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

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.

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)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k140089

B. Purpose for Submission:
New Device

C. Measurand:
Oxazepam, Morphine

D. Type of Test:
Qualitative lateral flow chromatographic immunoassay

E. Applicant:
Guangzhou Wondfo Biotech Co., Ltd.

F. Proprietary and Established Names:
CR3 Keyless Split Sample Cup Morphine-Oxazepam

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJG | Class II | 21 CFR 862.3650, Opiate Test System | Toxicology (91) |
| JXM | Class II | 21 CFR 862.3170, Benzodiazepine Test System | Toxicology (91) |

H. Intended Use:

1. Intended use(s):
See Indication(s) for use.

2. Indication(s) 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

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benzodiazepine class) in human urine at a cutoff concentration of 2000 ng/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 Morphine or 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.

3. Special conditions for use statement(s):

For Over the Counter and Prescription Use

For in vitro diagnostic use only

4. Special instrument requirements:

Not applicable. Device is visually read, single use device.

I. Device Description:

Each pouch contains a test cup and test card test card.

The OTC device also includes labeled vials for shipping the "preliminary" sample to the laboratory for confirmation, plastic transportation bags, mailing boxes, and personal identification numbers

Each test strip in the device consists of a conjugate pad containing colloidal gold coupled with the anti-drug antibodies and a nitrocellulose membrane containing two test lines coated with the conjugated drug antigen, and a procedural control line.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Wondfo Multi-Drug Urine Test Cup (Panel)

2. Predicate 510(k) number(s):

k130665

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3. Comparison with predicate:

| Item | Device | Predicate (K130665) |
| --- | --- | --- |
| Indication(s) for use | For the qualitative determination of Morphine and Oxazepam in human urine. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Morphine: 2000ng/ml Oxazepam: 300ng/ml | Same |
| Configurations | Split Keyless CupSplit Sample | Cup, Dip Card |
| Intended Use | OTC Use & Prescription Use | Same |

# K. Standard/Guidance Document Referenced (if applicable):

Not Applicable

# L. Test Principle:

The device 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 concentrations below the target cutoff, 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 the 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. When the sample contains target drug above the cutoff concentration no colored band shows in the test region, indicating a preliminary positive result.

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Precision studies were carried out for urine samples with concentrations of -100% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff. For each concentration, tests using masked and randomized samples were performed by three operators twice per day for 25 days with three different lots of devices. The results obtained are summarized in the following tables.

Morphine Testing

| Results per Lot | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off 2000 ng/mL | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Oxazepam Testing

| Results per Lot | -100% cut off | -75% cut off | -50% cut off | -25% cut off | cut off 300 ng/mL | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 44+/6- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 43+/7- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Quality control materials are not supplied with these devices. The labeling contains recommendations to confirm the test procedure and to verify proper test performance, the sponsor recommends that the user test these devices using external controls following the appropriate federal, state and local guidelines.

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Accelerated stability and real time stability tests were performed on three lots of dip cards and cups for morphine and oxazepam urine test devices using samples at -50% cutoff and +50% cutoff, and negative urine. The stability study results support the claimed shelf life of 18 months at 4 to 30 °C. The transport simulation study results support stability for 3 weeks when exposed to temperatures of ranging from -20 °C and 40 °C.

d. Detection limit:

Not applicable. The assay is intended for qualitative use.

e. Analytical specificity:

Analytical specificity studies were performed to determine whether drugs and drug metabolites within the same class of drugs or with similar molecular structures cross- react in the test system.

The target drug, drug metabolites, and other related compounds were added to drug-free urine. The cross reacting substances and the lowest concentration that produces a positive result was identified. A list of these compounds and their level of cross reactivity is provided in the tables below:

| Morphine, Cutoff=2000 ng/mL | Result Positive at 2,000 ng/mL | % Cross- Reactivity |
| --- | --- | --- |
| Codeine | Positive at 2,000 ng/mL | 100% |
| Ethylmorphine | Positive at 5,000 ng/mL | 40% |
| Hydrocodone | Positive at 12,500 ng/mL | 16% |
| Hydromorphone | 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 Positive at 300 ng/mL | % Cross- Reactivity |
| --- | --- | --- |
| Alprazolam | Positive at 200 ng/mL | 150% |
| α-Hydroxyalprazolam | Positive at 1,500 ng/mL | 20% |

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Interference Studies:

Interference studies were performed using 100 µg/mL of structurally unrelated compounds as well as endogenous compounds listed below.. These compounds were tested in drug-free urine and urine containing ±25% cutoff concentration for each analyte. The following compounds were found not to interfere when tested at 100 µg/mL concentration.

