(135 days)
Not Found
No
The device is described as a rapid lateral flow immunoassay, which is a traditional biochemical test method. There is no mention of AI, ML, image processing, or any computational analysis of the results. The performance studies focus on analytical performance and method comparison with standard laboratory techniques like GC/MS and LC/MS.
No
This device is a diagnostic tool used for the qualitative detection of various drugs in urine, providing only preliminary results. It does not provide any treatment or therapeutic function.
Yes
The device qualitatively detects multiple drugs in human urine to provide a preliminary result, which is a form of diagnosis for drug presence.
No
The device description explicitly states it consists of physical components like cups, cassettes, dip cards, and droppers, which are hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide diagnostic information (detection of specific substances).
- Device Description: The description details the components of the test kits, which are designed to perform the analysis of the urine sample.
- Performance Studies: The document describes performance studies conducted to evaluate the device's ability to accurately detect the target substances in urine samples. This is a key characteristic of IVDs.
- Comparison to Confirmatory Methods: The document mentions that the test provides a preliminary result and that a more specific alternative chemical method (like GC/MS or LC/MS) should be used for confirmation. This is typical for screening IVDs.
- Predicate Device: The mention of predicate devices (K182123 ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card) which are also drug screening devices, further supports its classification as an IVD.
The definition of an IVD generally includes devices intended for the examination of specimens derived from the human body to provide information for diagnostic purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette), and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 1000 |
| Cocaine (COC) | Benzoylecgonine | 300 |
| Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 |
| Methamphetamine (MET) | d-Methamphetamine | 1000 |
| Opiates(OPI) | Morphine | 2000 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DIO, DKZ, LDJ, DJC, LCM
Device Description
The LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The LYHER® Urine Multi-Drug Test Kit (Cup) device consists of 25 or 40 cup devices and a package insert. The LYHER® Urine Multi-Drug Test Kit (Dipcard) device consists of 10/15/20/25 Dip Card devices, a package insert. The LYHER® Urine Multi-Drug Test Kit (Cassette) device consists of 10/15/20/25 cassette devices, 10/15/20/25 droppers, a package insert.
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
prescription use only
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
Performance Characteristics and Method Comparison studies were performed.
Precision studies were carried out for samples with concentrations of -100% cut off, -75%cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off, These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. Each concentration has three lots, and 6 operators have joined the performance. Each specimen was analyzed in 50 replicates by each of the testing personnel at each Lab site by using three lots of the product separately.
Method comparison studies for the LYHER® Urine Multi-Drug Test were performed in-house with three laboratory assistants for each device. Operators ran samples unaltered clinical samples. The samples were blind labeled and compared to GC/MS results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance - Precision: The test results of the specimens at the concentrations at and below -25% of the cut off obtained by all the three personnel were all negative while the test results of the specimens at the concentration at and above +25% of the cut off value were all positive.
Analytical Performance - Cut-off: The following cut-off values for the candidate devices have been verified:
OPI: Morphine, 2000 ng/mL
COC: Benzoylecgonine, 300 ng/mL
AMP: d-Amphetamine, 1000 ng/mL
THC: 11-nor-Δ9-THC-9-COOH, 50 ng/mL
MET: d-Methamphetamine, 1000 ng/mL
PCP: Phencyclidine, 25 ng/mL
Analytical Performance - Interference: Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and target drugs urine with concentrations at 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL are summarized in the tables. There were no differences observed for different devices.
Analytical Performance - Specificity: To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed with their %Cross Reactivity. There were no differences observed for different devices.
Analytical Performance - Effect of Urine Specific Gravity and Urine pH: To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.003 to 1.032 specific gravity or urine samples with pH 3 to 9 were spiked with target drugs at 25% below and 25% above Cut-off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.
Method comparison: Discordant results are provided from testing with LC/MS results. For each drug (AMP, COC, MET, OPI, PCP, THC) and each device type (Cassettes, Dipcards, Cups), results were compared by operator across different concentration ranges relative to the cut-off (Negative urine, +50% cut off).
For AMP Cassettes, out of 80 tests by Operator 1, one discordant result was reported (LC/MS 1008, Lyher kit Negative).
For AMP Dipcards, out of 80 tests by Operator 1, one discordant result was reported (LC/MS 1008, Lyher kit Negative).
For AMP Cups, out of 80 tests by Operator 1, Operator 2 and Operator 3, no discordant results are reported for these operators with 80 tests. However, there is a table "Discordant Results of AMP Cups" with one entry: Operator 3 (SN 59, Specimen No. 202300501, LC/MS results 994, Results of Lyher kit Positive). This seems to indicate a positive result below the 1000ng/mL cut-off.
For COC Cassettes, out of 95 tests by Operator 1, two discordant results were reported (LC/MS 298, Lyher kit Positive; LC/MS 303, Lyher kit Negative).
For COC Dipcards, out of 95 tests by Operator 1, one discordant result was reported (LC/MS 303, Lyher kit Negative).
For COC Cups, out of 95 tests by Operator 1, Operator 2, one discordant result was reported respectively (LC/MS 303, Lyher kit Negative).
For MET Cassettes, out of 95 tests by Operator 1, one discordant result was reported (LC/MS 932, Lyher kit Positive), and an extra one (LC/MS 561, Lyher kit Positive). Operator 3 had two discordant results (LC/MS 561, Lyher kit Positive; LC/MS 1007, Lyher kit Negative).
For MET Dipcards, out of 95 tests by Operator 1, no discordant result reported. Operator 3 had one discordant result (LC/MS 1007, Lyher kit Negative).
For MET Cups, out of 95 tests by Operator 1, Operator 2, Operator 3, no discordant results are reported. However, there is a table "Discordant Results of MET Cups" with four entries. Operator 1 (SN 58, Specimen No. 202300374, LC/MS results 561, Results of Lyher kit Positive). Operator 2 (SN 58, Specimen No. 202300374, LC/MS results 561, Results of Lyher kit Positive). Operator 3 (SN 58, Specimen No. 202300374, LC/MS results 561, Results of Lyher kit Positive) and Operator 3 (SN 77, Specimen No. 202300393, LC/MS results 1007, Results of Lyher kit Negative).
