LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
Device Facts
| Record ID | K232597 |
|---|---|
| Device Name | LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) |
| Applicant | Hangzhou Laihe Biotech Co., Ltd. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Jan 9, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
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 positive 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.
Device Story
Rapid lateral flow immunoassay; detects drugs of abuse in human urine. Input: urine specimen. Principle: competitive binding on membrane strips coated with drug-protein conjugates; colloidal gold-labeled antibodies. Output: visual burgundy line (negative if T-line present; positive if T-line absent). Used in clinical settings; operated by healthcare professionals. Provides preliminary results; requires confirmatory testing via GC/MS or LC/MS for clinical decision-making. Benefits: rapid screening for drug presence.
Clinical Evidence
No clinical data. Performance established via bench testing, including precision studies (50 replicates per concentration across 3 lots/operators) and method comparison studies against LC/MS reference methods using clinical urine samples.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Materials: membrane strips with drug-protein conjugates, colloidal gold particles coated with mouse monoclonal antibodies and rabbit IgG. Form factors: Cup, Cassette, Dipcard. Storage: 2-30 °C. Connectivity: None (standalone). Sterilization: Not specified.
Indications for Use
Indicated for qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine, and THC-COOH in human urine. Intended for prescription use only to provide preliminary drug screening results.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card (K182123)
Related Devices
- K232604 — LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) · Hangzhou Laihe Biotech Co., Ltd. · Jan 10, 2024
- K131110 — ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD · Co-Innovation Biotech Co., Ltd. · Jan 15, 2014
- K152122 — Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) · Alfa Scientific Designs, Inc. · Jun 24, 2016
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K232597
B Applicant
Hangzhou Laihe Biotech Co., Ltd.
C Proprietary and Established Names
LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJG | Class II | 21 CFR 862.3650 - Opiate test system | TX - Clinical Toxicology |
| DIO | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| DKZ | Class II | 21 CFR 862.3100 - Amphetamine Test System | TX - Clinical Toxicology |
| LDJ | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
| DJC | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
| LCM | Unclassified | | |
## II Submission/Device Overview:
A Purpose for Submission:
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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New Device
## B Measurand:
Amphetamine, Methamphetamine, Cocaine, Morphine, Marijuana, and Phencyclidine
## C Type of Test:
Qualitative lateral flow immunoassay
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) 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 positive 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.
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C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
D Special Instrument Requirements:
Not Applicable.
IV Device/System Characteristics:
A 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.
B Principle of Operation:
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 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. The control line should always appear as a burgundy-colored band regardless of the presence of the drug, if enough sample volume has been added to the test and if the sample has correctly migrated up the test strip.
V Substantial Equivalence Information:
A Predicate Device Name(s):
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ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
## B Predicate 510(k) Number(s):
K182123
## C Comparison with Predicate(s):
| Device & Predicate Device(s): | K232597 | | K182123 | |
| --- | --- | --- | --- | --- |
| Device Trade Name | LYHER® Urine Multi-Drug Test Kit(Cup)
LYHER® Urine Multi-Drug Test Kit(Cassette)
LYHER® Urine Multi-Drug Test Kit(Dipcard) | | Advin Biotech, Inc ATTEST Drug Screen Cup
ATTEST Drug Screen Dip Card | |
| General Device Characteristic Similarities | | | | |
| Intended Use/Indications For Use | Qualitative detection of drugs of abuse and/or their metabolites in urine | | Same | |
| Methodology | Lateral flow immunochromatographic assay based on competitive binding | | Same | |
| Type of Test | Qualitative | | Same | |
| Specimen Type | Human Urine | | Same | |
| General Device Characteristic Differences | | | | |
| Configurations | Cup, Dip Card, Cassette | | Cup, Dip Card | |
| Cut-off Values | Calibrator | Cutoff ng/mL | Calibrator | Cutoff ng/mL |
| | d-Amphetamine | 1000 | 6-monoacetyl-morphine | 10 |
| | Benzoylecgonine | 300 | d-amphetamine | 500 |
| | 11-nor-Δ9-THC-9-COOH | 50 | d-amphetamine | 1000 |
| | | | Secobarbital | 300 |
| | d-Methamphetamine | 1000 | Oxazepam | 300 |
| | | | Buprenorphine | 10 |
| | | | Benzoylecgonine | 150 |
| | Morphine | 2000 | Benzoylecgonine | 300 |
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| | Phencyclidine | 25 | 2-ethylidene-1,5-dimethyl-3-3-diphenyl-pyrrolidine | 300 |
| --- | --- | --- | --- | --- |
| | | | d/l-methylenedioxy-meth-amphetamine | 500 |
| | | | d-methamphetamine | 500 |
| | | | d-methamphetamine | 1000 |
| | | | d/l-methadone | 300 |
| | | | Morphine | 300 |
| | | | Morphine | 2,000 |
| | | | Oxycodone | 100 |
| | | | Phencyclidine | 25 |
| | | | d-propoxyphene | 300 |
| | | | Nortriptyline | 1,000 |
| | | | THC-COOH | 5 |
VI Standards/Guidance Documents Referenced:
None.
