CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)

K140089 · Guangzhou Wondfo Biotech Co., Ltd. · DJG · Apr 8, 2014 · Clinical Toxicology

Device Facts

• Record ID: K140089
• Device Name: CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Apr 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

CR3 Keyless Split Sample Cup Morphine-Oxazepam is a rapid test for the qualitative detection of Morphine (a drug in the opiate class) and Oxazepam(a drug in the benzodiazepine class) in human urine at a cutoff concentration of 2000ng/mL and 300ng/mL, respectively. The tests may yield preliminary positive results even when prescription drugs including Morphine and Oxazepam are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for morphine and oxazepam in urine. 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. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of Morphine and Oxazepam in human urine; uses monoclonal antibody-dye conjugates with gold chloride, fixed drug-protein conjugates, and anti-mouse IgG polyclonal antibody on membranes. Device is a split keyless cup; user immerses absorbent end into urine sample; capillary action draws sample across pre-coated membrane. Competitive binding principle: analyte below cutoff allows antibody-dye to bind immobilized drug-protein (colored line = negative); analyte above cutoff binds antibody-dye, preventing line formation (no line = preliminary positive). Used in point-of-care or home settings by lay persons or clinicians. Output is visual qualitative result (presence/absence of colored band). Results provide preliminary screening; requires confirmatory testing (GC/MS) for clinical decision-making.

Clinical Evidence

Bench testing only. Precision/reproducibility studies performed over 25 days with three lots. Analytical specificity and interference studies conducted with structurally related and unrelated compounds. Method comparison against GC/MS performed with 80 clinical samples by three professionals and one lay user. Lay user study (n=260) evaluated performance across various concentrations relative to cutoff; results showed high agreement with GC/MS. No clinical diagnostic trials performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials include monoclonal antibody-dye conjugates, gold chloride, drug-protein conjugates, and anti-mouse IgG polyclonal antibody on membranes. Form factor is a split keyless cup. Stable at 4-30°C for 18 months. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Morphine and Oxazepam in human urine for OTC and prescription use. Intended for individuals requiring drug screening; not for distinguishing between prescription use and abuse. No specific age or gender restrictions.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate 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).

Predicate Devices

• Wondfo Multi-Drug Urine Test Cup (Panel) (k130665)

Submission Summary (Full Text)

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

APR 0 8 2014

### 510(k) SUMMARY

| 1. | Date: | February 28, 2014 |
|----|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitter: | Guangzhou Wondfo Biotech Co., Ltd.<br>South China University of Technology<br>Guangzhou, P.R. China 510641 |
| 3. | Contact person: | Joe Shia<br>LSI International Inc.<br>504 East Diamond Ave., Suite I<br>Gaithersburg, MD 20877<br>Telephone: [phone]<br>Fax: [phone]<br>Email:[e-mail] |

- 4. Device Name:
CR3 Keyless Split Sample Cup Morphine-Oxazepam

Classification:

| Product Code | CFR # | Panel |
|--------------|---------------------------------------------|------------|
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |
| JXM | 21 CFR, 862.3170 Benzodiazepine Test System | Toxicology |

- 5. Predicate Devices:
Guangzhou Wondfo Biotech Co., Ltd. Wondfo Multi-Drug Urine Test Cup (Panel) (K130665)

- 6. Intended Use
CR3 Keyless Split Sample Cup Morphine-Oxazepam is a rapid test for the qualitative detection of Morphine (a drug in the opiate class) and Oxazepam(a drug in the benzodiazepine class) in human urine at a cutoff concentration of 2000ng/mL and 300ng/mL, respectively.

The tests may yield preliminary positive results even when prescription drugs including Morphine and Oxazepam are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for morphine and oxazepam in urine. 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.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

- 7. Device Description
Immunochromatograph assays for Opiate and Benzodiazepines Urine Tests use a lateral flow, one step system for the qualitative detection of Morphine and Oxazepam 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.

- Substantial Equivalence Information 8.

