Wondfo Amphetamine Urine Test is an immunochromatographic assay for the qualitative determination of d-Amphetamine in human urine at a cutoff concentration of 1000ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GCMS 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 Secobarbital Urine Test is an immunochromatographic assay for the qualitative determination of Secobarbital (major metabolite of Barbiturates) in human urine at a cutoff concentration of 300ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use.

Wondfo Oxazepam Urine Test is an immunochromatographic assay for the qualitative determination of Oxazepam (major metabolite of Benzodiazepines) in human urine at a cutoff concentration of 300ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use.

The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a conformed analytical result. GCMS 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

Immunochromatograph assays for Amphetamine, Secobarbital, and Oxazepam Urine Tests use a lateral flow, one step system for the qualitative detection of d-Amphetamine , Secobarbital, 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.

AI/ML Overview

The acceptance criteria and study proving the device meets them are detailed below, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance characteristics demonstrated in the precision and comparison studies, particularly the accuracy against GC/MS. The document does not explicitly state pre-defined acceptance criteria values for agreement percentages, but the reported performance serves as the basis for substantial equivalence.

Implied Acceptance Criteria and Reported Device Performance (Cup and Dip Card Formats):

Drug	Concentration (relative to cutoff)	Implied Acceptance Criteria (Agreement with GC/MS)	Reported Performance (Cup Format)	Reported Performance (Dip Card Format)
Amphetamine	Negative	High agreement (e.g., ≥95-100%)	100%	100%
	-75%	High agreement (e.g., ≥95-100%)	100%	100%
	-50%	High agreement (e.g., ≥95-100%)	100%	100%
	-25%	High agreement (e.g., ≥85-95%)	90%	85%
	+25%	High agreement (e.g., ≥85-95%)	95%	95%
	+50%	High agreement (e.g., ≥95-100%)	100%	100%
	+75%	High agreement (e.g., ≥95-100%)	100%	100%
Secobarbital	Negative	High agreement (e.g., ≥95-100%)	100%	100%
	-75%	High agreement (e.g., ≥95-100%)	100%	100%
	-50%	High agreement (e.g., ≥95-100%)	100%	100%
	-25%	High agreement (e.g., ≥85-95%)	90%	85%
	+25%	High agreement (e.g., ≥85-95%)	90%	90%
	+50%	High agreement (e.g., ≥95-100%)	100%	100%
	+75%	High agreement (e.g., ≥95-100%)	100%	100%
Oxazepam	Negative	High agreement (e.g., ≥95-100%)	100%	100%
	-75%	High agreement (e.g., ≥95-100%)	100%	100%
	-50%	High agreement (e.g., ≥95-100%)	100%	100%
	-25%	High agreement (e.g., ≥85-95%)	90%	95%
	+25%	High agreement (e.g., ≥85-95%)	95%	95%
	+50%	High agreement (e.g., ≥95-100%)	100%	100%
	+75%	High agreement (e.g., ≥95-100%)	100%	100%

Note: The document implies acceptance by presenting these agreement percentages, suggesting they meet the regulatory expectations for accuracy in qualitative drug tests, especially around the cutoff concentrations where some variability is expected and observed.

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

The comparison studies used 80 unaltered clinical samples for each drug (40 negative and 40 positive).
The samples were "blind labeled."
The provenance refers to "unaltered clinical samples," implying they were genuine human urine samples from a clinical setting, but the country of origin is not specified. The study is retrospective in the sense that the samples were analyzed and then compared to a previously established ground truth (GC/MS).

For the lay user studies, for each drug and each format (cup/dip card):

140 lay persons were used.
140 samples were tested for each specific drug and format combination, prepared at various concentrations (Negative, +/-75%, +/-50%, +/-25% of cutoff) by spiking drug(s) into drug-free pooled urine specimens.
- This means a total of (7 concentrations * 20 samples per concentration) = 140 samples were used for each drug. So, each of the 140 lay persons likely tested one sample.
The provenance for these samples is that they were "prepared" by spiking drug(s) into "drug-free pooled urine specimens." This suggests a controlled laboratory setting, not necessarily directly collected clinical samples. The country of origin is not specified. This study is also retrospective in how samples were evaluated against a known ground truth.