VII Performance Characteristics (if/when applicable):
A Analytical Performance:
1. Precision/Reproducibility:
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. Three operators performed the study using three lots of each test format (dip card, test cup, and cassette). 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 was tested using 3 lots, by 6 operators. Each specimen was analyzed in 50 replicates by each of the testing personnel at three representative POC sites 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
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the concentration at and above +25% of the cut off value were all positive. One representative lot for each configuration is provided below.
Precision Study Result of Cassette:
| Drug Test | Results | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff | +100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| THC 50 | Neg | 50 | 50 | 50 | 50 | 5 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 45 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| AMP 1000 | Neg | 50 | 50 | 50 | 50 | 5 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 45 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| COC 300 | Neg | 50 | 50 | 50 | 50 | 10 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 40 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| MET 1000 | Neg | 50 | 50 | 50 | 50 | 5 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 45 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| OPI 2000 | Neg | 50 | 50 | 50 | 50 | 8 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 42 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| PCP 25 | Neg | 50 | 50 | 50 | 50 | 12 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 38 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
Precision Study Result of Dip Card:
| Drug Test | Results | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff | +100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| THC 50 | Neg | 50 | 50 | 50 | 50 | 9 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 41 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| AMP 1000 | Neg | 50 | 50 | 50 | 50 | 9 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 41 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| COC 300 | Neg | 50 | 50 | 50 | 50 | 10 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 40 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| MET 1000 | Neg | 50 | 50 | 50 | 50 | 10 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 40 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| OPI 2000 | Neg | 50 | 50 | 50 | 50 | 10 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 40 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
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Precision Study Result of Cup:
| Drug Test | Results | -100% Cutoff | -75% Cutoff | -50% Cutoff | -25% Cutoff | Cutoff | +25% Cutoff | +50% Cutoff | +75% Cutoff | +100% Cutoff |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| THC 50 | Neg | 50 | 50 | 50 | 50 | 11 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 39 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| AMP 1000 | Neg | 50 | 50 | 50 | 50 | 11 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 39 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| COC 300 | Neg | 50 | 50 | 50 | 50 | 10 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 40 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| MET 1000 | Neg | 50 | 50 | 50 | 50 | 9 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 41 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| OPI 2000 | Neg | 50 | 50 | 50 | 50 | 9 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 41 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
| PCP 25 | Neg | 50 | 50 | 50 | 50 | 11 | 0 | 0 | 0 | 0 |
| | Pos | 0 | 0 | 0 | 0 | 39 | 50 | 50 | 50 | 50 |
| | Total | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 | 50 |
2. Linearity:
Not Applicable.
3. Analytical Specificity/Interference:
**Interfering Substances:**
Analytical specificity for each test format was determined by adding potential interfering substances found in human urine of physiological or pathological conditions to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three lots of each device configuration. Compounds that showed no interference to the assays in this submission at a concentration of 100μg/mL are summarized in the following table. There were no differences observed for each of the different devices (i.e. cassette, dipcard, and cup).
| Substances | | |
| --- | --- | --- |
| Acetaminophen | Erythromycin | Penicillin-G |
| Acetone | Ethanol | Pheniramine |
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| 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 | Δ9-tetrahydrocannabinol |
| Dopamine | Oxalic acid | Methylamphetamine |
| EDDP | Oxycodone | MDMA |
| Ephedrine | Pantoprazole | Amphetamine |
## Cross Reactivity:
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three lot of each device configuration (cassette, dipcard, and cup). The lowest concentration that caused a positive result for each compound are listed below. There were no differences observed for different devices (i.e. cassette, dipcard, and cup).
| 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% |
| | | |
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| MARIJUANA (THC) | | |
| --- | --- | --- |
| Cannabinol | 20000 | 0.25% |
| 11-nor- Δ 8-THC-9 COOH | 30 | 167% |
| 11-nor- Δ 9 -THC-9 COOH | 50 | 100% |
| Δ 8 -THC | 15000 | 0.33% |
| Δ 9 -THC | 15000 | 0.33% |
| (±)-11-Hydroxy-Δ9-THC | 5000 | 1% |
| | | |
| | | |
| 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% |
| 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% |
**Effect of Urine Specific Gravity and Urine pH:**
To investigate the effect of urine specific gravity and urine pH, urine samples, with
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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 configuration (cassette, dipcard, and cup). 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.
4. Assay Reportable Range:
Not Applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The assay is traceable to a commercially-available, certified, standard material with the concentration verified by GC-MS or LC-MS/MS.
6. Detection Limit:
Not Applicable.
7. Assay Cutoff:
For characterization of how the device performs analytically around the claimed cutoff concentration, please refer to the Precision section VII.A.1., above.
