Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies describe a standard immunochromatographic assay, which relies on chemical reactions and visual interpretation, not AI/ML algorithms. There is no mention of AI, ML, or any computational analysis of results.

Therapeutic

No
This device is an immunochromatographic assay for the qualitative determination of substances in human urine, providing only preliminary test results. It is intended for diagnostic purposes (drug screening) and does not treat or prevent any medical condition.

Diagnostic

Yes

This device is an immunochromatographic assay for the qualitative determination of specific substances (d-Amphetamine, Secobarbital, Oxazepam) in human urine. Its intended use is to provide preliminary test results for these substances, which is a diagnostic function, even though confirmatory testing is required.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "immunochromatograph assay" available in "dip card format and a cup format," which are physical hardware components. The performance studies also involve testing these physical devices with urine samples.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is for the "qualitative determination of d-Amphetamine, Secobarbital, and Oxazepam in human urine." This indicates that the device is used to test a sample taken from the human body (urine) to provide information about a person's health status (presence of drugs).
Device Description: The description details an "immunochromatographic assay," which is a common type of in vitro diagnostic test. It describes the components used to detect the target analytes in the urine sample.
Sample Type: The device uses "human urine," which is a biological specimen.
Performance Studies: The document describes performance studies conducted using "clinical samples" and "urine samples," further confirming its use with human biological material.
Comparison to Predicate Device: The mention of a "Predicate Device" (K020771 Acon Laboratories, Inc. One Step Drug Screen Test) which is also a drug screen test, strongly suggests that this device falls under the same regulatory category, which for these types of tests is IVD.

The fact that it is intended for both prescription and over-the-counter use, and provides preliminary results requiring confirmation, are all consistent with the characteristics of many IVD devices, particularly drug screening tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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. 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 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.

Product codes

DKZ, DIS, JXM

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professional use and over the counter use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.

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.

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Performance
a. Precision: Precision studies were carried out for samples with concentrations of -100%cut off, -75%cut off, -50%cut off, -25%cut off, +25%cut off, +50%cut off , +75%cut off and +100%cut off. For each concentration, tests were performed two runs per day for 25 days.
b. Linearity: Not applicable
c. Stability: It is stable at 4-30℃ for 23 months.
d. Cut-off: Amphetamine (AMP) Calibrator: D-Amphetamine, Cut-off (ng/ml): 1000. Secobarbital Calibrator: Secobarbital, Cut-off (ng/ml): 300. Oxazepam Calibrator: Oxazepam, Cut-off (ng/ml): 300.
e. Interference: Compounds that show no interference at a concentration of 100 µg/mL are summarized in tables for AMP, Secobarbital, and Oxazepam.
f. Specificity: Compounds that produced positive results are listed in tables for AMP, Secobarbital, and Oxazepam, including various drug metabolites and other components.
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 tables for Amphetamine, Secobarbital, and Oxazepam for both Cup format and Dip Card format, showing viewer results (Positive/Negative) against GC/MS categories (Negative, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive). Discordant tables show specific sample numbers and GC/MS results where the viewer result differed from the reference.

Test Cup format: A lay user study was performed at three intended user sites with 140 lay persons. The results summarized indicate the %Agreement with GC/MS for various concentrations (Negative, +/-75%, +/-50%, +/-25%) for Amphetamine, Secobarbital, and Oxazepam. Agreement ranged from 90% to 100%.

Dip Card format: A lay user study was performed at three intended user sites with 140 lay persons. The results summarized indicate the %Agreement with GC/MS for various concentrations (Negative, +/-75%, +/-50%, +/-25%) for Amphetamine, Secobarbital, and Oxazepam. Agreement ranged from 85% to 100%.

Clinical Studies: Not applicable

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found (Specific values for sensitivity, specificity, PPV, NPV are not explicitly stated, though agreement percentages are provided.)

Predicate Device(s)

K020771 Acon Laboratories, Inc. One Step Drug Screen Test

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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 of
Amphetamine, Barbiturates,
Benzodiazepines individual in human
urine.	Same (but the number
of drugs detected
different)
Methodology	Competitive binding, lateral flow
immunochromatographic assays based
on the principle of antigen antibody
immunochemistry.	Same
Type Of Test	Immunoassay principles that rely on
antigen-antibody interactions to
indicate positive or negative result	Same
Results	Qualitative	Same
Specimen Type	Human urine	Same
Cut Off Values	Amphetamine: 1000ng/ml
Secobarbital : 300 ng/ml
Oxazepam: 300ng/ml	Same (but the
number of drugs
detected 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
Cup
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	11	29
	Negative	10	18	10	0	0
Viewer
B	Positive	0	0	2	11	29
	Negative	10	18	10	0	0
Viewer
C	Positive	0	0	1	11	29
	Negative	10	18	11	0	0

Amphetamine

8

| 211
1 |
Positive | ----------------------------------------
Market of the first and the contract and the complex of the count | -------------
| | An
l |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------------------------------------------------------------------------------------------------------------|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Person

------- | Negative
I | | | 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

| 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 | 1 | 11 | 29 |
| | Negative | 10 | 18 | 11 | 0 | 0 |
| Viewer
B | Positive | 0 | 0 | 2 | 11 | 29 |
| | Negative | 10 | 18 | 10 | 0 | 0 |
| Viewer
C | Positive | 0 | 0 | 2 | 11 | 29 |
| | Negative | 10 | 18 | 10 | 0 | 0 |
| Lay
Person | Positive | 0 | 0 | 2 | 11 | 29 |
| | Negative | 10 | 18 | 10 | 0 | 0 |

Discordant table:

| Viewer | Sample number | GC/MS result | Cup format
Viewer 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 Card
format viewer
results |
|------------|---------------|--------------|--------------------------------------|
| 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

:

| Cup
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 | 1 | 20 | 20 |
| | Negative | 10 | 10 | 19 | 0 | 0 |
| Lay
Person | 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 format
Viewer 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

:

.

. .

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 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%) |
|----------|----------|-------------------------------------------------|---------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| 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

| 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 format
Viewer 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 Card
format viewer
results |
|------------|---------------|--------------|--------------------------------------|
| 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 | With
GC/MS |
|-----------------|----- | Drug | Amphetamine | Negative | | -75% | | -50% | | -25% | | +25% | | +50% | | +75% | Secobarbital | Negative | | -75% | | -50% | | -25% | | +25% | | +50% | | +75% | Oxazepam | Negative | | -75% | | -50% | | -25% | | +25% | | +50% | | +75% | | OTC user | | %Agreement
----------|-------------------|----------|----------|-----------------------------|
| Concentration | Number of samples | Negative | Positive | |
| 20 | 20 | 0 | 100% |
| 20 | 20 | 0 | 100% |
| 20 | 20 | 0 | 100% |
| 20 | 17 | 3 | 85% |
| 20 | 1 | 19 | 95% |
| 20 | 0 | 20 | 100% |
| 20 | 0 | 20 | 100% |
| 20 | 20 | 0 | 100% |
| 20 | 20 | 0 | 100% |
| 20 | 20 | 0 | 100% |
| 20 | 17 | 3 | 85% |
| 20 | 2 | 18 | 90% |
| 20 | 0 | 20 | 100% |
| 20 | 0 | 20 | 100% |
| 20 | 20 | 0 | 100% |
| 20 | 20 | 0 | 100% |
| 20 | 20 | 0 | 100% |
| 20 | 19 | 1 | 95% |
| 20 | 1 | 19 | 95% |
| 20 | 0 | 20 | 100% |
| 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,

N

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:

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.

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:

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.

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.

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:

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.

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