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

The primary ground truth for the comparison studies was GC/MS (Gas Chromatography/Mass Spectrometry) results. GC/MS is a laboratory analytical method for specific compound identification and quantification and does not involve human experts establishing the ground truth in the same way, for example, a radiologist establishes ground truth for imaging. Samples' concentrations were "confirmed by GC/MS."

For the in-house comparison study, three laboratory assistants with relevant experience and one lay person with no experience other than reading instructions were used as "viewers" for the device result. Their role was to interpret the device's outcome, not to establish the ground truth for the presence or absence of the drug, which was done by GC/MS.

For the lay user study, 140 lay persons (with diverse educational and professional backgrounds, aged 21 to >50) interpreted the device results after reading instructions. Again, their role was to interpret the device, not establish the ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (like 2+1, 3+1 consensus) for establishing the ground truth or resolving discrepancies between GC/MS and device readings. The GC/MS result is presented as the definitive truth. Discrepancies between the device reader's interpretation and the GC/MS result are simply noted in the "Discordant table," but no further adjudication process is described for those specific discrepancies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

A formal MRMC comparative effectiveness study, as typically understood (e.g., comparing human readers with and without AI assistance on diagnosis accuracy), was not performed. The studies involved multiple "viewers" (laboratory assistants and lay persons) interpreting the rapid test results, but this is a multi-reader study of device performance, not direct "human reader improvement with AI vs. without AI assistance." This device is an immunoassay, not an AI-powered diagnostic. Therefore, no effect size of human improvement with AI assistance is applicable or reported.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This device is a rapid immunoassay test. Its mechanism relies on chemical reactions and visual interpretation of colored lines, not an algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply to this type of device. The device's "performance" is inherently based on a human reading the test result.

7. The Type of Ground Truth Used

The ground truth used for both the in-house comparison study and the lay user study was GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and generally accepted method for confirming the presence and concentration of specific substances in toxicology.

8. The Sample Size for the Training Set

The document describes the device's performance characteristics (precision, linearity, stability, cut-off, interference, specificity) and then "Comparison Studies" and "Lay User Studies." It does not explicitly mention a "training set" for the device itself, as it is a chemical immunoassay, not a machine learning model that typically requires a training set. The descriptions of device development and analytical performance relate to the overall design and validation of the chemical components and detection mechanism.

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

Since a "training set" in the context of machine learning is not applicable to this immunoassay device, the method for establishing its ground truth is also not applicable. The device's functionality is based on established biochemical principles and extensive internal analytical validation described in the "Analytical Performance" section (e.g., precision, specificity, interference against defined cut-off values), rather than being "trained" on a dataset.

Summary

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

510(k) SUMMARY

Date:

July 23, 2012

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

1 2012 AUG

1. 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: 4.

Wondfo Amphetamine Urine Test Wondfo Secobarbital Urine Test Wondfo Oxazepam Urine Test

Classification:

Product Code CFR # DKZ 21CFR 862.3100 DIS 21CFR 862.3150 JXM 21CFR 862.3170 K020771 Acon Laboratories, Inc.

Predicate Devices:

One Step Drug Screen Test

1. Intended Use
  Wondfo Amphetamine, Secobarbital, and Oxazepam Urine Tests are intended for the qualitative determination of d-Amphetamine , Secobarbital, and Oxazepam at a specific cut-off concentration in human urine samples. They are intended for healthcare professional use and over the counter use.
1. Device Description
  Immunochromatograph assays for Amphetamine, Secobarbital, and Oxazepam Urine Tests use a lateral flow, one step system for the qualitative detection of d-Amphetamine , Secobarbital, 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.

