(330 days)
The Instant-View® Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use) are rapid, qualitative immunoassays for the detection in human urine of one or more of the cutoff concentrations listed below. These devices will detect up to 13 of the drugs below in any combination. The tests are not intended to distinguish prescription use or abuse of any drugs.
These devices provide only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry 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 obtained.
This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
Tests for prescription drugs will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.
The Instant View® Multi-Drug Urine Test Cup (Home Use) and the Instant View® Multi-Drug Urine Test Panel (Home Use) are one-step lateral flow chromatographic immunoassays. Each device consists of any combination of one to thirteen individual test strip(s) for the analyte(s) being tested. Each test strip in the device consists of 1) a 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 burgundy-colored band during the test regardless of the presence of the drug.
This document describes the performance characteristics and a lay-user study for the Instant-View® Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use).
Here's an analysis of the provided information, structured according to your request:
Acceptance Criteria and Device Performance
The acceptance criteria for this device appear to be tied to the agreement rate of lay users' interpretations compared to GC/MS confirmed results. The performance is reported as the percentage of correctly interpreted results. The implicit acceptance criterion can be inferred from the overall results being "higher than 96%" on average for both device types when considering all concentrations, and 100% agreement at concentrations 150% and above, as well as 50% and below the cutoff. This suggests a high accuracy requirement for lay user interpretation.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state pre-defined acceptance criteria values in the form of thresholds (e.g., "must achieve >95% accuracy"). Instead, it presents the results of the study and concludes that "the participants were able to read the results correctly at an average of higher than 96%." Therefore, the reported performance is the demonstrated acceptance of the device's accuracy for lay users.
Given the phrasing and the detailed results, a simplified representation of the demonstrated performance can be derived:
| Drug Test | Cutoff (ng/ml) | Overall Average % Correct Interpretation (Cup) | Overall Average % Correct Interpretation (Panel) |
|---|---|---|---|
| Amphetamine (AMP) | 1000 | 99.25% | 99.5% |
| Barbiturates (BAR) | 200 | 99.5% | 99.25% |
| Buprenorphine (BUP) | 10 | 96.25% | 96.75% |
| Benzodiazepine (BZD) | 300 | 99.5% | 99.5% |
| Cocaine (COC) | 300 | 99.25% | 99.5% |
| Methamphetamine (MET) | 1000 | 99.5% | 99.5% |
| Methadone (MTD) | 300 | 99.5% | 99.5% |
| Phencyclidine (PCP) | 25 | 99.75% | 99.75% |
| Tricyclic Antidepressants (TCA) | 1000 | 99.75% | 99.75% |
| Marijuana (THC) | 50 | 99.5% | 99.5% |
| MDMA | 500 | 99.75% | 99.75% |
| Morphine/Opiate (MOR) | 2000 | 99.5% | 99.75% |
| Oxycodone (OXY) | 300 | 99.5% | 99.5% |
Implicit Acceptance Criteria:
- Average correct interpretation rate for lay users > 96% across all drugs and tested concentrations.
- 100% correct interpretation at concentrations 150% above and 50% below the cutoff. (This was achieved in the study based on the summary).
2. Sample Size and Data Provenance
- Sample Size for Test Set: 400 lay persons.
- Data Provenance: The study was performed at "three intended user sites." The document does not specify the country of origin but implies a domestic (US) setting given the FDA submission context. The study design is prospective, as it involved participants actively testing the devices with prepared blinded samples.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable in the context of this specific lay-user study's ground truth.
- Qualifications of Experts: Not applicable. The ground truth for the test set was established by analytical methods, not human expert consensus for interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" for the urine samples (presence/absence and concentration of drugs) was established by GC/MS, which is an objective chemical analysis method, not a subjective interpretation requiring adjudication. Lay users then interpreted the device results, and their interpretations were compared to the GC/MS ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, this was not an MRMC comparative effectiveness study in the typical sense of evaluating human readers' performance with and without AI assistance for image interpretation. This was a direct evaluation of lay user interpretation of a rapid diagnostic test.
- Effect Size of Human Reader Improvement: Not applicable, as it was not an AI-assisted interpretation study.
