SAFECARE® THC Urine Strip Test

K191924 · Safecare Biotech (Hangzhou) Co., Ltd. · NFW · Aug 16, 2019 · Clinical Toxicology

Device Facts

• Record ID: K191924
• Device Name: SAFECARE® THC Urine Strip Test
• Applicant: Safecare Biotech (Hangzhou) Co., Ltd.
• Product Code: NFW · Clinical Toxicology
• Decision Date: Aug 16, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

SAFECARE® THC Urine Strip Test is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The test is intended for over-the-counter use.

Device Story

Single-use lateral flow immunochromatographic assay; detects 11-nor-Δ9-THC-9 COOH in human urine. Principle: competitive binding; urine migrates via capillary action; target drug competes with drug-conjugate for limited antibody-coated particle binding sites. Output: visual colored line in test region (negative result) or absence of line (positive result); control line confirms test validity. Used in home/point-of-care settings by lay users. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits: rapid, accessible screening for marijuana metabolites.

Clinical Evidence

Bench testing only. Precision studies verified 50 ng/mL cutoff over 25 days. Interference testing confirmed no cross-reactivity with numerous physiological/pathological substances at 100µg/mL. Specificity testing evaluated cross-reactivity with THC metabolites. Method comparison study (n=80 clinical samples) showed high concordance with LC/MS. Lay-user study (n=140) demonstrated 90-100% accuracy across various concentrations relative to LC/MS, confirming ease of use and performance in intended user population.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Uses monoclonal mouse antibody-coated particles. Form factor: test strip. Storage: 4-30°C. No electronic components, energy source, or software. Materials: standard immunochromatographic test strip components.

Indications for Use

Indicated for qualitative detection of Marijuana (11-nor-Δ9-THC-9 COOH) in human urine at 50 ng/mL cutoff. Intended for over-the-counter use by the general population.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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

• SAFECARE Urine Test Marijuana (K153646)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 16, 2019

Safecare Biotech (Hangzhou) Co., Ltd. % Joe Shia, Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877

Re: K191924

Trade/Device Name: SAFECARE® THC Urine Strip Test Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: NFW Dated: July 16, 2019 Received: July 18, 2019

Dear Joe 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k191924

Device Name SAFECARE® THC Urine Strip Test

#### Indications for Use (Describe)

SAFECARE® THC Urine Strip Test is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.

The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The test is intended for over-the-counter use.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K191924 510(k) SUMMARY

| 1. Date: | August 15, 2019 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter: | Safecare Biotech (Hangzhou) Co., Ltd<br>18 Haishu Road, Yuhang District<br>Hangzhou, China |
| 3. Contact person: | Joe Shia<br>LSI International Inc.<br>504 East Diamond Ave.,<br>Suite I, Gaithersburg, MD 20877<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

- 4. Device Name: SAFECARE® THC Urine Strip Test

| Product<br>Code | CFR # | Panel |
|-----------------|------------------------------------------|------------|
| NFW | 21 CFR, 862.3870 Cannabinoid Test System | Toxicology |

- 5. Predicate Devices:
K153646 SAFECARE Urine Test Marijuana

- 6. Intended Use
SAFECARE® THC Urine Strip Test is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The test is intended for over-the-counter use.

- 7. Device Description
SAFECARE® THC Urine Strip Test devices are immunochromatographic assays for the qualitative detection of 11-nor-A9-THC-9 COOH (target analyte) in human urine. The product is a single-use in

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vitro diagnostic device. It contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

- 8. Substantial Equivalence Information
A summary comparison of features of the SAFECARE THC Urine Strip Test and the predicate device is provided in Table 1.

| Item | Device | Predicate - K153646 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of 11-<br>nor-Δ9-THC-9 COOH in human urine. | Same |
| Calibrator | 11-nor-Δ9-THC-9 COOH | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 50 ng/mL | Same |
| Intended<br>Population | For over-the-counter use. | For over-the-counter<br>use and prescription<br>uses. |
| Configurations | Strip | Cup, Dip Card,<br>Cassette |

| Table 1: Features Comparison of SAFECARE Marijuana Test and the Predicate Device | | | |
|----------------------------------------------------------------------------------|--|--|--|
| | | | |

## 9. Test Principle

SAFECARE THC Urine Strip Test devices are rapid tests for the qualitative detection of 11-nor-A9-THC-9 COOH in urine samples. Each assay test is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drug THC is present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody (monoclonal mouse antibody) coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoffconcentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample.

#### 10. Performance Characteristics

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#### 1. Analytical Performance

## a. Precision

Precision studies were carried out for samples with concentrations of -100% cut-off, -50% cut-off, -25% cut-off, at the cut-off, +25% cut-off, +75% cut-off, +75% cut-off and +100% cut-off. These samples were prepared by spiking drug in negative samples. THC drug concentration was confirmed by LC/MS. All sample aliquots were blinded labeled and randomized. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following tables:

| | Result | -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 |
|------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Drug | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Drug | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

The cut-off value of 50 ng/mL is verified for the device.

- b. Linearity
Not applicable, these are visually read devices.