{1}------------------------------------------------

1. Substantial Equivalence Information

Item	Device	Predicate
Indication(s) for use	For the qualitative determination ofAmphetamine, Barbiturates,Benzodiazepines individual in humanurine.	Same (but the numberof drugs detecteddifferent)
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Type Of Test	Immunoassay principles that rely onantigen-antibody interactions toindicate positive or negative result	Same
Results	Qualitative	Same
Specimen Type	Human urine	Same
Cut Off Values	Amphetamine: 1000ng/mlSecobarbital : 300 ng/mlOxazepam: 300ng/ml	Same (but thenumber of drugsdetected different)
Configurations	Cup, dip card	Strip, Device
Intended Use	OTC Use & Prescription Use	Prescription Use

တံ Standard/Guidance Document Reference
- . Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man. Biomedical Publications, Davis, CA, 1982.
- Ellenhorn, M.J. and Barceloux, D. G Medical Toxicology. Elservier Science Publishing . Company, Inc., New York, 1988
- . Gilman, A. G., and Goodman, L. S. The Pharmacological Fluids, in Martin WR(ed): Drug Addiction I, New York, Spring - Verlag, 1977.
- . Harvey, R.A., Champe, P.C. Lippincotts Illustrated Reviews. Pharmacology, 91-95, 1992.
- . Hawwks RL, CN Chiang. Urine Testing for drugs of Abuse. National Institute for Drug Abuse (NIDA), Research Monography 73, 1986
- Hofmann F.E., A Handbook on Drug and Alcohol Abuse: The Biomedical Aspects, . New York, Oxford University Press, 1983.
- McBay, A. J. Clin. Chem. 33,33B-40B, 1987 ●

10. Test Principle

It is a rapid test for the qualitative detection of d-Amphetamine, Secobarbital, 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.

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

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.

1. 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. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following table.

Drug	-100%cutoff	-75%cutoff	-50%cutoff	-25%Cutoff	cutoff	+25%cutoff	+50%cutoff	+75%cutoff	+100%cutoff
AMP	50-/0+	50-/0+	50-/0+	50-/0+	45+/5-	50+/0-	50+/0-	50+/0-	50+/0-
Secobarbital	50-/0+	50-/0+	50-/0+	50-/0+	43+/7-	50+/0-	50+/0-	50+/0-	50+/0-
Oxazepam	50-/0+	50-/0+	50-/0+	50-/0+	46+/4-	50+/0-	50+/0-	50+/0-	50+/0-

b. Linearity

Not applicable

c. Stability

It is stable at 4-30℃ for 23 months.

d. Cut-off

Test	Calibrator	Cut-off (ng/ml)
Amphetamine(AMP)	D-Amphetamine .	1 000
Secobarbital	Secobarbital	300
Oxazepam	Oxazepam	300

{3}------------------------------------------------

e. Interference

Compounds that show no interference at a concentration of 100 µg/mL are summarized in the following tables. . .

・

AMP

4-Acetamidophenol	(-) Y Ephedrine	Penicillin-G
Acetophenetidin	Erythromycin	Pentazocaine
N-Acetylprocainamide	β-Estradiol	Pentobarbital
Acetylsalicylic acid	Estrone-3-sulfate	Perphenazine
Aminopyrine	Ethyl-p-aminobenzoate	Phencyclidine
Amitryptyline	Fenfluramine	Phenelzine
Amobarbital	Fenoprofen	Phendimetrazine
Amoxicillin	Furosemide	Phenobarbital
Ampicillin	Gentisic acid	Phetoin
Ascorbic acid	Hemoglobin	L-Phenylephrine
Apomorphine	Hydralazine	β-Phenylethlamine
Aspartame	Hydrochlorothiazide	Phenylpropanolamine
Atropine	Hydrocodone	Prednisolone
Benzilic acid	Hydrocortisone	Prednisone
Benzoic acid	O-Hydroxyhippuric acid	Procaine
Benzoylecgonine	3-Hydroxytyramine	Promazine
Bilirubin	Ibuprofen	Promethazine
Brompheniramine	Imipramine	D,L-Propanolol
Caffeine	(-) Isoproterenol	Propiomazine
Cannabidiol	Isoxsuprine	D-Propoxyphene
Cannabinol	Ketamine	Quinidine
Chloralhydrate	Ketoprofen	Quinine
Chloramphenicol	Labetalol	Ranitidine
Chlordiazepoxide	Levorphanol	Salicylic acid
Chlorothiazide	Loperamide	Secobarbital
(±) Chlorpheniramine	Maprotiline	Serotonin
Chlorpromazine	Meperidine	Sulfamethazine
Chlorquine	Meprobamate	Sulindac
Cholesterol	Methadone	Temazepam
Clomipramine	Methylphenidate	Tetracycline
Clonidine	Morphine-3-Dglucuronide	Tetrahydrocortisone
Cocaine hydrochloride	Nalidixic acid	Tetrahydrozoline
Codeine	Naloxone	Δ9-THC-COOH
Cortisone	Naltrexone	Thebaine
(-) Cotinine	Naproxen	Thiamine
Creatinine	Niacinamide	Thioridazine
Deoxycorticosterone	Nifedipine	D,L-Thyroxine
Dextromethorphan	Norcodein	Tolbutamine
Diazepam	Norethindrone	Triamterene

