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.

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.

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.

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.

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.

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 uniformly 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.

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.

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.

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.

AI/ML Overview

The provided texts describe the acceptance criteria and performance of several in-vitro diagnostic devices for drug abuse testing. It outlines the sensitivity, specificity, accuracy, and reproducibility of tests for Amphetamine, Cocaine, Methamphetamine, Oxycodone (at two different cutoffs), and a Multi-Drug of Abuse Urine Test. The study primarily relies on comparison to GC/MS data for accuracy and general laboratory studies for reproducibility.

Here's a structured breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be "substantially equivalent" to predicate devices, and the performance metrics (sensitivity, specificity, accuracy, reproducibility) are reported. The provided cut-off levels are also part of the performance specification.

Performance Metric	Accepted Criteria (Implied by Predicate Equivalence & Regulatory Standards)	INSTANT-VIEW® Amphetamine (300) Urine Test	INSTANT-VIEW® Cocaine (150) Urine Test	INSTANT-VIEW® Methamphetamine (300) Urine Test	INSTANT-VIEW® Oxycodone (100) Urine Test	INSTANT-VIEW® Oxycodone (300) Urine Test	INSTANT-VIEW® Multi-Drug of Abuse Urine Test (Select Drugs from List based on individual clearances)
Sensitivity	Not explicitly stated as a numerical criterion, but expected to be high and comparable to predicate.	93.5%	96.4%	96.8%	97.6%	95.2%	Performance described as "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission."
Specificity	Not explicitly stated as a numerical criterion, but expected to be high and comparable to predicate.	98%	98.1%	98%	97.6%	100%	Performance described as "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission."
Accuracy (Overall Agreement to GC/MS)	Not explicitly stated as a numerical criterion, but expected to be high and comparable to predicate.	96.9%	97.2%	96.1%	97.6%	98.3%	Performance described as "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission."
Reproducibility (Agreement across sites)	Not explicitly stated as a numerical criterion, but expected to be high.	97.5%	97.9%	97.1%	96.7%	97.5%	Performance described as "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission."
Shelf Life Stability	Not explicitly stated as a numerical criterion, but demonstrated to be sufficient.	Predicted 2 years (24 months)	Predicted 2 years (24 months)	Predicted 2 years (24 months)	Predicted 2 years (24 months)	Predicted 2 years (24 months)	Predicted 2 years (24 months)
Urine Specific Gravity & pH Effect	No significant effect expected within a defined range.	No effect for specific gravity 1.002-1.035, pH 3.0-9.0	No effect for specific gravity 1.002-1.035, pH 3.0-9.0	No effect for specific gravity 1.002-1.035, pH 3.0-9.0	No effect for specific gravity 1.002-1.035, pH 3.0-9.0	No effect for specific gravity 1.002-1.035, pH 3.0-9.0	No effect for specific gravity 1.002-1.035, pH 3.0-9.0

2. Sample Sizes Used for the Test Set and Data Provenance

Amphetamine (300):
- Sample Size: 98 clinical confirmed specimens.
- Data Provenance: Clinical (implicitly from human subjects, country not specified but the manufacturing company is US-based). The studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa, suggesting real-world clinical data. Retrospective based on "clinical confirmed specimens."
Cocaine (150):
- Sample Size: 108 clinical confirmed specimens.
- Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
Methamphetamine (300):
- Sample Size: 127 clinical confirmed specimens.
- Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
Oxycodone (100):
- Sample Size: 75 clinical confirmed specimens.
- Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
Oxycodone (300):
- Sample Size: 115 clinical confirmed specimens.
- Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
Multi-Drug of Abuse Urine Test: The performance characteristics (accuracy, reproducibility, sensitivity and specificity) are stated to be "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission." This implies that the sample sizes and provenance for the multi-drug panel are derived from the individual drug tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC). These are analytical laboratory methods, not human experts. Therefore, the concept of "number of experts" or "qualifications" for establishing the ground truth as defined in this context is not applicable. The professionals operating these instruments would be trained laboratory personnel.

