Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolite, THC metabolite, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in screening of abuse samples. The detecting cut-off concentrations are as follows:

MET	D-Methamphetamine	1000 ng/ml
OPI	Morphine	300 ng/ml
COC	Benzoylecgonine	300 ng/ml
THC	11-nor-Δ9-9-carboxylic acid	50 ng/ml
PCP	Phencyclidine	25 ng/ml
Benzodiazepine	Oxazepam	300 ng/ml
Barbiturate	Secobarbital	300 ng/ml
Methadone	Methadone	300 ng/ml
TCA	Nortriptyline	1000 ng/ml
AMP	D-Amphetamine	1000 ng/ml

This assay provides only a preliminary analytical test result. A more specific alternate chemical method m ust be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/ MS)/High performance liquid chromatography (HPLC, for TCA) are the preferred confirmatory methods. Cl inical consideration and professional judgment should be applied to any drug of abuse test result, particula rly when preliminary positive results are obtained.

Device Description

The AccuSign® RCDOA 10 test device is a simple immuno-chromatographic test for the rapid, qualitative detection of methamphetamine, opiates, cocaine, THC, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, amphetamine and/or their metabolites in human urine. The test result can be read visually or with DXpress reader (K050955).

AI/ML Overview

Here's an analysis of the provided 510(k) summary, detailing the acceptance criteria and the study information.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (K983501: AccuSign® DOA10). Since the new device (AccuSign® RC-DOA 10) is stated to be "identical and use the same formula and manufacturing processes with the same reagents" as the predicate, and the key difference is the addition of a reader-compatible option, the acceptance criteria are effectively that its performance should be commensurate with the established performance of the predicate device.

The document directly states the detection cut-off concentrations for each substance as both the intended use and the "Detection Cutoff" in the substantial equivalence comparison table. This indicates that the device must accurately detect these substances at or above these specified cut-off levels.

Substance	Primary Metabolite/Drug	Detection Cut-off Concentration (ng/mL)	Reported Device Performance
MET	D-Methamphetamine	1000	(Implicitly meets cut-off)
OPI	Morphine	300	(Implicitly meets cut-off)
COC	Benzoylecgonine	300	(Implicitly meets cut-off)
THC	11-nor-Δ9-9-carboxylic acid	50	(Implicitly meets cut-off)
PCP	Phencyclidine	25	(Implicitly meets cut-off)
Benzodiazepine	Oxazepam	300	(Implicitly meets cut-off)
Barbiturate	Secobarbital	300	(Implicitly meets cut-off)
Methadone	Methadone	300	(Implicitly meets cut-off)
TCA	Nortriptyline	1000	(Implicitly meets cut-off)
AMP	D-Amphetamine	1000	(Implicitly meets cut-off)

Note on Reported Device Performance: The provided 510(k) summary does not contain specific performance metrics (e.g., sensitivity, specificity, accuracy) from a separate clinical study for the new device. Instead, the claim of substantial equivalence relies on the new device being "identical" to the predicate in its core biochemical function, with the only change being an additional reading method. Therefore, the "reported device performance" is essentially that it achieves the same detection capabilities as the legally marketed predicate device at the specified cut-off concentrations.

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

The provided 510(k) summary does not explicitly detail a separate test set size or its data provenance (e.g., country of origin, retrospective/prospective). The submission relies heavily on the claim that the new device is "identical" to the predicate device in terms of its chemical components and manufacturing process. Therefore, the performance data from the predicate device's original clearance would be presumed to apply.

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

The 510(k) summary does not mention the use of experts for establishing ground truth for a test set for this specific submission. This is because the device is a diagnostic test kit for drugs of abuse, and the "ground truth" for such tests typically comes from validated analytical methods (like GC/MS). Expert consensus is usually more relevant for image-based diagnostic devices or complex clinical scenarios where subjective interpretation is involved.

4. Adjudication Method for the Test Set

No adjudication method is described, as no specific test set or study requiring adjudication is detailed in this 510(k) summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was mentioned or performed for this submission. MRMC studies are typically used for devices where human readers interpret diagnostic images or data, and the AI system is intended to assist or replace human interpretation. This device is a rapid immunoassay test where results are either visually read or read by a simple optical reader (DXpress). The 510(k) focuses on the "Reader reading compatible" aspect, implying it's an alternative to visual reading, not an AI assistance for human interpretive tasks.

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

Yes, in a sense, a standalone performance is implied. The device, whether read visually or by the DXpress reader, functions as a standalone diagnostic tool for detecting the presence of drugs of abuse. The performance is based on its ability to react to specific concentrations of analytes, independent of human interpretive faculties beyond simply observing a line or reading a digital output. The "algorithm" here is the chemical reaction and optical detection mechanism. However, no specific separate standalone clinical study with new data is presented in this summary.

7. The Type of Ground Truth Used

The ground truth for this type of immunoassay is based on analytical chemical methods, specifically the concentration of the target drug or metabolite in urine samples. The document explicitly states that the test provides "only a preliminary analytical result" and that "a more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method." This indicates that Gas Chromatography/Mass Spectrometry (GC/MS) (and for TCA, HPLC) is the gold standard used to establish definitive ground truth for drug presence and concentration.

8. The Sample Size for the Training Set

The 510(k) summary does not mention a training set size. This is because the device is an immunoassay kit built on established chemical principles and reagents. It does not involve machine learning algorithms that require a training set in the conventional sense. The "training" in this context would refer to the development and optimization of the chemical formulations and reaction conditions, which were already established for the predicate device.