{4}------------------------------------------------

Diclofenac Diflunisal Digoxin Diphenhydramine Doxylamine Ecgonine hydrochloride Ecgonine methylester (IR,2S)-(-)-Ephedrine L-Ephedrine

D-Norpropoxyphene Noscapine D.L-Octopamine Oxalic acid Oxazepam Oxolinic acid Oxycodone Oxymetazoline Papaverine

Secobarbital

Acetaminophen Acetophenetidin N-Acetylprocainamide Acetylsalicylic acid Aminopyrine Amitryptyline Amoxicillin Ampicillin Ascorbic acid Apomorphine Aspartame Benzilic acid Benzoic acid Benzoylecgonine Bilirubin Brompheniramine Caffeine Cannabidiol Cannabinol Chloralhydrate Chloramphenicol Chlordiazepoxide Chlorothiazide (±) Chlorpheniramine Chlorpromazine Chlorquine Cholesterol Clomipramine Clonidine Cocaine hydrochloride Codeine

Cortisone (-) Cotinine Creatinine Deoxycorticosterone L-Ephedrine Erythromycin B-Estradiol Estrone-3-sulfate Ethyl-p-aminobenzoate Fenfluramine Fenoprofen Furosemide Gentisic acid Hemoglobin Hydralazine Hydrochlorothiazide Hydrocodone Hydrocortisone O-Hydroxyhippuric acid 3-Hydroxytyramine Ibuprofen Imipramine (-) Isoproterenol Isoxsuprine Ketamine Ketoprofen Labetalol Levorphanol Loperamide Maprotiline Meperidine Meprobamate Methadone Methylphenidate Morphine-3-ß-D glucuronide Nalidixic acid Naloxone Naltrexone Naproxen

Trifluoperazine Trimethoprim Trimipramine Tryptamine D, L-Tyrosine Uric acid Verapamil · Zomepirac

Oxycodone Oxymetazoline Papaverine Penicillin-G Pentazocaine Perphenazine Phencyclidine Phenelzine Phendimetrazine Phetoin L-Phenylephrine ß-Phenylethlamine Phenylpropanolamine Prednisolone Prednisone Procaine Promazine Promethazine D,L-Propanolol Propiomazine D-Propoxyphene Quinidine Quinine Ranitidine Salicylic acid Serotonin Sulfamethazine Sulindac Temazepam Tetracycline Tetrahydrocortisone

· Tetrahydrozoline Thiamine Thioridazine D.L-Thyroxine

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

Dextromethorphan Diazepam Diclofenac Diflunisal Digoxin Diphenhydramine Doxylamine Ecgonine hydrochloride Ecgonine methylester (IR,2S)(-)Ephedrine

Niacinamide Nifedipine Norcodein Norethindrone D-Norpropoxyphene Noscapine D.L-Octopamine Oxalic acid Oxazepam Oxolinic acid

Oxazepam

4-Acetamidophenol Acetophenetidin N-Acetvprocainamide Acetvsalicvlic acid Aminopvrine Amityptvline Amorbarbital Amoxicillin Ampicillin l-Ascorbic Acid D.L-Amphetamine Apormorphine
Aspartame Atropine Benzillic acid Benzoic acid Benzoylecaonine Benzphetamine Bilirubin (±) Chlorpheniramine Caffeine

