LYHER® Oral fluid Multi-Drug Test Kit (Cube)
Device Facts
| Record ID | K240287 |
|---|---|
| Device Name | LYHER® Oral fluid Multi-Drug Test Kit (Cube) |
| Applicant | Hangzhou Laihe Biotech Co., Ltd. |
| Product Code | DJC · Clinical Toxicology |
| Decision Date | Mar 18, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
Indications for Use
The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol in human oral fluid. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Test Calibrator Cut-off (ng/ml) Opiates(OPI) Morphine 40 Cocaine (COC) Benzoylecgonine 20 Amphetamine (AMP) d-Amphetamine 50 Marijuana (THC) Delta-9-Tetrahydrocannabinol 40 Methamphetamine (MET) d-Methamphetamine 50 Phencyclidine (PCP) Phencyclidine 10 The tests provide only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test 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
Lateral flow immunoassay for qualitative detection of drugs of abuse in human oral fluid; utilizes competitive binding principle. Input: oral fluid collected via swab. Transformation: drug-specific antibodies on test strips compete with drug in sample; presence of drug above cutoff prevents T-line formation; C-line indicates valid test. Output: visual burgundy lines (T-line/C-line). Used in clinical settings; operated by healthcare professionals. Results are preliminary; require confirmation via GC/MS or LC/MS. Benefits: rapid screening for drugs of abuse.
Clinical Evidence
No clinical studies performed. Analytical performance established via bench testing. Precision evaluated at three sites using three operators and three lots over 30 days. Method comparison against LC-MS/MS conducted on 150 subjects; discordant results analyzed. Interference testing (exogenous, endogenous, pH, smoking) showed no impact on performance. Stability/recovery studies confirmed sample integrity for confirmatory testing after storage.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Components: cube device, oral fluid collection swab. Qualitative visual readout. No energy source required. Standalone device.
Indications for Use
Indicated for qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine, and Delta-9-Tetrahydrocannabinol in human oral fluid. For prescription use. Provides preliminary results requiring confirmation by GC/MS or LC/MS.
Regulatory Classification
Identification
A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Special Controls
*Classification.* Class II (special controls). A methamphetamine 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
- OralTox™ Oral Fluid Drug Test (K171403)
Related Devices
- K181305 — OralTox Oral fluid Drug Test · Premier Biotech, Inc. · Sep 20, 2018
- K171403 — OralTox Oral Fluid Drug Test · Premier Biotech, Inc. · Feb 2, 2018
- K031759 — ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD AND ACON SPECTRUM MULTI-DRUG MULTI-LINE DRUG SCREEN TEST CARD · ACON Laboratories, Inc. · Aug 4, 2003
- K253705 — Healgen® Accurate Oral Fluid Drug Test · Healgen Scientific,, LLC · Mar 16, 2026
Submission Summary (Full Text)
{0}
FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY ONLY
## I Background Information:
A 510(k) Number
K240287
B Applicant
Hangzhou Laihe Biotech Co., Ltd.
C Proprietary and Established Names
LYHER® Oral fluid Multi-Drug Test Kit (Cube)
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| DJC | Class II | 21 CFR 862.3610 - Methamphetamine Test System | TX - Clinical Toxicology |
| DIO | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| DJG | Class II | 21 CFR 862.3650 - Opiate test system | TX - Clinical Toxicology |
| DKZ | Class II | 21 CFR 862.3100 - Amphetamine test system | TX - Clinical Toxicology |
| LCM | Unclassified | | |
| LDJ | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
## 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:
d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol
## 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® Oral fluid Multi-Drug Test Kit (Cube) is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol in human oral fluid. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/ml) |
| --- | --- | --- |
| Opiates(OPI) | Morphine | 40 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 |
| Methamphetamine (MET) | d-Methamphetamine | 50 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
The tests provide only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical test 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.
## C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
K240287 - Page 2 of 17
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D Special Instrument Requirements:
None
IV Device/System Characteristics:
A Device Description:
The LYHER® Oral fluid Multi-Drug Test Kit (Cube) is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of d-Amphetamine, d-Methamphetamine, Benzoylecgonine, Morphine, Phencyclidine and Delta-9-Tetrahydrocannabinol in human oral fluid. The LYHER® Oral fluid Multi-Drug Test Kit (Cube) device consists of a cube device, an oral fluid collection swab and a package insert.
