MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE

K063545 · Alfa Scientific Designs, Inc. · DJG · May 7, 2007 · Clinical Toxicology

Device Facts

• Record ID: K063545
• Device Name: MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
• Applicant: Alfa Scientific Designs, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: May 7, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

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.

Device Story

Lateral flow immunoassay for qualitative detection of drugs of abuse in human urine. Input: urine specimen. Principle: competitive binding; drug-specific antibody-coated particles compete with immobilized drug conjugate for binding sites. Output: visual burgundy line (negative) or absence of line (positive) at test region; control line indicates valid migration. Used in professional settings (clinics) and OTC (home/consumer). Operator: healthcare professional or lay user. Output interpreted visually by user to determine presence/absence of drugs at specific cutoffs. Results are preliminary; require confirmatory testing via GC/MS or HPLC for clinical decision-making. Benefits: rapid screening for potential drug abuse.

Clinical Evidence

Bench testing only. Clinical performance evaluated by comparing device results to GC/MS confirmatory data. Sensitivity (93.5%-97.6%) and specificity (98%-100%) reported across various drug analytes. Overall agreement with GC/MS ranged from 96.1% to 98.3%. Reproducibility studies conducted at multiple sites (POLs and reference labs) showed agreement rates of 96.7%-97.9%.

Technological Characteristics

Lateral flow immunochromatographic assay. Competitive binding principle. Formats: dip strip and cassette. Visual readout. No instrumentation required. Internal control line for migration validation. Analyte-specific cutoffs (e.g., 100/300 ng/mL for oxycodone).

Indications for Use

Indicated for rapid qualitative screening of drugs of abuse (Amphetamine, Barbiturates, Buprenorphine, Benzodiazepine, Cocaine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tricyclics, Marijuana, MDMA) in human urine at specified cutoff levels. For professional, point-of-care, or OTC consumer use. Provides preliminary results; requires confirmatory testing (GC/MS or HPLC).

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Instant-View Multi-Drug of Abuse Test (k022564)
• Instant-View Amphetamine Urine Test (k994395)
• Instant-View Cocaine Urine Test (k994403)
• Instant-View Methamphetamine Urine Test (k003845)
• Instant-View Propoxyphene Urine Test (k022915)
• Instant-View TCA Urine Test (k022693)
• Instant-View MDMA Screen Urine Test (k022501)
• Instant-View BUP/NBUP Screen Urine Test (k060527)
• Oxycodone (k033047)

Submission Summary (Full Text)

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FDA Registered • ISO 9001/EN 46001 Certified In-Vitro Diagnostic (IVD) Devices Manufacturer • Contract R&D • OEM

## 510(k) Summary

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I.S. EN ISO 9001
I.S. EN 46001

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K063545

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Safety and Effectiveness as Required by 21 CFR 807.92

| Manufacture and<br>Submitter | Name: | Alfa Scientific Designs, Inc. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| | Address: | 13200 Gregg Street<br>Poway, CA 92064 |
| | Telephone: | [phone] x 325 |
| | Fax: | [phone] |
| | Contact Person: | Daiting Rong, Ph.D.<br>E-mail:[e-mail] |
| Device Name | Trade Name: | <i>INSTANT-VIEW</i> ® Amphetamine (300) Urine Test (Cassette, Dip-Strip) |
| | | <i>INSTANT-VERDICT</i> ® 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<br>Preparation | Nov. 16, 2006 | |
| Predicate Devices | <i>INSTANT-VIEW</i> ® Amphetamine Urine Test (510K Number: K994395) | |
| | By Alfa Scientific Designs, Inc. | |
| Device<br>Description | This assay is a one-step lateral flow chromatographic immunoassay.<br>The test strip consists of 1) a burgundy-colored conjugate pad<br>containing mouse anti-amphetamine antibodies and rabbit IgG coupled<br>to colloidal gold; and 2) a nitrocellulose membrane containing a Test<br>(T) line and a Control (C) line. The T line is coated with amphetamine-<br>BSA, and the C line is coated with goat anti-rabbit IgG antibody. | |

113200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: [phone] ◆ Fax: [phone] Web Site: www.alfascientific.com ♦ E-mail: [e-mail]