4. Adjudication Method for the Test Set

The primary "adjudication" for the test results is the comparison against the GC/MS data. This is a direct comparison to a gold standard analytical method, not an expert adjudication process in the traditional sense of multiple human readers. The summary also notes that "Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained," indicating that final clinical decisions would involve human judgment, but the device performance is directly compared to GC/MS.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described as being performed to compare human readers with and without AI assistance. These are standalone in-vitro diagnostic devices (immunoassays), not AI-assisted diagnostic tools for human interpretation. The "Reproducibility" studies involved personnel with diverse educational backgrounds and working experiences, but this was to assess device consistency, not human reader improvement with AI.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

Yes, the studies described are for the standalone performance of the in-vitro diagnostic devices (the test cassettes/dip-strips themselves). The sensitivity, specificity, and accuracy are reported for the device's ability to detect the targeted substances compared to the GC/MS gold standard, without a human-in-the-loop component influencing the device's measurement. The "professional and point of care use only" and "health care professional use" statements indicate human involvement for interpretation and clinical decision-making, but the performance data presented is for the device's analytical capability.

7. The Type of Ground Truth Used

The type of ground truth used is analytical gold standard comparison, specifically Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) data. This is explicitly stated as the "preferred confirmatory method" to obtain a "confirmed analytical result."

8. The Sample Size for the Training Set

The documents do not explicitly mention a separate "training set" or its sample size. These are immunoassay devices, and the development process would involve formulation, optimization, and validation, rather than a distinct "training set" as understood in machine learning contexts. The clinical confirmed specimens mentioned primarily refer to the test/validation set for assessing performance metrics like accuracy, sensitivity, and specificity against the gold standard.

9. How the Ground Truth for the Training Set Was Established

Since a distinct "training set" with established ground truth is not explicitly mentioned or relevant in the context of these in-vitro diagnostic (IVD) immunoassay devices (as opposed to machine learning algorithms), this question is not directly applicable. The device's underlying chemical and immunological principles are pre-determined during its design and manufacturing, rather than "trained" on data.

Summary

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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

K063545

۲ ﮐﻪ ۲

Safety and Effectiveness as Required by 21 CFR 807.92

Manufacture andSubmitter	Name:	Alfa Scientific Designs, Inc.
	Address:	13200 Gregg StreetPoway, 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 SummaryPreparation	Nov. 16, 2006
Predicate Devices	INSTANT-VIEW ® Amphetamine Urine Test (510K Number: K994395)
	By Alfa Scientific Designs, Inc.
DeviceDescription	This assay is a one-step lateral flow chromatographic immunoassay.The test strip consists of 1) a burgundy-colored conjugate padcontaining mouse anti-amphetamine antibodies and rabbit IgG coupledto 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

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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 thequalitative detection of amphetamine in urine specimens. This testprovides only a preliminary result. A more specific alternate chemicalmethod 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 thePredicate 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 anadequate volume of specimen is applied and the liquid flow occurredproperly
Sensitivity andSpecificity	The sensitivity of the proposed device is 93.5% and the specificity is98%
Accuracy	Ninety-eight clinical confirmed specimens for AMP were studied,separately. The overall agreement of the AMP (300) device to theGC/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 wereperformed by personnel with diverse educational backgrounds andworking experiences.The agreement of the three sites is 97.5%.
Stability	To assess the shelf life stability claims of the proposed test, accelerateddegradation of the proposed device was studied. Three lots from eachof the two formats (cassette and dip strip) were tested. Based on theresults of the accelerated degradation study, two years (24 months)shelf life of the proposed test was predicted.
Urine SpecificGravity 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 affectthe test results.
Formats of theDevice	The proposed device has two formats, cassette and dip-strip. Thecassette 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 issubstantially equivalent to the predicate device.

213200 Gregg Street, Poway, CA 92064, USA ↑ Telephone: 858-513-3888 ● Fax: 858-513-8388

・

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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 92064Telephone: (858) 513-3888 x 325Fax: (858) 513-8388Contact 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 TestClassification: Cocaine Test SystemProduct 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