B Principle of Operation:
Each device employs lateral flow immunochromatographic technology and is based on the principle of competitive binding. Drugs, if present in concentrations below the cutoff level, will not saturate the binding sites of the antibody coated particles on the drug specific test strips. The goat-anti-rabbit IgG antibody-coated particles will then be captured by immobilized drug-specific conjugate. If the level of drug in the oral fluid specimen is below the cutoff concentration, the T line appears as a visible burgundy line. If the level of drug in the oral fluid 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):
OralTox Oral Fluid Drug Test
B Predicate 510(k) Number(s):
K171403
C Comparison with Predicate(s):
| Device & Predicate Device(s): | K240287 | K171403 |
| --- | --- | --- |
| Device Trade Name | LYHER® Oral fluid Multi-Drug Test Kit (Cube) | OralTox Oral Fluid Drug Test |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the qualitative determination of | Same |
K240287 - Page 3 of 17
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| | Amphetamine, cocaine, cannabinoids, methamphetamine, opiate, phencyclidine in human oral fluid | |
| --- | --- | --- |
| Methodology | Lateral flow immunochromatographic assay based on competitive binding | Same |
| Specimen Type | Human oral fluid | Same |
| Cutoffs | AMP 50 ng/mL
COC 20 ng/mL
THC 40 ng/mL
MET 50 ng/mL
OPI 40 ng/ML
PCP 10 ng/mL | Same |
| General Device Characteristic Differences | | |
| Configuration | Cube | Cups |
VI Standards/Guidance Documents Referenced:
None referenced.
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, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative oral fluid samples. All drug concentration were confirmed by LC-MS/MS and all sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. Precision of the product was characterized at three different sites using 3 operators with 3 lots of cubes. For each concentration, two runs per day for 30 days per device lot were performed in a randomized order. Results are summarized below.
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Amphetamine
| | -100% cut off | -75% cut off | -50% cut off | -25% cut off | Cut off | +25% cut off | +50% Cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 0+/60- | 0+/60- | 0+/60- | 5+/55- | 48+/12- | 54+/6- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 0+/60- | 0+/60- | 0+/60- | 5+/55- | 47+/13- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 0+/60- | 0+/60- | 0+/60- | 5+/55- | 47+/13- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
Cocaine
| | -100% cut off | -75% cut off | -50% cut off | -25% cut off | Cut off | +25% cut off | +50% Cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 0+/60- | 0+/60- | 0+/60- | 6+/54- | 48+/12- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 0+/60- | 0+/60- | 0+/60- | 5+/55- | 48+/12- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 0+/60- | 0+/60- | 0+/60- | 6+/54- | 49+/11- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
Methamphetamine
| | -100% cut off | -75% cut off | -50% cut off | -25% cut off | Cut off | +25% cut off | +50% Cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 0+/60- | 0+/60- | 0+/60- | 6+/54- | 47+/13- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 0+/60- | 0+/60- | 0+/60- | 5+/55- | 48+/12- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 0+/60- | 0+/60- | 0+/60- | 6+/54- | 49+/11- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
Morphine
| | -100% cut off | -75% cut off | -50% cut off | -25% cut off | Cut off | +25% cut off | +50% Cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 0+/60- | 0+/60- | 0+/60- | 5+/55- | 48+/12- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 0+/60- | 0+/60- | 0+/60- | 6+/54- | 49+/11- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 0+/60- | 0+/60- | 0+/60- | 6+/54- | 49+/11- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
Phencyclidine
| | -100% cut off | -75% cut off | -50% cut off | -25% cut off | Cut off | +25% cut off | +50% Cut off | +75% cut off | +100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 0+/60- | 0+/60- | 0+/60- | 6+/54- | 48+/12- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 0+/60- | 0+/60- | 0+/60- | 6+/54- | 48+/12- | 54+/6- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 0+/60- | 0+/60- | 0+/60- | 5+/55- | 48+/12- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
Cannabinoids
| | -100% cut off | -75% cut off | -50% cut off | -25% cut off | Cut off | 25% cut off | 50% Cut off | 75% cut off | 100% cut off |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Lot 1 | 0+/60- | 0+/60- | 0+/60- | 6+/54- | 49+/11- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 0+/60- | 0+/60- | 0+/60- | 6+/54- | 48+/12- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 0+/60- | 0+/60- | 0+/60- | 5+/55- | 48+/12- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
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Sample Volume:
A sample volume study was conducted to confirm the reproducibility of adequate sample volume collection by the device. Operators collected samples at two sites from a total 150 subjects (including drug users) following the device's instructions for use. Operators swept the inside of volunteer's mouth (cheek, gums, and tongue), and then held the swab in the subject's mouth for 3 minutes.