For OPI Cassettes, out of 96 tests by Operator 2, two discordant results were reported (LC/MS 2006, Lyher kit Negative; LC/MS 1978, Lyher kit Positive).
For OPI Dipcards, out of 96 tests by Operator 3, one discordant result was reported (LC/MS 2006, Lyher kit Negative).
For OPI Cups, out of 96 tests by Operator 1, one discordant result was reported (LC/MS 2006, Lyher kit Negative).
For PCP Cassettes, out of 96 tests by Operator 1, two discordant results were reported (LC/MS 23.0, Lyher kit Positive; LC/MS 25.2, Lyher kit Negative). Operator 2 reported one discordant result (LC/MS 25.2, Lyher kit Negative). Operator 3 reported two discordant results (LC/MS 25.2, Lyher kit Negative twice).
For PCP Dipcards, out of 96 tests by Operator 2, three discordant results were reported (LC/MS 23.0, Lyher kit Positive; LC/MS 25.2, Lyher kit Negative; LC/MS 25.2, Lyher kit Negative for specimen 100).
For PCP Cups, out of 96 tests by Operator 1, one discordant result was reported (LC/MS 25.2, Lyher kit Negative).
For THC Cassettes, out of 105 tests by Operator 1, one discordant result was reported (LC/MS 50.5, Lyher kit Negative). Operator 2 reported three discordant results (LC/MS 52.3, Lyher kit Negative; LC/MS 49.6, Lyher kit Positive; LC/MS 51.1, Lyher kit Negative).
For THC Dipcards, out of 105 tests by Operator 2, two discordant results were reported (LC/MS 50.5, Lyher kit Negative; LC/MS 52.3, Lyher kit Negative; LC/MS 51.1, Lyher kit Negative). Operator 1 reported one discordant result (LC/MS 49.6, Lyher kit Positive). Operator 3 reported one discordant result (LC/MS 52.3, Lyher kit Negative).
For THC Cups, out of 105 tests by Operator 2, two discordant results were reported (LC/MS 50.5, Lyher kit Negative; LC/MS 51.1, Lyher kit Negative). Operator 1 reported one discordant result (LC/MS 49.6, Lyher kit Positive). Operator 3 reported one discordant result (LC/MS 52.3, Lyher kit Negative).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.3870 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).
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Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Hangzhou Laihe Biotech Co., Ltd. % Ethan Liu RA specialist Shanghai Thinkwell Consulting Co., Ltd Xinling Rd., 211/6F Shanghai, Shanghai 201100 China
Re: K232597
Trade/Device Name: LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DIO, DKZ, LDJ, DJC, LCM Dated: November 27, 2023 Received: December 1, 2023
Dear Ethan Liu:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, Digitally signed by Jos Joseph A. A Kotarek -S Date: 2024.01.09 14:04:36 Kotarek -S Joseph Kotarek, PhD Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232597
Device Name
L YHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
Indications for Use (Describe)
The LYHER® Urine Multi-Drug Test Kit (Cup), LYHER® Urine Multi- Drug Test Kit (Cassette), and LYHER® Urine Multi-Drug Test Kit (Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 1000 |
| Cocaine (COC) | Benzoylecgonine | 300 |
| Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 |
| Methamphetamine (MET) | d-Methamphetamine | 1000 |
| Opiates(OPI) | Morphine | 2000 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography / Mass Spectrometry (LC/MS) and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
| 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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
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Image /page/3/Picture/0 description: The image shows the logo for Hangzhou Laihe Biotech Co., Ltd. The logo consists of the company name in a stylized font. The letters 'LY' are colored in yellow, while the rest of the letters are in green. The company's name is written in black below the logo.
510(k) Summary 510(k) Number: K232597
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
5.1 Submitter
| Submitted by: | Hangzhou Laihe Biotech Co., Ltd. | ||
|---|---|---|---|
| Address: Room 401-406, F1-3, Building 1, | |||
| No.425 | |||
| Miaohouwang Road, Xixing Street, Binjiang | |||
| District, | |||
| Hangzhou, 310051 Zhejiang P.R. China | |||
| Tel.: +86 571 8765 3090 | |||
| Fax: +86 571 8665 8000 | |||
| www.lyher.com | |||
| Contact Person: | Ethan Liu | ||
| Shanghai Thinkwell Consulting Co., Ltd | |||
| Address:Xinling Rd., 211/6F Shanghai, 201100,P.R. China | |||
| Phone:0086-15216699240 | |||
| Email:xtdeepwater@126.com | |||
| Date Prepared: | Dec 29, 2023 |
5.2 Device
LYHER® Urine Multi-Drug Test Kit(Cup) LYHER® Urine Multi-Drug Test Kit(Cassette) LYHER® Urine Multi-Drug Test Kit(Dipcard)
Classification:
| Test | Product Code | CFR # | Panel |
|---|---|---|---|
| Opiates(OPI) | DJG | 862.3650/Opiate test system. | Toxicology |
| Cocaine (COC) | DIO | 862.3250/Cocaine and | |
| cocaine metabolite test | |||
| system. | Toxicology | ||
| Amphetamine (AMP) | DKZ | 862.3100/Amphetamine Test | |
| System | Toxicology | ||
| Marijuana (THC) | LDJ | 862.3870/Cannabinoid test | |
| system. | Toxicology | ||
| Methamphetamine | |||
| (MET) | DJC | 862.3610/Methamphetamine | |
| test system. | Toxicology | ||
| Phencyclidine (PCP) | LCM | Unclassified | Toxicology |
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Image /page/4/Picture/0 description: The image shows the logo for LYHER, a company named Hangzhou Laihe Biotech Co., Ltd. The logo is in green and yellow, with the letters "LY" in yellow and the rest of the letters in green. The company name is written in black below the logo.
