consensus or adjudication process among them for the device readings. The comparison is then made against the single GC/MS ground truth.

5. 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, an MRMC comparative effectiveness study was not done.
This study is a comparison of a diagnostic device (Wondfo test kit) against a gold standard (GC/MS), interpreted visually by human "viewers" or "operators." It does not assess human reader improvement with or without AI assistance, as the device itself is a simple immunochromatographic assay, not an AI-based system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in effect, a standalone performance was demonstrated for the Wondfo device, with human interpretation being the "standalone algorithm" here. The "operators" or "viewers" simply read the device results. There is no complex human-in-the-loop interaction beyond visual interpretation of lines. The performance metrics presented (precision, specificity, comparison to GC/MS) reflect the device's inherent analytical characteristics when interpreted by a human, rather than the impact of an "algorithm only" in the sense of a machine learning model.

7. The Type of Ground Truth Used

The primary ground truth used across all studies (Precision, Cut-off, Interference, Specificity, Effect of SG/pH, and Method Comparison) was the Gas Chromatography/Mass Spectrometry (GC/MS) results.
For spiked samples, the concentration was also analytically confirmed by GC/MS.

8. The Sample Size for the Training Set

This information is not applicable as the Wondfo Methadone/Morphine Urine Test is an immunochromatographic assay, not an AI or machine learning-driven device that requires an explicit training set. The manufacturing process and quality control for the test strips would be developed using internal data and R&D, but this is not typically referred to as a "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated above (not an AI/ML device).

Summary

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510(k) SUMMARY

MAY 3 1 2013

Date:

May 29, 2013

Submitter:
Contact person:

Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641

Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6213 Email:shiajl@yahoo.com

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

Classification:

ProductCode	CFR #	Panel
DJR	21 CFR, 862.3620 Methadone TestSystem	Toxicology
DJG	21 CFR, 862.3640 Morphine TestSystem	Toxicology

1. Predicate Devices:
- K050394

Medtox Diagnostics Sure-Screen

1. Intended Use
  Wondfo Methadone Urine Test (MTD 200) is an immunochromatographic assay for the qualitative determination of Methadone in human urine at a Cut-Off concentration of 200 ng/mL. The test is available in a Dip Card format and a Cup format. This product is only intended for prescription use and is not intended for point-of-care use. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

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The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

7. Device Description

1. Substantial Equivalence Information
  A summary comparison of features of the Wondfo Methadone Urine Test (MTD 200) and Wondfo Morphine Urine Test (MOP 100) and the predicate device is provided in Table 1 & Table 2.

Item	Device	Predicate -K050394
Indication(s)for Use	For the qualitative determination ofMethadone in human urine. Forprescription use.	Same (but thenumber of drugsdetected isdifferent)
Calibrator	Methadone	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative to indicate positive or negativeresult	Same
Specimen Type	Human Urine	Same
Cut-Off Values	200 ng/mL	Same
Configurations	Cup, Dip Card	Cup

Table 1: Features Comparison of Wondfo Methadone Urine Test (MTD 200) and
the Predicate Devices

Table 2: Features Comparison of Wondfo Morphine Urine Test (MOP 100) and the Predicate Devices

Item	Device	Predicate - K050394
Indication(s)for Use	For the qualitative determination ofMorphine in human urine. Forprescription use.	Same(but the numberof drugs detected isdifferent)

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Item	Device	Predicate - K050394
Calibrator	Morphine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative to indicate positive ornegative result	Same
Specimen Type	Human Urine	Same
Cut-Off Values	100 ng/mL	Same
Configurations	Cup, Dip Card	Cup

9. Test Principle

It is a rapid test for the qualitative detection of Methadone and Morphine in urine samples. It is a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a urine sample, the urine is absorbed into the device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane. At analyte concentration below the target cut off, antibody-dye conjugates bind to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored test line that indicates a negative result. When analyte concentration is above the cutoff, analyte molecules bind to the antibody-dye conjugate, preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. No colored band shows in the test region, indicating a potentially positive result.

10. Performance Characteristics

1. Analytical Performance
- a.Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled by the person who prepared the samples and that person did not take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following table.

Cup Format

MTD 200

Result	-100%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
MTD 200
LOTW1570901	50-/0+	50-/0+	50-/0+	50-/0+	45+/5-	50+/0-	50+/0-	50+/0-	50+/0-

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~ Result -100% -75% -50% -25% Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Off Cut-Of

CU2
LOTW1570902 CU2		50-10+ 20-10+	50-10+	50-10+	44+/6-	50+/0-	50+/0-	50+/0-	50+/0-
LOTW1570903CU2	50-10+	50-10+	50-10+ 50-10+		46+/4-	50+/0-	50+/0-	50+/0-	50+/0-

MOP 100

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
LOTW1670901CU2	50-/0+	50-/0+	50-/0+	50-/0+	46+/4-	50+/0-	50+/0-	50+/0-	50+/0-
LOTW1670902CU2	50-/0+	50-/0+	50-/0+	50-/0+	46+/4-	50+/0-	50+/0-	50+/0-	50+/0-
LOTW1670903CU2	50-/0+	50-/0+	50-/0+	50-/0+	45+/5-	50+/0-	50+/0-	50+/0-	50+/0-

Dip Card Format

MTD 200

ResultMTD 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
LOTW1570901P	50-/0+	50-/0+	50-/0+	50-/0+	45+/5-	50+/0-	50+/0-	50+/0-	50+/0-
LOTW1570902P	50-/0+	50-/0+	50-/0+	50-/0+	47+/3-	50+/0-	50+/0-	50+/0-	50+/0-
LOTW1570903P	50-/0+	50-/0+	50-/0+	50-/0+	46+/4-	50+/0-	50+/0-	50+/0-	50+/0-

MOP 100

ResultMOR 100	-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
LOTW1670901P	50-/0+	50-/0+	50-/0+	50-/0+	45+/5-	50+/0-	50+/0-	50+/0-	50+/0-
LOTW1670902P	50-/0+	50-/0+	50-/0+	50-/0+	47+/3-	50+/0-	50+/0-	50+/0-	50+/0-
LOTW1670903P	50-/0+	50-/0+	50-/0+	50-/0+	49+/1-	50+/0-	50+/0-	50+/0-	50+/0-

b. Linearity

Not applicable, this is a visually read device

c.Stability

Stable at 4-30℃ for 18 months based on the accelerated stability study at 50°C and real time stability determination at both 4°C and 30°C.