6. Standalone Performance
- Standalone Performance: The study evaluates the human-device interaction for lay users. While the document mentions "analytical test result" and "chemical method" for confirmation, this specific lay-user study's performance data (the tables) represent the accuracy of the lay users' interpretation of the device results compared to the objective ground truth. The device itself (the immunochromatographic test) inherently provides a visual result that humans (lay users) then interpret. Thus, the performance described is the "human-in-the-loop" performance for the intended OTC use. The underlying analytical performance of the immunoassay itself is stated to be "the same as the predicate device," but the detailed performance data provided in the tables are for lay-user interpretation.
7. Type of Ground Truth Used
- Ground Truth: For the test set, the ground truth was established by Chromatography/Mass Spectrometry (GC/MS). The urine samples were "spiked with drugs into drug free-pooled urine specimens" at specific concentrations, and these concentrations were "confirmed by GC/MS."
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not provide information about a separate "training set" in the context of "training" an algorithm or AI. This is a traditional diagnostic device validation, not an AI/ML product. The "training" for the device's development (e.g., optimizing immunoassay reagents) is not detailed in this submission summary.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no specific "training set" described for an AI/ML algorithm. The "training" that occurs is for the device's internal chemistry and design, which is not elaborated upon as distinct data sets for ground truth establishment.
Summary of the Study Design and Findings:
The study aimed to assess how accurately lay users could interpret the results of the Instant-View® Multi-Drug Urine Test Cup and Panel.
- Participants: 400 lay persons (210 female, 190 male), diverse in education, professional background, and age (18 to >60), with no prior OTC drug test experience.
- Methodology: Participants received package inserts, one test cup, and one test panel. Each participant tested two different blinded urine samples. The samples were prepared at various concentrations (0%, +/- 25%, +/- 50%) relative to the cutoff, and their true concentrations were confirmed by GC/MS.
- Results: The lay users achieved an average correct interpretation rate higher than 96% for both device formats, and 100% accuracy at concentrations 150% above and 50% below the cutoff.
- Conclusion: The study demonstrated that lay users could correctly interpret the device results with high accuracy, supporting the device's suitability for over-the-counter (home) use. The findings indicate effective labelling and ease of use, further supported by participant survey comments that the devices were "very easy to operate" and there were "no difficulties in interpreting the results." The package inserts also had a Flesch-Kincaid reading grade level of 7, indicating appropriate readability for a general audience.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2016
ALFA SCIENTIFIC DESIGNS, INC. JIMMY JING DIRECTOR OF REGULATORY AFFAIRS 13200 GREGG ST. POWAY CA 92064
Re: K152122
Trade/Device Name: Instant-View Multi-Drug Urine Test Cup (Home Use). Instant-View Multi-Drug Urine Test Panel (Home Use) Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: II Product Code: DKZ, JXM, DIO, LDJ, DJC, LCM, DIS, DJG, DJR, LFG Dated: May 20, 2016 Received: May 24, 2016
Dear Dr. Jing:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152122
Device Name
Instant-View® Multi-Drug Urine Test Cup (Home Use) Instant-View@ Multi-Drug Urine Test Panel (Home Use)
Indications for Use (Describe)
The Instant-View@ Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use) are rapid, qualitative immunoassays for the detection in human urine of one or more of the cutoff concentrations listed below. These devices will detect up to 13 of the drugs below in any combination. The tests are not intended to distinguish prescription use or abuse of any drugs.
| Abbreviation | Test | Calibrator | Cut-off (ng/ml) |
|---|---|---|---|
| AMP | Amphetamine | d-Amphetamine | 1000 |
| BAR | Barbiturates | Secobarbital | 200 |
| BUP | Buprenorphine | Buprenorphine | 10 |
| BZD | Benzodiazepine | Oxazepam | 300 |
| COC | Cocaine | Benzoylecgonine | 300 |
| MDMA | MDMA or Ecstasy | Methylenedioxy-methamphetamine | 500 |
| MET | Methamphetamine | d-Methamphetamine | 1000 |
| MTD | Methadone | Methadone | 300 |
| MOR | Morphine/Opiate | Morphine | 2000 |
| OXY | Oxycodone | Oxycodone | 300 |
| РСР | Phencyclidine | Phencyclidine | 25 |
| TCA | Tricyclic Antidepressants | Nortriptyline | 1000 |
| THC | Marijuana | 11-nor-A9-THC-9-COOH | 50 |
These devices provide only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry 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 obtained.