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

As there is no conventional training set for a machine learning algorithm, the concept of establishing ground truth for it does not apply here. The fundamental "ground truth" for the device's design and operation, derived from the predicate, would have been established through a combination of:

Analytical validation: Testing the device with known concentrations of drug standards and interferences.
Clinical correlation: Comparing test results with confirmed results from definitive analytical methods (like GC/MS) on patient samples during the development and validation of the predicate device.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.

The assigned 510(k) number is: K062575

1. Date of Summary: August 28, 2006
Princeton BioMeditech Corporation 2. Submitted by: 4242 U.S. Route 1, Monmouth Jct., NJ 08852 Tel:732-274-1000 Fax:732-274-1010

NOV 2 6 2007

1. Device Name:
  Trade Names: AccuSign® RC-DOA10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP) StatusFirst® DOA10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP) Common or Usual Name: Immunoassay for detection of abused drugs in human urine Classification Name: Drugs of abuse test systems, Clinical toxicology test system
1. Identification of legally marketed device to which claims equivalence: K983501: AccuSign® DOA10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP) by Princeton BioMeditech Corporation
1. Device Description:

6. Intended Use:

AccuSign® RC-DOA 10 is intended to use for the qualitative detection of methamphetamine, THC, phencyclidine, benzodiazepines, barbiturates, tricyclic opiates. cocaine. antidepressants, methadone, amphetamine, and/or their metabolites in human urine to assist in screening of drugs of abuse samples. For in vitro diagnostic use. The detecting cut-off concentrations are as follows:

MET	D-Methamphetamine	1000 ng/mL
OPI	Morphine	300 ng/mL
COC	Benzoylecgonine	300 ng/mL
THC	11-nor-Δ9-9-carboxylic acid	50 ng/mL
PCP	Phencyclidine	25 ng/mL
Benzodiazepine	Oxazepam	300 ng/mL
Barbiturate	Secobarbital	300 ng/mL
Methadone	Methadone	300 ng/mL
TCA	Nortriptyline	1000 ng/mL
AMP	D-Amphetamine	1000 ng/mL

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This test provides only a preliminary analytical result and a more specific alternative chemical method must be used to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

1. Substantial Equivalence:
  AccuSign® RC DOA 10 is substantially equivalent in intended use, principle and performance to the current K983501, AccuSign® DOA 10. Both assays are in vitro immunochromatographic assays with an intended use for the qualitative detection of drugs of abuse in human urine to assist in screening of drugs of abuse samples. The two products are identical and use the same formula and manufacturing processes with the same reagents. The only difference is AccuSign® RCDOA 10, Reader reading compatible, allows an optical result reading method to customers by using a reader, DXpress, for result reading; on the other hand, AccuSign® DOA 10 is a visual read only test.

Conclusion: The device is substantially equivalent to a legally marketed device K983501.

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Substantial Equivalence

AccuSign® RC-DOA 10 test is substantially equivalent to AccuSign® DOA 10, K983501 by Princeton BioMeditech Corporation.

The table below compares the AccuSign® RC DOA 10 test to the predicate devices.

Item	AccuSign® ·DOA 10 (Predicate)	AccuSign® RC-DOA 10
Intended Use	For the qualitative detection of 10kinds of drugs of abuse in humanurine	For the qualitative detection of 10kinds of drugs of abuse in humanurine
Assay Principle	Lateral flow Immuno-chromatographic assay	Lateral flow Immuno-chromatographic assay
Test Procedure	Add 3 drops of urine into the samplewell.	Add 3 drops of urine into the samplewell.
Result readingtime	5-10 min	5 min
Method of resultreading	Visual Read only	DXpress reader (K050955) orvisual
Specimen Type	Human urine	Human urine
Sample Volume	3 drops	3 drops
Detection Cutoff	D-Methamphetamine 1000Morphine 300Benzoylecgonine 30011-nor-Δ9-9-carboxylic acid 50Phencyclidine 25Oxazepam 300Secobarbital 300Methadone 300Nortriptyline 1000D-Amphetamine 1000	D-Methamphetamine 1000Morphine 300Benzoylecgonine 30011-nor-Δ9-9-carboxylic acid 50Phencyclidine 25Oxazepam 300Secobarbital 300Methadone 300Nortriptyline 1000D-Amphetamine 1000

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 6 2007

Princeton BioMeditech Corporation c/o Kyung-Ah Kim 4242 US Route 1 Monmouth Junction, NJ 08852-1905

Re: K062575

Trade/Device Name: AccuSign ®RC-DOA 10 (MET/OPVCOC/THE/PEP/BZO BAR/MTD/TCA/AMP Regulation Number: 21 CFR 862.3160 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Code: LAG, DJG, DIO, DKE, DKZ, DIS, DJR, LFI, LCM, JXM Dated: October 1, 2007 Received: October 2, 2007

Dear Dr. Kim:

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, perroits 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 tolloffree ne (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. Cooper, M.S., D.V.M.

Sean 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): K062575

Device Name: AccuSign®RC·DOA10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP)

Indications For Use:

MET	D-Methamphetamine	1000 ng/ml
OPI	Morphine	300 ng/ml
COC	Benzoylecgonine	300 ng/ml
THC	11-nor-Δ9-9-carboxylic acid	50 ng/ml
PCP	Phencyclidine	25 ng/ml
Benzodiazepine	Oxazepam	300 ng/ml
Barbiturate	Secobarbital	300 ng/ml
Methadone	Methadone	300 ng/ml
TCA	Nortriptyline	1000 ng/ml
AMP	D-Amphetamine	1000 ng/ml

Prescription Use X (Part 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)

Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)	K062575
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Regulation Number and Section

§ 862.3610 Methamphetamine test system.

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