(124 days)
The Instant View® Multi-Drug of Abuse Urine Test Cup is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.
The Instant View® Multi-Drug of Abuse Urine Test Panel is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
The drug tests will provide a preliminary result only. A more specific. alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.
The Instant View® Multi-Drug of Abuse Urine Test Cup and the Instant View® Multi-Drug of Abuse Urine Test Panel are one-step lateral flow chromatographic immunoassays. Each device consists of any combination of one to twelve 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 burgundycolored band during the test regardless of the presence of the drug.
The provided document is a 510(k) summary for the Instant View® Multi-Drug of Abuse Urine Test Cup and Panel. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain acceptance criteria for device performance or the results of a study proving the device meets acceptance criteria.
The "Acceptance Criteria" for such a device would typically involve sensitivity, specificity, accuracy, and reproducibility in detecting the target drugs at or above specified cutoff levels. The "Study" would then present the results of clinical or laboratory testing to demonstrate that the device performs according to these criteria.
The document states:
- "The performance characteristics, such as accuracy, reproducibility, sensitivity and specificity of this drug of abuse test are the same as the predicate device." This is a claim of equivalence but does not present the actual performance data or acceptance criteria for the current device.
Therefore, I cannot provide the requested information from the provided document. The document primarily focuses on establishing substantial equivalence to a predicate device based on its technology, intended use, and general characteristics, rather than detailing specific performance studies with acceptance criteria for the new device.
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Image /page/0/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 telephone number, which is 858-513-3888, and the fax number, which is 858-513-8388.
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Image /page/0/Picture/1 description: The image shows a logo with the letters "MSAI" stacked on top of an eye symbol. Below the eye symbol, there is text that reads "ISO 13485 MEDICAL DEVICES". The logo is contained within a black square with a white border.
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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 | OCT 07 2013 | ||
| ContactPerson: | Naishu Wang, MD, Ph.D.Email: wnss@alfascientific.com858-413-1266 (direct) | |||
| Device Name | Trade Name:Instant View® Multi-Drug of Abuse Urine Test CupInstant View® Multi-Drug of Abuse Urine Test Panel | |||
| Common Name:Immunoassay, Drug of Abuse Screening Urine Test | ||||
| Classification Name:Amphetamine Test System, Barbiturate Test System, BenzodiazepineTest System, Cocaine and Cocaine Metabolite Test System,Methamphetamine Test System, Opiate/ Morphine Test System,Cannabinoid Test System, Tricyclic Antidepressant 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 | 09-19-2013 |
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Image /page/1/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.
Image /page/1/Picture/1 description: The image is a logo with the letters "nsai" at the top. Below the letters is an image of an eye. The bottom of the logo has the words "ISO 13485 MEDICAL DEVICES" printed on it. The logo is black and white.
Predicate Devices
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INSTANT-VIEW® Multi-Drug of Abuse Urine Test (K063545) Manufacture is Alfa Scientific Designs, Inc.
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Image /page/2/Picture/0 description: The image shows the logo and contact information for Alfa Scientific Designs Inc. The logo features a stylized "A" with circular elements. The contact information includes the address "13200 Gregg Street, Poway, CA 92064 - USA", the telephone number "858-513-3888", and the fax number "858-513-8388".
Image /page/2/Picture/1 description: The image shows a logo with the letters "nsai" at the top. Below the letters is an eye-shaped design. Underneath the eye design, the text "ISO 13485 MEDICAL DEVICES" is present. The logo appears to be a certification mark related to medical devices and the ISO 13485 standard.
Device Description
The Instant View® Multi-Drug of Abuse Urine Test Cup and the Instant View® Multi-Drug of Abuse Urine Test Panel are one-step lateral flow chromatographic immunoassays. Each device consists of any combination of one to twelve 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 burgundycolored band during the test regardless of the presence of the drug.
Intended Use
Instant View® Multi-Drug of Abuse Urine Test Cup
The Instant View® Multi-Drug of Abuse Urine Test Cup is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
| Abbreviation | Test | Cutoff |
|---|---|---|
| AMP | Amphetamine | 1000 ng/mL |
| BAR | Barbiturates | 200 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/Opiates | 2000 ng/mL |
| OXY | Oxycodone | 100 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
| TCA | Tricyclic antidepressants | 1000 ng/mL |
| THC | Marijuana | 50 ng/mL |
The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.
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Image /page/3/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 contact information includes the address 13200 Gregg Street, Poway, CA 92064 - USA, the telephone number 858-513-3888, and the fax number 858-513-8388.
