BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,

K080467 · Applied Dna Technologies, Inc. · LDJ · Nov 25, 2008 · Clinical Toxicology

Device Facts

• Record ID: K080467
• Device Name: BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,
• Applicant: Applied Dna Technologies, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Nov 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The Applied DNA Technologies Bionexia™ DOA Screen Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to thirteen of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows: [Table of analytes and cutoffs]. The test kits are for health care professionals use including professionals at point of care sites to assist in the determination of drug compliance. This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are 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 indicated.

Device Story

One-step, colloidal gold-based chromatographic immunoassay; detects drugs of abuse in human urine. Device format: single/multi-strip cassette or dipstick. Used by healthcare professionals at point-of-care sites. Input: human urine sample. Principle: competitive binding immunoassay; drug in sample competes with drug conjugate for limited antibody binding sites. Output: visual qualitative result (presence/absence of colored lines). Healthcare provider interprets visual lines to determine presumptive positive or negative status. Results assist in drug compliance assessment; preliminary nature requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making.

Clinical Evidence

Clinical performance evaluated via blind-labeled clinical specimen correlation studies and spiked control studies. Compared against GC/MS or LC/MS methodology. Total correlation >93.9%. Specificity, sensitivity, and precision demonstrated across all analytes. Table data shows high positive/negative agreement (e.g., AMP 98.1% overall, COC 98.2% overall, THC 97.5% overall).

Technological Characteristics

Lateral flow immunochromatographic assay. Components: membrane strips pre-coated with drug-protein conjugates, antibody-colloidal gold conjugate pad. Formats: cassette (plastic housing) or dipstick. Qualitative, visually read. No instrumentation required. Analyte-specific monoclonal antibodies used. Operates via capillary action. No specific materials or standards cited.

Indications for Use

Indicated for qualitative, simultaneous detection of 1-13 drugs (AMP, BAR, BZO, COC, THC, MET, MTD, MOR, PCP, NOR, MDMA, BUP, EDDP) in human urine. Intended for use by healthcare professionals, including at point-of-care sites, to assist in drug compliance determination. Provides preliminary analytical results; requires confirmation via GC/MS or LC/MS.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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

• ACON One Step Ecstasy Screen Test (k022589)
• ACON One Step Morphine 300 Test (k013380)

Submission Summary (Full Text)

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# 510(k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

# The Assigned 510(k) number is k080467

NOV 2 5 2008

Date of Summary: November 21, 2008

Common Name: Drugs of Abuse Screening Tests

#### Regulatory Information:

- 1. Regulation sections: 21 CFR part 862.3870 (THC), 3250 (COC), 3640 (MOR), 3100 (AMP), 3610 (MET), 3150 (BAR), 3170 (BZO), 3620 (MTD), 3910 (NOR), 3610 (MDMA), 3620 (EDDP), 3650 (BUP), 3640 (MOR300), and Non-applicable (PCP). 2. Classification: Class II: LDJ (THC), DIO (COC), DNK (MOR), DKZ (AMP), DJC (MET), DIS 3. Product Code: (BAR), JXM (BZO), DJR (MTD), LFG (NOR), DJC (MDMA), DJR (EDDP), DJG (BUP), DNK (MOR300), and LCM (PCP).
- Clinical Toxicology, 91 4. Panel:

## Name of Submitter:

Applied DNA Technologies Inc. 10239 Flanders Court San Diego, CA 92121

#### Contact Person:

Feng-Yu Lee

## Identification / Product Name:

Bionexia™ Single and Multi-Strip Cassette/Dipstick DOA Screen Panels

#### Description:

One-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines, Nortriptyline, Ecstasy, Buprenorphine and Methadone metabolite -EDDP, in human urine.