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

| Item | Device | Predicate |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s) for use | For the qualitative determination of<br>Morphine, Oxazepam individual in<br>human urine. | Same (but the number of<br>drugs detected different) |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Type Of Test | Immunoassay principles that rely on<br>antigen-antibody interactions to indicate<br>positive or negative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Morphine: 2000ng/ml<br>Oxazepam: 300ng/ml | Same (but the number<br>of drugs detected<br>different) |
| Configurations | Split Keyless Cup | Cup, Dip Card |
| Intended Use | OTC Use & Prescription Use | Same |

#### 9. Test Principle

It is a rapid test for the qualitative detection of Morphine and Oxazepam in urine samples. It is a lateral flow chromatographic immunoassay. When the absorbent end is immersed into a urine sample, the urine is absorbed into the device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane. At analyte concentration below the target cut off, antibody-dye conjugates bind to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored test line that indicates a negative result. When analyte concentration is above the cutoff, analyte molecules bind to the antibody-dye conjugate, preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. No colored band shows in the test region, indicating a preliminary 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. For each concentration, tests were performed two runs per day for 25 days with three different lots of devices. The results obtained are summarized in the following table.

### A. For Morphine testing

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| Result<br>OPI | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>Cut off | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| W11510201CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| W11510202CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| W11510203CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

# B. For Oxazepam testing

| Result<br>BZO | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>Cut off | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| W11510201CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| W11510202CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| W11510203CU5 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 42+/8- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

# b. Linearity

Not applicable ·

c. Stability

It is stable at 4-30°C for 18 months.

# d. Cut-off

| Test | Calibrator | Cut-off (ng/ml) |
|----------|------------|-----------------|
| Morphine | Morphine | 2000 |
| Oxazepam | Oxazepam | 300 |

# e. Interference

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

# Morphine

| 4-Acetamidophenol | Ecgonine methylester | Oxolinic acid |
|----------------------|-----------------------|---------------|
| Acetophenetidin | (-) -Y -Ephedrine | Oxymetazoline |
| N-Acetylprocainamide | Erythromycin | Papaverine |
| Acetylsalicylic acid | β-Estradiol | Penicillin-G |
| Aminopyrine | Estrone-3-sulfate | Pentazocine |
| Amitryptyline | Ethyl-p-aminobenzoate | Pentobarbital |
| Amobarbital | Fenoprofen | Perphenazine |
| Amoxicillin | Furosemide | Phencyclidine |

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Ampicillin Ascorbic acid D,L-Amphetamine Apomorphine Aspartame Atropine Benzilic acid Benzoic acid Benzovlecgonine Benzphetamine Bilirubin (±) Brompheniramine Caffeine Cannabidiol Chloralhydrate Chloramphenicol Chlordiazepoxide Chlorothiazide (±) Chlorpheniramine Chlorpromazine Chlorquine Cholesterol Clomipramine Clonidine Cocaine hydrochloride Cortisone (-) Cotinine Creatinine Deoxycorticosterone Dextromethorphan Diazepam Diclofenac Diflunisal Digoxin Diphenhydramine Doxylamine Ecgonine hydrochloride

### Oxazepam

4-Acetamidophenol Acetophenetidin N-Acetvprocainamide Acetvsalicvlic acid Aminopvrine

Gentisic acid Hemoglobin Hydralazine Hydrochlorothiazide Hydrocortisone O-Hvdroxyhippuric acid p-Hydroxy methamphetamine 3-Hydroxytyramine Ibuprofen Imipramine Iproniazid Isoprotereno] Isoxsuprine Ketamine Ketoprofen Labetalol Loperamide Maprotiline Meperidine Meprobamate Methadone Methoxyphenamine (+) 3,4-Methylenedioxyamphetamine (+)3,4-Methylenedioxymethamphetamine Nalidixic acid Nalorphine Naloxone Naltrexone Naproxen Niacinamide Nifedipine Norethindrone D-Norpropoxyphene Noscapine D,L-Octopamine Oxalic acid Oxazepam

Doxylamine Ecaonine dydrochloride Ecqonine methylester (-)-Y-Ephedrine Fenoprofen

