(164 days)
No
The device description and intended use clearly describe a lateral flow immunoassay, which is a chemical test and does not involve AI or ML. There is no mention of any software, algorithms, or computational analysis of the results.
No
The device is described as an immunoassay for the qualitative detection of drugs in urine specimens, providing only preliminary results. Its intended use is for screening and detection, not for treating or preventing disease.
Yes
The device is described as an "immunoassay for the qualitative detection of amphetamine in urine specimens" and similar statements for other drugs, indicating its purpose is to detect the presence of substances which is a diagnostic function. It is intended for professional, point-of-care, and even home use to provide information regarding the presence of drugs or their metabolites, even if it provides only preliminary results requiring confirmation.
No
The device description explicitly states it is a "lateral flow chromatographic immunoassay" consisting of physical components like a "conjugate pad" and "nitrocellulose membrane." This indicates a hardware-based test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the qualitative detection of various drugs or drug metabolites in urine specimens. Urine is a biological specimen taken from the human body.
- In Vitro: The test is performed in vitro (outside the living body) on the collected urine sample.
- Diagnostic: While the test provides a "preliminary result" and requires confirmation, its purpose is to provide information about the presence of substances in a biological sample, which is a diagnostic function. It's used to screen for potential drug abuse.
- Device Description: The description details the components of a lateral flow immunoassay, which is a common type of IVD used for detecting specific substances in biological fluids.
The fact that it's used on a human biological specimen (urine) to provide information about the presence of substances within that specimen firmly places it in the category of an In Vitro Diagnostic device. The different intended user groups (professional, point of care, home use, OTC) and the need for confirmatory testing do not change its fundamental classification as an IVD.
N/A
Intended Use / Indications for Use
The Amphetamine (300) test is a qualitative immunoassay for the rapid detection of amphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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.
The Cocaine (150) test device is a rapid qualitative immunoassay for the rapid detection of cocaine (benzoylecgonine) from human urine specimens at a cutoff concentration of 150 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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.
The Methamphetamine (300) test is a qualitative immunoassay for the rapid detection of methamphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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.
The Oxycodone (100) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 100 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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.
The Oxycodone (300) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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.
The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. It is for health care professional use.
The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no wiformly recognized drug levels for barbiturate, tricyclic antilegressant in urine. The malti-drug of absoce wine test device shows the drug was not present at the cutoff level. This test provides only a preliminary result. A more specifical nethod must be used in order to obtain a confirmed analy. Gas Chromatography / Mass Spectrometry (GCMS) or High Performance Liguid Chromatography (HPLC) is the preferred confirmatory nethod. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels.
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.
The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GCMS) or High Performance Liquid Chromatography (HPLC) 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.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIO, DJC, DJG, DIS, JXM, LCM, LDJ, LEG, LFG, NCI, NFV
Device Description
This assay is a one-step lateral flow chromatographic immunoassay.
The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-amphetamine antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with amphetamine-BSA, and the C line is coated with goat anti-rabbit IgG antibody.
This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti- benzoylecgonine (cocaine) antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with benzoylecnine-BTG, and the C line is coated with goat anti-rabbit
This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-methamphetamine antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with methamphetamine-BSA, and the C line is coated with goat anti-rabbit IgG antibody.
A one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-oxycodone antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with oxycodone-BSA, and the C line is coated with goat anti-rabbit IgG antibody.
A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to twelve (12) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a burgundy-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 burgundy-colored band during test regardless of the presence of the drug.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urine specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and point of care use only.
health care professional including point of care use.
OTC consumer use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Ninety-eight clinical confirmed specimens for AMP were studied, separately.
One hundred and eight clinical confirmed specimens for COC were studied, separately.
One hundred twenty-seven clinical confirmed specimens for MET were studied, separately.
Seventy-five clinical confirmed specimens for OXY were studied, separately.
One hundred fifteen clinical confirmed specimens for OXY were studied, separately.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The sensitivity of the proposed device is 93.5% and the specificity is 98%. The overall agreement of the AMP (300) device to the GC/MS data is 96.9%.
Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Evaluations were performed by personnel with diverse educational backgrounds and working experiences. The agreement of the three sites is 97.5%.
To assess the shelf life stability claims of the proposed test, accelerated degradation of the proposed device was studied. Three lots from each of the two formats (cassette and dip strip) were tested. Based on the results of the accelerated degradation study, two years (24 months) shelf life of the proposed test was predicted.
The specific gravity of urine specimens, ranging from 1.002 to 1.035, and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect the test results.
The proposed device has two formats, cassette and dip-strip. The cassette format is a dip-strip device assembled in a plastic housing. Studies demonstrated that the two formats are equivalent.
The sensitivity of the proposed device are 96.4% and the specificity is 98.1%. The overall agreement of the COC (150) device to the GC/MS data is 97.2%.
Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Evaluations were performed by personnel with diverse educational backgrounds and working experiences. The agreement of the three sites is 97.9%.
To assess the shelf life stability claims of the proposed test, accelerated degradation of the proposed device was studied. Three lots from each of the two formats (cassette and dip strip) were tested. Based on the results of the accelerated degradation study, two years (24 months) shelf life of the proposed test was predicted.
The specific gravity of urine specimens, ranging from 1.002 to 1.035, and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect the test results.
The proposed device has two formats, cassette and dip-strip. The cassette format is a dip-strip device assembled in a plastic housing. Studies demonstrated that the two formats are equivalent.
