BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx
Device Facts
| Record ID | K230238 |
|---|---|
| Device Name | BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx |
| Applicant | Shenzhen Bioeasy Biotechnology Co., Ltd. |
| Product Code | DJG · Clinical Toxicology |
| Decision Date | Mar 31, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Indications for Use
BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of cut-offs]. BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may vield positive results for the prescription drugs Burenorphine. Oxazenam, Secobarbital, d-Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Device Story
Single-use lateral flow immunochromatographic test cup for qualitative detection of drugs/metabolites in human urine. Device consists of test cup, package insert, and collection cup. Principle: competitive binding; target drugs in urine compete with drug-conjugate for limited antibody binding sites on particles. If drug concentration is below cutoff, antibody-coated particles bind to immobilized drug-conjugate, forming visible colored test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line forms regardless of drug presence to verify test performance. Used by lay users (OTC version) or healthcare professionals (Rx version) in point-of-care settings. Results are visual; preliminary only. Positive results require confirmation via GC/MS or LC/MS. Benefits include rapid, on-site screening for drug presence to inform clinical judgment.
Clinical Evidence
Bench testing only. Precision/reproducibility studies performed over 25 days using 3 lots. Cross-reactivity and interference testing conducted with various physiological/pathological substances. Method comparison study performed with 80 clinical samples per drug compared to LC/MS. Lay user study with 140 participants across three sites confirmed performance across various drug concentrations.
Technological Characteristics
Lateral flow immunochromatographic assay. Single-use cup form factor. Materials: test device, desiccant, aluminum pouch, urine collection cup. Principle: competitive binding antigen-antibody immunochemistry. Connectivity: none (standalone). Sterilization: not specified. Software: none.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse and metabolites in human urine for OTC or prescription use. Target analytes include Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline, Marijuana, and 6-Acetylmorphine (Rx only) at specified cutoff levels.
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
- AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests (K201630)
Related Devices
- K191841 — Accurate Multi Panel Drug Urine Test Cup · Healstone Biotech, Inc. · Aug 7, 2019
- K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Feb 27, 2025
- K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Apr 4, 2025
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
K230238
B Applicant
Shenzhen Bioeasy Biotechnology Co., Ltd.
C Proprietary and Established Names
BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NFT | Class II | 21 CFR 862.3100 - Amphetamine Test System | TX - Clinical Toxicology |
| NFW | Class II | 21 CFR 862.3870 - Cannabinoid test system | TX - Clinical Toxicology |
| NFY | Class II | 21 CFR 862.3250 - Cocaine and cocaine metabolite test system | TX - Clinical Toxicology |
| NGG | Class II | 21 CFR 862.3610 - Methamphetamine test system | TX - Clinical Toxicology |
| NGL | Class II | 21 CFR 862.3650 - Opiate test system | TX - Clinical Toxicology |
| NFV | Class II | 21 CFR 862.3170 - Benzodiazepine test system | TX - Clinical Toxicology |
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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| PTG | Class II | 21 CFR 862.3620 - Methadone test system | TX - Clinical Toxicology |
| --- | --- | --- | --- |
| PTH | Class II | 21 CFR 862.3150 - Barbiturate test system | TX - Clinical Toxicology |
| NGM | Unclassified | | |
| QAW | Class II | 21 CFR 862.3910 - Tricyclic antidepressant drugs test system | TX - Clinical Toxicology |
| QBF | Class II | 21 CFR 862.3700 - Propoxyphene test system | TX - Clinical Toxicology |
| DJG | Class II | 21 CFR 862.3650 - Opiate test system | TX - Clinical Toxicology |
## II Submission/Device Overview:
### A Purpose for Submission:
Modification of a previously cleared device (K182530) to add Amphetamine (500 ng/mL cutoff), Methamphetamine (500 ng/mL cutoff), Cocaine (150 ng/mL cutoff), EDDP (300 ng/mL cutoff), and 6-Acetylmorphine (10 ng/mL cutoff).
### B Measurand:
Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5- dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline, Cannabinoids and 6-Acetylmorphine
### C Type of Test:
Qualitative lateral flow immunochromatographic assay
## III Intended Use/Indications for Use:
### A Intended Use(s):
See Indications for Use below.