5.3 Predicate Device:
ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card, K182123
5.4 Device Description
The LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The LYHER® Urine Multi-Drug Test Kit (Cup) device consists of 25 or 40 cup devices and a package insert. The LYHER® Urine Multi-Drug Test Kit (Dipcard) device consists of 10/15/20/25 Dip Card devices, a package insert. The LYHER® Urine Multi-Drug Test Kit (Cassette) device consists of 10/15/20/25 cassette devices, 10/15/20/25 droppers, a package insert.
5.5 Indication for Use:
The LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are rapid lateral flow immunoassays for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 1000 |
| Cocaine (COC) | Benzoylecgonine | 300 |
| Marijuana (THC) | 11-nor-\u03949-THC-9-COOH | 50 |
| Methamphetamine (MET) | d-Methamphetamine | 1000 |
| Opiates(OPI) | Morphine | 2000 |
| Phencyclidine (PCP) | Phencyclidine | 25 |
The single or multi-test panels can consist of the above listed analytes in any combination, up to a maximum of 6 analytes. The drug screen tests are intended for prescription use only. The tests provide only a preliminary result. A more specific alternative chemical method should be used in order to obtain a confirmed presumptive positive result. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/Mass Spectrometry (LC/MS) and their tandem massspectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
5.8 Substantial Equivalence
A summary comparison of features of the LYHER® Urine Multi-Drug Test Kit(Cup/Cassette/Dipcard) and the predicate devices is provided in following tables.
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Image /page/5/Picture/0 description: The image shows the word "LYHER" in green and yellow letters. The "L", "H", "E", and "R" are green, while the "Y" is yellow. There is a registered trademark symbol next to the "R".
Section 5 510(k) Summary
Hangzhou Laihe Biotech Co., Ltd.
| Item | Proposed Device | Predicate Device-K182123 |
|---|---|---|
| Indications | ||
| for Use | For the qualitative determination of drugs of | |
| abuse and/or their metabolites in human urine. | Same | |
| Methodology | Lateral flow immunochromatographic assay | |
| based on competitive binding | Same | |
| Type of Test | Qualitative | Same |
| Specimen | ||
| Type | Human Urine | Same |
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Image /page/6/Picture/0 description: The image shows the logo for LYHER. The "LY" is in yellow, and the "HER" is in green. There is a registered trademark symbol next to the "R".
Section 5 510(k) Summary
Hangzhou Laihe Biotech Co., Ltd.
| Cut-off Values | ||||||
|---|---|---|---|---|---|---|
| Test | Calibrator | Cut-off ng/mL | Test | Calibrator | Cutoff ng/ml | |
| Opiates(OPI) | Morphine | 2000 | 6- | |||
| Acetylmorphine | 6-monoacetyl- | |||||
| morphine | 10 | |||||
| Cocaine (COC) | Benzoylecgonine | 300 | Amphetamine | |||
| 500 | d-amphetamine | 500 | ||||
| Amphetamine | ||||||
| (AMP) | d-Amphetamine | 1000 | Amphetamine | |||
| 1000 | d-amphetamine | 1000 | ||||
| Marijuana (THC) | 11-nor-Δ9-THC-9- | |||||
| COOH | 50 | Barbiturates | Secobarbital | 300 | ||
| Methamphetamine | ||||||
| (MET) | d-Methamphet- | |||||
| amine | 1000 | Benzodiazepine | Oxazepam | 300 | ||
| Phencyclidine (PCP) | Phencyclidine | 25 | Buprenorphine | Buprenorphine | 10 | |
| Cocaine | ||||||
| 150 | Benzoylecgonine | 150 | ||||
| Cocaine | ||||||
| 300 | Benzoylecgonine | 300 | ||||
| EDDP | 2-ethylidene-1,5- | |||||
| dimethyl-3-3-diphenyl- | ||||||
| pyrrolidine | 300 | |||||
| Ecstasy | d/l-methylenedioxy- | |||||
| meth- | ||||||
| amphetamine | 500 | |||||
| Methamphet- | ||||||
| amine 500 | d-methamphetamine | 500 | ||||
| Methamphet- | ||||||
| amine 1000 | d-methamphetamine | 1000 | ||||
| Methadone | d/l-methadone | 300 | ||||
| Morphine | Morphine | 300 | ||||
| Opiates | Morphine | 2,000 | ||||
| Oxycodone | Oxycodone | 100 | ||||
| Phencyclidine | Phencyclidine | 25 | ||||
| Propoxyphene | d-propoxyphene | 300 | ||||
| Tricyclics | Nortriptyline | 1,000 | ||||
| Marijuana | THC-COOH | 5 | ||||
| Intended Use | For prescription uses. | Same | ||||
| Configura- | ||||||
| tions | Cup,Dip Card, Cassette | Cup, Dip Card |
5.9 Test Principle
Each device employs lateral flow immunochromatographic technology and is based on the principle of competitive binding. The product contains membrane strips coated with drug-protein conjugates on the T zone, goat anti-rabbit polycolonal antibody at the C zone, and a conjugate pad which 5-4
7
Image /page/7/Picture/0 description: The image shows the word "LYHER" in a stylized font. The "LY" is colored in yellow, while the "HER" is colored in green. There is a registered trademark symbol next to the "R".
contains colloidal gold particles coated with mouse monoclonal antibodies specific against to the corresponding drugs and colloidal gold particles coated with rabbit IgG.
If the level of drug in the urine specimen is below the cutoff concentration, the T line appears as a visible burgundy line. If the level of drug in the urine specimen is above the cutoff, no T line develops.The control line (C line) serves as an internal quality control line should always appear as a burgundy-colored band regardless of the drug, if enough sample volume has been added to the test and if the sample has correctly migrated up the test strip. Testing is based on the principle of a competitive immunochemical reaction between a chemically labeled drug (drug-protein conjugate) and the drug or drug metabolites which may be present in the urine sample competing for the limited antibody binding sites.