The sensitivity of the proposed device is 96.8% and the specificity is 98%. The overall agreement of the MET (300) device to the GC/MS data is 96.1%.
Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Evaluations were performed by personnel with diverse educational backgrounds and working experiences. The agreement of the three sites is 97.1%.
To assess the shelf life stability claims of the proposed test, accelerated degradation of the proposed device was studied. Three lots from each of the two formats (cassette and dip strip) were tested. Based on the results of the accelerated degradation study, two years (24 months) shelf life of the proposed test was predicted.
The specific gravity of urine specimens, ranging from 1.002 to 1.035, and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect the test results.
The proposed device has two formats, cassette and dip-strip. The cassette format is a dip-strip device assembled in a plastic housing. Studies demonstrated that the two formats are equivalent.
Both the sensitivity and the specificity of the proposed device are 97.6%. The overall agreement of the OXY (100) device to the GC/MS data is 97.6%.
Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Evaluations were performed by personnel with diverse educational backgrounds and working experiences. The agreement of the three sites is 96.7%.
To assess the shelf life stability claims of the proposed test, accelerated degradation of the proposed device was studied. Three lots from each of the two formats (cassette and dip strip) were tested. Based on the results of the accelerated degradation study, two years (24 months) shelf life of the proposed test was predicted.
The specific gravity of urine specimens, ranging from 1.002 to 1.035, and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect the test results.
The proposed device has two formats, cassette and dip-strip. The cassette format is a dip-strip device assembled in a plastic housing. Studies demonstrated that the two formats are equivalent.
The sensitivity of the proposed device is 95.2% and the specificity is 100%. The overall agreement of the OXY (300) device to the GC/MS data is 98.3%.
Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Evaluations were performed by personnel with diverse educational backgrounds and working experiences. The agreement of the three sites is 97.5%.
To assess the shelf life stability claims of the proposed test, accelerated degradation of the proposed device was studied. Three lots from each of the two formats (cassette and dip strip) were tested. Based on the results of the accelerated degradation study, two years (24 months) shelf life of the proposed test was predicted.
The specific gravity of urine specimens, ranging from 1.002 to 1.035, and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect the test results.
The proposed device has two formats, cassette and dip-strip. The cassette format is a dip-strip device assembled in a plastic housing. Studies demonstrated that the two formats are equivalent.
The proposed multi-drug of abuse device uses exactly 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 the multi-drug of abuse test are exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission.
The shelf life stability of the test devices was estimated based on the accelerated degradation studies of individual test devices, three lots for each test, each format. Two years (24 months) shelf life of the proposed tests was predicted.
The proposed multi-drug of abuse device has two formats, cassette and urine cup. Both formats contain between one to twelve test strips, each for a drug.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 93.5% (Amphetamine), 96.4% (Cocaine), 96.8% (Methamphetamine), 97.6% (Oxycodone 100), 95.2% (Oxycodone 300)
Specificity: 98% (Amphetamine), 98.1% (Cocaine), 98% (Methamphetamine), 97.6% (Oxycodone 100), 100% (Oxycodone 300)
Overall Agreement to GC/MS data: 96.9% (Amphetamine), 97.2% (Cocaine), 96.1% (Methamphetamine), 97.6% (Oxycodone 100), 98.3% (Oxycodone 300)
Reproducibility Agreement: 97.5% (Amphetamine), 97.9% (Cocaine), 97.1% (Methamphetamine), 96.7% (Oxycodone 100), 97.5% (Oxycodone 300)
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.
INSTANT-VIEW ® Amphetamine Urine Test (510K Number: K994395), INSTANT-VIEW ® Cocaine Urine Test (510K Number: K994403), INSTANT-VIEW® Methamphetamine Urine Test (510K Number: K003845), OXYCODONE One Step Oxycodone Test Strip (510K Number: K033047), INSTANT-VIEW ® Multi-Drugs Urine Test (510K Number: K022564), INSTANT-VIEW ® Propoxyphene Test (510K Number: K022915), INSTANT-VIEW ® TCA Urine Test (510K Number: K022693), INSTANT-VIEW ® MDMA Urine Test (510K Number: K022501), INSTANT-VIEW ® BUP/NBUP Urine Test (510K Number: K060527)
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.
Not Found
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).
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
Image /page/0/Picture/2 description: The image shows a stylized, cursive letter 'alpha' in black against a white background. The letter is drawn with thick lines, giving it a bold appearance. The curves and loops of the letter are exaggerated, creating a visually distinct and recognizable symbol.
