(28 days)
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No
The description details a qualitative immunoassay based on immunochemical principles, with no mention of AI or ML technologies. The performance studies focus on the independent function of the assembled single test devices.
No.
The device is an immunoassay intended for detecting drugs and drug metabolites in human urine, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as 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". This function of detecting specific substances for the purpose of identifying drug use falls under the definition of a diagnostic device, which helps in the identification or detection of a disease or condition. While it only provides a "preliminary analytical test result," it is still used for detection, which is a diagnostic function.
No
The device description clearly indicates it is a physical "assemblage of single test devices" based on an "immunochemical principle," which are hardware components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to detect drugs and/or drug metabolites in human urine. This is a biological specimen taken from the human body.
- Qualitative Immunoassay: The device uses a qualitative immunoassay, which is a common method for in vitro diagnostic testing.
- Professional Use Only: While not a definitive requirement for all IVDs, the indication for professional use aligns with the typical use of many IVD devices in clinical or laboratory settings.
- Detection of Analytes: The device is designed to detect specific analytes (drugs and drug metabolites) within the biological specimen.
- Preliminary Analytical Test Result: The output is a preliminary analytical test result, which is a characteristic of many IVD tests that may require confirmation.
The description clearly indicates that the device is used to perform a test on a sample taken from the human body in vitro (outside the body) to provide information about the presence of specific substances. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIO, DIS, DJC, DJR, DOE, DPK, JXM, LAF, LCM, LDJ
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional use only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
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 |
1
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
4
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)