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 |
| Ampicillin | Gentisic acid | Phenelzine |
| Ascorbic acid | Hemoglobin | Phenobarbital |
| D,L-Amphetamine | Hydralazine | Phentermine |
| Apomorphine | Hydrochlorothiazide | L-Phenylephrine |
| Aspartame | Hydrocortisone | β-Phenylethylamine |

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| Atropine | O-Hydroxyhippuric acid | Phenylpropanolamine |
| --- | --- | --- |
| Benzilic acid | p-Hydroxy methamphetamine | Prednisone |
| Benzoic acid | 3-Hydroxytyramine | D,L-Propanolol |
| Benzoylecgonine | Ibuprofen | D-Propoxyphene |
| Benzphetamine | Imipramine | D-Pseudoephedrine |
| Bilirubin (±) | Iproniazid | Quinidine |
| Brompheniramine | Isoproterenol | Quinine |
| Caffeine | Isoxsuprine | Ranitidine |
| Cannabidiol | Ketamine | Salicylic acid |
| Chloral hydrate | Ketoprofen | Secobarbital |
| Chloramphenicol | Labetalol | Serotonin (5-Hydroxytyramine) |
| Chlordiazepoxide | Loperamide | Sulfamethazine |
| Chlorothiazide | Maprotiline | Sulindac |
| (±) Chlorpheniramine | Meperidine | Temazepam |
| Chlorpromazine | Meprobamate | Tetracycline |
| Chlorquine | Methadone | Tetrahydrocortisone, 3 Acetate |
| Cholesterol | Methoxyphenamine | Tetrahydrocortisone3 (β-D glucuronide) |
| Clomipramine | (+) 3,4-Methylenedioxy-amphetamine | Tetrahydrozoline |
| Clonidine | (+)3,4-Methylenedioxy-methamphetamine | Thiamine |
| Cocaine hydrochloride | Nalidixic acid | Thioridazine |
| Cortisone | Nalorphine | D, L-Tyrosine |
| (-) Cotinine | Naloxone | Tolbutamide |
| Creatinine | Naltrexone | Triamterene |
| Deoxycorticosterone | Naproxen | Trifluoperazine |
| Dextromethorphan | Niacinamide | Trimethoprim |
| Diazepam | Nifedipine | Trimipramine |
| Diclofenac | Norethindrone | Tryptamine |
| Diflunisal | D-Norpropoxyphene | D, L-Tryptophan |
| Digoxin | Noscapine | Tyramine |
| Diphenhydramine | D,L-Octopamine | Uric acid |
| Doxylamine | Oxalic acid | Verapamil |
| Ecgonine hydrochloride | Oxazepam | Zomepirac |

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Oxazepam

| 4-Acetamidophenol | Doxylamine | Oxolinic acid |
| --- | --- | --- |
| Acetophenetidin | Ecgonine hydrochloride | Pentobarbital |
| N-Acetylprocainamide | Ecgonine methylester | Perphenazine |
| Acetysalicylic acid | (-)-Y-Ephedrine | Phencyclidine |
| Aminopyrine | Fenoprofen | Phenelzine |
| Amitriptyline | Furosemide | Phenobarbital |
| Amorbarbital | Gentisic acid | Phentermine |
| Amoxicillin | Hemoglobin | L-Phenylephrine |
| Ampicillin | Hydrocortisone | -Phenylethylamine |
| l-Ascorbic Acid | O-Hydroxyhippuric acid | Phenylpropanolamine |
| D.L-Amphetamine | p-Hydroxy-methamphetamine | Prednisone |
| Apomorphine | 3-Hydroxytyramine | D.L-Propranolol |
| Aspartame | Ibuprofen | D-Propoxyphene |
| Atropine | Imipramine | D-Pseudoephedrine |
| Benzilic acid | Iproniazid | Quinine |
| Benzoic acid | (±)Isoproterenol | Ranitidine |
| Benzoylecgonine | Isoxsuprine | Salicylic acid |
| Benzphetamine | Ketamine | Secobarbital |
| Bilirubin | Ketoprofen | Serotonin (5-Hydroxytyramine) |
| (±) Chlorpheniramine | Labetalol | Sertraline |
| Caffeine | Loperamide | Sulfamethazine |
| Cannabidiol | Maprotiline | Sulindac |
| Chloral hydrate | Meperidine | Tetrahydrocortisone, 3 Acetate |
| Chloramphenicol | Meprobamate | Tetrahydrocortisone, ( -D glucuronide) |
| Chlorothiazide | Methadone | Tetrahydrozoline |
| (±)Chlorpheniramine | Methoxyphenamine | Thiamine |
| Chlorpromazine | (+) 3,4-Methylenedioxy-amphetamine | Thioridazine |
| Chloroquine | (+)3,4-Methylenedioxy-methamphetamine | D.L-Tyrosine |
| Cholesterol | Nalidixic acid | Tolbutamide |
| Clomipramine | Nalorphine | Triamterene |
| Clonidine | Naloxone | Trifluoperazine |
| Cocaine hydrochloride | Naltrexone | Trimethoprim |