Mean volume collected by the swabs for cube format was 2.05 mL with a minimum volume of 1.6 mL, and a maximum volume of 2.5 mL.
2. Linearity:
Not applicable.
3. Analytical Specificity/Interference:
Exogenous Interference: Potential interference from structurally unrelated compounds were tested by spiking the potentially interfering compound at a concentration of 10 ug/mL into drug free oral fluid or fluid containing the target drug with concentrations of 50% below and 50% above cutoff level. The following compounds were found not to interfere with test results at a concentration of 10 ug/mL for all samples tested.
| Acetaminophen | Digoxin | Nicotinamide |
| --- | --- | --- |
| Acetylcodeine | Dihydrocodeine | Nicotine |
| Allobarbital | diltiazem HCl | Noscapine |
| Alprazolam | Diphenhydramine HCl | Omeprazole |
| Amobarbital | DL-Propranolol | Papaverine |
| Apomorphine | Doxylamine | Pentazocine |
| Atenolol | Ecgonine methyl ester | Phentermine |
| Atropine | Estradiol | Phenylpropanolamine |
| Baclofen | Estrone | Phenytoin |
| Benzocaine | Fluconazole | Pioglitazone HCl |
| Butabarbital | Furosemide | Prednisolone |
| Caffeine | Hexobarbital | Prednisone |
| Cannabidiol | Hydrochlorothiazide | Procainamide HCl |
| Carbamazepine | Ibuprofen | Procaine HCL |
| Chlordiazepoxide | Imipramine | Promethazine |
| Chlorpromazine | Lamotrigine | Quinine HCl |
| Cimetidine | Levetiracetam | R,R(-)-Pseudoephedrine |
| Citalopram HBr | Lidocaine | Salicylic Acid |
| Clobazam | Lormetazepam | Sertraline HCL |
| Clomipramine | L-Thyroxine | Simvastatin |
| Clonazepam | Metformin HCl | Theophylline |
K240287 - Page 6 of 17
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The following potential interference from substances commonly present in oral fluid were evaluated by spiking into drug free oral fluid or oral fluid containing the target drug with concentrations of 50% below and 50% above cutoff level to a concentration of 5%: alcohol, baking soda, chewing gum, coffee, cola, cough syrup, cranberry juice, food coloring (blue, green, and red), methanol cough drops, milk, mouthwash, monosodium glutamate (MSG), orange juice, salt, sugar, tea, toothpaste, and tomatoes. None of these substances showed any interference with any of the analytes in the candidate device.
Potential interference from cigarette smoking was evaluated by asking a participant to smoke a cigarette, and after 15 minutes an oral fluid sample was collected and spiked with each drug at concentrations of cutoff +/- 50%. No interference was seen with any of the analytes in the candidate device.
Potential interference from Hemoglobin (blood) was evaluated by adding it to drug free oral fluid and oral fluid containing the target drug with concentrations of 50% above and 50% below cutoff level to a concentration of 100 ug/mL. No interference was seen with any of the analytes in the candidate device.
Effect of oral fluid pH: To investigate the effect of oral fluid pH, oral fluid samples with pH 3 to 9 were spiked with target drugs at 50% below and 50% above Cut-Off levels. These samples were tested using three lots of the device. Results were all positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off.
Cross-reactivity. To evaluate cross reactivity, drug metabolites and other components that may be present in oral fluid samples were tested using three lots of the device. The following are summaries of the cross-reactivities.