Cannabidiol Chloralhvdrate Chloramphenicol Chlordiazepoxide

Chlorothiazide

(±)Chlorpheniramine Chlorpromazine Chlorguine

Cholesterol

Diaoxin Diphenhydramine Doxylamine Ecaonine dydrochloride Ecqonine methylester (-)-0-Ephedrine Fenoprofen Furosemide Gentisic acid Hemoglobin Hydrocortisone O-Hydroxyhippuric acid

p-Hydroxy- methamphetamine 3-Hydroxytyramine Ibuprofen Imipramine Iproniazid (±)Isoproterenol Isoxsuprine Ketamine Ketoprofen

Labetalol Loperamide Maprotiline Meperidine

Meprobamate

Methadone Methoxyphenamine () 3,4-Methylenedioxyamphetamine (+)3,4-MethylenedioxyTolbutamine Triamterene Trifluoperazine Trimethoprim Trimipramine Tryptamine D, L-Tyrosine Uric acid Verapamil Zomepirac

D.L-Octopamine Oxalic acid Oxolinic acid Pentobarbital Perphenazine Phencyclidine Phenelzine Phenobarbital Phentermine L-Phenylephrine □-Phenylethylamine Phenylpropanotamin e Prednisone D.L-Propanolol D-Propoxyphene D-Pseudoephedrine Quinine Ranitidine Salicylic acid Secobarbital Serotonin (5-Hydroxytyramine) Sertraline Sulfamethazine Sulindac Tetrahydrocortisone, 3 Acetate Tetrahydrocortisone, (ß-D glucuronide) Tetrahydrozoline Thiamine Thioridazine

D.L-Tyrosine

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

	methamphetamine
Clomipramine	Nalidixic acid	Tolbutamide
Clonidine	Nalorphine	Triamterene
Cocaine hydrochloride	Naloxone	Trifluoperazine
Cortisone	Naltrexone	Trimethoprim
(-)cotinine	Naproxen	Tryptamine
Creatinine	Niacinamide	D.L-Tryptophan
Dextromethorphan	Nifedipine	Tyramine
Diazepam	Norethindrone	Uric acid
Diclofenac	D-Norpropoxyphene	Verapamil
Diflunisal	Noscapine	Zomepirac

.f. Specificity
.

To test the specificity, drug metabolites and other components that are likely to be present in urine samples were tested. Compounds that produced positive results are listed below.

AMP(Amphetamine)	Result
(d-Amphetamine, Cutoff=1000 ng/mL)	Positive at 1,000 ng/mL
l-Amphetamine	Positive at 50,000 ng/mL
dl-Amphetamine	Positive at 3,000 ng/mL
(+/-) 3,4-methylenedioxyamphetamine(MDA)	Positive at 5,000 ng/mL
Phentermine	Positive at 3,000 ng/mL
d-methamphetamine	Positive at >100,000
l-methamphetamine	Positive at >100,000
3,4-Methylenedioxyethylamphetamine(MDE)	Positive at 100,000
(+/-)3,4-methylenedioxumethamphetamine(MDMA)	Positive at 100,000

Secobarbital	Result
(Secobarbital, Cutoff=300 ng/mL)	Positive at 300 ng/mL
Amobarbital	Positive at 300 ng/mL
Alphenol	Positive at 150 ng/mL
Aprobarbital	Positive at 200 ng/mL
Butabarbital	Positive at 75 ng/mL
Butathal	Positive at 100 ng/mL
Butalbital	Positive at 2,500 ng/mL
Cyclopentobarbital	Positive at 600 ng/mL
Pentobarbital	Positive at 300 ng/mL
Phenobarbital	Positive at 100 ng/mL

・

{7}------------------------------------------------

Oxzaepam	Result
(Oxazepam, Cutoff=300 ng/mL)	Positive at 300 ng/mL
Alprazolam	Positive at 200 ng/mL
a-Hydroxyalprazolam	Positive at 1,500 ng/mL
Bromazepam	Positive at 1,500 ng/mL
Chlordiazepoxide	Positive at 1,500 ng/mL
Clonazepam HCl	Positive at 800 ng/mL
Clobazam	Positive at 100 ng/mL
Clonazepam	Positive at 800 ng/mL
Clorazepate dipotassium	Positive at 200 ng/mL
Delorazepam	Positive at 1,500 ng/mL
Desalkylflurazepam	Positive at 400 ng/mL
Diazepam	Positive at 200 ng/mL
Estazolam	Positive at 2,500 ng/mL
Flunitrazepam	Positive at 400 ng/mL
D,L-Lorazepam	Positive at 1,500 ng/mL
Midazolam	Positive at 12,500 ng/mL
Nitrazepam	Positive at 100 ng/mL
Norchlordiazepoxide	Positive at 200 ng/mL
Nordiazepam	Positive at 400 ng/mL
Temazepam	Positive at 100 ng/mL
Trazolam	Positive at 2,500 ng/mL