#### Intended Use:

The Applied DNA Technologies Bionexia™ DOA Screen Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to thirteen of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:

| Analyte | Abbreviation | Direct Calibrator | Cutoff Concentration |
|-----------------|--------------|------------------------------|----------------------|
| Amphetamine | AMP | Amphetamine | 1000 ng/ml |
| Barbiturate | BAR | Secobarbital | 300 ng/ml |
| Benzodiazepines | BZO | Oxazepam | 300 ng/ml |
| Cocaine | COC | Benzoylecgonine | 300 ng/ml |
| Marijuana | THC | 11-nor- $\Delta$ 9-THC9-COOH | 50 ng/ml |

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| Methamphetamine | MET | Methamphetamine | 1000 ng/ml |
|-----------------|------|-------------------------------------------------------|------------|
| Methadone | MTD | Methadone | 300 ng/ml |
| Morphine | MOR | Morphine | 2000 ng/ml |
| Morphine | MOR | Morphine | 300 ng/ml |
| Phencyclidine | PCP | Phencyclidine | 25 ng/ml |
| Nortriptyline | NOR | Nortriptyline | 1000 ng/ml |
| Ecstasy | MDMA | 3,4-Methylenediioxy-MET | 500 ng/ml |
| Buprenorphine | BUP | BUP-3-D-Glucuronide | 10 ng/ml |
| EDDP | EDDP | 2-ethylidene-1,5-dimethyl-<br>3,3-diphenylpyrrolidine | 100 ng/ml |

The test kits are for health care professionals use including professionals at point of care sites to assist in the determination of drug compliance.

This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are 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 indicated.

## Predicate Kit:

ACON One Step Drug Screen Tests are used as predicate device for ADT's Bionexia™ Single and Multi-Strip DOA Screen Panels to compare their performance with the GC/MS confirmed clinical urine specimens.

| 510(k) numbers for predicate devices are: | |
|-------------------------------------------|----------|
| ACON One Step Ecstasy Screen Test | K 022589 |
| ACON One Step Morphine 300 Test | K 013380 |

#### Performance:

The product performance characteristics of ADT's Bionexia™ DOA Screen Panels were evaluated in the blind-labeled clinical specimen correlation study and in the blind-labeled spiked control studies including point-of-care site study. The results of these studies demonstrate ADT's Bionexia"" DOA Screen Panels to be substantially equivalent to the performance characteristics of GC/MS methodology as well as ACON's One Step DOA Test Panels. Correlation studies, using clinical specimens, produced a > 93.9% total correlation when compared to the GC/MS or LC/MS methodology.

#### Bionexia™ DOA Screening Panels vs. GC/MS (or LC/MS) Analysis

Samples with drug concentration above the cutoff level were considered presumptive positive and concentration below the cutoff were considered negative.

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Table 1. (Previously approved panels)

| Test | Positive<br>Agreement | Negative<br>Agreement | Overall<br>Agreement |
|------|-----------------------|-----------------------|----------------------|
| AMP | 46/48 = 95.8% | 55/55 = 100% | 101/103 = 98.1% |
| BAR | 45/46 = 97.8% | 51/52 = 98.1 % | 96/98 = 98.0% |
| BZO | 41/43 = 95.3% | 52/56 = 92.9% | 93/99 = 93.9% |
| COC | 55/56 = 98.2% | 53/54 = 98.1% | 108/110 = 98.2% |
| MET | 61/63 = 96.8% | 52/52 = 100% | 113/115 = 98.3% |
| MOR | 40/41 = 97.6% | 63/64 = 98.4% | 103/105 = 98.1% |
| MTD | 49/51 = 96.1% | 54/54 = 100% | 103/105 = 98.1% |
| PCP | 45/46 = 97.8% | 48/48 = 100% | 93/94 = 98.9% |
| NOR | 35/38 = 92.1% | 57/57 = 100% | 92/95 = 96.8% |
| THC | 60/62 = 96.8% | 59/60 = 98.3% | 119/122 = 97.5% |