| d-Amphetamine (Cut-off=50 ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| D-Amphetamine | 50 | 100 |
| L-Amphetamine | 4000 | 1.25 |
| D,L-Amphetamine | 125 | 40 |
| Methoxyamphetamine | 500 | 10 |
| Methylenedioxyamphetamine(MDA) | 150 | 33 |
| Benzodioxolylbutanamine (BDB) | 10000 | 0.5 |
| 3-Hydroxy Tyramine | 5000 | 1 |
| d,l-p-Chloramphetamine | 500 | 10 |
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| d-Amphetamine (Cut-off=50 ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Phenethylamine | 4000 | 1.25 |
| Hydroxyamphetamine | 800 | 6.25 |
| d,l-Phenylpropanolamine | Negative at 10000 | <0.5% |
| Phentermine | | |
| Methylenedioxyethylamphetamine (MDEA) | | |
| Methylenedioxy-methamphetamine (MDMA) | | |
| d-Methamphetamine | | |
| l-Methamphetamine | | |
| Dimethylamylamine (DMAA) | | |
| Methylbenzodioxolylbutanamine | | |
| para-Methoxymethamphetamine | | |
| Phendimetrazine | | |
| Phenmetrazine | | |
| D-Ephedrine | | |
| L-Ephedrine | | |
| D,L-Ephedrine | | |
| diphenhydramine | | |
| d-Pseudoephedrine | | |
| Fenfluramine | | |
| Isoxsuprine | | |
| l-Pseudoephedrine | | |
| Mephentermine | | |
| Cocaine (Cut-off=20ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Cocaine | 20 | 100% |
| Benzoylecgonine | 20 | 100% |
| Cocaethylene | 25 | 80% |
| Procaine | Negative at 20000 | <0.1% |
| Ecgonine | 1500 | 1.30% |
| Ecgonine methyl ester | 12500 | 0.16% |
| Norcocaine | Negative at 20000 | <0.1% |
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K240287 - Page 9 of 17
| d-Methamphetamine (Cutoff=50 ng/mL) | Result Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| D-Methamphetamine | 50 | 100% |
| L-Methamphetamine | 3000 | 2% |
| Methoxymethamphetamine | 50 | 100% |
| Ephedrine | 400 | 13% |
| Phenylephrine | 4000 | 1% |
| Procaine | 2000 | 3% |
| Methylephedrine | 400 | 13% |
| Methylenedioxy-ethylamphetamine (MDEA) | 400 | 13% |
| 3,4-methylenedioxy-methamphetamine (MDMA) | 50 | 100% |
| Amphetamine | Negative at 10000 | <0.5% |
| L-Amphetamine | Negative at 10000 | <0.5% |
| D-Amphetamine | Negative at 10000 | <0.5% |
| 3,4-methylenedioxy-amphetamine (MDA) | Negative at 10000 | <0.5% |
| Morphine (Cut-off=40 ng/mL) | Result Positive at(ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Morphine | 40 | 100% |
| Acetylmorphine | 30 | 133% |
| Codeine | 10 | 400% |
| Ethylmorphine | 30 | 133% |
| Heroin | 50 | 80% |
| Hydromorphone | 100 | 40% |
| Thebaine | 1500 | 3% |
| Norcodeine | 1500 | 3% |
| Morphine 6-β-glucuronide | 50 | 80% |
| Oxycodone | 25000 | 0.2% |
| Oxymorphone | 25000 | 0.2% |
| Nalorphine | 10000 | 0.4% |
| Hydrocodone | 100 | 40% |
| 6-Monoacetylmorphine | 30 | 133% |
| Morphine 3-β-glucuronide | 50 | 80% |
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K240287 - Page 10 of 17
| PCP
(Cutoff=10ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Phencyclidine | 10 | 100% |
| Tenocyclidine (TCP) | 2000 | 0.5% |
| 1-(1-phenylcyclohexyl)morpholine(PCM) | 20 | 50.00% |
| 4-hydroxyphencyclidine | 20 | 50.00% |
| Hydrocodone | Negative at 30000 | <0.03% |
| Hydromorphone | Negative at 30000 | <0.03% |
| Nalorphine | Negative at 30000 | <0.03% |
| EDDP | Negative at 100000 | <0.01% |
| Ketamine | Negative at 100000 | <0.01% |
| Prazepam | Negative at 100000 | <0.01% |
| Amitriptyline | Negative at 100000 | <0.01% |
| (+) Brompheniramine | Negative at 100000 | <0.01% |
| (+) Chlorphenamine | Negative at 100000 | <0.01% |
| desmethylvenlafaxine | Negative at 100000 | <0.01% |
| Chlorpromazine | Negative at 100000 | <0.01% |
| Clomipramine | Negative at 100000 | <0.01% |
| Cyclizine | Negative at 100000 | <0.01% |
| Cyclobenzaprine | Negative at 100000 | <0.01% |
| Dexbrompheniramine | Negative at 100000 | <0.01% |
| Dextromethorphan | Negative at 100000 | <0.01% |
| Diphenhydramine | Negative at 100000 | <0.01% |
| Doxepin | Negative at 100000 | <0.01% |
| Doxylamine | Negative at 100000 | <0.01% |
| Imipramine | Negative at 100000 | <0.01% |
| Thioridazine | Negative at 100000 | <0.01% |
| Venlafaxine | Negative at 100000 | <0.01% |
