(132 days)
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No
The device is a lateral flow immunoassay that provides a qualitative result without the use of an instrument. There is no mention of any computational analysis or algorithms that would suggest the use of AI/ML.
No.
This device is an in vitro diagnostic (IVD) test for detecting drugs and drug metabolites in urine, providing preliminary analytical results which are not used for direct treatment.
Yes.
Explanation: The "Intended Use / Indications for Use" section explicitly states, "These tests are intended for in vitro diagnostics use."
No
The device is a lateral flow chromatographic immunoassay, which is a physical test strip/cup that detects substances in urine. It is explicitly stated that the tests are performed "without the use of an instrument," indicating it is a hardware-based diagnostic device, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "These tests are intended for in vitro diagnostics use."
- Nature of the Test: The device is a lateral flow chromatographic immunoassay designed to detect the presence of drugs and drug metabolites in human urine. This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide diagnostic information.
- Purpose: The purpose is to qualitatively detect the presence of specific substances (drugs and metabolites) in a biological sample, which is a core function of IVDs.
The other sections, such as the Device Description and Performance Studies, further support this by describing the test's mechanism and how its performance is evaluated using biological samples.
N/A
Intended Use / Indications for Use
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
Marijuana (THC): Delta-9-THC-COOH 50 ng/mL
Cocaine (COC): Benzoylecgonine 300 ng/mL
Methylenedioxymethamphetamine (MDMA): 3,4-Methylenedioxymethamphetamine 500 ng/mL
Methamphetamine (MET): D-Methamphetamine 1000 ng/mL
Morphine 300 (MOP): Morphine 300 ng/mL
The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use.
The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DIO, LDJ, DJC
Device Description
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Cocaine, Marijuana, Methamphetamine, Morphine, Methylenedioxymethamphetamine at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.
The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
8.1 Cross-reactivity with structurally similar compounds: To test the cross reactivity of the test, 2 lots of test Dipcard and one lot of test Cup was used to test with drug metabolites and drug structurally similar compounds in urine. All the components were added to drug-free normal human urine. Each sample was tested in 5 replicates using 3 lots of Test Cup and Test Dipcard. If any positive result was observed, the compounds were further diluted with known drug-free urine specimen sequentially to different concentrations and tested in quintuplicate, until the highest concentration that generates a negative result was identified. The cross reacting substances with the lowest concentration that produced a positive result was identified and is listed in the table. If no cross reactivity was observed the highest concentration tested is shown.
8.2 Interference: Clinical urine samples may contain substances that could potentially interfere with the test. The compounds listed were added to drug-free urine or drug positive urine containing THC, COC, MET, MOP, MDMA with the concentration 50% below the cutoff and the concentration 50% above the cutoff, respectively. All potential interfering substances were added at a concentration of 100ug/mL (All concentrations of the drugs were confirmed with GC/MS). The urine specimens were tested with two lots of the corresponding Rapid Single/Multi-drug Test Cup and Test Dipcard. None of the compounds listed were shown to interfere.
8.3 Effect of urinary pH: The pH of an aliquot negative urine pool is adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with each drug at 50% below and 50% above cutoff levels (All concentrations were confirmed with GC/MS). Each sample was tested by two lots of the corresponding Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. The results demonstrate that varying ranges of pH do not interfere with the performance of the test.
8.4 Effect of Urinary specific gravity: The specific gravity studies were conducted on different specific gravity including 1.002.1.010. 1.020, 1.030, 1.040 specimens with drug free urine containing THC, COC, MET, MOP, MDMA at 50% below and 50% above cutoff level (All concentrations were confirmed with GC/MS). Each sample was tested by two lots of the corresponding Xenta Drug Screen Cup and Xenta Drug Screen Dipcard. The results demonstrate that varying ranges of urinary specific gravity do not affect the test result.
8.5 Precision: Precision studies were performed using the single drug and multi-drug test formats. Drug free specimens were spiked with analytes at 0, +/-75% cutoff, +/-50% cutoff, +/-25% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with GC/MS. In both the single drug test and multi-drug test precision studies each concentration of the urine specimen was divided into aliquots. Each aliquot was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing. The study was conducted by 6 operators at 3 Point-of-Care sites. Two operators per location tested 3 aliquots at each concentration for each lot per day (3 runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the test dipcard format and the second operator tested the test cup format. There were 1620 observations by 3 sites at 9 concentrations.
8.6 Accuracy: 80 clinical urine specimens for each drug were analyzed by GC/MS and by two lots of the corresponding Single/Multi-drug Test Cup and Test Dipcard. Samples were divided by concentration into five categories: drug free, less than half the cutoff negative, near cutoff positive, and high positive. All samples were blindly labeled by a nonparticipant. Separate sets of the blind coded were assigned. Samples were also randomized prior to testing. The study was conducted by 4 nurses at two Point-of-Care sites. The test dipcard format was performed at one site and the test cup format at the second site. Each operator only performed one test format and different nurses tested each format.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics are presented in tables within the "Precision" and "Accuracy" sections, showing positive/negative results at various concentrations and compared to GC/MS analysis. No single aggregated sensitivity, specificity, PPV, or NPV values are provided.
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.
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
§ 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).
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.
February 6, 2023
Xenta Biomedical Science Co., Ltd. Huang Ling Product Manager Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue Huangpu District Guangzhou, Guangdong 510535 China
Re: K222955
Trade/Device Name: Xenta Drug Screen Cup, Xenta Drug Screen Dipcard Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, DIO, LDJ, DJC Dated: September 27, 2022 Received: September 27, 2022
Dear Huang Ling:
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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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, Paula Caposino Digitally signed by Paula
Caposino Caposino -S Caposimo -3
Date: 2023.02.06 13:24:53
-05'00' -5
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222955
Device Name Xenta Drug Screen Cup Xenta Drug Screen Dipcard
Indications for Use (Describe)
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off level |
|---|---|---|
| Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL |
| Morphine 300 (MOP) | Morphine | 300 ng/mL |
The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use.