FDA Registered • ISO 9001/EN 46001 Certified In-Vitro Diagnostic (IVD) Devices Manufacturer • Contract R&D • OEM
510(k) Summary
sai
I.S. EN ISO 9001
I.S. EN 46001
1
۲ ﮐﻪ ۲
Safety and Effectiveness as Required by 21 CFR 807.92
| Manufacture and
| Submitter | Name: | Alfa Scientific Designs, Inc. |
|---|---|---|
| Address: | 13200 Gregg Street | |
| Poway, CA 92064 | ||
| Telephone: | (858) 513-3888 x 325 | |
| Fax: | (858) 513-8388 | |
| Contact Person: | Daiting Rong, Ph.D. | |
| E-mail:drong@alfascientific.com | ||
| Device Name | Trade Name: | INSTANT-VIEW ® Amphetamine (300) Urine Test (Cassette, Dip-Strip) |
| INSTANT-VERDICT ® Amphetamine (300) Urine Test (Cassette, Dip-Strip) | ||
| Amphetamine (300) Urine Test (Cassette, Dip-Strip) | ||
| Common Name: | Immunoassay, AMP Urine Test | |
| Classification: | Amphetamine Test System | |
| Product Code: | ||
| DKZ | ||
| Date of Summary | ||
| Preparation | Nov. 16, 2006 | |
| Predicate Devices | INSTANT-VIEW ® Amphetamine Urine Test (510K Number: K994395) | |
| By Alfa Scientific Designs, Inc. | ||
| Device | ||
| Description | This assay is a one-step lateral flow chromatographic immunoassay. | |
| The test strip consists of 1) a burgundy-colored conjugate pad | ||
| containing mouse anti-amphetamine antibodies and rabbit IgG coupled | ||
| to colloidal gold; and 2) a nitrocellulose membrane containing a Test | ||
| (T) line and a Control (C) line. The T line is coated with amphetamine- | ||
| BSA, and the C line is coated with goat anti-rabbit IgG antibody. |
113200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: 858-513-3888 ◆ Fax: 858-513-8388 Web Site: www.alfascientific.com ♦ E-mail: sales@alfascientific.com
1
| 510(k) Summary | Drug of Abuse AMP300 Urine Test |
|---|---|
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the |
| qualitative detection of amphetamine in urine specimens. This test | |
| provides only a preliminary result. A more specific alternate chemical | |
| method must be used in order to obtain a confirmed analytical result. | |
| The proposed test is for professional and point of care use only. | |
| Similarity to the | |
| Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays. |
| • Both are intended to provide qualitative detection of drug abuse. | |
| • Both are in-vitro diagnostic devices. | |
| • Both have a built-in quality control feature, C line, to indicate that an | |
| adequate volume of specimen is applied and the liquid flow occurred | |
| properly | |
| Sensitivity and | |
| Specificity | The sensitivity of the proposed device is 93.5% and the specificity is |
| 98% | |
| Accuracy | Ninety-eight clinical confirmed specimens for AMP were studied, |
| separately. The overall agreement of the AMP (300) device to the | |
| GC/MS data is 96.9%. | |
| Reproducibility | Studies were carried out at two Physician's Office Laboratories (POL) |
| and one medical reference laboratory outside Alfa. Evaluations were | |
| performed by personnel with diverse educational backgrounds and | |
| working experiences. | |
| The agreement of the three sites is 97.5%. | |
| Stability | To assess the shelf life stability claims of the proposed test, accelerated |
| degradation of the proposed device was studied. Three lots from each | |
| of the two formats (cassette and dip strip) were tested. Based on the | |
| results of the accelerated degradation study, two years (24 months) | |
| shelf life of the proposed test was predicted. | |
| Urine Specific | |
| Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to 1.035, |
| and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect | |
| the test results. | |
| Formats of the | |
| Device | The proposed device has two formats, cassette and dip-strip. The |
| cassette format is a dip-strip device assembled in a plastic housing. | |
| Studies demonstrated that the two formats are equivalent. | |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity, |
| and interference studies demonstrate that the proposed test is | |
| substantially equivalent to the predicate device. |
213200 Gregg Street, Poway, CA 92064, USA ↑ Telephone: 858-513-3888 ● Fax: 858-513-8388
2
.
・
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Image /page/2/Picture/2 description: The image shows a stylized logo with overlapping Greek letters. The letters appear to be variations of the alpha symbol, with one being a more traditional rounded form and the other having a more cursive or calligraphic style. The logo has a textured or slightly distressed appearance, giving it a vintage or artistic feel.
FDA Registered • ISO 9001/EN 46001 Certified In-Vitro Diagnostic (IVD) Devices Manufacturer • Contract R&D • OEM
Image /page/2/Picture/5 description: The image shows a logo with the letters "nsai" on top of an eye-shaped design. Below the design, there are two lines of text. The first line reads "I.S. EN ISO 9001", and the second line reads "I.S. EN 46001". The logo appears to be a certification mark related to quality management systems.
510(k) Summary
| Manufacture and Submitter | Name: Alfa Scientific Designs, Inc.
Address: 13200 Gregg Street, Poway, CA 92064
Telephone: (858) 513-3888 x 325
Fax: (858) 513-8388
Contact Person: Daiting Rong, Ph.D.
