Predicate Devices

K 022589, K 013380

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies describe a rapid chromatographic immunoassay, which is a traditional chemical test method and does not involve AI or ML. There are no mentions of AI, ML, or related technologies in the provided text.

Therapeutic

No.
This device is a diagnostic immunoassay used to detect drugs of abuse in urine, not to treat a condition.

Diagnostic

Yes

The device is described as a rapid chromatographic immunoassay that performs qualitative and simultaneous detection of drugs in human urine. It is used by healthcare professionals to assist in the determination of drug compliance, indicating its role in identifying specific conditions or markers for medical purposes.

SaMD (Software as a Medical Device)

No

The device is described as a "rapid chromatographic immunoassay" and a "colloidal gold based chromatographic immunoassay," which are descriptions of a physical test kit or strip, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the device is for the "qualitative and simultaneous detection of one to thirteen of the following drugs... in human urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
Device Description: The description confirms it's a "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." This further reinforces its nature as an in vitro test.
Intended User/Care Setting: It's intended for "health care professionals use including professionals at point of care sites (POC)," indicating its use in a healthcare setting for diagnostic purposes.
Performance Studies: The document describes performance studies using "clinical specimens," which are biological samples used to evaluate the diagnostic accuracy of the device.
Predicate Device(s): The mention of predicate devices with K numbers (K 022589 and K 013380) strongly suggests that this device is being compared to other legally marketed IVD devices.

All of these points align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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
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.

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.

Product codes (comma separated list FDA assigned to the subject device)

LDJ, DIO, DNK, DKZ, DJC, DIS, JXM, DJR, LFG, DJC, DJR, DJG, LCM

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care professionals use including professionals at point of care sites (POC)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Table 1. (Previously approved panels)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K 022589, K 013380

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

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:

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

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.

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.

2

Table 1. (Previously approved panels)

| Test | Positive
Agreement | Negative
Agreement | Overall
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
/
Cutoff
(ng/ml) | Candidate
Device
Results | No Drug
present | Negative
(Less than
50% the
cutoff
concentration
on by
GC/MS or
LC/MS
analysis | Near Cutoff
Negative
(Between
50% below
the cutoff
and the
cutoff
concentration
) | Near Cutoff
Positive
(Between the
cutoff and
50% above
the cutoff
concentration
) | High
Positive
(Greater than
50% above
the cutoff
concentration
) | %
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:

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.

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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

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