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| Cortisone | Naproxen | Tryptamine |
| --- | --- | --- |
| (-)cotinine | Niacinamide | D.L-Tryptophan |
| Creatinine | Nifedipine | Tyramine |
| Dextromethorphan | Norethindrone | Uric acid |
| Diclolfenac | D-Norpropoxyphene | Verapamil |
| Diflunisal | Noscapine | Zomepirac |
| Dioxin | D.L-Octopamine | |
| Diphenhydramine | Oxalic acid | |

Specific Gravity:

Twelve urine samples with density ranges (1.000-1.035) were collected and spiked with each drug at 25% below and 25% above cutoff levels. Each sample was tested using three lots of CR3 Keyless Split Sample Cup Morphine-Oxazepam. The results showed that specific gravity range of 1.000 to 1.035 does not affect the accuracy of the test.

pH:

A negative urine pool was adjusted to a pH range of 4.00 to 9.00 in 1 pH unit increments and was spiked with each drug at 25% below and 25% above cutoff levels. Samples were tested using three lots of CR3 Keyless Split Sample Cup Morphine-Oxazepam and results showed that urine pH range of 4.00 to 9.00 does not affect the accuracy of the accuracy of the test.

f. Assay cut-off:

Characterization of how the device performs around the claimed cutoff concentration is shown in the precision section M.1.a. above as well as the Lay User Study below.

2. Comparison studies:

a. Method comparison with predicate device:

The method comparison for the CR3 Keyless Split Sample Cup Morphine-Oxazepam was performed at the manufacturer's site.. Operators ran 80 unaltered masked and randomized clinical samples. The samples were compared to GC/MS results. Four "viewers" separately read results (3 experienced viewers, 1 OTC viewer). Viewers A, B, and C in the table below were experienced professionals. Viewer D was a lay person. The results are presented in the table below:

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Morphine

| Results per Operator | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and | 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 | 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 |
| Viewer D | Positive | 0 | 0 | 3 | 18 | 20 |
| | Negative | 10 | 20 | 7 | 2 | 0 |

The following table lists the CR3 Keyless Split Sample results and GCMS results for the discordant samples shown in the table above.

| GC/MS Morphine Concentration (ng/mL) | CR3 Morphine Result |
| --- | --- |
| 1997 | Positive |
| 1994 | Positive |
| 2025 | Negative |
| 1994 | Positive |
| 2025 | Negative |
| 1943 | Positive (for viewers B and D) |
| 2043 | Negative (for viewers (B, C, and D) |

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Oxazepam

| Results per Operator | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and | 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 |
| Viewer D | Positive | 0 | 0 | 3 | 15 | 21 |
| | Negative | 10 | 10 | 17 | 4 | 0 |

The following table lists the CR3 Keyless Split Sample results and GCMS results for the discordant samples shown in the table above.

| GC/MS Oxazepam Concentration (ng/mL) | CR3 results |
| --- | --- |
| 357 | Negative |
| 296 | Positive |
| 358 | Negative for viewers A, C, D |
| 344 | Negative for viewers A, C, D |
| 312 | Negative for viewers B, C, D |
| 288 | Positive for 3 viewers B, C, D |
| 291 | Positive for viewers A, B, D |

A lay user study was performed at three sites with 260 lay persons. In the study, 79 males and 47 females tested the Morphine samples and 74 males and 60 females tested the Oxazepam samples. The participants 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

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individual containers. Each participant was provided with the package insert, one masked and randomized sample, and a device. The results are summarized below.

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

b. Matrix comparison:

Not applicable. The assay is intended for use with urine samples only.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not applicable

4. Clinical cut-off:

Not applicable

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5. Expected values/Reference range:

Not applicable

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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