This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
Tests for prescription drugs will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for Alfa Scientific Designs, Inc. The logo includes the company name and address, which is 13200 Gregg Street, Poway, CA 92064, USA. The telephone number is 858-513-3888, and the fax number is 858-513-8388.
510(k) Summary
Safety and effectiveness as required by 21 CFR 807.92
| Manufacturerand Submitter | Name: | Alfa Scientific Designs, Inc. | |
|---|---|---|---|
| Address: | 13200 Gregg StreetPoway, CA 92064Telephone: 858-513-3888Fax: 858-513-8388 | ||
| ContactPerson: | Jimmy Jing, Ph.D.Email: jjing@alfascientific.com858-413-1279 (direct) | ||
| Device Name | Trade Name: | Instant View® Multi-Drug Urine Test Cup (Home Use)Instant View® Multi-Drug Urine Test Panel (Home Use) | |
| Common Name: | Immunoassay, Drug of Abuse Screening Urine Test | ||
| Classification Name: | Amphetamine Test System, Barbiturate Test System, Buprenorphine TesSystem, Benzodiazepine Test System, Cocaine and Cocaine MetaboliteTest System, Methamphetamine Test System, Opiate/ Morphine TestSystem, Cannabinoid Test System, Methadone Test System, TricyclicAntidepressant Drugs Test System, Phencyclidine Test System | ||
| Product Code: | DKZ (21 CFR 862.3100), DIS (21 CFR 862.3150), JXM (21 CFR862.3170), DIO (21 CFR 862.3250), DJC (21 CFR 862.3610), DJG (21CFR 862.3650), DJR (21 CFR 862.3620), LCM (21 CFR 862.3100),LFG (21 CFR 862.3910), LDJ (21 CFR 862.3870) | ||
| Date ofSummaryPreparation | 6/23/2016 | ||
| PredicateDevices | Instant View® Multi-Drug Urine Test (510(k) Number: K063545)Made by Alfa Scientific Designs, Inc | ||
| DeviceDescription | The Instant View® Multi-Drug Urine Test Cup (Home Use) and theInstant View® Multi-Drug Urine Test Panel (Home Use) are one-steplateral flow chromatographic immunoassays. Each device consists of anycombination of one to thirteen individual test strip(s) for the analyte(s)being tested. Each test strip in the device consists of 1) a conjugate padcontaining colloidal gold coupled with the anti-drug antibodies and 2)nitrocellulose membrane containing a test line (T line) coated with theconjugated drug antigen and a control line (C line). The C line serves asan internal quality control of the system and appears as a burgundy-colored band during the test regardless of the presence of the drug. | ||
| Intended Use | Instant View® Multi-Drug Urine Test Cup (Home Use)Instant View® Multi-Drug Urine Test Panel (Home Use)The Instant-View Multi-Drug Urine Test Cup (Home Use) and Instant-View Multi-Drug Urine Test Panel (Home Use) are rapid, qualitativeimmunoassays for the detection in human urine of one or more of thedrugs at the cutoff concentrations listed below. These devices will detectup to 13 of the drugs below in any combination. The tests are not intendedto distinguish prescription use or abuse of any drugs. | ||
| Abbreviation | Test | Cutoff | |
| AMP | Amphetamine | 1000 ng/mL | |
| BAR | Barbiturates | 200 ng/mL | |
| BUP | Buprenorphine | 10 ng/ml | |
| BZD | Benzodiazepine | 300 ng/mL | |
| COC | Cocaine | 300 ng/mL | |
| MDMA | MDMA or Ecstasy | 500 ng/mL | |
| MET | Methamphetamine | 1000 ng/mL | |
| MTD | Methadone | 300 ng/mL | |
| MOR | Morphine/Opiate | 2000 ng/mL | |
| OXY | Oxycodone | 300 ng/mL | |
| PCP | Phencyclidine | 25 ng/mL | |
| TCA | Tricyclic antidepressants | 1000 ng/mL | |
| THC | Marijuana | 50 ng/mL | |
| These devices provide only a preliminary analytical test result. A morespecific alternate chemical method must be used in order to obtain aconfirmed analytical result. Chromatography/mass spectrometry is thepreferred confirmatory method. Clinical consideration and professional |
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Image /page/5/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs, Inc. The logo features the word "ALFA" in a stylized font. The address is listed as 13200 Gregg Street, Poway, CA 92064 – USA. The telephone number is 858-513-3888, and the fax number is 858-513-8388.
judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
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Image /page/6/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs Inc. The logo features the word "ALFA" in a stylized font. The address is listed as 13200 Gregg Street, Poway, CA 92064, USA. The telephone number is 858-513-3888, and the fax number is 858-513-8388.
This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.
Tests for prescription drugs will vield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.
Similarity to Predicate Devices
- · Devices are one-step lateral-flow chromatographic immunoassays.
- · Devices are intended to provide qualitative detection of drug abuse.
- Devices have built-in quality control feature, C line, to indicate that an adequate volume of specimen is applied and the liquid flow occurred properly.
- · Devices consist test strips, each for one analyte.
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Image /page/7/Picture/0 description: The image shows the logo for Alfa Scientific Designs, Inc. The logo includes the company name and address, which is 13200 Gregg Street, Poway, CA 92064 – USA. The image also includes the company's telephone number, which is 858-513-3888, and fax number, which is 858-513-8388.
Performance Characteristics
The proposed multi-drug urine test devices use the same technology and formulations for the detection of the drugs as individual test devices.
The performance characteristics, such as accuracy, reproducibility, sensitivity and specificity of this drug of abuse test are the same as the predicate device.
Lay-user study:
A lay user study was performed at three intended user sites with 400 lay persons testing cup and panel devices. A total of 210 females and 190 males tested the devices. They had diverse educational and professional backgrounds and ranged in age from 18 to >60 years. The participants had no previous experience with an over the counter (OTC) drug test. Urine samples were prepared at the following concentrations: negative, ± 50%, ± 25% of the cutoff by spiking drugs 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 inserts for the test cup and the test panel, 2 different blinded samples, 1 test cup, and 1 test panel. Each participant tested 1 test cup device and 1 test panel device using 2 different blinded samples.
The lay user study results are summarized in the tables below:
| Summary of the Results - Cup | |||||
|---|---|---|---|---|---|
| Drug | CutoffConcentration%(ng/ml) | Number ofstudies | Correctlyinterpreted | Incorrectlyinterpreted | % of agreement |
| AMP | 0% (0) | 350 | 350 | 0 | 100% |
| 75% (750) | 10 | 8 | 2 | 80% | |
| 125% (1250) | 10 | 9 | 1 | 90% | |
| 150% (1500) | 30 | 30 | 0 | 100% | |
| average = 99.25% | |||||
| BAR | 0% (0) | 350 | 350 | 0 | 100% |
| 75% (150) | 10 | 9 | 1 | 90% | |
| 125% (250) | 10 | 9 | 1 | 90% | |
| 150% (300) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| BUP | 0% (0) | 20 | 20 | 0 | 100% |
| 50% (5) | 60 | 60 | 0 | 100% | |
| 75% (7.5) | 60 | 56 | 4 | 93.3% | |
| 125% (12.5) | 120 | 109 | 11 | 90.8% | |
| 150% (15) | 140 | 140 | 0 | 100% | |
| average = 96.25% | |||||
| BZD | 0% (0) | 350 | 350 | 0 | 100% |
| 75% (225) | 10 | 9 | 1 | 90% | |
| 125% (375) | 10 | 9 | 1 | 90% | |
| 150% (450) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| 0% (0) | 350 | 350 | 0 | 100% | |