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| 510(k) Summary | Drug of Abuse AMP300 Urine Test |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the<br>qualitative detection of amphetamine in urine specimens. This test<br>provides only a preliminary result. A more specific alternate chemical<br>method must be used in order to obtain a confirmed analytical result.<br>The proposed test is for professional and point of care use only. |
| Similarity to the<br>Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays.<br>• Both are intended to provide qualitative detection of drug abuse.<br>• Both are in-vitro diagnostic devices.<br>• Both have a built-in quality control feature, C line, to indicate that an<br>adequate volume of specimen is applied and the liquid flow occurred<br>properly |
| Sensitivity and<br>Specificity | The sensitivity of the proposed device is 93.5% and the specificity is<br>98% |
| Accuracy | Ninety-eight clinical confirmed specimens for AMP were studied,<br>separately. The overall agreement of the AMP (300) device to the<br>GC/MS data is 96.9%. |
| Reproducibility | Studies were carried out at two Physician's Office Laboratories (POL)<br>and one medical reference laboratory outside Alfa. Evaluations were<br>performed by personnel with diverse educational backgrounds and<br>working experiences.<br>The agreement of the three sites is 97.5%. |
| Stability | To assess the shelf life stability claims of the proposed test, accelerated<br>degradation of the proposed device was studied. Three lots from each<br>of the two formats (cassette and dip strip) were tested. Based on the<br>results of the accelerated degradation study, two years (24 months)<br>shelf life of the proposed test was predicted. |
| Urine Specific<br>Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to 1.035,<br>and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect<br>the test results. |
| Formats of the<br>Device | The proposed device has two formats, cassette and dip-strip. The<br>cassette format is a dip-strip device assembled in a plastic housing.<br>Studies demonstrated that the two formats are equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity,<br>and interference studies demonstrate that the proposed test is<br>substantially equivalent to the predicate device. |

213200 Gregg Street, Poway, CA 92064, USA ↑ Telephone: [phone] ● Fax: [phone]

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.<br>Address: 13200 Gregg Street, Poway, CA 92064<br>Telephone: [phone] x 325<br>Fax: [phone]<br>Contact Person: Daiting Rong, Ph.D.<br>E-mail: [e-mail] |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Trade Name: <i>INSTANT-VIEW</i> ® Cocaine (150) Urine Test (Cassette, Dip-Strip)<br><i>INSTANT-VERDICT</i> ® Cocaine (150) Urine Test (Cassette, Dip-Strip)<br>Cocaine (150) Urine Test (Cassette, Dip-Strip)<br>Common Name: Immunoassay, Cocaine Urine Test<br>Classification: Cocaine Test System<br>Product Code: DIO |
| Date of Summary Preparation | Nov. 16, 2006 |
| Predicate Devices | <i>INSTANT-VIEW</i> ® Cocaine Urine Test (510K Number: K994403)<br>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: [phone] ◆ Fax: [phone] Web Site: www.alfascientific.com ♦ E-mail: [e-mail]

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| 510(k) Summary | Drug of Abuse COC150 Urine Test |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the<br>qualitative detection of cocaine (benzoylecgonine) in urine specimens.<br>This test provides only a preliminary result. A more specific alternate<br>chemical method must be used in order to obtain a confirmed analytical<br>result.<br>The proposed test is for professional and point of care use only. |
| Similarity to the<br>Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays.<br>• Both are intended to provide qualitative detection of drug abuse.<br>• Both are in-vitro diagnostic devices.<br>• 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<br>adequate volume of specimen is applied and the liquid flow occurred<br>properly |
| Sensitivity and<br>Specificity | The sensitivity of the proposed device are 96.4% and the specificity is<br>98.1% |
| Accuracy | One hundred and eight clinical confirmed specimens for COC were<br>studied, separately. The overall agreement of the COC (150) device to<br>the GC/MS data is 97.2%. |
| Reproducibility | Studies were carried out at two Physician's Office Laboratories (POL)<br>and one medical reference laboratory outside Alfa. Evaluations were<br>performed by personnel with diverse educational backgrounds and<br>working experiences.<br>The agreement of the three sites is 97.9%. |
| Stability | To assess the shelf life stability claims of the proposed test, accelerated<br>degradation of the proposed device was studied. Three lots from each<br>of the two formats (cassette and dip strip) were tested. Based on the<br>results of the accelerated degradation study, two years (24 months)<br>shelf life of the proposed test was predicted. |
| Urine Specific<br>Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to 1.035,<br>and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect<br>the test results. |
| Formats of the<br>Device | The proposed device has two formats, cassette and dip-strip. The<br>cassette format is a dip-strip device assembled in a plastic housing.<br>Studies demonstrated that the two formats are equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity,<br>and interference studies demonstrate that the proposed test is |

substantially equivalent to the predicate device.

