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-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.

Device 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.

AI/ML Overview

This document describes the validation of the Bionexia™ Single and Multi-Strip Cassette/Dipstick DOA Screen Panels for detecting various drugs of abuse in human urine.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported "Overall Agreement" percentages, which demonstrate the device's accuracy compared to confirmatory methods (GC/MS or LC/MS). While explicit numerical acceptance criteria for each analyte are not stated, the consistently high agreement rates (all above 93%) suggest a benchmark for acceptable performance.

Analyte	Reported Agreement (Previously Approved Panels)	Reported Agreement (Additional Panels)
Amphetamine (AMP)	98.1%	N/A
Barbiturate (BAR)	98.0%	N/A
Benzodiazepines (BZO)	93.9%	N/A
Cocaine (COC)	98.2%	N/A
Methamphetamine (MET)	98.3%	N/A
Morphine (MOR)	98.1%	97.9% (for 300 ng/ml cutoff)
Methadone (MTD)	98.1%	N/A
Phencyclidine (PCP)	98.9%	N/A
Nortriptyline (NOR)	96.8%	N/A
Marijuana (THC)	97.5%	N/A
MDMA	N/A	100.0%
EDDP	N/A	100.0%
Buprenorphine (BUP)	N/A	100.0%

Note: For analytes listed in both tables, the 'Previously Approved Panels' table likely refers to clinical specimen correlation against GC/MS/LC/MS, while the 'Additional Panels' table further breaks down agreement by concentration range for newer analytes. The morphine (MOR) entry appears twice with different cutoffs, 2000 ng/ml in the first table and 300 ng/ml in the second.

2. Sample Sizes and Data Provenance

Previously Approved Panels (Table 1):

The sample sizes for the test set vary by analyte and are provided as the denominator in the agreement percentages. For example:

AMP: 103 samples
BAR: 98 samples
BZO: 99 samples
COC: 110 samples
MET: 115 samples
MOR (2000 ng/ml): 105 samples
MTD: 105 samples
PCP: 94 samples
NOR: 95 samples
THC: 122 samples

Additional Panels (Table 2):

For each drug, the total number of samples is the sum of all categories (No Drug present, Negative, Near-Cutoff Negative, Near-Cutoff Positive, High Positive). For example:

MDMA: 35 + 7 + 9 + 12 + 63 = 126 samples
EDDP: 38 + 0 + 4 + 1 + 65 = 108 samples
BUP: 35 + 1 + 5 + 0 + 72 = 113 samples
MOR (300 ng/ml): 35 + 0 + 12 + 2 + 50 = 99 samples

Data Provenance: The data is derived from "blind-labeled clinical specimen correlation study" and "blind-labeled spiked control studies including point-of-care site study." This indicates the data is retrospective (clinical specimens) and prospective (spiked control studies). The country of origin for the data is not specified, but the submission is to the U.S. FDA, suggesting the studies were conducted to U.S. regulatory standards.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of human experts to establish ground truth for the test set. Instead, the ground truth is established by "Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) methodology," which are analytical chemical methods.

4. Adjudication Method for the Test Set

Since the ground truth is established by GC/MS or LC/MS, there is no human adjudication method (e.g., 2+1, 3+1) described or implied for the test set. The device results are directly compared to the analytical results from the confirmatory methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no MRMC comparative effectiveness study mentioned in the document. The study focuses on the performance of the Bionexia™ device compared to predicate devices and confirmatory chemical methods. There is no information provided regarding human readers' performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The tables provided (Table 1 and Table 2) detail the Bionexia™ device's performance (algorithm only, as it's an immunoassay) against the gold standard methods (GC/MS or LC/MS) or predicate devices. This represents the device's performance without a human-in-the-loop directly influencing the test result interpretation (though a healthcare professional would interpret the device's output).

7. Type of Ground Truth Used

The type of ground truth used is confirmatory analytical chemical methods, specifically Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). The document explicitly states these are "the preferred confirmatory method."

8. Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its sample size. The studies described are performance evaluations, implying these samples were used for validation rather than algorithm training. For a traditional immunoassay, there wouldn't typically be an "algorithm training set" in the same sense as machine learning. The device's characteristics are determined during its development and manufacturing process, then validated against known samples.

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

As there is no mention of a training set in the context of algorithm development, there is no information on how its ground truth was established. For the validation/test sets, as described in point 7, the ground truth was established using GC/MS or LC/MS.

Summary

{0}------------------------------------------------

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:

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

{1}------------------------------------------------

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-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.

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.

{2}------------------------------------------------

Table 1. (Previously approved panels)

Test	PositiveAgreement	NegativeAgreement	OverallAgreement
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/Cutoff(ng/ml)	CandidateDeviceResults	No Drugpresent	Negative(Less than50% thecutoffconcentrationon byGC/MS orLC/MSanalysis	Near CutoffNegative(Between50% belowthe cutoffand thecutoffconcentration)	Near CutoffPositive(Between thecutoff and50% abovethe cutoffconcentration)	HighPositive(Greater than50% abovethe cutoffconcentration)	%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.

{3}------------------------------------------------

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).

{4}------------------------------------------------

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 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

{5}------------------------------------------------

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:

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-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.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 801 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)

Page 1 of	1
-----------	---

Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
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 includedelta -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.(b)
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).