5.10 Performance Characteristics
5.10.1 Analytical Performance
- a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off, -75%cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off, These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. Each concentration has three lots, and 6 operators have joined the performance. Each specimen was analyzed in 50 replicates by each of the testing personnel at each Lab site by using three lots of the product separately.
The test results of the specimens at the concentrations at and below -25% of the cut off obtained by all the three personnel were all negative while the test results of the specimens at the concentration at and above +25% of the cut off value were all positive.
- b. Linearity
Not applicable
Stability ﻥ
The devices are stable at 2-30 °C for 24 months based on the accelerated stability study.
d. Cut-off
Dilute the solution by negative urine to the concentration of +50% cut off, +25%cut off, -25%cut off, -50%cut off respectively. To test all these above specimens by three different batches of the candidate product and each concentration will be tested for 25 replicates.
The following cut-off values for the candidate devices have been verified.
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| Opiates(OPI) | Morphine | 2000 |
| Cocaine (COC) | Benzoylecgonine | 300 |
| Amphetamine | ||
| (AMP) | d-Amphetamine | 1000 |
8
Image /page/8/Picture/0 description: The image shows the word "LYHER" in a stylized font. The "L" and "HER" are green, while the "Y" is orange. There is a registered trademark symbol next to the "R".
| Marijuana (THC) | 11-nor-Δ9-THC-9-COOH | 50 |
|---|---|---|
| Methamphetamine | ||
| (MET) | d-Methamphetamine | 1000 |
| Phencyclidine | ||
| (PCP) | Phencyclidine | 25 |
e. Interference
Potential interfering substances found in human urine of physiological conditions were added to drug-free urine and target drugs urine with concentrations at 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL are summarized in the following tables. There were no differences observed for different devices
Amphetamine:
| Substance | Substance | Substance |
|---|---|---|
| Acetaminophen | Erythromycin | Penicillin-G |
| Acetone | Ethanol | Pheniramine |
| Acetylsalicylic acid | Furosemide | Phenothiazine |
| Albumin | Gabapentin | Pregablin |
| Ampicillin | Glucose | Procaine |
| Ascorbic acid | Guaiacol glyceryl ether | Propoxyphene |
| Aspartame | Hemoglobin | Quinidine |
| Atropine | Ibuprofen | Ranitidine |
| Benzocaine | Isoproterenol | Riboflavin |
| Bilirubin | Isoproterenol | Sertraline |
| Caffeine | Ketamine | Sodium chloride |
| Chloroquine | Lidocaine | Sulindac |
| Chlorpheniramine | I-Phenylephrine | Theophylline |
| Creatine | Methadone | Tyramine |
| Dexbrompheniramine | Methylephedrine | β-Phenylethylamine |
| Dextromethorphan | Naproxen | Phencyclidine(PCP) |
| Dimenhydrinate | Niacinamide | Cocaine |
| Dimethylaminoantipyrine | Nicotine | Morphine |
| Diphenhydramine | Norephedrine | Δ9-tetrahydrocannabinol |
| Dopamine | Oxalic acid | |
| EDDP | Oxycodone |
9
Image /page/9/Picture/0 description: The image shows the logo for LYHER. The letters are in a sans-serif font, with the "LY" in yellow and the "HER" in green. There is a registered trademark symbol next to the "R".
| Ephedrine | Pantoprazole |
|---|---|
| ----------- | -------------- |
Cocaine(COC)
| Substance | Substance | Substance |
|---|---|---|
| Acetaminophen | Erythromycin | Penicillin-G |
| Acetone | Ethanol | Pheniramine |
| Acetylsalicylic acid | Furosemide | Phenothiazine |
| Albumin | Gabapentin | Pregablin |
| Ampicillin | Glucose | Procaine |
| Ascorbic acid | Guaiacol glyceryl ether | Propoxyphene |
| Aspartame | Hemoglobin | Quinidine |
| Atropine | Ibuprofen | Ranitidine |
| Benzocaine | Isoproterenol | Riboflavin |
| Bilirubin | Isoproterenol | Sertraline |
| Caffeine | Ketamine | Sodium chloride |
| Chloroquine | Lidocaine | Sulindac |
| Chlorpheniramine | l-Phenylephrine | Theophylline |
| Creatine | Methadone | Tyramine |
| Dexbrompheniramine | Methylephedrine | β-Phenylethylamine |
| Dextromethorphan | Naproxen | Phencyclidine(PCP) |
| Dimenhydrinate | Niacinamide | Morphine |
| Dimethylaminoantipyrine | Nicotine | Methylamphetamine |
| Diphenhydramine | Norephedrine | MDMA |
| Dopamine | Oxalic acid | Δ9-tetrahydrocannabinol |
| EDDP | Oxycodone | Amphetamine |
| Ephedrine | Pantoprazole |
MET
| Substance | Substance | Substance |
|---|---|---|
| Acetaminophen | Erythromycin | Penicillin-G |
| Acetone | Ethanol | Pheniramine |
| Acetylsalicylic acid | Furosemide | Phenothiazine |
| Albumin | Gabapentin | Pregablin |
| Ampicillin | Glucose | Procaine |
| Ascorbic acid | Guaiacol glyceryl ether | Propoxyphene |
| Aspartame | Hemoglobin | Quinidine |
| Atropine | Ibuprofen | Ranitidine |
| Benzocaine | Isoproterenol | Riboflavin |
| Bilirubin | Isoproterenol | Sertraline |
| Caffeine | Ketamine | Sodium chloride |
| Chloroquine | Lidocaine | Sulindac |
| Chlorpheniramine | l-Phenylephrine | Theophylline |
10
Image /page/10/Picture/0 description: The image shows the word "LYHER" in a stylized font. The "L" and "HER" are in green, while the "Y" is in orange. There is a registered trademark symbol next to the "R".