E-mail: drong@alfascientific.com |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Trade Name: INSTANT-VIEW ® Cocaine (150) Urine Test (Cassette, Dip-Strip)
INSTANT-VERDICT ® Cocaine (150) Urine Test (Cassette, Dip-Strip)
Cocaine (150) Urine Test (Cassette, Dip-Strip)
Common Name: Immunoassay, Cocaine Urine Test
Classification: Cocaine Test System
Product Code: DIO |
| Date of Summary Preparation | Nov. 16, 2006 |
| Predicate Devices | INSTANT-VIEW ® Cocaine Urine Test (510K Number: K994403)
By Alfa Scientific Designs, Inc. |
| Device Description | This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti- benzoylecgonine (cocaine) antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with benzoylecnine-BTG, and the C line is coated with goat anti-rabbit |
Safety and Effectiveness as Required by 21 CFR 807.92
113200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: 858-513-3888 ◆ Fax: 858-513-8388 Web Site: www.alfascientific.com ♦ E-mail: sales@alfascientific.com
3
| 510(k) Summary | Drug of Abuse COC150 Urine Test |
|---|---|
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the |
| qualitative detection of cocaine (benzoylecgonine) in urine specimens. | |
| This test provides only a preliminary result. A more specific alternate | |
| chemical method must be used in order to obtain a confirmed analytical | |
| result. | |
| The proposed test is for professional and point of care use only. | |
| Similarity to the | |
| Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays. |
| • Both are intended to provide qualitative detection of drug abuse. | |
| • Both are in-vitro diagnostic devices. | |
| • Both have a built-in quality control feature. C line, to indicate that an | |
| Predicate Device | • Both have a built-in quality control feature, C line, to indicate that an |
| adequate volume of specimen is applied and the liquid flow occurred | |
| properly | |
| Sensitivity and | |
| Specificity | The sensitivity of the proposed device are 96.4% and the specificity is |
| 98.1% | |
| Accuracy | One hundred and eight clinical confirmed specimens for COC were |
| studied, separately. The overall agreement of the COC (150) device to | |
| the GC/MS data is 97.2%. | |
| Reproducibility | Studies were carried out at two Physician's Office Laboratories (POL) |
| and one medical reference laboratory outside Alfa. Evaluations were | |
| performed by personnel with diverse educational backgrounds and | |
| working experiences. | |
| The agreement of the three sites is 97.9%. | |
| Stability | To assess the shelf life stability claims of the proposed test, accelerated |
| degradation of the proposed device was studied. Three lots from each | |
| of the two formats (cassette and dip strip) were tested. Based on the | |
| results of the accelerated degradation study, two years (24 months) | |
| shelf life of the proposed test was predicted. | |
| Urine Specific | |
| Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to 1.035, |
| and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect | |
| the test results. | |
| Formats of the | |
| Device | The proposed device has two formats, cassette and dip-strip. The |
| cassette format is a dip-strip device assembled in a plastic housing. | |
| Studies demonstrated that the two formats are equivalent. | |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity, |
| and interference studies demonstrate that the proposed test is |
substantially equivalent to the predicate device.
and interference studies demonstrate that the proposed test is
4
Image /page/4/Picture/2 description: The image shows a stylized, overlapping representation of the Greek letter alpha. The letters are rendered in a textured, grayscale pattern, giving them a three-dimensional appearance. The design is simple and iconic, focusing on the shape and form of the alpha symbol. The image is in black and white.
FDA Registered • ISO 9001/EN 46001 Certified In-Vitro Diagnostic (IVD) Devices Manufacturer • Contract R&D • OEM
Image /page/4/Picture/5 description: The image shows a logo with the letters "nsai" stacked on top of an eye-shaped symbol. Below the symbol, there are two lines of text. The first line reads "I.S. EN ISO 9001", and the second line reads "I.S. EN 46001". There is also some text in another language above the logo.
510(k) Summary
| Manufacture and
| Submitter | Name: | Alfa Scientific Designs, Inc. |
|---|---|---|
| Address: | 13200 Gregg Street | |
| Poway, CA 92064 | ||
| Telephone: (858) 513-3888 x 325 | ||
| Fax: (858) 513-8388 | ||
| Contact Person: | Daiting Rong, Ph.D. | |
| E-mail:drong@alfascientific.com | ||
| Trade Name: | ||
| Device Name | INSTANT-VIEW® Methamphetamine (300) Urine Test (Cassette, Dip-Strip) | |
| INSTANT-VERDICT® Methamphetamine (300) Urine Test (Cassette, Dip-Strip) | ||
| Methamphetamine (300) Urine Test (Cassette, Dip-Strip) | ||
| Common Name: | ||
| Immunoassay, Methamphetamine Urine Test | ||
| Classification: | ||
| Methamphetamine Test System | ||
| Product Code: | ||
| DJC | ||
| Date of Summary | ||
| Preparation | Nov. 16, 2006 | |
| Predicate Devices | INSTANT-VIEW® Methamphetamine Urine Test (510K Number: K003845) | |
| By Alfa Scientific Designs, Inc. | ||
| Device | ||
| Description | This assay is a one-step lateral flow chromatographic immunoassay. | |
| The test strip consists of 1) a burgundy-colored conjugate pad | ||
| containing mouse anti-methamphetamine antibodies and rabbit IgG | ||
| coupled to colloidal gold; and 2) a nitrocellulose membrane containing | ||
| a Test (T) line and a Control (C) line. The T line is coated with | ||
| methamphetamine-BSA, and the C line is coated with goat anti-rabbit | ||
| IgG antibody. |
Safety and Effectiveness as Required by 21 CFR 807.92
113200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: 858-513-3888 ◆ Fax: 858-513-8388 Web Site: www.alfascientific.com ◆ E-mail: sales@alfascientific.com
l
5
| 510(k) Summary | Drug of Abuse MET300 Urine Test |
|---|---|
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the |
| qualitative detection of methamphetamine in urine specimens. This test | |
| provides only a preliminary result. A more specific alternate chemical | |
| method must be used in order to obtain a confirmed analytical result. | |
| The proposed test is for professional and point of care use only. | |
| Similarity to the | |
| Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays. |
| • Both are intended to provide qualitative detection of drug abuse. | |
| • Both are in-vitro diagnostic devices. | |
| • Both have a built-in quality control feature, C line, to indicate that an | |
| adequate volume of specimen is applied and the liquid flow occurred | |
| properly | |
| Sensitivity and | |
| Specificity | The sensitivity of the proposed device is 96.8% and the specificity is |
| 98% | |
| Accuracy | One hundred twenty-seven clinical confirmed specimens for MET were |
| studied, separately. The overall agreement of the MET (300) device to | |
| the GC/MS data is 96.1 %. | |
| Reproducibility | Studies were carried out at two Physician's Office Laboratories (POL) |
| and one medical reference laboratory outside Alfa. Evaluations were | |
| performed by personnel with diverse educational backgrounds and | |
| working experiences. | |
| The agreement of the three sites is 97.1%. | |
| Stability | To assess the shelf life stability claims of the proposed test, accelerated |
| degradation of the proposed device was studied. Three lots from each | |
| of the two formats (cassette and dip strip) were tested. Based on the | |
| results of the accelerated degradation study, two years (24 months) | |
| shelf life of the proposed test was predicted. | |
| Urine Specific | |
| Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to 1.035, |
| and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect | |
| the test results. | |
| Formats of the | |
| Device | The proposed device has two formats, cassette and dip-strip. The |
| cassette format is a dip-strip device assembled in a plastic housing. | |
| Studies demonstrated that the two formats are equivalent. | |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity, |
| and interference studies demonstrate that the proposed test is | |
| substantially equivalent to the predicate device. |
:
6
Image /page/6/Picture/2 description: The image shows a stylized logo consisting of three overlapping Greek alpha symbols. The alphas are rendered in a grayscale pattern, giving them a textured appearance. The design is simple and abstract, focusing on the repetition and layering of the alpha character.
