Applied DNA Technologies ACCUSTEP DOA Panels are rapid chromatographic The immunoassays for the qualitative and simultaneous detection of one to ten 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
Phencyclidine	PCP	Phencyclidine	25 ng/ml
Nortriptyline	NOR	Nortriptyline	1000 ng/ml

These test kits are intended for health care professional use only.

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 and Nortriptyline, a Tricyclic Antidepressant, in human urine.

AI/ML Overview

The ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels are rapid chromatographic immunoassays designed for the qualitative and simultaneous detection of various drugs in human urine. The study presented supports the device's substantial equivalence to predicate devices and GC/MS methodology.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Overall Agreement" reported against GC/MS analysis. While specific numerical acceptance criteria (e.g., "must achieve >95% overall agreement") are not explicitly stated, the presented performance data demonstrates high agreement with the gold standard.

Analyte	Acceptance Criteria (Implied)	Reported Device Performance (Overall Agreement with GC/MS)
Amphetamine	High agreement with GC/MS	98.1% (101/103)
Barbiturate	High agreement with GC/MS	98.0% (96/98)
Benzodiazepines	High agreement with GC/MS	93.9% (93/99)
Cocaine	High agreement with GC/MS	98.2% (108/110)
Methamphetamine	High agreement with GC/MS	98.3% (113/115)
Morphine	High agreement with GC/MS	98.1% (103/105)
Methadone	High agreement with GC/MS	98.1% (103/105)
Phencyclidine	High agreement with GC/MS	98.9% (93/94)
Nortriptyline	High agreement with GC/MS	96.8% (92/95)
Marijuana (THC)	High agreement with GC/MS (or >92% correlation with predicate)	97.5% (119/122)

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

The sample sizes for the test set vary by analyte, ranging from 94 to 122 clinical urine specimens.

AMP: 103 samples (48 positive, 55 negative)
BAR: 98 samples (46 positive, 52 negative)
BZO: 99 samples (43 positive, 56 negative)
COC: 110 samples (56 positive, 54 negative)
MET: 115 samples (63 positive, 52 negative)
MOR: 105 samples (41 positive, 64 negative)
MTD: 105 samples (51 positive, 54 negative)
PCP: 94 samples (46 positive, 48 negative)
NOR: 95 samples (38 positive, 57 negative)
THC: 122 samples (62 positive, 60 negative)

The data provenance is stated as "blind-labeled clinical specimen correlation study" using "clinical urine specimens." The country of origin is not specified, but the submission is to the US FDA, implying that the specimens would be relevant to the US population or a general population. This is a retrospective study using previously collected clinical samples.

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

The ground truth for the test set was established using Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) as the "preferred confirmatory method." These are analytical chemical methods, not human expert evaluations for establishing ground truth in this context. Therefore, human experts were not used to establish the ground truth for the test set; rather, a laboratory analytical method was used.

4. Adjudication Method for the Test Set

No adjudication method for the test set is mentioned, as the ground truth was established by analytical chemical methods (GC/MS or LC/MS), not by human expert consensus that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This device is a rapid diagnostic immunoassay for drug detection, not an AI-powered image analysis system or a device that directly assists human readers in interpreting complex cases. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.

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

Yes, the performance study directly evaluates the "ACCUSTEP DOA Screening Panels vs. GC/MS Analysis," which represents the standalone performance of the device without human interpretation or intervention in the analytical result. The device itself produces a "qualitative and simultaneous detection" result, which is then compared to the GC/MS result. Health care professionals interpret this result, but the study focuses on the device's accuracy in detecting the drug.

7. The Type of Ground Truth Used

The type of ground truth used is analytical chemical confirmation via Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This is typical for immunoassay submissions where the device's analytical performance is evaluated rather than an AI model's learning phase. The "performance characteristics... were evaluated in the laboratory settings and in the blind-labeled clinical specimen correlation study" implies an evaluation of the final product, not a training phase.

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

As no training set is explicitly mentioned for an AI model, the method for establishing its ground truth is not applicable. The device's underlying immunoassay technology does not involve machine learning that requires a separate training set in the conventional sense.

Summary

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

The Assigned 510(k) number is K061005

Name of Submitter:

Applied DNA Technologies Inc. 3337 Fosca Street Carlsbad, CA 92009 Tel .: (714) 624-2347 Fax: (949) 348-2372

Contact Person:

Feng-Yu Lee

Identification / Product Name:

ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels

Description:

Intended Use:

The Applied DNA Technologies ACCUSTEP DOA Screen Panels are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to ten of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct callbrator 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- $Δ9$ -THC9-COOH	50 ng/ml
Methamphetamine	MET	Methamphetamine	1000 ng/ml
Methadone	MTD	Methadone	300 ng/ml
Morphine	MOR	Morphine	2000 ng/ml
Phencyclidine	PCP	Phencyclidine	25 ng/ml
Nortriptyline	NOR	Nortriptyline	1000 ng/ml

These test kits are intended for health care professional use only.

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

OCT - 4 2006

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Predicate Kit:

Predicate KIT:
ACON One Step Multi-Drug Screen Test Card are used as predicate device for ACCUSTEP Single ACON One Step Multi-Drug Goreen Post Sare are are are are with the GC/MS confirmed clinical urine specimens.

510(k) number for these predicate devices are:
ACON One Step Multi-Drug and Multi-Line Screen Test Card and Device	K023946
ACON One Step Multi-Drug and Multi-Line Screen Test Card and Device	K020313

Performance:

reflorinance characteristics of ACCUSTEP DOA Screen Panels were evaluated in the The product performance characteriand in the blind-labeled clinical specimen correlation study. The results of these studies demonstrate the ACCUSTEP DOA Screen Panels to be substantially equivalent to the performance characteristics of GC/MS methodology as well as ACON's One Step equivalent to the performance entines, using clinical specimens, produced a >92% correlation when compared to the GC/MS methodology.

ACCUSTEP DOA Screening Panels vs. GC/MS Analysis

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

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%

Conclusion:

Convilles of Accuracy, Sensitivity, Precision, Specificity and Interference studies demonstrate the substantial equivalency between the ACCUSTEP DOA Screen Panels and the ACON One Step Multi-Drug Screen Test Card. It is also demonstrated that ACCUSTEP DOA Screen Panels are safe and effective in detecting Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methamphetamine, Methadone, Morphine, Phencyclidine, and Nortriptyline, a Tricyclic Antidepressant, in human urine specimen.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a stylized drawing of a bird in flight. The bird is depicted with three parallel lines forming its body and wings, giving it a sense of movement and dynamism. The lines are thick and bold, creating a strong visual impact against the white background. The overall design is simple yet elegant, capturing the essence of a bird soaring through the air.

Public Hoa to Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

OCT = 4 2006

Re: K061005

Trade/Device Name: ACCUSTEP 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: DKZ, DIS, JXM, DIO, LDJ, DNK, DJC, DJR, LCM, LFG Dated: August 4, 2006 Received: August 8, 2006

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, Trug, 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, insting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, noand 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 (240) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez, Ph.D. 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): K061005

Device Name: ACCUSTEP 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
Phencyclidine	PCP	Phencyclidine	25 ng/ml
Nortriptyline	NOR	Nortriptyline	1000 ng/ml

These test kits are intended for health care professional use only.

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

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

vision Sign-Oi

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Office of In Vitro Diagnostic Device Evaluation and S

5106(k) K061005

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).