INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k100051 B. Purpose for Submission: Modification of a cleared device. Adding OTC use for morphine/opiates 300, oxycodone 100, and oxycodone 300. C. Measurand: Morphine/opiates 300, oxycodone 100, and oxycodone 300 D. Type of Test: Qualitative lateral flow immunoassay E. Applicant: Alfa Scientific Designs, Inc. F. Proprietary and Established Names: Instant-View Drug of Abuse Urine Cassette Test Instant-View Drug of Abuse Urine Cup Test G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | DJG | Class II | 862.3650 – Opiate Test System | 91-Toxicology | | NGI | Class II | 862.3640 - Morphine Test, Over the Counter | 91-Toxicology | H. Intended Use: 1. Intended use(s): See indications for use statement below. {1} 2 2. **Indication(s) for use:** The Drug of Abuse Urine (Cassette/Cup) Test is a rapid qualitative immunoassay for the detection of potential abuse of one or more drugs: Morphine/Opiates, and Oxycodone (see list below). The device is intended for in vitro diagnostic home use. | Abbreviation | Test | Calibrator | Cutoff | | --- | --- | --- | --- | | MOR/OPI300 | Morphine/Opiates | Morphine | 300 ng/mL | | OXY100 | Oxycodone | Oxycodone | 100 ng/mL | | OXY300 | Oxycodone | Oxycodone | 300 ng/mL | This assay provides only preliminary results. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. 3. **Special conditions for use statement(s):** For over the counter (OTC) use 4. **Special instrument requirements:** Not applicable I. **Device Description:** The device is available in a cup or cassette format. The device consists of any combination between one (1) to three (3) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a colored band during test regardless of the presence of the drug. J. **Substantial Equivalence Information:** 1. **Predicate device name(s):** Alpha Scientific **INSTANT-VIEW®** Oxycodone Urine Test Alpha Scientific **INSTANT-VIEW®** Morphine (300) Urine Test 2. **Predicate 510(k) number(s):** k063545, k060527 {2} 3 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Indication(s) for use | A rapid qualitative immunoassay for the detection of potential abuse of one or more drugs | Same | | Assay Technology | one-step lateral-flow chromatographic immunoassays | Same | | Results | Qualitative | Same | | Format | Cup and cassette | Same | | Quality Control | Built in QC | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Intended Use | OTC Use | Prescription Use | K. Standard/Guidance Document Referenced (if applicable): None Referenced L. Test Principle: The 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 urine specimen is below the cutoff concentration, the T line appears as a visible 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 of certain testing steps. It should always appear as a colored band regardless of the presence of the drug if enough sample volume has been added to the test and if sample has correctly migrated up the test strip. M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: {3} Established in k063545 and k060527. b. Linearity/assay reportable range: Established in k063545 and k060527. c. Traceability, Stability, Expected values (controls, calibrators, or methods): Established in k063545 and k060527. d. Detection limit: Established in k063545 and k060527. e. Analytical specificity: Established in k063545 and k060527. f. Assay cut-off: Established in k063545 and k060527. 2. Comparison studies: a. Method comparison with predicate device: Established in k063545 and k060527. b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): OTC Accuracy study – cup format {4} Over the counter (OTC) accuracy studies were carried out at three independent sites. A total of 136 OTC users participated in the study. 