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Cut-off

Total of 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for both methadone and morphine. The following cut-off values for the test devices have been verified.

Test	Calibrator	Cut-off(ng/mL)
Wondfo Methadone Urine Test (MTD200)	Methadone	200
Wondfo Morphine Urine Test (MOP100)	Morphine	100

d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% below and 25% above Cut-Off level respectively. These urine samples were tested using three batches of each device for both Dip Card and Cup formats.

Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. There were no differences observed for both Dip Card and Cup formats.

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

MTD 200

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and the comments of the country

and the contraction of the comments of the country of

. . . . .

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MOP 100

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

・

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. .

ﻬﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

ﺎ

: ·

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e. Specificity

To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for both Dip Card and Cup formats. Compounds that produced positive results are listed below. There were no differences observed for both Dip Card and Cup formats.

	MTD 200
MTD(Methadone)(Methadone, Cut-off=200 ng/mL)	Minimum ConcentrationRequired to Obtain aPositive Result (ng/mL)	%Cross-Reactivity
Methadone	200	100
Doxylamine	40,000	0.5
	MOP 100
MOR(Morphine)	Minimum Concentration	%
(Morphine, Cut-off=100 ng/mL)	Required to Obtain a	Cross-Reactivity

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

f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, the urine samples, with 1.000~~1.035 specific gravity or urine samples with pH 4~~9 were spiked with target drugs at 25% below and 25% above Cut-Off level, respectively. These samples were tested using three batches of each device for both Dip Card and Cup formats. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for both Dip Card and Cup formats.

1. Comparison Studies
  The method comparison for the Wondfo Methadone Urine Test (MTD200), Wondfo Morphine Urine Test (MOP100) was performed in-house with three laboratory assistants. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results. The results are presented in the table below:

MTD 200:

11	H 1		111ormat
		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

	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	15	25
	Negative	10	13	15	0	0
Viewer B	Positive	0	0	2	15	25

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

Dip Card Format

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

Discordant Results of MTD 200

Viewer	Sample Number	GC/MS Result	Cup FormatViewer Result
Viewer A	MTD2061	I 86	Positive
Viewer A	MTD2063	192	Positive
Viewer B	MTD2061	186	Positive
Viewer B	MTD2063	192	Positive
Viewer C	MTD2063	192	Positive

Viewer	Sample Number	GC/MS Result	Dip Card FormatViewer Results
Viewer A	MTD2061	186	Positive
Viewer B	MTD2061	186	Positive
Viewer B	MTD2063	192	Positive
Viewer C	MTD2061	186	Positive
Viewer C	MTD2063	192	Positive

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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	28	12
	Negative	10	16	12	0	0
Viewer B	Positive	0	0	3	28	12
	Negative	10	16	11	0	0
Viewer C	Positive	0	0	2	28	12
	Negative	10	16	12	0	0

Dip Card Format

	Wondfo Result	Drug-free	Low 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	28	12
	Negative	10	16	11	0	0
Viewer B	Positive	0	0	2	28	12
	Negative	10	16	12	0	0
Viewer C	Positive	0	0	3	28	12
	Negative	10	16	11	0	0

Discordant Results of MOP 100

Viewer	Sample Number GC/MS Result	Cup FormatViewer Result

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Viewer	Sample Number	GC/MS Result	Cup FormatViewer Result
Viewer A	OPI1061	98	Positive
Viewer A	OPI1215	97	Positive
Viewer B	OPI1063	95	Positive
Viewer B	OPI1061	98	Positive
Viewer B	OPI1215	97	Positive
Viewer C	OPI1064	93	Positive
Viewer C	OPI1061	98	Positive

Viewer	Sample Number	GC/MS Result	Dip Card FormatViewer Results
Viewer A	OPI1064	93	Positive
Viewer A	OPI1061	98	Positive
Viewer A	OPI1215	97	Positive
Viewer B	OPI1063	95	Positive
Viewer B	OPI1215	97	Positive
Viewer C	OPI1062	94	Positive
Viewer C	OPI1065	94	Positive
Viewer C	OPI1063	95	Positive

1. Clinical Studies ﻟﻘﺮﺭ ﺍﻟﻤﺮﺍﺟﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ
  Not applicable

11. Conclusion

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

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

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

May 31, 2013 ,

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

Re: K131232

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

Dear Mr. Shia:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson -S for

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

Enclosure

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Indications for Use

510(k) Number (if known): K131232

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

Indications for Use:

Wondfo Methadone Urine Test (MTD 200)

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

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

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

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

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

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

510(k) K131232

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

Indications for Use

510(k) Number (if known): K131232

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

Indications for Use:

Wondfo Morphine Urine Test (MOP 100)

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

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

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

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

Denise Johnson

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

510(k) K131232

Regulation Number and Section

§ 862.3620 Methadone test system.

(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).