| Creatine | Methadone | Tyramine |
|---|---|---|
| Dexbrompheniramine | Methylephedrine | β-Phenylethylamine |
| Dextromethorphan | Naproxen | Phencyclidine(PCP) |
| Dimenhydrinate | Niacinamide | Cocaine |
| Dimethylaminoantipyrine | Nicotine | Morphine |
| Diphenhydramine | Norephedrine | Δ9-tetrahydrocannabinol |
| Dopamine | Oxalic acid | |
| EDDP | Oxycodone | |
| Ephedrine | Pantoprazole |
OPI
| OPI | ||
|---|---|---|
| Substance | Substance | Substance |
| Acetaminophen | Erythromycin | Penicillin-G |
| Acetone | Ethanol | Pheniramine |
| Acetylsalicylic acid | Furosemide | Phenothiazine |
| Albumin | Gabapentin | Pregablin |
| Ampicillin | Glucose | Procaine |
| Ascorbic acid | Guaiacol glyceryl ether | Propoxyphene |
| Aspartame | Hemoglobin | Quinidine |
| Atropine | Ibuprofen | Ranitidine |
| Benzocaine | Isoproterenol | Riboflavin |
| Bilirubin | Isoproterenol | Sertraline |
| Caffeine | Ketamine | Sodium chloride |
| Chloroquine | Lidocaine | Sulindac |
| Chlorpheniramine | L-Phenylephrine | Theophylline |
| Creatine | Methadone | Tyramine |
| Dexbrompheniramine | Methylephedrine | β-Phenylethylamine |
| Dextromethorphan | Naproxen | Phencyclidine(PCP) |
| Dimenhydrinate | Niacinamide | Cocaine |
| Dimethylaminoantipyrine | Nicotine | Methylamphetamine |
| Diphenhydramine | Norephedrine | MDMA |
| Dopamine | Oxalic acid | Amphetamine |
| EDDP | Oxycodone | Δ9-tetrahydrocannabinol |
| Ephedrine | Pantoprazole |
РСР
| Substance | Substance | Substance |
|---|---|---|
| Acetaminophen | Erythromycin | Penicillin-G |
| Acetone | Ethanol | Pheniramine |
| Acetylsalicylic acid | Furosemide | Phenothiazine |
| Albumin | Gabapentin | Pregablin |
| Ampicillin | Glucose | Procaine |
11
Image /page/11/Picture/0 description: The image shows the word "LYHER" in a stylized font. The "LY" portion of the word is in orange, while the "HER" portion is in green. The letters are bold and have a rounded appearance. There is a registered trademark symbol next to the "R".
| Ascorbic acid | Guaiacol glyceryl ether | Propoxyphene |
|---|---|---|
| Aspartame | Hemoglobin | Quinidine |
| Atropine | Ibuprofen | Ranitidine |
| Benzocaine | Isoproterenol | Riboflavin |
| Bilirubin | Isoproterenol | Sertraline |
| Caffeine | Ketamine | Sodium chloride |
| Chloroquine | Lidocaine | Sulindac |
| Chlorpheniramine | I-Phenylephrine | Theophylline |
| Creatine | Methadone | Tyramine |
| Dexbrompheniramine | Methylephedrine | β-Phenylethylamine |
| Dextromethorphan | Naproxen | Cocaine |
| Dimenhydrinate | Niacinamide | Morphine |
| Dimethylaminoantipyrine | Nicotine | Methylamphetamine |
| Diphenhydramine | Norephedrine | MDMA |
| Dopamine | Oxalic acid | Amphetamine |
| EDDP | Oxycodone | Δ9-tetrahydrocannabinol |
| Ephedrine | Pantoprazole |
THC
| Substance | Substance | Substance |
|---|---|---|
| Acetaminophen | Erythromycin | Penicillin-G |
| Acetone | Ethanol | Pheniramine |
| Acetylsalicylic acid | Furosemide | Phenothiazine |
| Albumin | Gabapentin | Pregablin |
| Ampicillin | Glucose | Procaine |
| Ascorbic acid | Guaiacol glyceryl ether | Propoxyphene |
| Aspartame | Hemoglobin | Quinidine |
| Atropine | Ibuprofen | Ranitidine |
| Benzocaine | Isoproterenol | Riboflavin |
| Bilirubin | Isoproterenol | Sertraline |
| Caffeine | Ketamine | Sodium chloride |
| Chloroquine | Lidocaine | Sulindac |
| Chlorpheniramine | l-Phenylephrine | Theophylline |
| Creatine | Methadone | Tyramine |
| Dexbrompheniramine | Methylephedrine | β-Phenylethylamine |
| Dextromethorphan | Naproxen | Phencyclidine(PCP) |
| Dimenhydrinate | Niacinamide | Cocaine |
| Dimethylaminoantipyrine | Nicotine | Morphine |
| Diphenhydramine | Norephedrine | Methylamphetamine |
| Dopamine | Oxalic acid | MDMA |
| EDDP | Oxycodone | Amphetamine |
| Ephedrine | Pantoprazole |
12
f. Specificity
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below. There were no differences observed for different devices.
