(28 days)
The Instant-View™ Multi-Drug Screen Urine Test is a qualitative immunoassay intended to be used to detect any combination (variants from 2 to 12) of the following drugs and/or drug metabolites in human urine at the specified cutoff levels. It is intended for professional use only.
| Drug | Cutoff Level (ng/ml) |
|---|---|
| Amphetamine (AMP) | 1000 |
| Barbiturate (BAR) | 200 |
| Benzodiazepine (BZD) | 300 |
| Cocaine (COC) | 300 |
| Marijuana (THC) | 50 |
| Methadone (MTD) | 300 |
| Methamphetamine (METH) | 1000 |
| Methamphetamine (METH) | 500 |
| Morphine (MOR) | 300 |
| Morphine (MOR) | 2000 |
| Phencyclidine (PCP) | 25 |
Instant-View™ Multi-Drug Screen Urine Test provides only a preliminary analytical test result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/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 used.
The Instant-View™ Multi-Drug Screen Urine Test device is an assemblage of single test devices. It works similarly as the single devices because each device functions independently, but conveniently provides the detection of multiple drugs instead of only one in the same time frame. All the devices are based on the same immunochemical principle of recognition and formation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Instant-View™ Multi-Drug Screen Urine Test:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy percentages) that the device must meet to be considered effective. Instead, the study's acceptance is based on the device being "substantially equivalent" to previously cleared single-drug test devices.
The reported device performance, however, is broadly described:
| Drug | Cutoff Level (ng/ml) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Amphetamine (AMP) | 1000 | Based on substantial equivalence to single-drug tests | "each device performed normally" and "no interference was observed between different single test devices" |
| Barbiturate (BAR) | 200 | ||
| Benzodiazepine (BZD) | 300 | ||
| Cocaine (COC) | 300 | ||
| Marijuana (THC) | 50 | ||
| Methadone (MTD) | 300 | ||
| Methamphetamine (METH) | 1000 | ||
| Methamphetamine (METH) | 500 | ||
| Morphine (MOR) | 300 | ||
| Morphine (MOR) | 2000 | ||
| Phencyclidine (PCP) | 25 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing. It mentions "in-house evaluation" but provides no details on the number of samples or their origin. Therefore, the data provenance (e.g., country of origin, retrospective or prospective) cannot be determined from the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a ground truth for the performance testing. The study focuses on demonstrating substantial equivalence to existing single-drug tests, and it's implied that the performance of those predicate devices served as the benchmark.
4. Adjudication Method for the Test Set
No adjudication method is described, as there is no mention of expert review or consensus for establishing ground truth within the context of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This document describes a diagnostic device for drug screening, not an AI-assisted diagnostic system. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone immunoassay test; it's not an algorithm. The performance described is its inherent analytical performance. The document doesn't detail performance in terms of typical diagnostic metrics for such devices (e.g., sensitivity, specificity) but rather asserts its performance relative to existing single-drug tests.
7. The Type of Ground Truth Used
The ground truth for the performance of the modified multi-drug screen is implicitly based on the established performance of the individual, 510(k)-cleared Instant-View™ single test devices for each drug. The logic is that if the assembled multi-drug device performs like the individual components without interference, then its performance is considered equivalent to the well-characterized performance of those components. The document implies that Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method for any preliminary positive results from the test, suggesting GC/MS is the ultimate "ground truth" for confirming drug presence in clinical practice, though not explicitly an internal ground truth for the study validating the multi-drug device itself.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or machine learning. For this immunoassay device, the "training" would have been the development and optimization of the individual single-drug test components, which are already 510(k) cleared. No specific sample size for this developmental process is provided.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the typical sense for this device, there's no description of how ground truth for such a set was established. The focus is on the substantial equivalence of the combined device to its individual, pre-cleared components.
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Special 510(k)
AUG 3 0 2002
KO22564
Alfa Scientific Designs Inc.