and interference studies demonstrate that the proposed test is

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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<br>Submitter | Name: | Alfa Scientific Designs, Inc. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| | Address: | 13200 Gregg Street<br>Poway, CA 92064 |
| | | Telephone: [phone] x 325<br>Fax: [phone] |
| | Contact Person: | Daiting Rong, Ph.D.<br>E-mail:[e-mail] |
| | 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<br>Preparation | Nov. 16, 2006 | |
| Predicate Devices | INSTANT-VIEW® Methamphetamine Urine Test (510K Number: K003845) | |
| | By Alfa Scientific Designs, Inc. | |
| Device<br>Description | This assay is a one-step lateral flow chromatographic immunoassay.<br>The test strip consists of 1) a burgundy-colored conjugate pad<br>containing mouse anti-methamphetamine antibodies and rabbit IgG<br>coupled to colloidal gold; and 2) a nitrocellulose membrane containing<br>a Test (T) line and a Control (C) line. The T line is coated with<br>methamphetamine-BSA, and the C line is coated with goat anti-rabbit<br>IgG antibody. | |

Safety and Effectiveness as Required by 21 CFR 807.92

113200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: [phone] ◆ Fax: [phone] Web Site: www.alfascientific.com ◆ E-mail: [e-mail]

l

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| 510(k) Summary | Drug of Abuse MET300 Urine Test |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the<br>qualitative detection of methamphetamine in urine specimens. This test<br>provides only a preliminary result. A more specific alternate chemical<br>method must be used in order to obtain a confirmed analytical result.<br>The proposed test is for professional and point of care use only. |
| Similarity to the<br>Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays.<br>• Both are intended to provide qualitative detection of drug abuse.<br>• Both are in-vitro diagnostic devices.<br>• Both have a built-in quality control feature, C line, to indicate that an<br>adequate volume of specimen is applied and the liquid flow occurred<br>properly |
| Sensitivity and<br>Specificity | The sensitivity of the proposed device is 96.8% and the specificity is<br>98% |
| Accuracy | One hundred twenty-seven clinical confirmed specimens for MET were<br>studied, separately. The overall agreement of the MET (300) device to<br>the GC/MS data is 96.1 %. |
| Reproducibility | Studies were carried out at two Physician's Office Laboratories (POL)<br>and one medical reference laboratory outside Alfa. Evaluations were<br>performed by personnel with diverse educational backgrounds and<br>working experiences. |
| | The agreement of the three sites is 97.1%. |
| Stability | To assess the shelf life stability claims of the proposed test, accelerated<br>degradation of the proposed device was studied. Three lots from each<br>of the two formats (cassette and dip strip) were tested. Based on the<br>results of the accelerated degradation study, two years (24 months)<br>shelf life of the proposed test was predicted. |
| Urine Specific<br>Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to 1.035,<br>and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect<br>the test results. |
| Formats of the<br>Device | The proposed device has two formats, cassette and dip-strip. The<br>cassette format is a dip-strip device assembled in a plastic housing.<br>Studies demonstrated that the two formats are equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity,<br>and interference studies demonstrate that the proposed test is<br>substantially equivalent to the predicate device. |

:

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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<br>Submitter | Name: | Alfa Scientific Designs, Inc. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Address: | 13200 Gregg Street<br>Poway, CA 92064 |
| | Telephone: | [phone] x 325 |
| | Fax: | [phone] |
| | Contact Person: | Daiting Rong, Ph.D.<br>E-mail:[e-mail] |
| Device Name | Trade Name: | <i>INSTANT-VIEW</i> ® Oxycodone (100) Urine Test (Cassette, Dip-Strip)<br><i>INSTANT-VERDICT</i> ® Oxycodone (100) Urine Test (Cassette, Dip-Strip)<br>Oxycodone (100) Urine Test (Cassette, Dip-Strip) |
| | Common Name: | Immunoassay, Oxycodone Urine Test |
| | Classification: | Opiate Test System |
| | Product Code: | DJG |
| Date of Summary<br>Preparation | Nov. 16, 2006 | |
| Predicate Devices | OXYCODONE One Step Oxycodone Test Strip (510K Number:<br>K033047)<br>By Acon Laboratories, Inc. | |
| Device<br>Description | This assay is a one-step lateral flow chromatographic immunoassay.<br>The test strip consists of 1) a burgundy-colored conjugate pad<br>containing mouse anti-oxycodone antibodies and rabbit IgG coupled to<br>colloidal gold; and 2) a nitrocellulose membrane containing a Test (T)<br>line and a Control (C) line. The T line is coated with oxycodone-BSA,<br>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: [phone] ◆ Fax: [phone] Web Site: www.alfascientific.com ♦ E-mail: [e-mail]

{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<br>Predicate Device | • Both are one-step lateral-flow chromatographic immunoassays.<br>• Both are intended to provide qualitative detection of drug abuse.<br>• Both are in-vitro diagnostic devices.<br>• 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<br>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.<br>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<br>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<br>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. |

