CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)

• K Number: K140089
• Device Name: CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
• Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.
• Date Cleared: 2014-04-08 ( 84 days)
• Product Code: DJG JXM
• Regulation Number: 862.3650

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 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.

Predicate Devices

K130665

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard immunochromatographic assay, with no mention of AI/ML components or algorithms.

Therapeutic

No.
The device is a rapid test for the qualitative detection of specific drugs in human urine, providing preliminary test results for in vitro diagnostic use, not for treating or preventing disease.

Diagnostic

Yes

The device is explicitly stated as being "For in vitro diagnostic use only." It detects substances in human urine to provide preliminary test results for Morphine and Oxazepam, which are indicative of a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "Immunochromatograph assay" using "lateral flow" and "monoclonal antibody-dye conjugate," which are physical components of a hardware test kit, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

• Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
• Nature of the Test: The device performs a test on a biological sample (human urine) to detect the presence of specific substances (Morphine and Oxazepam) for diagnostic purposes (detecting drug use). This aligns with the definition of an in vitro diagnostic device.
• Device Description: The description of the device as an "Immunochromatograph assay" for detecting substances in urine further supports its classification as an IVD.

The other information provided, such as the intended user, performance studies, and comparison to a predicate device, are all consistent with the regulatory requirements and documentation typically associated with IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

DJG, JXM

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.

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

Over-The-Counter Use (21 CFR 801 Subpart C), Prescription Use (Part 21 CFR 801 Subpart D)

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

Not Found

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

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.

   b. Linearity
   Not applicable

   c. Stability
   It is stable at 4-30°C for 18 months.

   d. Cut-off
   Morphine: 2000 ng/ml
   Oxazepam: 300 ng/ml

   e. Interference
   Compounds that show no interference at a concentration of 100 ug/mL were summarized.

   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.

   g. Effects of Urine Density and pH
   Density (Specific Gravity): 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.
   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.

3. 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.

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

Key metrics presented in tables in the Summary of Performance Studies (comparison studies and lay-user study tables).

• Precision study: Number of positive and negative results for different concentrations relative to cutoff.
• Cross-reactivity: %Cross-Reactivity for various compounds.
• Comparison studies: Number of positive/negative results per operator group (Viewer A, B, C, Lay Person) against GC/MS results for different concentration ranges (Negative, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive). Discordant table also provided.
• Lay-user study: Number of positive/negative results and %Agreement with GC/MS for various concentrations.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K130665

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
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.(b)
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).

Summary

0

APR 0 8 2014

510(k) SUMMARY

1.	Date:	February 28, 2014
2.	Submitter:	Guangzhou Wondfo Biotech Co., Ltd.
South China University of Technology
Guangzhou, P.R. China 510641
3.	Contact person:	Joe Shia
LSI International Inc.
504 East Diamond Ave., Suite I
Gaithersburg, MD 20877
Telephone: [phone]
Fax: [phone]
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
Morphine, Oxazepam 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	Morphine: 2000ng/ml
Oxazepam: 300ng/ml	Same (but the number
of drugs detected
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

2

| Result
OPI | -100%
cut off | -75%
cut off | -50%
cut off | -25%
Cut off | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| 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
BZO | -100%
cut off | -75%
cut off | -50%
cut off | -25%
Cut off | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| 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

3

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

5

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)

6

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

7

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
Operators | | 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 | 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
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、

:

8

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.

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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized human figure with outstretched arms, representing care and protection, above three horizontal lines that symbolize the department's various services and programs.

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.

10

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

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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

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

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