### B Indication(s) for Use:
BIOEASY™ U-Catch MAX Multi-Drug Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine,
K230238 - Page 2 of 21
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Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
| --- | --- |
| Amphetamine (AMP) | 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| d-Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Marijuana (THC) | 50 ng/mL |
BIOEASY™ U-Catch MAX Multi-Drug Test Cup offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.
The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, d-Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline, Cannabinoids and 6- Acetylmorphine in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
| --- | --- |
| Amphetamine (AMP) | 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
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K230238 - Page 4 of 21
| Cocaine (COC) | 150 ng/mL |
| --- | --- |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| d-Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| 6-Acetylmorphine | 10 ng/mL |
BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.
The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, d-Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
## C Special Conditions for Use Statement(s):
Rx and OTC
## D Special Instrument Requirements:
Not applicable
## IV Device/System Characteristics:
## A Device Description:
The BIOEASY™ U-Catch MAX Multi-Drug Test Cup and the BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drugs and drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The candidate device contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
The BIOEASY™ U-Catch MAX Multi-Drug Test Cup (OTC use) detects all analytes listed above except 6-Acetylmorphine.
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The BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx (Prescription Use) detects all analytes listed above.
## B Principle of Operation:
The candidate devices are rapid tests for the qualitative detection of target drugs and drug metabolites in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cutoff concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
## V Substantial Equivalence Information:
### A Predicate Device Name(s):
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
### B Predicate 510(k) Number(s):
K201630
### C Comparison with Predicate(s):
| Device & Predicate Device(s): | K230238 | K201630 |
| --- | --- | --- |
| Device Trade Name | BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | For the qualitative determination of drugs-of-abuse in human urine. | Same |
| Specimen | Human urine | Same |
| Methodology | Competitive binding, Lateral flow Immunochromatographic assay based on the principle of antigen antibody | Same |
K230238 - Page 5 of 21
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K230238 - Page 6 of 21
| | immunochemistry | |
| --- | --- | --- |
| Cutoff | Amphetamine (AMP): 500 ng/ml
Oxazepam (BZO): 300 ng/ml
Cocaine (COC): 150 ng/ml
Methamphetamine (MET): 500 ng/ml
Morphine (MOR): 300 ng/mL
Oxycodone(OXY) : 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Methadone (MTD): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
Methylenedioxymethamphetamine (MDMA): 500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Nortriptyline (TCA): 1000 ng/ml
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/ml
d-Propoxyphene (PPX): 300 ng/ml | Same |
| **General Device Characteristic Differences** | | |
| Intended users | Over the Counter (OTC)
Use and Prescription Use | Prescription Use Only |
| Marijuana (11-Nor-Δ9-Tetrahydrocannabinol-9-COOH) (THC) | 50 ng/ml | 20 ng/mL |
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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% cutoff, -75% cutoff, -50% cutoff, -25% cutoff, cutoff, +25% cutoff, +50% cutoff, +75% cutoff and +100% cutoff. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were tested in a blinded fashion. For each concentration, tests were performed in two runs per day for 25 days per device in a randomized order using 3 reagent lots. The results obtained are summarized in the following tables for Amphetamine 500, Cocaine 150, Methamphetamine 500, 2- ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM). The data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Oxazepam, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Cannabinoids were previously reported in K182530.
K230238 - Page 7 of 21
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| Drug test | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| AMP 500 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 0 |
| | -75% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 28 | 22 | 24 | 26 | 24 | 26 |
| | +25% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| COC 150 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 22 | 28 | 21 | 29 | 28 | 22 |
| | +25% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| MET 500 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 23 | 27 | 27 | 23 | 25 | 25 |
| | +25% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| EDDP 300 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 26 | 24 | 24 | 26 | 25 | 25 |
| | +25% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| 6-AM 10 | Negative | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -75% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -50% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | -25% cutoff | 50 | 0 | 50 | 0 | 50 | 0 | 50 |
| | cutoff | 50 | 24 | 26 | 26 | 24 | 27 | 23 |
K230238 - Page 8 of 21
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K230238 - Page 9 of 21
| Drug test | % of cutoff | Number of Determinations per lot | Result | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | | Lot 2 | | Lot 3 | |
| | | | + | - | + | - | + | - |
| | +25% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +50% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +75% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
| | +100% cutoff | 50 | 50 | 0 | 50 | 0 | 50 | 0 |
2. Linearity:
Not Applicable.