2. Comparison Studies

The method comparison for the Wondfo Amphetamine Urine Test, Wondfo Secobarbital Urine Test and Wondfo Oxazepam Urine Test was performed in-house with three laboratory assistants with relevant experience and a lay person with no experience other than reading the instructions for use. 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:

Amphetamine
Cupformat		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	2	11	29
	Negative	10	18	10	0	0
ViewerB	Positive	0	0	2	11	29
	Negative	10	18	10	0	0
ViewerC	Positive	0	0	1	11	29
	Negative	10	18	11	0	0

Amphetamine

{8}------------------------------------------------

2111	Positive	----------------------------------------Market of the first and the contract and the complex of the count	-------------		Anl
Person-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	NegativeI			Accomments courses, consines, concess, call charges, and charges of the contribution of the contribution of the contribution of the contribution of the contribution of the co

Amphetamine

DipCardformat		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	1	11	29
	Negative	10	18	11	0	0
ViewerB	Positive	0	0	2	11	29
	Negative	10	18	10	0	0
ViewerC	Positive	0	0	2	11	29
	Negative	10	18	10	0	0
LayPerson	Positive	0	0	2	11	29
	Negative	10	18	10	0	0

Discordant table:

Viewer	Sample number	GC/MS result	Cup formatViewer result
Viewer A	AMP63	987	positive
Viewer A	AMP65	993	positive
Viewer B	AMP62	921	positive
Viewer B	AMP65	993	positive
Viewer C	AMP62	921	positive
Lay person	AMP62	921	positive
Lay person	AMP63	987	positive
Lay Person	AMP65	993	positive

Viewer	Sample number	GC/MS result	Dip Cardformat viewerresults
Viewer A	AMP62	921	positive
Viewer B	AMP62	921	positive
Viewer B	AMP65	993	positive
Viewer C	AMP35	797	positive
Viewer C	AMP63	987	positive
Lay Person	AMP35	797	positive
Lay person	AMP65	993	positive

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

Secobarbital

Cupformat		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	2	20	20
	Negative	10	10	18	0	0
ViewerB	Positive	0	0	2	20	20
	Negative	10	10	18	0	0
ViewerC	Positive	0	0	1	20	20
	Negative	10	10	19	0	0
LayPerson	Positive	0	0	2	20	20
	Negative	10	10	18	0	0

Secobarbital

Dip Card format		Negative	Low Negative by GC/MS (less than -50%)	Near Cutoff Negative by GC/MS (Between -50% and cutoff)	Near Cutoff Positive by GC/MS (Between the cutoff and +50%)	High Positive by GC/MS (greater than +50%)
Viewer A	Positive	0	0	2	20	20
	Negative	10	10	18	0	0
Viewer B	Positive	0	0	2	20	20
	Negative	10	10	18	0	0
Viewer C	Positive	0	0	2	20	20
	Negative	10	10	18	0	0
Lay Person	Positive	0	0	3	20	20
	Negative	10	10	17	0	0

. .

Discordant result

Viewer	Sample number	GC/MS result	Cup formatViewer result
Viewer A	BAR61	293	positive
Viewer A	BAR216	280	positive
Viewer B	BAR34	243	positive
Viewer B	BAR216	280	positive
Viewer C	BAR35	237	positive
Lay Person	BAR61	293	positive
Lay Person	BAR216	280	positive

. .

