Predicate Devices

K153646 SAFECARE Urine Test Marijuana

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a standard immunochromatographic assay for drug detection, with no mention of AI or ML technologies. The analysis relies on visual interpretation of a lateral flow test.

Therapeutic

No

Explanation: This device is an in vitro diagnostic test designed to detect the presence of Marijuana in human urine. It provides preliminary test results and is not intended for treatment or mitigation of a disease or condition.

Diagnostic

Yes

The device is described as an "immunochromatographic assay for qualitative detection of Marijuana in human urine" and explicitly referred to as a "single-use in vitro diagnostic device" in the "Device Description" section.

SaMD (Software as a Medical Device)

No

The device is a lateral flow immunochromatographic assay, which is a physical test strip, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it's for the "qualitative detection of Marijuana in human urine." This is a diagnostic purpose, analyzing a biological sample (urine) to detect a specific substance.
Device Description: The device description clearly states, "The product is a single-use in vitro diagnostic device." This is a direct declaration of its classification.
Anatomical Site: The test is performed on "human urine," which is a biological specimen collected from the human body for diagnostic analysis.
Performance Studies: The document describes performance studies, including comparison studies with a reference method (LC/MS), which are standard for evaluating the performance of IVD devices.

The term "in vitro diagnostic" refers to medical devices that are used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body to detect diseases, conditions, or infections. This description perfectly aligns with the SAFECARE® THC Urine Strip Test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

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

NFW

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

over-the-counter use.

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

Not Found

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

Not Found

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

1. Analytical Performance

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 cut-off value of 50 ng/mL is verified for the device.
Linearity: Not applicable, these are visually read devices.
Stability: The devices are stable at 4-30°C (39-86°F) for 24 months based on the accelerated stability study at 50°C.
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 were summarized in a table.
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. Cross-reactivity results were provided for various THC derivatives and cannabinoids.
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

Method Comparison: 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. Discordant results were also provided.
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. 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.

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

Not Found (Performance provided in numbers of positive/negative results at various concentrations, not as calculated metrics like sensitivity/specificity).

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.

K153646 SAFECARE Urine Test Marijuana

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

§ 862.3870 Cannabinoid test system.

(a)
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 includedelta -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.(b)
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).

Summary

0

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

1

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

Page 2

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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
18 Haishu Road, Yuhang District
Hangzhou, China
3. Contact person:	Joe Shia
LSI International Inc.
504 East Diamond Ave.,
Suite I, Gaithersburg, MD 20877
Telephone: 301-250-0831
Fax: 301-916-6213
Email: jxia@lsi-consulting.org

1. Device Name: SAFECARE® THC Urine Strip Test

| Product

Code	CFR #	Panel
NFW	21 CFR, 862.3870 Cannabinoid Test System	Toxicology

1. Predicate Devices:
  K153646 SAFECARE Urine Test Marijuana
1. 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.
1. 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

4

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

1. 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)
for Use	For the qualitative determination of 11-
nor-Δ9-THC-9 COOH in human urine.	Same
Calibrator	11-nor-Δ9-THC-9 COOH	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based
on the principle of antigen antibody
immunochemistry.	Same
Specimen Type	Human Urine	Same
Cut-Off Values	50 ng/mL	Same
Intended
Population	For over-the-counter use.	For over-the-counter
use and prescription
uses.
Configurations	Strip	Cup, Dip Card,
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

5

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%
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 |
|------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| 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

6

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.

1. 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
THC
Urine
Strip Test | | Negative | Low
Negative
by LC/MS
(less than -
50%) | Near Cutoff
Negative by
LC/MS
(Between -
50% and cut-
off) | Near Cutoff
Positive by
LC/MS
(Between
the cut-off
and +50%) | High
Positive by
LC/MS
(greater
than
+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

8

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
Concentration by LC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------|-----------------------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
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.