Phenelzine Phenobarbital Phentermine L-Phenylephrine ß-Phenylethylamine Phenylpropanolamine Prednisone D.L-Propanolol D-Propoxyphene D-Pseudoephedrine Quinidine Quinine Ranitidine Salicylic acid Secobarbital Serotonin (5-Hydroxytyramine) Sulfamethazine Sulindac Temazepam Tetracycline Tetrahydrocortisone, 3 Acetate Tetrahydrocortisone3 ( B -D glucuronide) Tetrahydrozoline Thiamine Thioridazine D. L-Tyrosine Tolbutamide Triamterene Trifluoperazine Trimethoprim Trimipramine Tryptamine

D. L-Tryptophan Tyramine Uric acid Verapamil Zomepirac

Oxolinic acid Pentobarbital Perphenazine Phencyclidine Phenelzine

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

Amityptvline Furosemide Amorbarbital Gentisic acid Amoxicillin Hemoglobin Ampicillin Hydrocortisone l-Ascorbic Acid O-Hydroxyhippuric acid D.L-Amphetamine p-Hydroxy- methamphetamine Apormorphine 3-Hydroxytyramine Aspartame Ibuprofen Atropine Imipramine Benzillic acid Iproniazid Benzoic acid (±)Isoproterenol Benzoylecaonine Isoxsuprine Benzphetamine Ketamine Bilirubin Ketoprofen (±) Chlorpheniramine Labetalol Caffeine Loperamide Cannabidiol Maprotiline Chloralhvdrate Meperidine Chloramphenicol Meprobamate Chlorothiazide Methadone (±)Chlorpheniramine Methoxyphenamine Chlorpromazine (+) 3,4-Methylenedioxyamphetamine (+)3,4-Methylenedioxy-Chlorquine methamphetamine Cholesterol Nalidixic acid Clomipramine Nalorphine Clonidine Naloxone Cocaine hydrochloride Naltrexone Cortisone Naproxen (-)cotinine Niacinamide Creatinine Nifedipine Dextromethlorphan Norethindrone DicloIrfenac D-Norpropoxyphene Diflunisal Noscapine Diaoxin D.L-Octopamine Diphenhydramine Oxalic acid

Phenobarbital Phentermine L-Phenylephrine ß-Phenylethylamine Phenylpropanotamine Prednisone D.L-Propanolol D-Propoxyphene D-Pseudoephedrine Quinine Ranitidine Salicylic acid Secobarbital Serotonin (5-Hydroxytyramine) Sertraline Sulfamethazine Sulindac Tetrahydrocortisone,3 Acetate Tetrahydrocortisone.(B-D glucuronide) Tetrahydrozoline Thiamine Thioridazine

D.L-Tyrosine

Tolbutamide Triamterene Trifluoperazine Trimethoprim Triyptamine D.L-Tryptophan Tyramine Uric acid Verapamil Zomepirac

f. Specificity/Cross-Reactivity

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

7

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| Morphine, Cutoff=2000 ng/mL | Result | %Cross-Reactivity |
|-----------------------------|---------------------------|-------------------|
| | Positive at 2,000 ng/mL | 100% |
| Codeine | Positive at 2,000 ng/mL | 100% |
| Ethylmorphine | Positive at 5,000 ng/mL | 40% |
| Hydrocodone | Positive at 12,500 ng/mL | 16% |
| Hydromorphine | Positive at 5,000 ng/mL | 40% |
| Levorphanol | Positive at 75,000 ng/mL | 2.7% |
| σ-Monoacetylmorphine | Positive at 5,000 ng/mL | 40% |
| Morphine 3-b-D-glucuronide | Positive at 2,000 ng/mL | 100% |
| Norcodeine | Positive at 12,500 ng/mL | 16% |
| Normorphone | Positive at 50,000 ng/mL | 4% |
| Oxycodone | Positive at 25,000 ng/mL | 8% |
| Oxymorphone | Positive at 25,000 ng/mL | 8% |
| Procaine | Positive at 150,000 ng/mL | 1.3% |
| Thebaine | Positive at 100,000 ng/mL | 2% |