3. Analytical Specificity/Interference:
Cross-Reactivity:
To test cross-reactivity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound is listed below for Amphetamine 500, Cocaine 150, Methamphetamine 500, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM). The data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Oxazepam, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Cannabinoids were reported in K182530.
| AMP500
(Cutoff=500 ng/mL) | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| D - Amphetamine | 500 | 100% |
| L - Amphetamine | 10000 | 5% |
| DL - Amphetamine | 1500 | 33% |
| Phentermine | 15000 | 3.3% |
| Hydroxyamphetamine | 4000 | 12.5% |
| Methylenedioxyamphetamine
(MDA) | 10000 | 5% |
| d-Methamphetamine | >100000 | <0.5% |
| 1-Methamphetamine | >100000 | <0.5% |
| Ephedrine | >100000 | <0.5% |
| Methylenedioxyethylamphetamine | >100000 | <0.5% |
| 3,4-
methylenedioxymethamphetamine
(MDMA) | >100000 | <0.5% |
| COC150
(Cutoff=150 ng/mL) | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| Benzoylecgonine | 150 | 100% |
| Cocaine HCl | 375 | 40% |
| Cocaethylene | 6250 | 2.4% |
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| Eczgonine | 16000 | 0.9% |
| --- | --- | --- |
| Norcocaine | 50000 | 0.3% |
| MET500
(Cutoff=500 ng/mL) | Result
Positive at (ng/ml) | %Cross-Reactivity |
| --- | --- | --- |
| D(+)-Methamphetamine | 500 | 100% |
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA) | 5000 | 10% |
| D/L-Methamphetamine | 500 | 100% |
| p-Hydroxymethamphetamine | 5000 | 10% |
| D-Amphetamine | >100000 | <0.5% |
| L-Amphetamine | >100000 | <0.5% |
| Chloroquine | 25000 | 2% |
| (+/-)-Ephedrine | 2000 | 25% |
| L-Methamphetamine | 5000 | 10% |
| (+/-)3,4-Methylenedioxyamphetamine (MDA) | >100000 | <0.5% |
| β-Phenylethylamine | 3750 | 13.3% |
| Trimethobenzamide | 10000 | 5% |
| (+/-)3,4-Methylenedioxymethamphetamine (MDMA) | 5000 | 10% |
| EDDP
(Cutoff=300 ng/mL) | Result
Positive at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| EDDP | 300 | 100% |
| Methadone | 300000 | 0.1% |
| Doxylamine | >100000 | <0.3% |
| LAAM HCl | >100000 | <0.3% |
| Alpha Methadol | >100000 | <0.3% |
| Disopyramide | >100000 | <0.3% |
| EMDP | >100000 | <0.3% |
| 6-AM
(Cutoff=10 ng/mL) | Result
Positive at (ng/ml) | % Cross-Reactivity |
| --- | --- | --- |
| 6-acetylmorphine | 10 | 100% |
| Acetylcodeine | >10000 | <0.1% |
| Buprenorphine | >10000 | <0.1% |
| Codeine | >10000 | <0.1% |
| Diacetylmorphine | 1000 | 0.01% |
| Dihydrocodeine | >10000 | <0.1% |
| Ethylmorphine | >10000 | <0.1% |
| Hydrocodone | >10000 | <0.1% |
K230238 - Page 10 of 21
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Interfering substances:
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and urine samples with concentrations of the target drugs at 25% below and 25% above cutoff levels. These urine samples were tested using three lots of each device. The compounds were tested at 100 ug/mL (unless otherwise noted in the table). No interference was observed for any of the compounds tested, and the list of compounds is provided in the following table.