FDA Registered • ISO 9001/EN 46001 Certified In-Vitro Diagnostic (IVD) Devices Manufacturer • Contract R&D • OEM
Image /page/6/Picture/5 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 are the text strings "I.S. EN ISO 9001" and "I.S. EN 46001".
510(k) Summary
| Manufacture and
| Submitter | Name: | Alfa Scientific Designs, Inc. |
|---|---|---|
| Address: | 13200 Gregg Street | |
| Poway, CA 92064 | ||
| Telephone: | (858) 513-3888 x 325 | |
| Fax: | (858) 513-8388 | |
| Contact Person: | Daiting Rong, Ph.D. | |
| E-mail:drong@alfascientific.com | ||
| Device Name | Trade Name: | INSTANT-VIEW ® Oxycodone (100) Urine Test (Cassette, Dip-Strip) |
| INSTANT-VERDICT ® Oxycodone (100) Urine Test (Cassette, Dip-Strip) | ||
| Oxycodone (100) Urine Test (Cassette, Dip-Strip) | ||
| Common Name: | Immunoassay, Oxycodone Urine Test | |
| Classification: | Opiate Test System | |
| Product Code: | DJG | |
| Date of Summary | ||
| Preparation | Nov. 16, 2006 | |
| Predicate Devices | OXYCODONE One Step Oxycodone Test Strip (510K Number: | |
| K033047) | ||
| By Acon Laboratories, Inc. | ||
| Device | ||
| Description | This assay is a one-step lateral flow chromatographic immunoassay. | |
| The test strip consists of 1) a burgundy-colored conjugate pad | ||
| containing mouse anti-oxycodone antibodies and rabbit IgG coupled to | ||
| colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) | ||
| line and a Control (C) line. The T line is coated with oxycodone-BSA, | ||
| and the C line is coated with goat anti-rabbit IgG antibody. |
Safety and Effectiveness as Required by 21 CFR 807.92
113200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: 858-513-3888 ◆ Fax: 858-513-8388 Web Site: www.alfascientific.com ♦ E-mail: sales@alfascientific.com
7
| 510(k) Summary | Drug of Abuse OXY100 Urine Test |
|---|---|
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of oxycodone in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only. |
| Similarity to the | |
| Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays. |
| • Both are intended to provide qualitative detection of drug abuse. | |
| • Both are in-vitro diagnostic devices. | |
| • Both have a built-in quality control feature, C line, to indicate that an adequate volume of specimen is applied and the liquid flow occurred properly | |
| Sensitivity and | |
| Specificity | Both the sensitivity and the specificity of the proposed device are 97.6% |
| Accuracy | Seventy-five clinical confirmed specimens for OXY were studied, separately. The overall agreement of the OXY (100) device to the GC/MS data is 97.6 %. |
| Reproducibility | Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Evaluations were performed by personnel with diverse educational backgrounds and working experiences. |
| The agreement of the three sites is 96.7%. | |
| Stability | To assess the shelf life stability claims of the proposed test, accelerated degradation of the proposed device was studied. Three lots from each of the two formats (cassette and dip strip) were tested. Based on the results of the accelerated degradation study, two years (24 months) shelf life of the proposed test was predicted. |
| Urine Specific | |
| Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to 1.035, and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect the test results. |
| Formats of the | |
| Device | The proposed device has two formats, cassette and dip-strip. The cassette format is a dip-strip device assembled in a plastic housing. Studies demonstrated that the two formats are equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity, and interference studies demonstrate that the proposed test is substantially equivalent to the predicate device. |
8
Image /page/8/Picture/2 description: The image contains a stylized, black and white graphic of the lowercase Greek letter alpha (α). The letter is rendered in a bold, slightly ornate font, with thick strokes that create a sense of depth and visual weight. The design is simple yet elegant, focusing on the distinctive shape of the alpha symbol.
FDA Registered • ISO 9001/EN 46001 Certified In-Vitro Diagnostic (IVD) Devices Manufacturer • Contract R&D • OEM
Image /page/8/Picture/5 description: The image shows a logo with the text "nsai" at the top. Below the text is a symbol that resembles an eye. Underneath the eye symbol are the text strings "I.S. EN ISO 9001" and "I.S. EN 46001" stacked on top of each other. The text and symbols are all in black and are set against a white background.