| Oxazepam, Cutoff=300 ng/mL | Result | %Cross-Reactivity |
|----------------------------|--------------------------|-------------------|
| | Positive at 300 ng/mL | 100% |
| Alprazolam | Positive at 200 ng/mL | 150% |
| a-Hydroxyalprazolam | Positive at 1,500 ng/mL | 20% |
| Bromazepam | Positive at 1,500 ng/mL | 20% |
| Chlordiazepoxide | Positive at 1,500 ng/mL | 20% |
| Clonazepam HCl | Positive at 800 ng/mL | 37.5% |
| Clobazam | Positive at 100 ng/mL | 300% |
| Clonazepam | Positive at 800 ng/mL | 37.5% |
| Clorazepate dipotassium | Positive at 200 ng/mL | 150% |
| Delorazepam | Positive at 1,500 ng/mL | 20% |
| Desalkylflurazepam | Positive at 400 ng/mL | 75% |
| Diazepam | Positive at 200 ng/mL | 150% |
| Estazolam | Positive at 2,500 ng/mL | 12% |
| Flunitrazepam | Positive at 400 ng/mL | 75% |
| D,L-Lorazepam | Positive at 1,500 ng/mL | 20% |
| Midazolam | Positive at 12,500 ng/mL | 2.4% |
| Nitrazepam | Positive at 100 ng/mL | 300% |
| Norchlordiazepoxide | Positive at 200 ng/mL | 150% |
| Nordiazepam | Positive at 400 ng/mL | 75% |
| Temazepam | Positive at 100 ng/mL | 300% |
| Trazolam | Positive at 2,500 ng/mL | 12% |

g. Effects of Urine Density and pH

Density (Specific Gravity)

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12 urine samples with density ranges (1.000-1.035) are collected and spiked with each drug at 25% below and 25% above cutoff levels. Each sample was tested by three batches of CR3 Keyless Split Sample Cup Morphine-Oxazepam. It shows that urine density does not affect test results.

## Effect of Urine pH

The pH of an aliquot negative urine pool is adjusted to a pH range of 4 to 9 in 1 pH unit increments and spiked with each drug at 25% below and 25% above cutoff levels. Each sample was tested by three batches of CR3 Keyless Split Sample Cup Morphine-Oxazepam. It shows that urine pH does not interfere with the performance of the test.

#### 2. Comparison Studies

The method comparison for the CR3 Keyless Split Sample Cup Morphine-Oxazepam 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 were blind labeled and compared to GC/MS results. The results are presented in the table below:

# Morphine

| Group | | Negative | Low Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|---------------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operators | Positive | 0 | 0 | 2 | 19 | 20 |
| | Negative | 10 | 20 | 8 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 18 | 20 |
| | Negative | 10 | 20 | 7 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 10 | 20 | 8 | 2 | 0 |
| Lay<br>Person | Positive | 0 | 0 | 3 | 18 | 20 |
| | Negative | 10 | 20 | 7 | 2 | 0 |

Discordant table:

| Viewer | Sample number | GC/MS result | Viewer result |
|----------|---------------|--------------|---------------|
| Viewer A | OPIC1061 | 1997 | positive |
| Viewer A | OPIC1064 | 1994 | positive |
| Viewer A | OPIC1065 | 2025 | negative |
| Viewer B | OPIC1061 | 1997 | positive |
| Viewer B | OPIC1062 | 1943 | positive |
| Viewer B | OPIC1063 | 2043 | negative |
| Viewer B | OPIC1064 | 1994 | positive |
| Viewer B | OPIC1065 | 2025 | negative |
| Viewer C | OPIC1061 | 1997 | positive |

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| Viewer C | OPIC1063 | 2043 | negative |
|------------|----------|------|----------|
| Viewer C | OPIC1064 | 1994 | positive |
| Viewer C | OPIC1065 | 2025 | negative |
| Lay person | OPIC1061 | 1997 | positive |
| Lay person | OPIC1062 | 1943 | positive |
| Lay person | OPIC1063 | 2043 | negative |
| Lay person | OPIC1064 | 1994 | positive |
| Lay person | OPIC1065 | 2025 | negative |

# Oxazepam

| Group<br>Operators | | Negative | Low Negative<br>by GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|--------------------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 2 | 17 | 21 |
| | Negative | 10 | 10 | 18 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 18 | 21 |
| | Negative | 10 | 10 | 17 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 16 | 21 |
| | Negative | 10 | 10 | 18 | 3 | 0 |
| Lay<br>Person | Positive | 0 | 0 | 3 | 15 | 21 |
| | Negative | 10 | 10 | 17 | 4 | 0 |