| Acetaminophen | Creatinine | Ketamine | Prednisone |
| --- | --- | --- | --- |
| Acetophenetidin | Deoxycorticosterone | Ketoprofen | (±)-Propranolol |
| Hydromorphone | 5000 | 0.002% |
| --- | --- | --- |
| Morphine | 10000 | 0.001% |
| Morphine-3-glucuronide | >10000 | <0.1% |
| Nalorphine | 5000 | 0.002% |
| Thebaine | >20000 | <0.05% |
| Dextromethorphan | >100,000 | <0.01% |
| Heroin | 100000 | 0.0001% |
| Imipramine | >100,000 | <0.01% |
| LAAM (Levacetylmethadol) | >100,000 | <0.01% |
| Levorphanol | >100,000 | <0.01% |
| Meperidine | >100,000 | <0.01% |
| Methadone | >100,000 | <0.01% |
| Mitragynine (kratom) | >20,000 | <0.05% |
| Morphine 6-D-glucuronide | >100,000 | <0.01% |
| Naloxone | >100,000 | <0.01% |
| Naltrexone | >100,000 | <0.01% |
| Naproxen | >100,000 | <0.01% |
| Norbuprenorphine | >10,000 | <0.1% |
| Norbuprenorphine glucuronide | >100,000 | <0.01% |
| Norcodeine | >100,000 | <0.01% |
| Norhydrocodone | >100,000 | <0.01% |
| Normorphine | >100,000 | <0.01% |
| Noroxycodone | >100,000 | <0.01% |
| Noroxymorphone | >100,000 | <0.01% |
| Norpropoxyphene | >100,000 | <0.01% |
| Oxycodone | >100,000 | <0.01% |
| Oxymorphone | >100,000 | <0.01% |
| Oxymorphone-3β-D-glucuronide | >100,000 | <0.01% |
| Tapentadol HCl | >100,000 | <0.01% |
| Tramadol | >100,000 | <0.01% |
K230238 - Page 11 of 21
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| N-Acetylprocainamide | Dextromethorphan | Labetalol | Pseudoephedrine |
| --- | --- | --- | --- |
| Acetylsalicylic acid | Diclofenac | Loperamide | Quinine |
| Albumin (100mg/dL) | Diflunisal | Meperidine | Ranitidine |
| Aminopyrine | Digoxin | Meprobamate | Salicylic acid |
| Amoxicillin | Diphenhydramine | Methoxyphenamine | Serotonin (5-Hydroxytyramine) |
| Ampicillin | 1% Ethanol | Nalidixic acid | Sulfamethazine |
| Apomorphine | Ecgonine methyl ester | Naloxone | Sulindac |
| Ascorbic acid | β-Estradiol | Naltrexone | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Aspartame | Erythromycin | Naproxen | Tetrahydrocortisone 3-acetate |
| Atropine | Fenoprofen | Niacinamide | Tetrahydrozoline |
| Benzilic acid | Furosemide | Nifedipine | Thiamine |
| Benzoic acid | Gentisic acid | Norethindrone | Thioridazine |
| Bilirubin (500 μg/mL) | Hemoglobin | Noscapine | Triamterene |
| Chloral hydrate | Hydralazine | (±)-Octopamine | Trifluoperazine |
| Chloramphenicol | Hydrochlorothiazide | Oxalic acid | Trimethoprim |
| Chlorothiazide | Hydrocortisone | Oxolinic acid | DL-Tryptophan |
| Chlorpromazine | O-Hydroxyhippuric acid | Oxymetazoline | Tyramine |
| Cholesterol | 3-Hydroxytyramine | Papaverine | DL-Tyrosine |
| Clonidine | Ibuprofen | Penicillin G | Uric acid |
| Cortisone | Isoproterenol | Perphenazine | Verapamil |
| (-)-Cotinine | Isoxsuprine | Phenelzine | Zomepirac |
## Effect of Urinary Specific Gravity and pH:
To investigate the effect of urine specific gravity and urine pH, urine samples, with specific gravity ranging from 1.000 to 1.035 or urine samples with pH ranging from 4 to 9 were spiked with the target drugs to concentrations at 25% below and 25% above cutoff levels. These samples were tested using three lots of each device. Results were all positive for samples at +25% cutoff and all negative for samples at -25% cutoff.
4. Assay Reportable Range:
Not applicable.
5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
The device is traceable to commercially available reference materials.
6. Detection Limit:
Not applicable.
K230238 - Page 12 of 21
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7. Assay Cutoff:
Refer to Section VII.A.1
B Comparison Studies:
1. Method Comparison with Predicate Device:
Method comparison studies for the BIOEASY U-Catch MAX Multi-Drug Test Cup Rx were performed by three operators. Eighty (80) unaltered clinical samples were run for each target drug. The samples were tested in a blinded fashion and compared to LC/MS results. The results are presented in the tables below for Amphetamine 500, Cocaine 150, Methamphetamine 500, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP), and 6-acetylmorphine (6-AM). The data for Buprenorphine, Methylenedioxymethamphetamine, Secobarbital, Oxazepam, Morphine, Methadone, Oxycodone, Phencyclidine, d-Propoxyphene, Nortriptyline and Cannabinoids were previously reported in K182530.