| Compound | Concentration
(ng/mL) | %Cross Reactivity |
|---------------------------------------------------|--------------------------|-------------------|
| Amphetamine (AMP) | | |
| D-Amphetamine | 1000 | 100% |
| D,L-Amphetamine sulfate | 2500 | 40% |
| β-Phenylethylamine | 60000 | 1.67% |
| (±)3,4-Methylenedioxyamphetamine (MDA) | 1500 | 66.7% |
| Phentermine | 2500 | 40% |
| Tryptamine | 60000 | 1.67% |
| Tyramine | 5000 | 20% |
| L-amphetamine | 100000 | 1% |
| COCAINE (COC) | ng/ml | |
| Benzoylecgonine | 300 | 100% |
| Cocaine | 750 | 40% |
| Cocaethylene | 10000 | 3% |
| Ecgonine | 20000 | 1.5% |
| Ecgonine methylester | 50000 | 0.6% |
| MARIJUANA (THC) | | |
| Cannabinol | 20000 | 0.25% |
| 11-nor-Δ8-THC-9 COOH | 30 | 167% |
| 11-nor-Δ9 -THC-9 COOH | 50 | 100% |
| △8 -THC | 15000 | 0.33% |
| △9 -THC | 15000 | 0.33% |
| (±)-11-Hydroxy-Δ9-THC | 5000 | 1% |
| Cannabidiol | 20000 | 0.25% |
| METHAMPHETAMINE (MET) | | |
| p-Hydroxymethamphetamine | 30000 | 3.33% |
| D-Methamphetamine | 1000 | 100% |
| L-Methamphetamine | 8000 | 12.5% |
| (±)-3,4-Methylenedioxymethamphetamine | 2000 | 50% |
| Mephentermine | 50000 | 2% |
| D-Amphetamine | 100000 | 1% |
| Compound | Concentration
(ng/mL) | %Cross Reactivity |
| L-Amphetamine | 100000 | 1% |
| (1R, 2S)-(-)-Ephedrine | 100000 | 1% |
| (+/-) 3,4-Methylenedioxy-nethylamphetamine (MDEA) | 30000 | 3.33% |
| OPIATES (OPI) | | |
| Morphine | 2000 | 100% |
| Codeine | 1500 | 133% |
| Ethylmorphine | 30000 | 6.67% |
| Hydrocodone | 80000 | 2.5% |
| Hydromorphone | 10000 | 20% |
| Levophanol | 5000 | 40% |
| 6-Monoacetylmorphine | 2000 | 100% |
| Morphine 3-β-D-glucuronide | 5000 | 40% |
| Norcodeine | 30000 | 6.67% |
| Normorphone | 100000 | 2% |
| Oxycodone | 100000 | 2% |
| Oxymorphone | 100000 | 2% |
| Procaine | 60000 | 3.33% |
| Thebaine | 30000 | 6.67% |
| 6-Acetylmorphine (6-AM) | 2000 | 100% |
| Diacetylmorphine (heroin) | 5000 | 40% |
| Phencyclidine (PCP) | | |
| Phencyclidine | 25 | 100% |
| 4-hydroxy-PCP | 12500 | 0.2% |
13
Image /page/13/Picture/0 description: The image shows the word "LYHER" in a stylized font. The "LY" is in orange, while the "HER" is in green. There is a registered trademark symbol to the right of the "R".
g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.003 to 1.032 specific gravity or urine samples with pH 3 to 9 were spiked with target
drugs at 25% below and 25% above Cut-off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.
5.10.2 Method comparison
Method comparison studies for the LYHER® Urine Multi-Drug Test were performed in-house with three laboratory assistants for each device. Operators ran samples unaltered clinical samples. The samples were blind labeled and compared to GC/MS results are presented in the tables below:
14
Image /page/14/Picture/1 description: The image shows the logo for LYHER. The logo is green, except for the Y, which is orange. There is a registered trademark symbol to the right of the word.
| AMP
Cassettes | Test result | Negative
urine | +50%cut
off |
|------------------|-------------|-------------------|------------------|-------------------------|---------------------------|-----------------|
| Operator 1 | Negative | 43 | 0 | 12 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 22 | 17 |
| Operator 2 | Negative | 43 | 0 | 11 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 23 | 17 |
| Operator 3 | Negative | 43 | 0 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 23 | 17 |
Discordant Results of AMP Cassettes
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 2 | 59 | 202300501 | 994 | Positive |
| Operator 1 | 75 | 202300517 | 1008 | Negative |
| AMP
Dipcards | Test result | Negative
urine | +50%cut
off |
|-----------------|-------------|-------------------|------------------|-------------------------|---------------------------|-----------------|
| Operator 1 | Negative | 43 | 0 | 12 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 22 | 17 |
| Operator 2 | Negative | 43 | 0 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 23 | 17 |
| Operator 3 | Negative | 43 | 0 | 11 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 23 | 17 |
Discordant Results of AMP Dipcards
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 3 | 59 | 202300501 | 994 | Positive |
| Operator 1 | 75 | 202300517 | 1008 | Negative |
| AMP Cups | Test result | Negative urine | +50%cut off |
|------------|-------------|----------------|---------------|----------------------|---------------------|--------------|
| Operator 1 | Negative | 43 | 0 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 23 | 17 |
| Operator 2 | Negative | 43 | 0 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 23 | 17 |
| Operator 3 | Negative | 43 | 0 | 11 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 23 | 17 |
15
Image /page/15/Picture/0 description: The image shows the word "LYHER" in a stylized font. The "LY" portion of the word is in orange, while the "HER" portion is in green. There is a registered trademark symbol to the right of the word.