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| Delta-9-Tetrahydrocannabinol (Cut-off=40 ng/mL) | Result Positive at(ng/mL) | % Cross-Reactivity |
| --- | --- | --- |
| Delta-9-Tetrahydrocannabinol | 40 | 100% |
| 11-nor-Δ9-THC-9 COOH | 12 | 333% |
| Δ8-Tetrahydrocannabinol | 12500 | 0.32% |
| 11-hydroxy-Δ9-THC | 400 | 10% |
| Cannabinol | 12500 | 0.32% |
| Cannabidol | Negative at 12500 | 0.32% |
| 11-Nor-Δ9-THC-carboxy-glucuronide | 80 | 50% |
| (-)-11-nor-9-carboxy-Δ9-THC | 60 | 67% |
| 11-nor-Δ8-THC-9-COOH | 5 | 800% |
| 8-beta-11-dihydroxy-Δ9-THC | 400 | 10% |
| 8-beta-hydroxy-Δ9-THC | 300 | 13% |
| Exo-THC | 80 | 50% |
| l-11-Nor-Δ9-THC-9-Carboxylic Acyl-Glucuronide | 15 | 267% |
| Δ8-THC | 6000 | 1% |
| Δ8-THC Carboxylic Acid | 5 | 800% |
| Δ9-THC Carboxylic Acid | 12 | 333% |
4. Assay Reportable Range:
Not applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Sample Recovery
Volume:
A sample volume study was conducted to confirm that adequate sample volume could be extracted from the device for confirmatory testing after collection and shipping. Operators collected samples at two sites from a total 150 subjects (including drug users) following the device's instructions for use. Devices containing oral fluid samples were then sent to the confirmation laboratory using overnight shipping. The sponsor reported that the confirmation lab was able to extract sufficient sample volume for the confirmation testing of all six analytes for all samples collected.
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Analyte recovery:
In order to confirm that preliminary positive results can be adequately measured via confirmation testing after being subject to the temperature conditions required for shipping and storage, negative oral fluid samples in glass bottles were spiked with a single analyte/bottle to concentrations approximately -50% and +50% of the cutoff. Samples were spiked using known standards. Each drug concentration was confirmed by LC-MS/MS. The samples were transferred to Lyher devices using the collection sponges. For each of 3 storage conditions (-20°C, 20-25°C, and 40°C), 12 devices were used (4 devices from each of 3 lots. For each device, drug was measured by LC-MS/MS at day 0 and the devices containing the specimens were stored under the specified condition. Drug in the devices stored at 20-25°C and 40°C was measured by LC-MS/MS at two (2) days, and drug in the devices stored at -20°C was measured by LC-MS/MS at 90 days. The minimum and maximum recovery across all lots per storage condition is shown below.
Room Temperature 20-25°C (two day storage) % Recovery
| | MET +50 | MET -50 | COC +50 | COC -50 | OPI +50 | OPI -50 |
| --- | --- | --- | --- | --- | --- | --- |
| Max | 105.7 | 109.6 | 108.3 | 109.7 | 107.0 | 100.5 |
| Min | 91.7 | 94.0 | 98.3 | 96.5 | 91.0 | 91.5 |
| | AMP +50 | AMP -50 | PCP +50 | PCP -50 | THC +50 | THC -50 |
| Max | 105.7 | 109.6 | 107.4 | 105.1 | 103.9 | 109.8 |
| Min | 91.7 | 94.0 | 92.7 | 93.1 | 92.0 | 91.1 |
40 °C (two day storage) % Recovery
| | MET +50 | MET -50 | COC +50 | COC -50 | OPI +50 | OPI -50 |
| --- | --- | --- | --- | --- | --- | --- |
| Max | 103.7 | 110.2 | 109.3 | 109.3 | 107.7 | 109.4 |
| Min | 91.4 | 93.5 | 94.6 | 96.8 | 91.7 | 91.6 |
| | AMP +50 | AMP -50 | PCP +50 | PCP -50 | THC +50 | THC -50 |
| Max | 103.8 | 110.2 | 109.1 | 106.6 | 107.0 | 109.2 |
| Min | 91.4 | 93.5 | 95.4 | 92.3 | 91.2 | 91.4 |
-20 °C (90 day storage) % Recovery
| | MET +50 | MET -50 | COC +50 | COC -50 | OPI +50 | OPI -50 |
| --- | --- | --- | --- | --- | --- | --- |
| Max | 108.1 | 109.2 | 107.2 | 106.4 | 108.4 | 104.9 |
| Min | 91.7 | 93.6 | 93.4 | 92.8 | 93.1 | 91.3 |
| | AMP +50 | AMP -50 | PCP +50 | PCP -50 | THC +50 | THC -50 |
| Max | 108.1 | 109.2 | 105.7 | 109.6 | 107.2 | 109.2 |
| Min | 91.6 | 93.6 | 92.1 | 90.5 | 91.7 | 93.0 |
Results indicate that samples may be stored at room temperature for up to two days, elevated temperature for up to two days (40 °C), and for up to 90 days at -20 °C, prior to confirmatory testing.