AMP 500:
| BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 3 | 17 | 20 |
| | Negative | 7 | 16 | 14 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 7 | 16 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 3 | 18 | 20 |
| | Negative | 7 | 16 | 14 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | AMPLC063 | 473 | Positive |
| Viewer C | AMPLC063 | 473 | Positive |
| Viewer B | AMPLC040 | 477 | Positive |
| Viewer A | AMPLC039 | 490 | Positive |
| Viewer B | AMPLC039 | 490 | Positive |
| Viewer C | AMPLC039 | 490 | Positive |
| Viewer A | AMPLC004 | 494 | Positive |
| Viewer C | AMPLC004 | 494 | Positive |
| Viewer A | AMPLC018 | 520 | Negative |
| Viewer B | AMPLC018 | 520 | Negative |
| Viewer A | AMPLC064 | 525 | Negative |
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| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer B | AMPLC064 | 525 | Negative |
| Viewer C | AMPLC064 | 525 | Negative |
| Viewer A | AMPLC009 | 540 | Negative |
| Viewer C | AMPLC014 | 570 | Negative |
COC 150
| BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 19 | 19 |
| | Negative | 7 | 16 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 18 | 19 |
| | Negative | 7 | 16 | 15 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 19 | 19 |
| | Negative | 7 | 16 | 15 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer B | COCLC046 | 139 | Positive |
| Viewer A | COCLC019 | 142 | Positive |
| Viewer C | COCLC019 | 142 | Positive |
| Viewer B | COCLC026 | 142 | Positive |
| Viewer A | COCLC060 | 145 | Positive |
| Viewer C | COCLC060 | 145 | Positive |
| Viewer A | COCLC049 | 154 | Negative |
| Viewer B | COCLC049 | 154 | Negative |
| Viewer C | COCLC049 | 154 | Negative |
| Viewer A | COCLC024 | 157 | Negative |
| Viewer B | COCLC062 | 157 | Negative |
| Viewer C | COCLC062 | 157 | Negative |
| Viewer B | COCLC029 | 159 | Negative |
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MET 500
| BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 17 | 20 |
| | Negative | 7 | 16 | 15 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 18 | 20 |
| | Negative | 7 | 16 | 14 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 17 | 20 |
| | Negative | 7 | 16 | 15 | 3 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer B | METL055 | 427 | Positive |
| Viewer B | METL005 | 447 | Positive |
| Viewer C | METL005 | 447 | Positive |
| Viewer A | METL020 | 465 | Positive |
| Viewer B | METL020 | 465 | Positive |
| Viewer A | METL063 | 486 | Positive |
| Viewer C | METL063 | 486 | Positive |
| Viewer B | METL053 | 525 | Negative |
| Viewer C | METL053 | 525 | Negative |
| Viewer A | METL060 | 530 | Negative |
| Viewer C | METL060 | 530 | Negative |
| Viewer A | METL036 | 540 | Negative |
| Viewer B | METL036 | 540 | Negative |
| Viewer A | METL059 | 555 | Negative |
| Viewer C | METL059 | 555 | Negative |
EDDP
| BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 6 | 18 | 14 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 6 | 18 | 14 | 2 | 0 |
K230238 - Page 15 of 21
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| BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer C | Positive | 0 | 0 | 3 | 18 | 20 |
| | Negative | 6 | 18 | 13 | 2 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | EDDPLC042 | 244 | Positive |
| Viewer C | EDDPLC042 | 244 | Positive |
| Viewer B | EDDPLC004 | 291 | Positive |
| Viewer C | EDDPLC004 | 291 | Positive |
| Viewer A | EDDPLC051 | 294 | Positive |
| Viewer B | EDDPLC051 | 294 | Positive |
| Viewer C | EDDPLC051 | 294 | Positive |
| Viewer A | EDDPLC074 | 303 | Negative |
| Viewer B | EDDPLC074 | 303 | Negative |
| Viewer C | EDDPLC074 | 303 | Negative |
| Viewer B | EDDPLC052 | 327 | Negative |
| Viewer A | EDDPLC018 | 330 | Negative |
| Viewer C | EDDPLC018 | 330 | Negative |
6-AM
| BIOEASY U-Catch MAX Multi-Drug Test Cup Rx | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between cutoff and +50%) | High Positive by LC/MS (greater than +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Viewer A | Positive | 0 | 0 | 2 | 16 | 22 |
| | Negative | 6 | 17 | 15 | 2 | 0 |
| Viewer B | Positive | 0 | 0 | 2 | 16 | 22 |
| | Negative | 6 | 17 | 15 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 2 | 15 | 22 |
| | Negative | 6 | 17 | 15 | 3 | 0 |
Discordant Results
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer B | 6-AMLC016 | 9.23 | Positive |