| COC | 75% (225) | 10 | 9 | 1 | 90% |
| 125% (375) | 10 | 8 | 2 | 80% | |
| 150% (450) | 30 | 30 | 0 | 100% | |
| average = 99.25% | |||||
| 0% (0) | 350 | 350 | 0 | 100% | |
| MET | 75% (750) | 10 | 9 | 1 | 90% |
| 125% (1250) | 10 | 9 | 1 | 90% | |
| 150% (1500) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| 0% (0) | 350 | 350 | 0 | 100% | |
| 75% (225) | 10 | 8 | 2 | 80% | |
| MTD | 125% (375) | 10 | 10 | 0 | 100% |
| 150% (450) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| PCP | 0% (0) | 350 | 350 | 0 | 100% |
| 50% (12.5) | 10 | 10 | 0 | 100% | |
| 125% (31.25) | 10 | 9 | 1 | 90% | |
| 150% (37.5) | 30 | 30 | 0 | 100% | |
| average = 99.75% | |||||
| TCA | 0% (0) | 350 | 350 | 0 | 100% |
| 50% (500) | 10 | 10 | 0 | 100% | |
| 125% (1250) | 10 | 9 | 1 | 90% | |
| 150% (1500) | 30 | 30 | 0 | 100% | |
| average = 99.75% | |||||
| 0% (0) | 350 | 350 | 0 | 100% | |
| THC | 50% (25) | 10 | 10 | 0 | 100% |
| 125% (62.5) | 10 | 8 | 2 | 80% | |
| 150% (75) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| 0% (0) | 350 | 350 | 0 | 100% | |
| MDMA | 50% (250) | 10 | 10 | 0 | 100% |
| 125% (625) | 10 | 9 | 1 | 90% | |
| 150% (750) | 30 | 30 | 0 | 100% | |
| average = 99.75% | |||||
| MOR | 0% (0) | 350 | 350 | 0 | 100% |
| 50% (100) | 10 | 10 | 0 | 100% | |
| 125% (2500) | 10 | 8 | 2 | 80% | |
| 150% (3000) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| 0% (0) | 350 | 350 | 0 | 100% | |
| OXY | 50% (150) | 10 | 10 | 0 | 100% |
| 125% (375) | 10 | 8 | 2 | 80% | |
| 150% (450) | 30 | 30 | 0 | 100% | |
| average - 99.5% | |||||
Summary of the Results - Cup
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Image /page/8/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs, Inc. The logo features a stylized "A" and "L" intertwined. The address is listed as 13200 Gregg Street, Poway, CA 92064 – USA. The telephone number is 858-513-3888, and the fax number is 858-513-8388.
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Image /page/9/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs, Inc. The logo features a stylized "A" and "L" in black and gray. The address is listed as 13200 Gregg Street, Poway, CA 92064, USA, and the telephone number is 858-513-3888, while the fax number is 858-513-8388.
| Drug | CutoffConcentration%(ng/ml) | Number ofstudies | Correctlyinterpreted | Incorrectlyinterpreted | % ofagreement |
|---|---|---|---|---|---|
| AMP | 0% (0) | 350 | 350 | 0 | 100% |
| 75% (750) | 10 | 9 | 1 | 90% | |
| 125% (1250) | 10 | 9 | 1 | 90% | |
| 150% (1500) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| BAR | 0% (0) | 350 | 350 | 0 | 100% |
| 75% (150) | 10 | 9 | 1 | 90% | |
| 125% (250) | 10 | 8 | 2 | 80% | |
| 150% (300) | 30 | 30 | 0 | 100% | |
| average = 99.25% | |||||
| BUP | 0% (0) | 20 | 20 | 0 | 100% |
| 50% (5) | 60 | 60 | 0 | 100% | |
| 75% (7.5) | 60 | 55 | 5 | 91.7% | |
| 125% (12.5) | 120 | 112 | 8 | 93.3% | |
| 150% (15) | 140 | 140 | 0 | 100% | |
| average = 96.75% | |||||
| BZD | 0% (0) | 350 | 350 | 0 | 100% |
| 75% (225) | 10 | 9 | 1 | 90% | |
| 125% (375) | 10 | 9 | 1 | 90% | |
| 150% (450) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| COC | 0% (0) | 350 | 350 | 0 | 100% |
| 75% (225) | 10 | 9 | 1 | 90% | |
| 125% (375) | 10 | 9 | 1 | 90% | |
| 150% (450) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| MET | 0% (0) | 350 | 350 | 0 | 100% |