6. Detection Limit:
Not applicable.
K240287 - Page 12 of 17
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7. Assay Cut-Off:
Characterization of how the device performs analytically around the claimed cutoff concentration appears in the precision section VII A1 above.
B Comparison Studies:
1. Method Comparison with Predicate Device:
Method comparison studies were performed at three testing sites A, B, and C with three operators and two lots of the candidate device. One lot was used at site A and a second lot was used at sites B and C. Subjects provided three independent samples, each to one of three different operators. Operators tested all samples and compared to LC-MS/MS results. The results are presented in the tables below:
d-Amphetamine
| | Lyher Test result | Negative oral fluid | <-50% cut off | -50% cut off - cut off | Cut off - +50%cut off | >+50%cut off |
| --- | --- | --- | --- | --- | --- | --- |
| All operators | Negative | 360 | 93 | 74 | 9 | 0 |
| | Positive | 0 | 0 | 1 | 180 | 183 |
Discordant Results (d-Amphetamine)
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 2 | 202301228 | 49.2 | Pos |
| Operator 3 | 202301233 | 51.2 | Neg |
| Operator 2 | 202301282 | 50.3 | Neg |
| Operator 3 | 202301282 | 50.3 | Neg |
| Operator 1 | 202301776 | 53.5 | Neg |
| Operator 3 | 202401819 | 50.6 | Neg |
| Operator 1 | 202401878 | 53.0 | Neg |
| Operator 1 | 202401892 | 50.1 | Neg |
| Operator 1 | 202401974 | 50.7 | Neg |
| Operator 3 | 202401995 | 51.0 | Neg |
Cocaine
| | Lyher Test result | Negative oral fluid | <-50% cut off | -50% cut off - cut off | Cut off - +50%cut off | >+50%cut off |
| --- | --- | --- | --- | --- | --- | --- |
| All operators | Negative | 360 | 69 | 83 | 8 | 0 |
| | Positive | 0 | 0 | 4 | 172 | 186 |
K240287 - Page 13 of 17
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Discordant Results (Cocaine)
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202301824 | 21.3 | Neg |
| Operator 1 | 202301842 | 19.6 | Pos |
| Operator 3 | 202301842 | 19.6 | Pos |
| Operator 1 | 202301863 | 20.2 | Neg |
| Operator 3 | 202301863 | 20.2 | Neg |
| Operator 2 | 202301868 | 20.8 | Neg |
| Operator 1 | 202301891 | 19.1 | Pos |
| Operator 2 | 202401343 | 20.8 | Neg |
| Operator 3 | 202401440 | 19.5 | Pos |
| Operator 1 | 202401495 | 20.4 | Neg |
| Operator 3 | 202401495 | 20.4 | Neg |
| Operator 3 | 202401517 | 20.1 | Neg |
d-Methamphetamine
| | Lyher Test result | Negative oral fluid | <-50% cut off | -50% cut off - cut off | Cut off - +50%cut off | >+50%cut off |
| --- | --- | --- | --- | --- | --- | --- |
| All operators | Negative | 360 | 63 | 70 | 7 | 0 |
| | Positive | 0 | 0 | 2 | 164 | 189 |
Discordant Results (d-Methamphetamine)
| Operator 2 | 202301396 | 56.6 | Neg |
| --- | --- | --- | --- |
| Operator 1 | 202301412 | 50.4 | Neg |
| Operator 3 | 202301414 | 44.4 | Pos |
| Operator 2 | 202301444 | 37.1 | Pos |
| Operator 2 | 202301460 | 50.9 | Neg |
| Operator 3 | 202401183 | 51.2 | Neg |
| Operator 1 | 202401185 | 51.7 | Neg |
| Operator 1 | 202401301 | 50.9 | Neg |