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| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
| --- | --- | --- | --- |
| Viewer A | 6-AMLC074 | 9.68 | Positive |
| Viewer C | 6-AMLC074 | 9.68 | Positive |
| Viewer B | 6-AMLC026 | 9.93 | Positive |
| Viewer A | 6-AMLC037 | 9.95 | Positive |
| Viewer C | 6-AMLC037 | 9.95 | Positive |
| Viewer A | 6-AMLC009 | 10.3 | Negative |
| Viewer C | 6-AMLC009 | 10.3 | Negative |
| Viewer B | 6-AMLC027 | 11.1 | Negative |
| Viewer C | 6-AMLC027 | 11.1 | Negative |
| Viewer A | 6-AMLC038 | 11.4 | Negative |
| Viewer B | 6-AMLC038 | 11.4 | Negative |
| Viewer C | 6-AMLC035 | 11.8 | Negative |
# Lay user study
A lay user study was performed using the BIOEASY U-Catch MAX Multi-Drug Test Cup at three intended use sites with 140 lay persons. The lay users had diverse ages and educational and professional backgrounds. Urine samples were prepared at multiple concentrations (Negative $(-100\%)$ , $+/-75\%$ , $+/-50\%$ , $+/-25\%$ of the cutoff) by spiking drugs into drug free pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and tested in a blinded fashion. Each participant was provided with the package insert, one blind-labeled sample and a device, and no additional training. Summary results are shown below:
| Drugs | % of Cutoff | Number of samples | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| AMP | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 0 | 20 | 100 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| BAR | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 0 | 20 | 100 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
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| Drugs | % of Cutoff | Number of samples | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| COC | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 1 | 19 | 95 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| BZO | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 1 | 19 | 95 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| MET | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 0 | 20 | 100 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| MTD | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 0 | 20 | 100 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| MOP | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 1 | 19 | 95 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 0 | 20 | 100 |
K230238 - Page 18 of 21
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| Drugs OXY | % of Cutoff | Number of samples | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| THC | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 1 | 19 | 95 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| TCA | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 0 | 20 | 100 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| BUP | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 1 | 19 | 95 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| PCP | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 1 | 19 | 95 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| MDMA | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 0 | 20 | 100 |
| | +25% cutoff | 20 | 19 | 1 | 95 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
K230238 - Page 19 of 21
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| Drugs | % of Cutoff | Number of samples | Lay person results | | The percentage of correct results (%) |
| --- | --- | --- | --- | --- | --- |
| | | | No. of Positive | No. of Negative | |
| EDDP | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 1 | 19 | 95 |
| | +25% cutoff | 20 | 20 | 0 | 100 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
| PPX | -100% cutoff | 20 | 0 | 20 | 100 |
| | -75% cutoff | 20 | 0 | 20 | 100 |
| | -50% cutoff | 20 | 0 | 20 | 100 |
| | -25% cutoff | 20 | 1 | 19 | 95 |
| | +25% cutoff | 20 | 20 | 0 | 100 |
| | +50% cutoff | 20 | 20 | 0 | 100 |
| | +75% cutoff | 20 | 20 | 0 | 100 |
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):
Read Time:
The sponsor provided data to support the recommendation for read time. The sponsor recommends that the results should be read 5-30 minutes after testing.
D Clinical Cutoff:
Not Applicable.
E Expected Values/Reference Range:
Not Applicable.
K230238 - Page 20 of 21
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VIII Proposed Labeling:
The labeling support 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.
K230238 - Page 21 of 21