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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<br>Submitter | Name: | Alfa Scientific Designs, Inc. |
| | Address: | 13200 Gregg Street<br>Poway, CA 92064<br>Telephone: [phone] x 325<br>Fax: [phone] |
| | Contact Person: | Daiting Rong, Ph.D.<br>E-mail:[e-mail] |
| Device Name | Trade Name: | INSTANT-VIEW® Oxycodone (300) Urine Test (Cassette, Dip-Strip)<br>INSTANT-VERDICT® Oxycodone (300) Urine Test (Cassette, Dip-Strip)<br>Oxycodone (300) Urine Test (Cassette, Dip-Strip) |
| | Common Name: | Immunoassay, Oxycodone Urine Test |
| | Classification: | Opiate Test System |
| | Product Code: | DJG |
| Date of Summary<br>Preparation | Nov. 16, 2006 | |
| Predicate Devices | OXYCODONE One Step Oxycodone Test Strip (510K Number:<br>K033047) | |
| | By Acon Laboratories, Inc. | |
| Device<br>Description | This assay is a one-step lateral flow chromatographic immunoassay.<br>The test strip consists of 1) a burgundy-colored conjugate pad<br>containing mouse anti-oxycodone antibodies and rabbit IgG coupled to<br>colloidal gold; and 2) a nitrocellulose membrane containing a Test (T)<br>line and a Control (C) line. The T line is coated with oxycodone-BSA,<br>and the C line is coated with goat anti-rabbit IgG antibody. | |

113200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: [phone] ◆ Fax: [phone] Web Site: www.alfascientific.com ♦ E-mail: [e-mail]

- 1

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| 510(k) Summary | Drug of Abuse OXY300 Urine Test |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The proposed test is a lateral flow, one-step immunoassay for the<br>qualitative detection of oxycodone in urine specimens. This test<br>provides only a preliminary result. A more specific alternate chemical<br>method must be used in order to obtain a confirmed analytical result.<br>The proposed test is for professional and point of care use only. |
| Comparison with<br>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<br>Specificity | The sensitivity of the proposed device is 95.2% and the specificity is<br>100% |
| Accuracy | One hundred fifteen clinical confirmed specimens for OXY were<br>studied, separately. The overall agreement of the OXY (300) device to<br>the GC/MS data is 98.3 %. |
| Reproducibility | Studies were carried out at two Physician's Office Laboratories (POL)<br>and one medical reference laboratory outside Alfa. Evaluations were<br>performed by personnel with diverse educational backgrounds and<br>working experiences.<br>The agreement of the three sites is 97.5%. |
| Stability | To assess the shelf life stability claims of the proposed test, accelerated<br>degradation of the proposed device was studied. Three lots from each<br>of the two formats (cassette and dip strip) were tested. Based on the<br>results of the accelerated degradation study, two years (24 months)<br>shelf life of the proposed test was predicted. |
| Urine Specific<br>Gravity and pH | The specific gravity of urine specimens, ranging from 1.002 to 1.035,<br>and the pH of urine specimens, ranging from 3.0 to 9.0, did not affect<br>the test results. |
| Formats of the<br>Device | The proposed device has two formats, cassette and dip-strip. The<br>cassette format is a dip-strip device assembled in a plastic housing.<br>Studies demonstrated that the two formats are equivalent. |
| Conclusion | The results of specificity, sensitivity, reproducibility, cross reactivity,<br>and interference studies demonstrate that the proposed test is<br>substantially equivalent to the predicate device. |

213200 Gregg Street, Poway, CA 92064, USA ◆ Telephone: [phone] ◆ Fax: [phone] Web Site: www.alfascientific.com ♦ E-mail: [e-mail]

{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<br>Submitter | Name: | Alfa Scientific Designs, Inc. |
| | Address: | 13200 Gregg Street<br>Poway, CA 92064<br>Telephone: [phone] x 325<br>Fax: [phone] |
| | Contact Person: | Daiting Rong, Ph.D.<br>E-mail:[e-mail] |
| Device Name | Trade Name: | INSTANT-VIEW® Multi-Drug of Abuse Urine Test (Panel, Cup)<br>INSTANT-VERDICT® Multi-Drug of Abuse Urine Test (Panel, Cup)<br>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<br>Test System, Cocaine and Cocaine Metabolite Test System,<br>Methamphetamine Test System, Opiate Test System, Propoxyphene<br>Test System, Cannabinoid Test System, Tricyclic Antidepressant Drugs<br>Test System, Phencyclidine Test System |
| | Product Code: | DKZ, DIS, JXM, DIO, DJC, DJG, JXN, LDJ, LEG, LCM |
| | Date of Summary<br>Preparation…