| 75% (750) | 10 | 8 | 2 | 80% | |
| 125% (1250) | 10 | 10 | 0 | 100% | |
| 150% (1500) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| MTD | 0% (0) | 350 | 350 | 0 | 100% |
| 75% (225) | 10 | 9 | 1 | 90% | |
| 125% (375) | 10 | 9 | 1 | 90% | |
| 150% (450) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| PCP | 0% (0) | 350 | 350 | 0 | 100% |
| 50% (12.5) | 10 | 10 | 0 | 100% | |
| 125% (31.25) | 10 | 9 | 1 | 90% | |
| 150% (37.5) | 30 | 30 | 0 | 100% | |
| average = 99.75% | |||||
| TCA | 0% (0) | 350 | 350 | 0 | 100% |
| 50% (500) | 10 | 10 | 0 | 100% | |
| 125% (1250) | 10 | 9 | 1 | 90% | |
| 150% (1500) | 30 | 30 | 0 | 100% | |
| average = 99.75% | |||||
| 0% (0) | 350 | 350 | 0 | 100% | |
| THC | 50% (25) | 10 | 10 | 0 | 100% |
| 125% (62.5) | 10 | 8 | 2 | 80% | |
| 150% (75) | 30 | 30 | 0 | 100% | |
| average = 99.5% | |||||
| MDMA | 0% (0) | 350 | 350 | 0 | 100% |
| 50% (250) | 10 | 10 | 0 | 100% | |
| 125% (625) | 10 | 9 | 1 | 90% | |
| 150% (750) | 30 | 30 | 0 | 100% | |
| average = 99.75% | |||||
| MOR | 0% (0) | 350 | 350 | 0 | 100% |
| 50% (100) | 10 | 10 | 0 | 100% | |
| 125% (2500) | 10 | 9 | 1 | 90% | |
| 150% (3000) | 30 | 30 | 0 | 100% | |
| average = 99.75% | |||||
| OXY | 0% (0) | 350 | 350 | 0 | 100% |
| 50% (150) | 10 | 10 | 0 | 100% | |
| 125% (375) | 10 | 8 | 2 | 80% | |
| 150% (450) | 30 | 30 | 0 | 100% | |
| average = 99.5% |
Summary of the Results - Panel
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In both formats, the participants were able to read the results correctly at an average of higher than 96%, and 100% at 150% and above, as well as at 50% and below in this study.
Compared with GC/MS results, the lay users are able to obtain similar results with Instant-View® Multi-Drug urine test panel (Home Use) and Instant-View® Multi-Drug urine test cup (Home Use) devices.
All participants completed questionnaires after they completed the testing. The majority of the participants commented that the devices are very easy to operate and they have no difficulties in interpreting the results.
| Summary of Survey and Labeling Assessments | ||||||
|---|---|---|---|---|---|---|
| Very easy tounderstand | Easy tounderstand | Understandablew/ somedifficulty | Difficult tounderstand | Impossible tounderstand | Total | |
| Explanation ofintended use ofthe test | 166(41.5%) | 217(54.25%) | 17(4.25%) | 0 | 0 | 400 |
| Directions todo the test | 154(38.5%) | 231(57.75%) | 15(3.75%) | 0 | 0 | 400 |
| Performing thetest | 178(44.5%) | 202(50.5%) | 20(5%) | 0 | 0 | 400 |
| Direction tointerpret theresults | 164(41%) | 223(55.75%) | 13(3.25%) | 0 | 0 | 400 |
| Actualinterpretationof the testresults | 164(41%) | 220(55%) | 16(4%) | 0 | 0 | 400 |
Summary of Survey and Labeling Assessments
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Image /page/11/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs, Inc. The logo features a stylized "A" and the company name in gray text. The address is listed as 13200 Gregg Street, Poway, CA 92064, USA. The telephone number is 858-513-3888, and the fax number is 858-513-8388.
Additionally, a Flesh-Kincaid reading analysis revealed that package inserts (cup and panel) had a reading grade level of 7.
Conclusion The proposed test is substantially equivalent to the predicate device.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).