510(k) Summary
| Safety and Effectiveness as Required by 21 CFR 807.92 | ||
|---|---|---|
| Manufacture and | ||
| Submitter | Name: | Alfa Scientific Designs, Inc. |
| Address: | 13200 Gregg Street | |
| Poway, CA 92064 | ||
| Telephone: (858) 513-3888 x 325 | ||
| Fax: (858) 513-8388 | ||
| Contact Person: | Daiting Rong, Ph.D. | |
| E-mail:drong@alfascientific.com | ||
| Device Name | Trade Name: | INSTANT-VIEW® Oxycodone (300) Urine Test (Cassette, Dip-Strip) |
| INSTANT-VERDICT® Oxycodone (300) Urine Test (Cassette, Dip-Strip) | ||
| Oxycodone (300) Urine Test (Cassette, Dip-Strip) | ||
| Common Name: | Immunoassay, Oxycodone Urine Test | |
| Classification: | Opiate Test System | |
| Product Code: | DJG | |
| Date of Summary | ||
| Preparation | Nov. 16, 2006 | |
| Predicate Devices | OXYCODONE One Step Oxycodone Test Strip (510K Number: | |
| K033047) | ||
| By Acon Laboratories, Inc. | ||
| Device | ||
| Description | This assay is a one-step lateral flow chromatographic immunoassay. | |
| The test strip consists of 1) a burgundy-colored conjugate pad | ||
| containing mouse anti-oxycodone antibodies and rabbit IgG coupled to | ||
| colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) | ||
| line and a Control (C) line. The T line is coated with oxycodone-BSA, | ||
| and the C line is coated with goat anti-rabbit IgG antibody. |
113200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: 858-513-3888 ◆ Fax: 858-513-3388 Web Site: www.alfascientific.com ♦ E-mail: sales@alfascientific.com
- 1
9
| 510(k) Summary | Drug of Abuse OXY300 Urine Test |
|---|---|
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the |
| qualitative detection of oxycodone in urine specimens. This test | |
| provides only a preliminary result. A more specific alternate chemical | |
| method must be used in order to obtain a confirmed analytical result. | |
| The proposed test is for professional and point of care use only. | |
| Comparison with | |
| the Predicate | Similarity Both are one-step lateral-flow chromatographic immunoassays. Both are intended to provide qualitative detection of drug abuse. Both are in-vitro diagnostic devices. Both have a built-in quality control feature, C line, to indicate that an adequate volume of specimen is applied and the liquid flow occurred properly Difference The cutoff value is 100 ng/ml for the predicate device and 300 ng/ml for the proposed device |
| Sensitivity and | |
| Specificity | The sensitivity of the proposed device is 95.2% and the specificity is |
| 100% | |
| Accuracy | One hundred fifteen clinical confirmed specimens for OXY were |
| studied, separately. The overall agreement of the OXY (300) device to | |
| the GC/MS data is 98.3 %. | |
| Reproducibility | Studies were carried out at two Physician's Office Laboratories (POL) |
| and one medical reference laboratory outside Alfa. Evaluations were | |
| performed by personnel with diverse educational backgrounds and | |
| working experiences. | |
| The agreement of the three sites is 97.5%. | |
| Stability | To assess the shelf life stability claims of the proposed test, accelerated |
| degradation of the proposed device was studied. Three lots from each | |
| of the two formats (cassette and dip strip) were tested. Based on the | |
| results of the accelerated degradation study, two years (24 months) | |
| shelf life of the proposed test was predicted. | |
| Urine Specific | |
| Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to 1.035, |
| and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect | |
| the test results. | |
| Formats of the | |
| Device | The proposed device has two formats, cassette and dip-strip. The |
| cassette format is a dip-strip device assembled in a plastic housing. | |
| Studies demonstrated that the two formats are equivalent. | |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity, |
| and interference studies demonstrate that the proposed test is | |
| substantially equivalent to the predicate device. |
213200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: 858-513-3888 ◆ Fax: 858-513-3388 Web Site: www.alfascientific.com ♦ E-mail: sales@alfascientific.com
10
Image /page/10/Picture/2 description: The image shows a stylized graphic of two overlapping Greek alpha symbols. The alpha on the left is filled with a gray halftone pattern, while the alpha on the right is outlined in black. The overlapping creates a three-dimensional effect, with the gray alpha appearing to be behind the black alpha.
FDA Registered • ISO 9001/EN 46001 Certified In-Vitro Diagnostic (IVD) Devices Manufacturer • Contract R&D • OEM
Image /page/10/Picture/5 description: The image shows a logo with the letters "nsai" on top of an oval shape. Inside the oval shape, there is a design that looks like two stylized eyes facing each other. Below the oval shape, there are two lines of text: "I.S. EN ISO 9001" and "I.S. EN 46001".