| Operator 3 | 202401301 | 50.9 | Neg |
Morphine
| | Lyher Test result | Negative oral fluid | <-50% cut off | -50% cut off - cut off | Cut off - +50%cut off | >+50%cut off |
| --- | --- | --- | --- | --- | --- | --- |
| All operators | Negative | 360 | 57 | 84 | 6 | 0 |
K240287 - Page 14 of 17
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Discordant Results (Morphine)
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202301524 | 39.5 | Pos |
| Operator 2 | 202301524 | 39.5 | Pos |
| Operator 1 | 202301531 | 40.2 | Neg |
| Operator 2 | 202301531 | 40.2 | Neg |
| Operator 2 | 202301578 | 41.6 | Neg |
| Operator 1 | 202301580 | 38.3 | Pos |
| Operator 2 | 202301799 | 44.5 | Neg |
| Operator 1 | 202301803 | 46.6 | Neg |
| Operator 2 | 202401044 | 40.9 | Neg |
Phencyclidine
| | Lyher Test result | Negative oral fluid | <-50% cut off | -50% cut off - cut off | Cut off - +50%cut off | >+50%cut off |
| --- | --- | --- | --- | --- | --- | --- |
| All operators | Negative | 360 | 51 | 109 | 13 | 0 |
| | Positive | 0 | 0 | 5 | 170 | 192 |
Discordant Results (Phencyclidine)
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 2 | 202301979 | 9.59 | Pos |
| Operator 1 | 202301987 | 10.2 | Neg |
| Operator 3 | 202301987 | 10.2 | Neg |
| Operator 1 | 202302035 | 9.68 | Pos |
| Operator 2 | 202302036 | 10.2 | Neg |
| Operator 3 | 202302036 | 10.2 | Neg |
| Operator 2 | 202302045 | 11.6 | Neg |
| Operator 2 | 202302060 | 9.96 | Pos |
| Operator 2 | 202401633 | 10.1 | Neg |
| Operator 3 | 202401633 | 10.1 | Neg |
| Operator 1 | 202401669 | 9.89 | Pos |
| Operator 2 | 202401680 | 10.2 | Neg |
| Operator 1 | 202401683 | 11.1 | Neg |
| Operator 3 | 202401729 | 10.1 | Neg |
| Operator 1 | 202401739 | 9.83 | Pos |
| Operator 2 | 202401776 | 11 | Neg |
| Operator 1 | 202401777 | 10 | Neg |
| Operator 1 | 202401791 | 10.1 | Neg |
K240287 - Page 15 of 17
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Cannabinoids
| | Lyher Test result | Negative oral fluid | <-50% cut off | -50% cut off - cut off | Cut off - +50%cut off | >+50%cut off |
| --- | --- | --- | --- | --- | --- | --- |
| All operators | Negative | 360 | 93 | 96 | 8 | 0 |
| | Positive | 0 | 0 | 3 | 172 | 195 |
Discordant Results (Cannabinoids)
| Operator | Specimen No. | LC/MS results | Results of Lyher kit |
| --- | --- | --- | --- |
| Operator 1 | 202302124 | 41.1 | Neg |
| Operator 3 | 202302127 | 40.7 | Neg |
| Operator 1 | 202302138 | 37.6 | Pos |
| Operator 2 | 202302200 | 28.4 | Pos |
| Operator 3 | 202402037 | 38.8 | Pos |
| Operator 1 | 202402048 | 41.4 | Neg |
| Operator 2 | 202402091 | 41.5 | Neg |
| Operator 3 | 202402164 | 41 | Neg |
| Operator 3 | 202402175 | 40.8 | Neg |
| Operator 1 | 202402180 | 40.2 | Neg |
| Operator 3 | 202402180 | 40.2 | Neg |
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.
K240287 - Page 16 of 17
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D Clinical Cut-Off:
Not applicable.
E Expected Values/Reference Range:
Not applicable.
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.
K240287 - Page 17 of 17