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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 thequalitative detection of cocaine (benzoylecgonine) in urine specimens.This test provides only a preliminary result. A more specific alternatechemical method must be used in order to obtain a confirmed analyticalresult.The proposed test is for professional and point of care use only.
Similarity to thePredicate 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 anadequate volume of specimen is applied and the liquid flow occurredproperly
Sensitivity andSpecificity	The sensitivity of the proposed device are 96.4% and the specificity is98.1%
Accuracy	One hundred and eight clinical confirmed specimens for COC werestudied, separately. The overall agreement of the COC (150) device tothe 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 wereperformed by personnel with diverse educational backgrounds andworking experiences.The agreement of the three sites is 97.9%.
Stability	To assess the shelf life stability claims of the proposed test, accelerateddegradation of the proposed device was studied. Three lots from eachof the two formats (cassette and dip strip) were tested. Based on theresults of the accelerated degradation study, two years (24 months)shelf life of the proposed test was predicted.
Urine SpecificGravity 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 affectthe test results.
Formats of theDevice	The proposed device has two formats, cassette and dip-strip. Thecassette 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

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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 andSubmitter	Name:	Alfa Scientific Designs, Inc.
	Address:	13200 Gregg StreetPoway, CA 92064
		Telephone: (858) 513-3888 x 325Fax: (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 SummaryPreparation	Nov. 16, 2006
Predicate Devices	INSTANT-VIEW® Methamphetamine Urine Test (510K Number: K003845)
	By Alfa Scientific Designs, Inc.
DeviceDescription	This assay is a one-step lateral flow chromatographic immunoassay.The test strip consists of 1) a burgundy-colored conjugate padcontaining mouse anti-methamphetamine antibodies and rabbit IgGcoupled to colloidal gold; and 2) a nitrocellulose membrane containinga Test (T) line and a Control (C) line. The T line is coated withmethamphetamine-BSA, and the C line is coated with goat anti-rabbitIgG 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

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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 thequalitative detection of methamphetamine in urine specimens. This testprovides only a preliminary result. A more specific alternate chemicalmethod 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 thePredicate 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 anadequate volume of specimen is applied and the liquid flow occurredproperly
Sensitivity andSpecificity	The sensitivity of the proposed device is 96.8% and the specificity is98%
Accuracy	One hundred twenty-seven clinical confirmed specimens for MET werestudied, separately. The overall agreement of the MET (300) device tothe 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 wereperformed by personnel with diverse educational backgrounds andworking experiences.
	The agreement of the three sites is 97.1%.
Stability	To assess the shelf life stability claims of the proposed test, accelerateddegradation of the proposed device was studied. Three lots from eachof the two formats (cassette and dip strip) were tested. Based on theresults of the accelerated degradation study, two years (24 months)shelf life of the proposed test was predicted.
Urine SpecificGravity 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 affectthe test results.
Formats of theDevice	The proposed device has two formats, cassette and dip-strip. Thecassette 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 issubstantially 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 andSubmitter	Name:	Alfa Scientific Designs, Inc.
	Address:	13200 Gregg StreetPoway, 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 SummaryPreparation	Nov. 16, 2006
Predicate Devices	OXYCODONE One Step Oxycodone Test Strip (510K Number:K033047)By Acon Laboratories, Inc.
DeviceDescription	This assay is a one-step lateral flow chromatographic immunoassay.The test strip consists of 1) a burgundy-colored conjugate padcontaining mouse anti-oxycodone antibodies and rabbit IgG coupled tocolloidal 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 thePredicate 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 andSpecificity	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 SpecificGravity 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 theDevice	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 andSubmitter	Name:	Alfa Scientific Designs, Inc.
	Address:	13200 Gregg StreetPoway, CA 92064Telephone: (858) 513-3888 x 325Fax: (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 SummaryPreparation	Nov. 16, 2006
Predicate Devices	OXYCODONE One Step Oxycodone Test Strip (510K Number:K033047)
	By Acon Laboratories, Inc.
DeviceDescription	This assay is a one-step lateral flow chromatographic immunoassay.The test strip consists of 1) a burgundy-colored conjugate padcontaining mouse anti-oxycodone antibodies and rabbit IgG coupled tocolloidal 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