510(k) Summary
| Safety and Effectiveness as Required by 21 CFR 807.92 | ||
|---|---|---|
| Manufacture and | ||
| Submitter | Name: | Alfa Scientific Designs, Inc. |
| Address: | 13200 Gregg Street | |
| Poway, CA 92064 | ||
| Telephone: (858) 513-3888 x 325 | ||
| Fax: (858) 513-8388 | ||
| Contact Person: | Daiting Rong, Ph.D. | |
| E-mail:drong@alfascientific.com | ||
| Device Name | Trade Name: | INSTANT-VIEW® Multi-Drug of Abuse Urine Test (Panel, Cup) |
| INSTANT-VERDICT® Multi-Drug of Abuse Urine Test (Panel, Cup) | ||
| Multi-Drug of Abuse Urine Test (Panel, Cup) | ||
| Common Name: | Immunoassay, Drug of Abuse Screen Urine Test | |
| Classification: | Amphetamine Test System, Barbiturate Test System, Benzodiazepine | |
| Test System, Cocaine and Cocaine Metabolite Test System, | ||
| Methamphetamine Test System, Opiate Test System, Propoxyphene | ||
| Test System, Cannabinoid Test System, Tricyclic Antidepressant Drugs | ||
| Test System, Phencyclidine Test System | ||
| Product Code: | DKZ, DIS, JXM, DIO, DJC, DJG, JXN, LDJ, LEG, LCM | |
| Date of Summary | ||
| Preparation | October 31, 2006 | |
| 510(k) Summary | Multi-Drug of Abuse Urine Test | |
| Predicate Devices | INSTANT-VIEW ® Multi-Drugs Urine Test (510K Number: K022564) | |
| INSTANT-VIEW ® Propoxyphene Test (510K Number: K022915) | ||
| INSTANT-VIEW ® TCA Urine Test (510K Number: K022693) | ||
| INSTANT-VIEW ® MDMA Urine Test (510K Number: K022501) | ||
| INSTANT-VIEW ® BUP/NBUP Urine Test (510K Number: K060527) | ||
| INSTANT-VIEW ® Amphetamine Urine Test (510K Number: K994395) | ||
| INSTANT-VIEW ® Methamphetamine Urine Test (510K Number: K003845) | ||
| INSTANT-VIEW ® Cocaine Urine Test (510K Number: K994403) | ||
| All by Alfa Scientific Designs, Inc. | ||
| Oxycodone Test (510K Number: K033047) by Acon Laboratories, Inc. | ||
| Device Description | A one-step lateral flow chromatographic immunoassay. The device | |
| consists of any combination between one (1) to twelve (12) individual | ||
| test strip(s) for the drug(s) being tested. Each test strip in the device | ||
| consists of 1) a burgundy-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 burgundy-colored band | ||
| during test regardless of the presence of the drug. | ||
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the | |
| qualitative detection of one or more drugs or drug metabolites in urine | ||
| specimens. This test provides only a preliminary result. A more specific | ||
| alternate chemical method must be used in order to obtain a confirmed | ||
| analytical result. | ||
| The BAR, BZD, TCA test will yield preliminary positive results when | ||
| BAR, BZD, and TCA is ingested at or above therapeutic doses. There are | ||
| no uniformly recognized drug levels for barbiturate, benzodiazepine, | ||
| tricyclic antidepressant in urine. The multi-drug of abuse urine test device | ||
| shows the drug was or was not present at the cutoff level. | ||
| The proposed test is for health care professional including point of care use. | ||
| Similarity to the | ||
| Predicate Devices | • Both are one-step lateral-flow chromatographic immunoassays. | |
| • Both are intended to provide qualitative detection of drug abuse. | ||
| • Both are in-vitro diagnostic devices. | ||
| • Both have a built-in quality control feature, C line, to indicate that an | ||
| adequate volume of specimen is applied and the liquid flow occurred properly | ||
| Performance | ||
| Characteristics | The proposed multi-drug of abuse device uses exactly 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 the multi-drug of abuse | ||
| test are exactly the same as the individual tests, which have been | ||
| 510(K) cleared previously or are filed in separated sections of this | ||
| submission. | ||
| Stability | The shelf life stability of the test devices was estimated based on the | |
| accelerated degradation studies of individual test devices, three lots for | ||
| each test, each format. Two years (24 months) shelf life of the | ||
| proposed tests was predicted. | ||
| Formats of the | ||
| Device | The proposed multi-drug of abuse device has two formats, cassette and | |
| urine cup. Both formats contain between one to twelve test strips, each | ||
| for a drug. | ||
| Conclusion | The proposed test is substantially equivalent to the predicate device. |
11
12
13
Image /page/13/Picture/2 description: The image shows a stylized logo with two overlapping Greek letters, alpha. The letter on the left is filled with a gray halftone pattern, while the letter on the right is outlined in black. The letters are intertwined, creating a sense of unity and connection. The logo has a classic and elegant feel, possibly representing a brand or organization with a connection to Greek culture or academia.
FDA Registered • ISO 9001/EN 46001 Certified In-Vitro Diagnostic (IVD) Devices Manufacturer • Contract R&D • OEM
Image /page/13/Picture/5 description: The image shows a logo with the letters "nsai" on top of an eye-shaped design. Below the eye design, there are two lines of text. The first line reads "I.S. EN ISO 9001", and the second line reads "I.S. EN 46001".