- c. Stability
The devices are stable at 4-30°C (39-86°F) for 24 months based on the accelerated stability study at 50°C.

- d. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% above cut-off levels. These urine samples were tested using three batches of the device.

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

| Acetaminophen | ß-Estradiol | Oxalic acid |
|----------------------|------------------|---------------|
| Acetophenetidin | Erythromycin | Oxolinic acid |
| N-Acetylprocainamide | Ethanol (1% v/v) | Oxymetazoline |
| AcetyIsalicylic acid | Fenoprofen | Papaverine |

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| Albumin (100 mg/dL) | Furosemide | Penicillin G |
|-----------------------|------------------------|----------------------------------------|
| Aminopyrine | Gentisic acid | Perphenazine |
| Amoxicillin | Hemoglobin | Phenelzine |
| Ampicillin | Hydralazine | Prednisone |
| Apomorphine | Hydrochlorothiazide | (±)-Propranolol |
| Ascorbic acid | Hydrocortisone | D-Pseudoephedrine |
| Aspartame | O-Hydroxyhippuric acid | Quinine |
| Atropine | 3-Hydroxytyramine | Ranitidine |
| Benzilic acid | Ibuprofen | Salicylic acid |
| Benzoic acid | D,L-Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Chloral hydrate | Ketamine | Sulindac |
| Chloramphenicol | Ketoprofen | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate |
| Chlorpromazine | Loperamide | Tetrahydrozoline |
| Cholesterol | Meperidine | Thiamine |
| Clonidine | Meprobamate | Thioridazine |
| Cortisone | Methoxyphenamine | Triamterene |
| (-)-Cotinine | Nalidixic acid | Trifluoperazine |
| Creatinine | Naloxone | Trimethoprim |
| Deoxycorticosterone | Naltrexone | DL-Tryptophan |
| Dextromethorphan | Naproxen | Tyramine |
| Diclofenac | Niacinamide | DL-Tyrosine |
| Diflunisal | Nifedipine | Uric acid |
| Digoxin | Norethindrone | Verapamil |
| Diphenhydramine | Noscapine | Zomepirac |
| Ecgonine methyl ester | (±)-Octopamine | |

#### e. Specificity

To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of the device. The obtained lowest detectable concentration was used to calculate the cross-reactivity.

| Drugs | Cross Reactivity Cut off(ng/ml) | % Cross-Reactivity |
|---------------------------------------|---------------------------------|--------------------|
| 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 | 100% |
| 11-Hydroxy-△9-Tetrahydrocannabinol | 5000 | 1% |
| 11-Nor-△8-Tetrahydrocannabinol-9-COOH | 50 | 100% |

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| Cannabinol | 20000 | 0.25% |
|-----------------------------------|-------|-------|
| △8-Tetrahydrocannabinol | 10000 | 0.5% |
| △9-Tetrahydrocannabinol | 10000 | 0.5% |
| Cannabidiol | 20000 | 0.25% |
| 11-Nor-△9-THC-carboxy glucuronide | 2500 | 2% |
| (-)-11-nor-9-carboxy-△ 9-THC | 2500 | 2% |

#### f. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine samples with of 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drug THC at 25% below and 25% above cut-off levels. These samples were tested using three batches of device. Results were all positive for samples at and above +25% cut-off and all negative for samples at and below -25% Cut-Off.

- 2. Comparison Studies
The method comparison studies for the SAFECARE THC Urine Strip Test were performed by three different laboratory assistants. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below:

| Safecare<br>THC<br>Urine<br>Strip Test | | Negative | Low<br>Negative<br>by LC/MS<br>(less than -<br>50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between -<br>50% and cut-<br>off) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between<br>the cut-off<br>and +50%) | High<br>Positive by<br>LC/MS<br>(greater<br>than<br>+50%) |
|----------------------------------------|----------|----------|-----------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 10 | 19 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 10 | 19 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 10 | 20 | 1 | 0 |

#### Discordant Results

| Viewer | Sample Number | LC/MS Result | Viewer Results |
|----------|---------------|--------------|----------------|
| Viewer A | MT540 | 49 | Positive |
| Viewer B | MT630 | 48 | Positive |
| Viewer A | MT299 | 51 | Negative |
| Viewer A | MT527 | 52 | Negative |
| Viewer B | MT527 | 52 | Negative |
| Viewer C | MT527 | 52 | Negative |

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Lay-user study

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

| % of Cutoff | Number of samples | 11-nor-D9-THC-9-COOH<br>Concentration by LC/MS<br>(ng/mL) | Lay person results | | The<br>percentage of<br>correct results<br>(%) |
|--------------|-------------------|-----------------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 37 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 63 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 76 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 88 | 20 | 0 | 100 |

## Comparison between LC/MS and Lay Person Results

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

## 3. Clinical Studies

Not applicable.

# 11.Conclusion

Based on the test principle and acceptable performance characteristics including precision, interference, specificity and method comparison of the device, it's concluded that the SAFECARE THC Urine Strip Test devices are substantially equivalent to the predicate.