{9}------------------------------------------------

510(k) Summary	Drug of Abuse OXY300 Urine Test
Intended Use	The proposed test is a lateral flow, one-step immunoassay for thequalitative detection of oxycodone in urine specimens. This testprovides only a preliminary result. A more specific alternate chemicalmethod must be used in order to obtain a confirmed analytical result.The proposed test is for professional and point of care use only.
Comparison withthe 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 andSpecificity	The sensitivity of the proposed device is 95.2% and the specificity is100%
Accuracy	One hundred fifteen clinical confirmed specimens for OXY werestudied, separately. The overall agreement of the OXY (300) device tothe 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 wereperformed by personnel with diverse educational backgrounds andworking experiences.The agreement of the three sites is 97.5%.
Stability	To assess the shelf life stability claims of the proposed test, accelerateddegradation of the proposed device was studied. Three lots from eachof the two formats (cassette and dip strip) were tested. Based on theresults of the accelerated degradation study, two years (24 months)shelf life of the proposed test was predicted.
Urine SpecificGravity 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 affectthe test results.
Formats of theDevice	The proposed device has two formats, cassette and dip-strip. Thecassette 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 issubstantially 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 andSubmitter	Name:	Alfa Scientific Designs, Inc.
	Address:	13200 Gregg StreetPoway, CA 92064Telephone: (858) 513-3888 x 325Fax: (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, BenzodiazepineTest System, Cocaine and Cocaine Metabolite Test System,Methamphetamine Test System, Opiate Test System, PropoxypheneTest System, Cannabinoid Test System, Tricyclic Antidepressant DrugsTest System, Phencyclidine Test System
	Product Code:	DKZ, DIS, JXM, DIO, DJC, DJG, JXN, LDJ, LEG, LCM
	Date of SummaryPreparation	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 deviceconsists of any combination between one (1) to twelve (12) individualtest strip(s) for the drug(s) being tested. Each test strip in the deviceconsists of 1) a burgundy-colored conjugate pad containing colloidalgold coupled with the anti-drug antibodies and 2) nitrocellulosemembrane containing a test line (T line) coated with the conjugateddrug antigen and a control line (C line). The C line serves as an internalquality control of the system and appears as a burgundy-colored bandduring test regardless of the presence of the drug.
Intended Use	The proposed test is a lateral flow, one-step immunoassay for thequalitative detection of one or more drugs or drug metabolites in urinespecimens. This test provides only a preliminary result. A more specificalternate chemical method must be used in order to obtain a confirmedanalytical result.The BAR, BZD, TCA test will yield preliminary positive results whenBAR, BZD, and TCA is ingested at or above therapeutic doses. There areno uniformly recognized drug levels for barbiturate, benzodiazepine,tricyclic antidepressant in urine. The multi-drug of abuse urine test deviceshows 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 thePredicate 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 anadequate volume of specimen is applied and the liquid flow occurred properly
PerformanceCharacteristics	The proposed multi-drug of abuse device uses exactly the sametechnology and formulations for the detection of the drugs as individualtest devices. The performance characteristics, such as accuracy,reproducibility, sensitivity and specificity of the multi-drug of abusetest are exactly the same as the individual tests, which have been510(K) cleared previously or are filed in separated sections of thissubmission.
Stability	The shelf life stability of the test devices was estimated based on theaccelerated degradation studies of individual test devices, three lots foreach test, each format. Two years (24 months) shelf life of theproposed tests was predicted.
Formats of theDevice	The proposed multi-drug of abuse device has two formats, cassette andurine cup. Both formats contain between one to twelve test strips, eachfor 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 andSubmitter	Name:	Alfa Scientific Designs, Inc.
	Address:	13200 Gregg StreetPoway, CA 92064Telephone: (858) 513-3888 x 325Fax: (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, BenzodiazepineTest System, Cocaine and Cocaine Metabolite Test System,Methamphetamine Test System, Opiate Test System, Cannabinoid TestSystem, Tricyclic Antidepressant Drugs Test System, PhencyclidineTest System
	Product Code:	DKZ, DIS, JXM (NFV), DIO, DJC, DJG (NCI), JXN, LDJ, LEG, LCM
Date of SummaryPreparation	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