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

Viewer	Sample number	GC/MS result	Dip Card format viewer results
Viewer A	BAR34	243	positive
Viewer A	BAR216	280	positive
Viewer B	BAR34	243	positive
Viewer B	BAR61	293	positive
Viewer C	BAR35	237	positive
Viewer C	BAR216	280	positive
Lay Person	BAR34	243	positive
Lay Person	BAR35	237	positive
Lay Person	BAR61	293	positive

Oxazepam

and the country of the country of the county of

	Negative	Low Negativeby GC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between -50%and cutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
Positive	0	0	1	20	20
Negative	10	10	19	0	0
Positive	0	0	2	20	20
Negative	10	10	18	0	0
Positive	0	0	2	20	20
Negative	10	10	18	0	0
Positive	0	0	3	20	20
Negative	10	10	17	0	0

. .

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

Oxazepam

DipCardformat		Negative	LowNegative byGC/MS(less than-50%)	Near CutoffNegative byGC/MS(Between-50% andcutoff)	Near CutoffPositive byGC/MS(Between thecutoff and+50%)	High Positiveby GC/MS(greater than+50%)
ViewerA	Positive	0	0	2	20	20
	Negative	10	10	18	0	0
ViewerB	Positive	0	0	2	20	20
	Negative	10	10	18	0	0
ViewerC	Positive	0	0	2	20	20
	Negative	10	10	18	0	0
LayPerson	Positive	0	0	3	20	20
	Negative	10	10	17	0	0

Discordant result

Viewer	Sample number	GC/MS result	Cup formatViewer result
Viewer A	BZO32	226	positive
Viewer B	BZO32	226	positive
Viewer B	BZO211	233	positive
Viewer C	BZO34	243	positive
Viewer C	BZO65	277	positive
Lay Person	BZO34	243	positive
Lay Person	BZO65	277	positive
Lay Person	BZO211	233	positive

Viewer	Sample number	GC/MS result	Dip Cardformat viewerresults
Viewer A	BZO34	243	positive
Viewer A	BZO65	277	positive
Viewer B	BZO32	226	positive
Viewer B	BZO211	233	positive
Viewer C	BZO34	243	positive
Viewer C	BZO65	277	positive
Lay Person	BZO32	226	positive
Lay Person	BZO34	243	positive.
Lay Person	BZO211	233	positive

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

Test Cup format:

A lay user study was performed at three intended user sites with 140 lay persons. Participants in the study were 58 females and 82 males tested the amphetamine samples, 59 females and 81 males tested the secobarbital samples 71 females and 69 males tested the oxazepam samples. They had diverse educational and professional backgrounds and ranged in age from 21 to >50. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled samples and a device. The results are summarized below.

Cup format			OTC user		%Agreement
Drug	Concentration	Number of samples	Negative	Positive	With GC/MS
Amphetamine	Negative	20	20	0	100%
	-75%	20	20	0	100%
	-50%	20	20	0	100%
Amphetamine	-25%	20	18	2	90%
Amphetamine	+25%	20	1	19	95%
Amphetamine	+50%	20	0	20	100%
Amphetamine	+75%	20	0	20	100%
Secobarbital	Negative	20	20	0	100%
	-75%	20	20	0	100%
	-50%	20	20	0	100%
Secobarbital	-25%	20	18	2	90%
Secobarbital	+25%	20	2	18	90%
Secobarbital	+50%	20	0	20	100%
Secobarbital	+75%	20	0	20	100%
Oxazepam	Negative	20	20	0	100%
	-75%	20	20	0	100%
	-50%	20	20	0	100%
Oxazepam	-25%	20	18	2	90%
Oxazepam	+25%	20	1	19	95%
Oxazepam	+50%	20	0	20	100%
Oxazepam	+75%	20	0	20	100%

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

Dip Card format:

A lay user study was performed at three intended user sites with 140 lay persons. Participants in the study were 61 females and 79 males tested the amphetamine samples. 64 females and 76 males tested the secobarbital samples 66 females and 74 males tested the oxazepam samples. They had diverse educational and professional backgrounds and ranged in age from 21 to >50. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled samples and a device. The results are summarized below.