40-50 OTC users ranging in age from 18 to 72 with diverse educational and professional backgrounds participated at each site. 38% of the participants were female and 62% were male. Urine samples were prepared at the concentrations in the table below by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert and 3 blind labeled samples and devices. Each participant tested 3 samples for the 3 drugs. There was no significant difference between the results at the 3 sites so data were pooled and analyzed. The results are summarized below. Test Results for Cup format | Instant-View Cup | | Number of samples | OTC User | | Agreement With GC/MS | Accuracy | | --- | --- | --- | --- | --- | --- | --- | | Drug | Concentration | | Negative | Positive | | | | MOR300 | <50% cutoff | 211 | 211 | 0 | 100% | 98.78% | | | 50% cutoff | 41 | 41 | 0 | 100% | | | | 75% cutoff | 41 | 38 | 3 | 92.7% | | | | 125% cutoff | 39 | 0 | 39 | 100% | | | | 150% cutoff | 34 | 0 | 34 | 100% | | | | >150% cutoff | 42 | 0 | 42 | 100% | | | OXY100 | <50% cutoff | 84 | 84 | 0 | 100% | 97.9% | | | 50% cutoff | 44 | 44 | 0 | 100% | | | | 75% cutoff | 44 | 43 | 1 | 97.7% | | | | 125% cutoff | 39 | 4 | 35 | 89.7% | | | | 150% cutoff | 41 | 0 | 41 | 100% | | | | >150% cutoff | 156 | 0 | 156 | 100% | | | OXY300 | <50% cutoff | 211 | 211 | 0 | 100% | 97.16% | | | 50% cutoff | 41 | 41 | 0 | 100% | | | | 75% cutoff | 41 | 34 | 7 | 82.93% | | | | 125% cutoff | 39 | 0 | 39 | 100% | | | | 150% cutoff | 34 | 0 | 34 | 100% | | | | >150% cutoff | 42 | 0 | 42 | 100% | | All OTC study participants completed questionnaires after they performed the test and recorded their results. The questionnaires covered evaluation of the package insert regarding the intended user, the directions for performing the test, the ease of performing the test, directions for interpreting the results, and ease of interpretation of the results. These questionnaires demonstrated that the test instructions were easy to understand and that the testing procedure was easy to perform and the results were easy to read. {5} OTC Accuracy study - Cassette format Over the counter (OTC) accuracy studies were carried out at three independent sites. A total of 128 OTC users participated in the study. 39-45 OTC users ranging in age from 18 to 60 with diverse educational and professional backgrounds participated at each site. $55\%$ of the participants were female and $45\%$ were male. Urine samples were prepared at the concentrations in the table below by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert and 3 blind labeled samples and devices. Each participant tested 3 samples for the 3 drugs. There was no significant difference between the results at the 3 sites so data were pooled and analyzed. The results are summarized below. Test Results - cassette device | Instant-View Cassette | | Number of samples | OTC User | | Agreement With GC/MS | Accuracy | | --- | --- | --- | --- | --- | --- | --- | | Drug | Concentration | | Negative | Positive | | | | MOR300 | <50% cutoff | 212 | 212 | 0 | 100% | 98.7% | | | 50% cutoff | 29 | 29 | 0 | 100% | | | | 75% cutoff | 52 | 49 | 3 | 94.2% | | | | 125% cutoff | 47 | 1 | 46 | 97.9% | | | | 150% cutoff | 27 | 0 | 27 | 100% | | | | >150% cutoff | 17 | 0 | 17 | 100% | | | OXY100 | <50% cutoff | 101 | 101 | 0 | 100% | 97.8% | | | 50% cutoff | 27 | 27 | 0 | 100% | | | | 75% cutoff | 47 | 45 | 2 | 95.7% | | | | 125% cutoff | 46 | 4 | 42 | 91.3% | | | | 150% cutoff | 30 | 0 | 30 | 100% | | | | >150% cutoff | 133 | 0 | 133 | 100% | | | OXY300 | <50% cutoff | 221 | 221 | 0 | 100% | 97.7% | | | 50% cutoff | 30 | 30 | 0 | 100% | | | | 75% cutoff | 45 | 43 | 2 | 95.6% | | | | 125% cutoff | 43 | 4 | 39 | 90.7% | | | | 150% cutoff | 28 | 0 | 28 | 100% | | | | >150% cutoff | 17 | 0 | 17 | 100% | | All OTC study participants completed questionnaires after they performed the test and recorded their results. The questionnaires covered evaluation of the package insert regarding the intended user, the directions for performing the test, the ease of performing the test, directions for interpreting the results, and {6} ease of interpretation of the results. These questionnaires demonstrated that the test instructions were easy to understand and that the testing procedure was easy to perform and the results were easy to read. The temperature strip that is part of the test cup was evaluated by the participants at three sites. The participants that performed the temperature evaluation were the same participants that performed the cup format evaluation. Water samples were adjusted to different temperatures and added to the sample cups. Participants read the temperature on the strip on the cup and recorded the results. The testing monitor then immediately measured and recorded the water temperature. The results demonstrated that 95.3% of the participants accurately identified the temperature of the water using the temperature strip on the test cup. 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Not applicable N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 7