# Discordant table:

| Viewer | Sample number | GC/MS result | viewer results |
|------------|---------------|--------------|----------------|
| Viewer A | BZOC1062 | 291 | positive |
| Viewer A | BZOC1064 | 296 | positive |
| Viewer A | BZOC1093 | 358 | negative |
| Viewer A | BZOC1095 | 344 | negative |
| Viewer B | BZOC1062 | 291 | positive |
| Viewer B | BZOC1063 | 312 | negative |
| Viewer B | BZOC1064 | 296 | positive |
| Viewer B | BZOC1065 | 288 | positive |
| Viewer C | BZOC1063 | 312 | negative |
| Viewer C | BZOC1064 | 296 | positive |
| Viewer C | BZOC1065 | 288 | positive |
| Viewer C | BZOC1092 | 357 | negative |
| Viewer C | BZOC1093 | 358 | negative |
| Viewer C | BZOC1095 | 344 | negative |
| Lay Person | BZOC1062 | 291 | positive |
| Lay person | BZOC1064 | 296 | positive |
| Lay person | BZOC1065 | 288 | positive |

は、

:

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| Lay Person | BZOC1063 | 312 | negative |
|------------|----------|-----|----------|
| Lay Person | BZOC1092 | 357 | negative |
| Lay Person | BZOC1093 | 358 | negative |
| Lay Person | BZOC1095 | 344 | negative |

### Lay-user study

A lay user study was performed at three intended user sites with 260 lay persons. Participants in the study were 79 males and 47 females tested the Morphine samples, 74 males and 60 females 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; -100%, +/-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, I blind labeled samples and a device. The results are summarized below.

| Cup format | | Number of | OTC user | | %Agreement |
|------------|---------------|-----------|----------|----------|------------|
| Drug | Concentration | samples | Negative | Positive | With GC/MS |
| Drug -free | -100% | 20 | 20 | 0 | 100% |
| | -75% | 20 | 20 | 0 | 100% |
| | -50% | 20 | 20 | 0 | 100% |
| | -25% | 20 | 18 | 2 | 90% |
| Morphine | +25% | 20 | 3 | 17 | 85% |
| | +50% | 20 | 0 | 20 | 100% |
| | +75% | 20 | 0 | 20 | 100% |
| | -75% | 20 | 20 | 0 | 100% |
| | -50% | 20 | 20 | 0 | 100% |
| | -25% | 20 | 17 | 3 | 85% |
| Oxazepam | +25% | 20 | 3 | 17 | 85% |
| | +50% | 20 | 0 | 20 | 100% |
| | +75% | 20 | 0 | 20 | 100% |

- 3. Clinical Studies
Not applicable

- ll. Conclusion
Based on the test principle and performance characteristics of the device, it's concluded that CR3 Keyless Split Sample Cup Morphine-Oxazepam is substantially equivalent to the predicate.

11

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

April 8, 2014

GUANGZHOU WONDFO BIOTECH CO., LTD. C/O JOE SHIA 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20878

Re: K140089

Trade/Device Name: CR3 Keyless Split Sample Cup Morphine-Oxazepam Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, JXM Dated: January 06, 2014 Received: January 14, 2014

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Shia

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

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

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

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known) K140089

#### Device Name

CR3 Keyless Split Sample Cup Morphine-Oxazepan

#### Indications for Use (Describe)

CR3 Keyless Split Sample Cup Morphine-Oxazepan is a rapid test for the qualitative detection of Morphine (a drug in the opiate class) and Oxazepam(a drug in the benzodinzepine class) in human urine at a cutoff concentration of 2000ng/mL and 300ng/mL. respectively.

The tests may vield preliminary positive results even when prescription drugs including Morphine and Oxazepam are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of there are no uniformly recognized cutoff concentration levels for morphine and oxazepan in urinc. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confimed 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.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

# Avis T. Danishefsky -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response. Including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@Ida.hhs.gov

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FORM FDA 3881 (1/14)