B Comparison Studies:
1. Method Comparison with Predicate Device:
Method comparison studies for the LYHER® Urine Multi-Drug Test were performed with three operators for each test configuration of the device (cassettes, dipcards, and cups). Operators ran at least 80 (40 negative and 40 positive) unaltered clinical samples for each analyte. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below:
AMP
| AMP Cassettes | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 |
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Discordant Results of AMP Cassettes
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 2 | 202300501 | 994 | Positive |
| Operator 1 | 202300517 | 1008 | Negative |
| AMP Dipcards | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 3 | 202300501 | 994 | Positive |
| Operator 1 | 202300517 | 1008 | Negative |
| AMP Cups | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 |
Discordant Results of AMP Cups
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 3 | 202300501 | 994 | Positive |
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COC
| COC Cassettes | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202300680 | 298 | Positive |
| Operator 3 | 202300680 | 298 | Positive |
| Operator 1 | 202300684 | 303 | Negative |
| COC Dipcards | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 2 | 202300680 | 298 | Positive |
| Operator 3 | 202300680 | 298 | Positive |
| Operator 1 | 202300684 | 303 | Negative |
| COC Cups | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+50%cut off |
| --- | --- | --- | --- | --- | --- | --- |
| Operator 1 | Negative | 42 | 0 | 14 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 38 | 5 |
| Operator 2 | Negative | 42 | 0 | 13 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 37 | 5 |
| | Negative | 42 | 0 | 13 | 0 | 0 |
K232597 - Page 12 of 19
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K232597 - Page 13 of 19
| Operator 3 | Positive | 0 | 0 | 1 | 38 | 5 |
| --- | --- | --- | --- | --- | --- | --- |
Discordant Results of COC Cups
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 2 | 202300680 | 298 | Positive |
| Operator 3 | 202300680 | 298 | Positive |
| Operator 2 | 202300684 | 303 | Negative |
# MET
| MET Cassettes | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202300331 | 932 | Positive |
| Operator 1 | 202300374 | 561 | Positive |
| Operator 2 | 202300374 | 561 | Positive |
| Operator 3 | 202300374 | 561 | Positive |
| Operator 3 | 202300393 | 1007 | Negative |
| MET Dipcards | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 |
{13}
Discordant Results of MET Dipcards
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202300374 | 561 | Positive |
| Operator 2 | 202300374 | 561 | Positive |
| Operator 3 | 202300374 | 561 | Positive |
| Operator 3 | 202300393 | 1007 | Negative |
| MET Cups | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 Cups
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202300374 | 561 | Positive |
| Operator 2 | 202300374 | 561 | Positive |
| Operator 3 | 202300374 | 561 | Positive |
| Operator 3 | 202300393 | 1007 | Negative |
OPI
| OPI Cassettes | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 2 | 202300180 | 2006 | Negative |
| Operator 2 | 202300201 | 1978 | Positive |
K232597 - Page 14 of 19
{14}
| OPI Dipcards | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 3 | 202300180 | 2006 | Negative |
| Operator 2 | 202300201 | 1978 | Positive |
| OPI Cups | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202300180 | 2006 | Negative |
| Operator 2 | 202300201 | 1978 | Positive |
| Operator 3 | 202300201 | 1978 | Positive |
PCP
| PCP Cassettes | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 |
K232597 - Page 15 of 19
{15}
Discordant Results of PCP Cassettes
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202300810 | 23.0 | Positive |
| Operator 2 | 202300822 | 25.2 | Negative |
| Operator 3 | 202300822 | 25.2 | Negative |
| Operator 1 | 202301750 | 25.2 | Negative |
| Operator 3 | 202301750 | 25.2 | Negative |
| PCP Dipcards | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 2 | 202300810 | 23.0 | Positive |
| Operator 2 | 202300822 | 25.2 | Negative |
| Operator 2 | 202301750 | 25.2 | Negative |
| PCP Cups | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202301750 | 25.2 | Negative |
K232597 - Page 16 of 19
{16}
THC
| THC Cassettes | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+50%cut off |
| --- | --- | --- | --- | --- | --- | --- |
| 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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202301036 | 50.5 | Negative |
| Operator 2 | 202301060 | 52.3 | Negative |
| Operator 2 | 202301069 | 49.6 | Positive |
| Operator 2 | 202301651 | 51.1 | Negative |
| THC Dipcards | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 2 | 202301036 | 50.5 | Negative |
| Operator 2 | 202301060 | 52.3 | Negative |
| Operator 1 | 202301069 | 49.6 | Positive |
| Operator 3 | 202301099 | 52.3 | Negative |
| Operator 2 | 202301651 | 51.1 | Negative |
K232597 - Page 17 of 19
{17}
| THC Cups | Test result | Negative urine | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+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 |
| Operator 3 | Negative | 44 | 4 | 17 | 2 | 0 |
| | Positive | 0 | 0 | 0 | 23 | 15 |
Discordant Results of THC Cups
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 2 | 202301036 | 50.5 | Negative |
| Operator 3 | 202301060 | 52.3 | Negative |
| Operator 1 | 202301069 | 49.6 | Positive |
| Operator 3 | 202301651 | 51.1 | Negative |
2. Matrix Comparison:
Not Applicable.
C Clinical Studies:
1. Clinical Sensitivity:
Not Applicable.
2. Clinical Specificity:
Not Applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not Applicable.
D Clinical Cutoff:
Not Applicable.
E Expected Values/Reference Range:
Not Applicable.
K232597 - Page 18 of 19
{18}
VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
K232597 - Page 19 of 19