510 (k) SUMMARY AS REQUIRED BY SECTION 807.92(c)
Product Name: Instant-View™ Multi-Drug Screen Urine Test L
II. Manufacturer:
Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway, CA 92064 (858) 513-3888 Telephone: Fax: (858) 513-8388 info@alfascientific.com Email:
III. Common Name of the Device: Multiple Drugs of Abuse Urine Test
IV. Trade Name of the Device: Instant-View ™Multi-Drug Screen Urine Test
V. Establishment Registration Number: 2060833
VI. Classification of the Device:
The Test Device is classified as Class II
VII. Intended Use:
The intended use of the modified device, Instant-View™ Multi-Drug Screen Urine Test, has not changed as a result of the modification(s).
The Instant-View™ Multi-Drug Screen Urine Test is a qualitative immunoassav intended to be used to detect any combination (variants from 2 to 12) of the following drugs and/or drug metabolites in human urine at the specified cutoff levels. It is intended for professional use only.
| Drug | Cutoff Level (ng/ml) |
|---|---|
| Amphetamine (AMP) | 1000 |
| Barbiturate (BAR) | 200 |
| Benzodiazepine (BZD) | 300 |
| Cocaine (COC) | 300 |
| Marijuana (THC) | 50 |
| Methadone (MTD) | 300 |
| Methamphetamine (METH) | 1000 |
| Methamphetamine (METH) | 500 |
| Morphine (MOR) | 300 |
| Morphine (MOR) | 2000 |
| Phencyclidine (PCP) | 25 |
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Instant-View™ Multi-Drug Screen Urine Test provides only a preliminary analytical test result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/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 used.
VIII. Fundamental Scientific Technology:
The Instant-View™ Multi-Drug Screen Urine Test device is an assemblage of single test devices. It works similarly as the single devices because each device functions independently, but conveniently provides the detection of multiple drugs instead of only one in the same time frame. The 510(k)-approved Instant View™ single test devices are used for substantial equivalence predicate kit, for there is no change for each device in the intended use, in the way the test actually runs, and in the expected result. All the devices are based on the same immunochemical principle of recognition and formation.
IX. Performance Summary:
The performance characteristics of Instant-View™ Multi-Drug Screen Urine Test are significantly based on the single test devices, which are independently 510(k) cleared. During the in-house evaluation, no interference was observed between different single test devices while each test device performed normally. Moreover, the study on accelerated degradation of the device demonstrates that the device have a lifetime of at least two years, further indicating that the assembled devices perform independently as single devices and do not affect each other.
X. Conclusion:
For the reasons mentioned above, it is possible to conclude that the Instant-View™ Multi-Drug Screen Urine Test is substantially equivalent to the Instant-View™ single drug of abuse urine tests presently distributed commercially.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Naishu Wang, M.D., Ph.D. President Alfa Scientific Designs, Inc. 12330 Stowe Drive Poway, California 92064
AUG 3 0 2002
Re: K022564
Trade/Device Name: Instant-View™ Multi-Drug Screen Urine Test Regulation Number: 21 CFR § 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: II Product Code: DKZ, DIO, DIS, DJC, DJR, DOE, DPK, JXM, LAF, LCM, LDJ Dated: August 15, 2002 Received: August 19, 2002
Dear Dr. Wang:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801): 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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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(K) NUMBER (IF KNOWN):
DEVICE NAME : Instant-View™ Multi-Drug Screen Urine Test
INDICATIONS FOR USE:
The Instant-View™ Multi-Drug Screen Urine Test is a qualitative immunoassay intended to be used to detect any combination (variants from 2 to 12) of the following drugs and/or drug metabolites in human urine at the specified cutoff levels. It is intended for professional use only.
| Drug | Cutoff Level (ng/ml) |
|---|---|
| Amphetamine (AMP) | 1000 |
| Barbiturate (BAR) | 200 |
| Benzodiazepine (BZD) | 300 |
| Cocaine (COC) | 300 |
| Marijuana (THC) | 50 |
| Methadone (MTD) | 300 |
| Methamphetamine (METH) | 1000 |
| Methamphetamine (METH) | 500 |
| Morphine (MOR) | 300 |
| Morphine (MOR) | 2000 |
| Phencyclidine (PCP) | 25 |
Instant-View™ Multi-Drug Screen Urine Test provides only a preliminary andlytical test result. A more specific alternate chemical method must be used to obtain a confirmed Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred analytical result. confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Stan Cooper
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED . )
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
§ 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).