Image /page/3/Picture/1 description: The image shows a logo with the text "NSAI" at the top. Below the text is an eye-shaped graphic. Underneath the eye graphic is the text "ISO 13485 MEDICAL DEVICES". The logo appears to be a certification mark related to medical devices.
Instant View® Multi-Drug of Abuse Urine Test Panel
Instant View® Multi-Drug of Abuse Urine Test Panel is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
| Abbreviation | Test | Cutoff |
|---|---|---|
| AMP | Amphetamine | 1000 ng/mL |
| BAR | Barbiturates | 200 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/Opiates | 300 ng/mL |
| OXY | Oxycodone | 100 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
| TCA | Tricyclic antidepressants | 1000 ng/mL |
| THC | Marijuana | 50 ng/mL |
The drug tests will provide a preliminary result only. A more specific. alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.
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Poway, CA 92064 – USA
Poway, CA 92064 – USA
Jemec Designs.nrc Telephone: 858-513-3888 ♦ Fax: 858-513-8388
Image /page/4/Picture/1 description: The image shows a logo with the letters "nsai" at the top. Below the letters is an eye-shaped design. Underneath the eye design, the text "ISO 13485 MEDICAL DEVICES" is present. The logo appears to be a certification mark related to medical devices.
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| Similarity toPredicateDevices | • Devices are one-step lateral-flow chromatographic immunoassays.• Devices are intended to provide qualitative detection of drug abuse.• Devices are in-vitro diagnostic devices for OTC use.• Devices have built-in quality control feature, C line, to indicate that anadequate volume of specimen is applied and the liquid flow occurredproperly.• Devices consist test strips, each for one analyte. |
|---|---|
| TechnologicalCharacteristics | The proposed multi-drug urine test devices use the same technology andformulations 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 thepredicate device. |
| Conclusion | The proposed test is substantially equivalent to the predicate devices. |
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2013
Alfa Scientific Designs c/o Naishu Wang, Ph.D. 13200 Gregg St. POWAY CA 92064
Re: K131645
Trade/Device Name: Instant-View Multi-Drug of Abuse Urine Test Cup Instant-View Multi-Drug of Abuse Urine Test Panel Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DIS, JXM, DJC, DJG, DJR, LCM, LFG, LDJ, DIO Dated: September 23, 2013 Received: September 24, 2013
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. 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 (QS) 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-Dr. Wang
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Courtney H. Lias, Ph.D.
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): kl31645
Device Name: Instant-View Multi-Drug of Abuse Urine Test Cup Instant-View Multi-Drug of Abuse Urine Test Panel
Indications for Use:
The Instant-View Multi-Drug of Abuse Urine Test Cup is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
| Abbreviation | Test | Cutoff |
|---|---|---|
| AMP | Amphetamine | 1000 ng/mL |
| BAR | Barbiturates | 200 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/Opiates | 2000 ng/mL |
| OXY | Oxycodone | 100 ng/mL |
| PCP | Phencvclidine | 25 ng/mL |
| TCA | Tricyclic antidepressants | 1000 ng/mL |
| THC | Marijuana | 50 ng/mL |
The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.
| Prescription Use(Part 21 CFR 801 Subpart D) | |
|---|---|
| AND/OR | |
| Over-The-Counter Use(21 CFR 807 Subpart C) | X |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Denise Johnson-lyles -S
2013.10.07 07:47:06 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health K131645 510(k) =
l of 2
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Indications for Use
510(k) Number (if known): K131645
Device Name: Instant-View Multi-Drug of Abuse Urine Test Cup Instant-View Multi-Drug of Abuse Urine Test Panel
Indications for Use:
The Instant-View Multi-Drug of Abuse Urine Test Panel is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
| Abbreviation | Test | Cutoff |
|---|---|---|
| AMP | Amphetamine | 1000 ng/mL |
| BAR | Barbiturates | 200 ng/mL |
| BZD | Benzodiazepine | 300 ng/mL |
| COC | Cocaine | 300 ng/mL |
| MDMA | MDMA or Ecstasv | 500 ng/mL |
| MET | Methamphetamine | 1000 ng/mL |
| MTD | Methadone | 300 ng/mL |
| MOR | Morphine/Opiates | 300 ng/mL |
| OXY | Oxycodone | 100 ng/mL |
| PCP | Phencvclidine | 25 ng/mL |
| TCA | Tricyclic antidepressants | 1000 ng/mL |
| THC | Marijuana | 50 ng/mL |
The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.
| Prescription Use | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) X |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ·
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson-lyles - S 2013.10.07 07:47:30 -04'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k) K131645
§ 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).