The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
| 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) |
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3
Section 5 - 510(k) Summary
Date of Summary Preparation: 2/2/2023 510(k) Number: K222955
1. Submitter's Identifications
Submitter: Xenta Biomedical Science Co., Ltd. Address: Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue, Huangpu District, Guangzhou, 510535, P.R. China Contact Person: Huang Ling Contact Email Address: 1433969171@gq.com Telephone: +86-20-31707187 Fax: +86-20-31707187
2. Correspondent's Identifications
Correspondent's Name: Xenta Biomedical Science Co., Ltd. Address: Building C5, 9th Floor, Rm 901, No. 11 Kaiyuan Avenue, Huangpu District, Guangzhou, 510535, P.R. China Contact Person: Huang Ling Contact Email Address: 1433969171@gq.com Telephone: 86-20-31707187 Fax: 86-20-31707187
3. Name of the Device
Proprietary names:
Xenta Drug Screen Cup Xenta Drug Screen Dipcard
Recommended classification regulation:
21 CFR 862.3250 Cocaine test system 21 CFR 862.3650 Morphine test system 21 CFR 862.3870 Cannabinoid test system 21 CFR 862.3610 Methamphetamine test system
Device class: Class II Panel: Toxicology Product code: DIO,DJG,LDJ,DJC
4. The Predicate Devices
- K153050 Rapid Single/Multi-drug Test Cup Rapid Single/Multi-drug Test Dipcard
5. Device Description
4
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Cocaine, Marijuana, Methamphetamine, Morphine, Methylenedioxymethamphetamine at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.
The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.
6. Indications for Use
Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:
| Test | Calibrator | Cut-off level |
|---|---|---|
| Marijuana (THC) | Delta-9-THC-COOH | 50 ng/mL |
| Cocaine (COC) | Benzoylecgonine | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL |
| Methamphetamine (MET) | D-Methamphetamine | 1000 ng/mL |
| Morphine 300 (MOP) | Morphine | 300 ng/mL |
The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use.
The assays provide only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
7. Comparison to Predicate Devices:
A summary comparison of features of the Xenta Drug Screen Cup and Xenta Drug Screen Dipcard and the predicate devices is provided in the following Table:
| Item | Device | Predicate (K153050) |
|---|---|---|
| Indication for use | Qualitative detection of | |
| drugs-of-abuse in urine | ||
| (Cocaine ,Morphine, | ||
| Methamphetamine, Marijuana, | ||
| Methylenedioxymethamphetamine) | Same (but the number of drugs | |
| detected different) | ||
| Intended Users | Prescription Use | Over the Counter (OTC) Use and |
5
| Prescription Use | ||
|---|---|---|
| Specimen | Urine | Same |
| Cutoff | Cocaine:300 ng/mL | |
| Methamphetamine:1000 ng/mL | ||
| Morphine:300 ng/mL | ||
| Marijuana:50 ng/mL | ||
| Methylenedioxymethamphetamine:500 ng/mL | Cocaine:300 ng/mL | |
| Methamphetamine:1000 ng/mL | ||
| Morphine:300 ng/mL | ||
| Marijuana:50 ng/mL | ||
| Methylenedioxymethamphetamine: 500 ng/mL | ||
| Read time | 5 minutes | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateral flow | |
| immunochromatographic assay | ||
| based on the principle of antigen | ||
| antibody immunochemistry | Same | |
| Configuration | Dipcard and Cup | Cassette,Dip Card and Cup |
8. Performance Data:
8.1 Cross-reactivity with structurally similar compounds
To test the cross reactivity of the test, 2 lots of test Dipcard and one lot of test Cup was used to test with drug metabolites and drug structurally similar compounds in urine. All the components were added to drug-free normal human urine. Each sample was tested in 5 replicates using 3 lots of Test Cup and Test Dipcard. If any positive result was observed, the compounds were further diluted with known drug-free urine specimen sequentially to different concentrations and tested in quintuplicate, until the highest concentration that generates a negative result was identified. The cross reacting substances with the lowest concentration that produced a positive result was identified and is listed in the table below. If no cross reactivity was observed the highest concentration tested is shown.
| Cannabinoids (THC) | Lowest
Concentrat
ion
(ng/mL) | %
Cross-react
ivity | Methylenedioxymethamph
etamine (MDMA) | Lowest
Concentrat
ion
(ng/mL) | %
Cross-react
ivity |
|------------------------|----------------------------------------|---------------------------|---------------------------------------------------|----------------------------------------|---------------------------|
| 11-nor-Δ9-THC-9-COOH | 50 | 100% | (+/-)3,4-Methylenedioxymet
hamphetamine (MDMA) | 500 | 100% |
| 11-nor-Δ8-THC-9-COOH | 50 | 100% | 3,4-methylenedioxyampheta
mine (MDA) | 2200 | 22.7% |
| Δ 9-THC | 15000 | 0.3% | 3,4-Methylenedioxyethylam
phetamine (MDEA) | 240 | 208.3% |
| Δ 8-THC | 10000 | 0.5% | D-methamphetamine(MAM
P) | 100000 | 0.5% |
| Cannabidiol | 20000 | 0.3% | D-Amphetamine | >100000 | 100000 | 100000 | 100000 | 75000 | 90000 | 50000 |