510(k) Summary
| Safety and Effectiveness as Required by 21 CFR 807.92 | ||
|---|---|---|
| Manufacture and | ||
| Submitter | Name: | Alfa Scientific Designs, Inc. |
| Address: | 13200 Gregg Street | |
| Poway, CA 92064 | ||
| Telephone: (858) 513-3888 x 325 | ||
| Fax: (858) 513-8388 | ||
| Contact Person: | Daiting Rong, Ph.D. | |
| E-mail:drong@alfascientific.com | ||
| Trade Name: | INSTANT-VIEW® Multi-Drug of Abuse Urine Test (Panel, Cup) | |
| INSTANT-VERDICT® Multi-Drug of Abuse Urine Test (Panel, Cup) | ||
| Multi-Drug of Abuse Urine Test (Panel, Cup) | ||
| Device Name | Common Name: | Immunoassay, Drug of Abuse Screen Urine Test |
| Classification: | Amphetamine Test System, Barbiturate Test System, Benzodiazepine | |
| Test System, Cocaine and Cocaine Metabolite Test System, | ||
| Methamphetamine Test System, Opiate Test System, Cannabinoid Test | ||
| System, Tricyclic Antidepressant Drugs Test System, Phencyclidine | ||
| Test System | ||
| Product Code: | DKZ, DIS, JXM (NFV), DIO, DJC, DJG (NCI), JXN, LDJ, LEG, LCM | |
| Date of Summary | ||
| Preparation | October 31, 2006 | |
| Predicate Devices | INSTANT-VIEW® Multi-Drugs Urine Test (510K Number: K022564) | |
| INSTANT-VIEW® TCA Urine Test (510K Number: K022693) | ||
| INSTANT-VIEW® MDMA Urine Test (510K Number: K022501) | ||
| INSTANT-VIEW® Amphetamine Urine Test (510K Number: K994395) | ||
| INSTANT-VIEW® Methamphetamine Urine Test (510K Number: K003845) | ||
| INSTANT-VIEW® Cocaine Urine Test (510K Number: K994403) | ||
| All by Alfa Scientific Designs, Inc. |
113200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: 858-513-3888 ◆ Fax: 858-513-8388 Web Site: www.alfascientific.com ♦ E-mail: sales@alfascientific.com
1
14
| Device
Description | A one-step lateral flow chromatographic immunoassay. The device
consists of any combination between one (1) to twelve (12) individual
test strip(s) for the drug(s) being tested. Each test strip in the device
consists of 1) a burgundy-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 burgundy-colored band
during test regardless of the presence of the drug. |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the
qualitative detection of one or more drugs or drug metabolites in urine
specimens. This test provides only a preliminary result. A more specific
alternate chemical method must be used in order to obtain a confirmed
analytical result.
The BAR, BZD, TCA test will yield preliminary positive results when
BAR, BZD, and TCA is ingested at or above therapeutic doses. There
are no uniformly recognized drug levels for barbiturate, benzodiazepine,
tricyclic antidepressant in urine. The multi-drug of abuse urine test
device shows the drug was or was not present at the cutoff level.
The proposed test is for home use. |
| Similarity to the
Predicate Devices | • Both are one-step lateral-flow chromatographic immunoassays.
• Both are intended to provide qualitative detection of drug abuse.
• Both are in-vitro diagnostic devices.
• Both have a built-in quality control feature, C line, to indicate that an
adequate volume of specimen is applied and the liquid flow occurred
properly |
| Performance
Characteristics | The proposed multi-drug of abuse device uses exactly 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 the multi-drug of abuse
test are exactly the same as the individual tests, which have been
510(K) cleared previously or are filed in separated sections of this
submission. |
| Stability | The shelf life stability of the test devices was estimated based on the
accelerated degradation studies of individual test devices, three lots for
each test, each format. Two years (24 months) shelf life of the
proposed tests was predicted. |
| Formats of the
Device | The proposed multi-drug of abuse device has two formats, cassette and
urine cup. Both formats contain between one to twelve test strips, each
for a drug. |
| Conclusion | The proposed test is substantially equivalent to the predicate device. |
213200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: 858-513-3888 ◆ Fax: 858-513-8388 Web Site: www.alfascientific.com ♦ E-mail: sales@alfascientific.com
15
Image /page/15/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract eagle design, with three stylized stripes representing the feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Alfa Scientific Designs, Inc. c/o Dr. Daiting Rong 13200 Gregg Street Poway, CA 92064
MAY - 7 2007
Re: K063545
Trade/Device Name: Instant-View® Amphetamine, Cocaine, Methamphetamine, Oxycodone, and Multi-Drug Urine Tests and Instant-Verdict® Amphetamine Cocaine, Methamphetamine, Oxycodone, and Multi-Drug Urine Tests Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, DKZ, DIO, DJC, DIS, NFV, JXM, NCI, DJG, DJR, LCM, LFG, LDJ Dated: March 07, 2007 Received: March 08, 2007
Dear Dr. Rong:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
16
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
17
510(k) Number (if known): WA
Device Name:
INSTANT-VIEW® Amphetamine (300) Urine Test (Cassette, Dip-Strip) INSTANT-VERDICT® Amphetamine (300) Urine Test (Cassette, Dip-Strip) Amphetamine (300) Urine Test (Cassette, Dip-Strip)
Indications For Use:
The Amphetamine (300) test is a qualitative immunoassay for the rapid detection of amphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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.
Prescription Use × (Pert 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of In Vitro Djagnostic Devices (OIVD)
Office of In Vitro Diagnostic Device Evaluation and Safety
12-6 551
1 33
18
/ 003545
510(k) Number (if known): ★物な
Device Name:
INSTANT-VIEW® Cocaine (150) Urine Test (Cassette, Dip-Strip) INSTANT-VERDICT® Cocaine (150) Urine Test (Cassette, Dip-Strip) Cocaine (150) Urine Test (Cassette, Dip-Strip)
Indications For Use:
The Cocaine (150) test device is a rapid qualitative immunoassay for the rapid detection of cocaine (benzoylecgonine) from human urine specimens at a cutoff concentration of 150 ng/ml. It is for health care professional use only.
This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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.
Prescription Use X (Pert 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Office of In Vitro Diagnostic Device Evaluation and Safe
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