Discordant Results of AMP Cups
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 3 | 59 | 202300501 | 994 | Positive |
coc
| COC
Cassettes | Test
result | Negative
urine | +50%cut
off |
|------------------|----------------|-------------------|------------------|-------------------------|---------------------------|-----------------|
| Operator 1 | Negative | 42 | 0 | 13 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 37 | 5 |
| Operator 2 | Negative | 42 | 0 | 14 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 38 | 5 |
| Operator 3 | Negative | 42 | 0 | 13 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 38 | 5 |
Discordant Results of COC Cassettes
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 1 | 17 | 202300680 | 298 | Positive |
| Operator 3 | 17 | 202300680 | 298 | Positive |
| Operator 1 | 21 | 202300684 | 303 | Negative |
| COC
Dipcards | Test result | Negative
urine | +50%cut
off |
|-----------------|-------------|-------------------|------------------|-------------------------|---------------------------|-----------------|
| Operator 1 | Negative | 42 | 0 | 14 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 37 | 5 |
| Operator 2 | Negative | 42 | 0 | 13 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 38 | 5 |
| Operator 3 | Negative | 42 | 0 | 13 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 38 | 5 |
Discordant Results of COC Dipcards
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 2 | 17 | 202300680 | 298 | Positive |
| Operator 3 | 17 | 202300680 | 298 | Positive |
| Operator 1 | 21 | 202300684 | 303 | Negative |
| COC Cups | Test result | Negative urine | +50%cut off |
|------------|-------------|----------------|---------------|----------------------|---------------------|--------------|
| Operator 1 | Negative | 42 | 0 | 14 | 0 | 0 |
| Operator 1 | Positive | 0 | 0 | 0 | 38 | 5 |
16
Image /page/16/Picture/0 description: The image shows the word "LYHER" in a stylized font. The "L" and "Y" are in yellow, while the "HER" is in green. There is a small registered trademark symbol to the right of the "R".
| Operator 2 | Negative | 42 | 0 | 13 | 1 | 0 |
|---|---|---|---|---|---|---|
| Positive | 0 | 0 | 1 | 37 | 5 | |
| Operator 3 | Negative | 42 | 0 | 13 | 0 | 0 |
| Positive | 0 | 0 | 1 | 38 | 5 |
Discordant Results of COC Cups
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 2 | 17 | 202300680 | 298 | Positive |
| Operator 3 | 17 | 202300680 | 298 | Positive |
| Operator 2 | 21 | 202300684 | 303 | Negative |
MET
| MET
Cassettes | Test result | Negative
urine | +50%cut
off |
|------------------|-------------|-------------------|------------------|-------------------------|---------------------------|-----------------|
| Operator 1 | Negative | 43 | 0 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 2 | 24 | 16 |
| Operator 2 | Negative | 43 | 0 | 11 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 24 | 16 |
| Operator 3 | Negative | 43 | 0 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 23 | 16 |
Discordant Results of MET Cassettes
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 1 | 15 | 202300331 | 932 | Positive |
| Operator 1 | 58 | 202300374 | 561 | Positive |
| Operator 2 | 58 | 202300374 | 561 | Positive |
| Operator 3 | 58 | 202300374 | 561 | Positive |
| Operator 3 | 77 | 202300393 | 1007 | Negative |
| MET
Dipcards | Test result | Negative
urine | +50%cut
off |
|-----------------|-------------|-------------------|------------------|-------------------------|---------------------------|-----------------|
| Operator 1 | Negative | 43 | 0 | 11 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 24 | 16 |
| Operator 2 | Negative | 43 | 0 | 11 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 24 | 16 |
| Operator 3 | Negative | 43 | 0 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 23 | 16 |
Discordant Results of MET Dipcards
17
Image /page/17/Picture/0 description: The image shows the word "LYHER" in green and yellow. The "LY" is green, but the middle of the "Y" is yellow. The rest of the word is green. There is a registered trademark symbol in the upper right corner of the word.
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 1 | 58 | 202300374 | 561 | Positive |
| Operator 2 | 58 | 202300374 | 561 | Positive |
| Operator 3 | 58 | 202300374 | 561 | Positive |
| Operator 3 | 77 | 202300393 | 1007 | Negative |
| MET Cups | Test result | Negative | +50%cut |
|------------|-------------|----------|-----------|-------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | | urine | Off | offcut off | off+50%cut | ેન્દ્રિક રીકેની વિદ્વારા નિર્માન નામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત |
| | | | | | ેન્દ્રિક રીકેની વિદ્વારા નિર્માન નામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત | |
| Operator 1 | Negative | 43 | O | 11 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 24 | 16 |
| Operator 2 | Negative | 43 | 0 | 11 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 24 | 16 |
| Operator 3 | Negative | 43 | O | 11 | 1 | 0 |
| | Positive | O | 0 | 1 | 23 | 16 |
Discordant Results of MET Cups
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 1 | 58 | 202300374 | 561 | Positive |
| Operator 2 | 58 | 202300374 | 561 | Positive |
| Operator 3 | 58 | 202300374 | 561 | Positive |
| Operator 3 | 77 | 202300393 | 1007 | Negative |
OPI
| OPI
Cassettes | Test result | Negative
urine | +50%cut
off |
|------------------|-------------|-------------------|---------------|-------------------------|---------------------------|-----------------|
| Operator 1 | Negative | 45 | 0 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 33 | 8 |
| Operator 2 | Negative | 45 | 0 | 9 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 32 | 8 |
| Operator 3 | Negative | 45 | 0 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 33 | 8 |
Discordant Results of OPI Cassettes
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 2 | 59 | 202300180 | 2006 | Negative |
| Operator 2 | 80 | 202300201 | 1978 | Positive |
18
Image /page/18/Picture/0 description: The image shows the logo for LYHER. The logo is green, except for the "Y" which is yellow. There is a small registered trademark symbol next to the "R" in the logo.