# Table 2. (Additional Panels)

| Drug<br>/<br>Cutoff<br>(ng/ml) | Candidate<br>Device<br>Results | No Drug<br>present | Negative<br>(Less than<br>50% the<br>cutoff<br>concentration<br>on by<br>GC/MS or<br>LC/MS<br>analysis | Near Cutoff<br>Negative<br>(Between<br>50% below<br>the cutoff<br>and the<br>cutoff<br>concentration<br>) | Near Cutoff<br>Positive<br>(Between the<br>cutoff and<br>50% above<br>the cutoff<br>concentration<br>) | High<br>Positive<br>(Greater than<br>50% above<br>the cutoff<br>concentration<br>) | %<br>Agreement |
|--------------------------------|--------------------------------|--------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------|
| MDMA | + | 0 | 0 | 0 | 12 | 63 | 100.0 % |
| 500 | - | 35 | 7 | 9 | 0 | 0 | 100.0 % |
| EDDP | + | 0 | 0 | 0 | 3 | 65 | 98.6% |
| 100 | - | 38 | 0 | 4 | 1 | 0 | 100.0% |
| BUP | + | 0 | 0 | 0 | 4 | 72 | 100.0% |
| 10 | - | 35 | 1 | 5 | 0 | 0 | 100.0% |
| MOR | + | 0 | 0 | 1 | 11 | 50 | 96.8 % |
| 300 | - | 35 | 0 | 12 | 2 | 0 | 97.9 % |

## Conclusion:

Results of Accuracy, Sensitivity, Precision, POC site study, Specificity and Interference studies dcmonstrate the substantial equivalency between ADT's Bionexia™ DOA Screen Panels and the ACON One Step DOA Screen Test panels. It is also demonstrated that ADT's Bionexia™ DOA Scroon Panels are safe and effective in detecting Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methamphetamine, Methadone, Morphine, Phencyclidine, Nortriptyline, Ecstasy, Buprenorphine and Methadone metabolite - EDDP, in human urine specimen.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three overlapping lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Applied DNA Technologies, Inc. c/o Ms. Feng-Yu Lee Vice President of Operation 26251 Verona Place Mission Viejo, CA 92692

NOV 2 5 2008

k080467 Re:

Trade Name: ADT's Bionexia™ Single and Multi-Strip Cassette/Dipstick DOA Screen Panels Regulation Number: 21 CFR §862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: LDJ, DIO, DNK, DKZ, DJC, DIS, JXM, DJR, LFG, DJC, DJR, DJG, LCM Dated: November 11, 2008 Received: November 13, 2008

Dear Ms. Lee:

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).

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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 [phone]. 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 [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Coopes, M.S., D.V.M.

Yean 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

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# Indications for Use

510(k) Number (if known): k080467

Device Name: ADT's Bionexia™ Single and Multi-Strip Cassette/Dipstick DOA Screen Panels

#### Indications For Use:

The Applied DNA Technologies Bionexia™ DOA Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to thirteen of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:

| Analyte | Abbreviation | Calibrator | Cutoff Concentration |
|-----------------|--------------|-------------------------------------------------------|----------------------|
| Amphetamine | AMP | Amphetamine | 1000 ng/ml |
| Barbiturate | BAR | Secobarbital | 300 ng/ml |
| Benzodiazepines | BZO | Oxazepam | 300 ng/ml |
| Cocaine | COC | Benzoylecgonine | 300 ng/ml |
| Marijuana | THC | 11-nor- $\Delta^{9}$ -THC9-COOH | 50 ng/ml |
| Methamphetamine | MET | Methamphetamine | 1000 ng/ml |
| Methadone | MTD | Methadone | 300 ng/ml |
| Morphine | MOR | Morphine | 2000 ng/ml |
| Morphine | MOR | Morphine | 300 ng/ml |
| Phencyclidine | PCP | Phencyclidine | 25 ng/ml |
| Nortriptyline | NOR | Nortriptyline | 1000 ng/ml |
| Ecstasy | MDMA | 3,4-Methylenediioxy-MET | 500 ng/ml |
| Buprenorphine | BUP | BUP-3-D-Glucuronide | 10 ng/ml |
| EDDP | EDDP | 2-ethylidene-1,5-dimethyl-<br>3,3-diphenylpyrrolidine | 100 ng/ml |

For health care professionals use including professionals at point of care sites (POC) to assist in the determination of drug compliance.

This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are 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 indicated.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) |
|-------------------------------------------------|---|--------|------------------------------------------------|
|-------------------------------------------------|---|--------|------------------------------------------------|

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