Dip card format			OTC user		%AgreementWithGC/MS
Drug	Concentration	Number of samples	Negative	Positive
Amphetamine	Negative	20	20	0	100%
	-75%	20	20	0	100%
	-50%	20	20	0	100%
	-25%	20	17	3	85%
	+25%	20	1	19	95%
	+50%	20	0	20	100%
	+75%	20	0	20	100%
Secobarbital	Negative	20	20	0	100%
	-75%	20	20	0	100%
	-50%	20	20	0	100%
	-25%	20	17	3	85%
	+25%	20	2	18	90%
	+50%	20	0	20	100%
	+75%	20	0	20	100%
Oxazepam	Negative	20	20	0	100%
	-75%	20	20	0	100%
	-50%	20	20	0	100%
	-25%	20	19	1	95%
	+25%	20	1	19	95%
	+50%	20	0	20	100%
	+75%	20	0	20	100%

Clinical Studies

Not applicable

12. Conclusion

Based on the test principle and performance characteristics of the device, it's concluded that Wondfo Amphetamine, Secobarbital, and Oxazepam Urine Tests are substantially equivalent to the predicate.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Guangzhou Wondfo Biotech Co., Ltd. c/o Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20877

K121987 Re: K121987
Trade Name: Wondfo Amphetamine Urine Test
Trade Name: Wondfo Same beckitel Urine Test Wondfo Secobarbital Urine Test Wondfo Oxazepam Urine Test Regulation Number: 21 CFR §862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Regulator Codes: DKZ, DIS, JXM Dated: June 18, 2012 Received: July 6, 2012

1 2012 AUG

Dear Mr. Shia:

Dour and We have reviewed your Section 10(K) prematics is substantially equivalent (for the
referenced above and have determined the devices man we are of and have detemined the device is substancially courages marketed in
indications for use stated in the enclosure) to legally marketed in
the enclosed on the enclosur interstate commerce prior to May 28, 1976, the enactment date of the Medical Device
interstate commerce prior to May 28, 1976, the enactment date of the provision interstate commerce prior to May 28, 1976, the enactment the provisions of
Amendments, or to devices that have been recuassified in accordance with the provisions of mendments, or to devices that have been reclassified in accordination while in the premaired
the Federal Food, Drug, and Cosmetic Act (Act (hat do not require apprematic Allettanente)
the Federal Food, Drug, and Cosmetic Act (Act) that do not requires, which the general
approval application (PMA). You may, therefore, market the device, subje approval application (PMA). You may, therefore, inance the Act include appen a provisions of the Act. The general controls provisions of the New York of the Section
requirements for announce interestmises michranding and adulteration. requirements for annual registration, noning of an are and adulteration.
Iabeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III
nto in a major and the the same additional controls. Existing major regulation If your device is classified (see above) into either class in (special one of the major regulations affecting
(PMA), it may be subject to such additional controls. Existing If your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 8 (111) - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11, 14 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 12 Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA's issuance of a substantial equirements with other requirements
mean that FDA has made a determination that your device with other Federal agencies Prease of and modified on any Federal statutes and regulations administered by only institution of the Act of any the Act of any the Act of essessions
You must connect of the Act's requir ou must comply with all the Act's requirements, including our I da listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 807); model
and listing (21 CFR Part 807); labeling (21 CFR 803); and good
reporting (reporting of medical devi and hims (reporting of medical device-related adverse evellis) (21 CP (2016) - 11:18
manufacturing practice requirements as set forth in the quality systems (QS) regulation ( CFR Part 820).

Image /page/14/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird with outstretched wings, with three distinct wing segments visible. The bird is facing towards the right side of the image.

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

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 productions in the me stimms regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) Office of but velhance and 250 in the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Tou may other butter gefacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.html

Sincerely yours,

K. C. Au, Ph.D.

Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

Indications for Use Form

510(k) Number (if known): ____K121987

Device Name: Wondfo Amphetamine Urine Test

Indications for Use:

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

Over the Counter Use_ ਮ (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 Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121987

Page 1 of 3

{17}------------------------------------------------

Indications for Use Form

510(k) Number (if known): ___K121987

Device Name: Wondfo Secobarbital Urine Test

Indications for Use:

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 Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121987

Page 2 of 3

{18}------------------------------------------------

Indications for Use Form

510(k) Number (if known): __ K121987

Device Name: Wondfo Oxazepam Urine Test

Indications for Use:

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

Over the Counter Use_ X (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 Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K121987

Page 3 of 3

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).