{14}------------------------------------------------

DeviceDescription	A one-step lateral flow chromatographic immunoassay. The deviceconsists of any combination between one (1) to twelve (12) individualtest strip(s) for the drug(s) being tested. Each test strip in the deviceconsists of 1) a burgundy-colored conjugate pad containing colloidalgold coupled with the anti-drug antibodies and 2) nitrocellulosemembrane containing a test line (T line) coated with the conjugateddrug antigen and a control line (C line). The C line serves as an internalquality control of the system and appears as a burgundy-colored bandduring test regardless of the presence of the drug.
Intended Use	The proposed test is a lateral flow, one-step immunoassay for thequalitative detection of one or more drugs or drug metabolites in urinespecimens. This test provides only a preliminary result. A more specificalternate chemical method must be used in order to obtain a confirmedanalytical result.The BAR, BZD, TCA test will yield preliminary positive results whenBAR, BZD, and TCA is ingested at or above therapeutic doses. Thereare no uniformly recognized drug levels for barbiturate, benzodiazepine,tricyclic antidepressant in urine. The multi-drug of abuse urine testdevice shows the drug was or was not present at the cutoff level.The proposed test is for home use.
Similarity to thePredicate 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 anadequate volume of specimen is applied and the liquid flow occurredproperly
PerformanceCharacteristics	The proposed multi-drug of abuse device uses exactly the sametechnology and formulations for the detection of the drugs as individualtest devices. The performance characteristics, such as accuracy,reproducibility, sensitivity and specificity of the multi-drug of abusetest are exactly the same as the individual tests, which have been510(K) cleared previously or are filed in separated sections of thissubmission.
Stability	The shelf life stability of the test devices was estimated based on theaccelerated degradation studies of individual test devices, three lots foreach test, each format. Two years (24 months) shelf life of theproposed tests was predicted.
Formats of theDevice	The proposed multi-drug of abuse device has two formats, cassette andurine cup. Both formats contain between one to twelve test strips, eachfor 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:

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:

Prescription Use X (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 Diagnostic Devices (OIVD)

Signature

Office of In Vitro Diagnostic Device Evaluation and Safe

K063545

{19}------------------------------------------------

<063545

510(k) Number (if known): NYA

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)

Indications For Use:

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 Diagnostic Devices (OIVD)

Sign-On

fice of In Vitro Diagnostic Device Evaluation and Safety

KD63545

{20}------------------------------------------------

< 063545 510(k) Number (if known): N///

Device 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)

Indications For Use:

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 Diagnostic Devices (OIVD)

Diagnostic Devices (OTVD)

Consign-On

Tice of In Vitro Diagnostic Device intion and Sately

Alfa Scientific Designs, Inc.

{21}------------------------------------------------

KD63595 510(k) Number (if known): 柳州

Device 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)

Indications For Use:

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 Diagnostic Devices (OIVD)

Office of In Vitro Diagnostic Device
Evaluation and Safety

{22}------------------------------------------------

D63545

510(k) Number (if known): 19/2

Device 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)

Indications For Use:

Abbreviation	Test	Cutoff
AMP	Amphetamine	1000 ng/ml
AMP300	Amphetamine	300 ng/ml
BAR	Barbiturates	200 ng/ml
BUP	Buprenorphine/Norbuprenorphine	10 ng/ml
BZD	Benzodiazepine	300 ng/ml
COC	Cocaine	300 ng/ml
COC150	Cocaine	150 ng/ml
MET	Methamphetamine	1000 ng/ml
MET500	Methamphetamine	500 ng/ml
MET300	Methamphetamine	300 ng/ml
MOR	Morphine	2000 ng/ml
MOR300	Morphine	300 ng/ml
MTD	Methadone	300 ng/ml
OXY100	Oxycodone	100 ng/ml
OXY300	Oxycodone	300 ng/ml
PCP	Phencyclidine	25 ng/ml
PPX	Propoxyphene	300 ng/ml
TCA	Tricyclics	1000 ng/ml
THC	Marijuana	50 ng/ml
XTC	MDMA or Ecstasy	500 ng/ml

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.

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 Diagnostic Devices (OIVD)

{23}------------------------------------------------

510(k) Number (if known): WA

Device 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)

Indications For Use:

Abbreviation	Test	Cutoff
AMP	Amphetamine	1000 ng/ml
BAR	Barbiturates	200 ng/ml
BZD	Benzodiazepine	300 ng/ml
COC	Cocaine	300 ng/ml
MET	Methamphetamine	1000 ng/ml
MOR	Morphine	2000 ng/ml
MTD	Methadone	300 ng/ml
PCP	Phencyclidine	25 ng/ml
TCA	Tricyclics	1000 ng/ml
THC	Marijuana	50 ng/ml
XTC	MDMA or Ecstasy	500 ng/ml

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.

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.)
CDRH Office of In Vitro Diagnostic Devices (OVD)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Approval Sign-Off

Office of In Vitro Diagnostic Devi

valuation and Safety

Regulation Number and Section

§ 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).