| OPI
Dipcards | Test result | Negative
urine | +50%cut
off |
|-----------------|-------------|-------------------|------------------|-------------------------|---------------------------|-----------------|
| Operator 1 | Negative | 45 | 0 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 33 | 8 |
| Operator 2 | Negative | 45 | 0 | 9 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 33 | 8 |
| Operator 3 | Negative | 45 | 0 | 10 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 32 | 8 |
Discordant Results of OPI Dipcards
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 3 | 59 | 202300180 | 2006 | Negative |
| Operator 2 | 80 | 202300201 | 1978 | Positive |
| OPI Cups | Test result | Negative urine | +50%cut off |
|------------|-------------|----------------|---------------|----------------------|---------------------|--------------|
| Operator 1 | Negative | 45 | 0 | 10 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 32 | 8 |
| Operator 2 | Negative | 45 | 0 | 9 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 33 | 8 |
| Operator 3 | Negative | 45 | 0 | 9 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 33 | 8 |
Discordant Results of OPI Cups
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 1 | 59 | 202300180 | 2006 | Negative |
| Operator 2 | 80 | 202300201 | 1978 | Positive |
| Operator 3 | 80 | 202300201 | 1978 | Positive |
РСР
| PCP
Cassettes | Test result | Negative
urine | +50%cut
off |
|------------------|-------------|-------------------|------------------|-------------------------|---------------------------|-----------------|
| Operator 1 | Negative | 45 | 2 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 34 | 8 |
| Operator 2 | Negative | 45 | 2 | 12 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 34 | 8 |
| Operator 3 | Negative | 45 | 2 | 12 | 2 | 0 |
| | Positive | 0 | 0 | 0 | 33 | 8 |
19
Image /page/19/Picture/0 description: The image shows the word "LYHER" in a stylized font. The "LY" portion of the word is in orange, while the "HER" portion is in green. There is a registered trademark symbol to the right of the word.
Discordant Results of PCP Cassettes
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 1 | 25 | 202300810 | 23.0 | Positive |
| Operator 2 | 37 | 202300822 | 25.2 | Negative |
| Operator 3 | 37 | 202300822 | 25.2 | Negative |
| Operator 1 | 100 | 202301750 | 25.2 | Negative |
| Operator 3 | 100 | 202301750 | 25.2 | Negative |
| PCP
Dipcards | Test result | Negative
urine | +50%cut
off |
|-----------------|-------------|-------------------|------------------|-------------------------|---------------------------|-----------------|
| Operator 1 | Negative | 45 | 2 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 35 | 8 |
| Operator 2 | Negative | 45 | 2 | 11 | 2 | 0 |
| | Positive | 0 | 0 | 1 | 33 | 8 |
| Operator 3 | Negative | 45 | 2 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 35 | 8 |
Discordant Results of PCP Dipcards
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 2 | 25 | 202300810 | 23.0 | Positive |
| Operator 2 | 37 | 202300822 | 25.2 | Negative |
| Operator 2 | 100 | 202301750 | 25.2 | Negative |
| PCP Cups | Test result | Negative urine | +50%cut off |
|------------|-------------|----------------|---------------|----------------------|---------------------|--------------|
| Operator 1 | Negative | 45 | 2 | 12 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 34 | 8 |
| Operator 2 | Negative | 45 | 2 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 35 | 8 |
| Operator 3 | Negative | 45 | 2 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 35 | 8 |
Discordant Results of PCP Cups
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 1 | 100 | 202301750 | 25.2 | Negative |
THC
| THC
Cassettes | Test result | Negative
urine | +50%cut
off |
| ------------------ | ------------- | ------------------- | ------------------ | ------------------------- | ------------------------ | ----------------- |
|---|
20
Image /page/20/Picture/0 description: The image shows the logo for LYHER. The "LY" is in orange, and the "HER" is in green. There is a registered trademark symbol in the upper right corner of the logo.
| Operator 1 | Negative | 44 | 4 | 17 | 1 | 0 |
|---|---|---|---|---|---|---|
| Positive | 0 | 0 | 0 | 24 | 15 | |
| Operator 2 | Negative | 44 | 4 | 16 | 2 | 0 |
| Positive | 0 | 0 | 1 | 23 | 15 | |
| Operator 3 | Negative | 44 | 4 | 17 | 0 | 0 |
| Positive | 0 | 0 | 0 | 25 | 15 |
Discordant Results of THC Cassettes
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 1 | 12 | 202301036 | 50.5 | Negative |
| Operator 2 | 36 | 202301060 | 52.3 | Negative |
| Operator 2 | 45 | 202301069 | 49.6 | Positive |
| Operator 2 | 92 | 202301651 | 51.1 | Negative |
| THC
Dipcards | Test result | Negative
urine | +50%cut off |
|-----------------|-------------|-------------------|---------------|----------------------|---------------------|--------------|
| Operator 1 | Negative | 44 | 4 | 16 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 25 | 15 |
| Operator 2 | Negative | 44 | 4 | 17 | 3 | 0 |
| | Positive | 0 | 0 | 0 | 22 | 15 |
| Operator 3 | Negative | 44 | 4 | 17 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 24 | 15 |
Discordant Results of THC Dipcards
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 2 | 12 | 202301036 | 50.5 | Negative |
| Operator 2 | 36 | 202301060 | 52.3 | Negative |
| Operator 1 | 45 | 202301069 | 49.6 | Positive |
| Operator 3 | 75 | 202301099 | 52.3 | Negative |
| Operator 2 | 92 | 202301651 | 51.1 | Negative |
| THC Cups | Test result | Negative urine | +50%cut off |
|------------|-------------|----------------|---------------|----------------------|---------------------|--------------|
| Operator 1 | Negative | 44 | 4 | 16 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 25 | 15 |
| Operator 2 | Negative | 44 | 4 | 17 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 24 | 15 |
21
Image /page/21/Picture/0 description: The image shows the word "LYHER" in a stylized font. The "LY" portion of the word is in yellow, while the "HER" portion is in green. There is a registered trademark symbol to the right of the word.
| Operator 3 Negative | ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ | 1 - | |||
|---|---|---|---|---|---|
| Positive | C | ||||
| J | 1 P | ||||
| ﻟ |
Discordant Results of THC Cups
| Operator | SN. | Specimen No. | LC/MS results | Results of Lyher kit |
|---|---|---|---|---|
| Operator 2 | 12 | 202301036 | 50.5 | Negative |
| Operator 3 | 36 | 202301060 | 52.3 | Negative |
| Operator 1 | 45 | 202301069 | 49.6 | Positive |
| Operator 3 | 92 | 202301651 | 51.1 | Negative |
5.11 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou Laihe Biotech Co., Ltd has demonstrated that proposed device LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) are substantially equivalent to ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card, K182123.