The Status DSTM OXY is an immunochromatograhic test for the qualitative detection of Oxycodone in urine samples. The decetion cut-off concentration of Oxycodone is 100 ng/ml. The test may be read visually or by using a DX press™ Reader. It is intended for clinical laboratory use only.

This assay provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (CCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to the test result, particularly when preliminary positive results are obtained.

Device Description

The Status DSTM OXY test device is a simple immuno-chromatographic test for the rapid, qualitative detection of oxycodone and/or their metabolites in human urine. The test may be read visually or by using a DXpress™ Reader. The DXpress reader captures an image of an inserted compatible test device and uses a software algorithm to calculate the intensity of the test line. The DXpress reader interprets test result automatically by comparing the intensity of the test line to the preset cutoff value. In addition, the software will use the presence of the control line to determine whether or not the test result is valid.

AI/ML Overview

The Status DS™ OXY device is an immunochromatographic test for the rapid, qualitative detection of oxycodone and/or its metabolites in human urine. The test can be read visually or with a DXpress™ Reader which automatically interprets the results by comparing test line intensity to a preset cutoff.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Comparison to predicate device K060351: MedTox Oxycodone)	Reported Device Performance (Status DS™ OXY vs. MedTox Oxycodone)
No explicit acceptance criteria were stated in terms of specific percentages for positive and negative agreement. However, the basis for substantial equivalence comparison indicates that the device should demonstrate comparable performance to the predicate device.	98% agreement for positive samples
	96% agreement for negative samples

2. Sample Size and Data Provenance

Test Set Sample Size: Not explicitly stated in the provided text. The text only mentions "In the performance study," without specifying the number of samples used.
Data Provenance: Not explicitly stated. However, given that this is a 510(k) submission to the FDA, it is highly likely that the study was conducted within a clinical laboratory setting, potentially in the US, but the specific country of origin is not mentioned. The nature of the study (retrospective or prospective) is also not stated.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. The ground truth in this study was established using a legally marketed predicate device (MedTox Oxycodone, K060351) as the reference, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The study compares the performance of the Status DS™ OXY test directly against a predicate device. There is no mention of human readers or an adjudication process for discrepancy resolution in the context of establishing ground truth for the test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The study described is a direct comparison of the new device's performance against a predicate device, not an evaluation of human reader improvement with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the Status DS™ OXY test performance was evaluated independently against a legally marketed predicate device. The DXpress™ Reader component itself includes a "software algorithm to calculate the intensity of the test line" and "interprets test result automatically," indicating a standalone algorithmic interpretation capability. The comparison of "98% agreement for positive samples and 96% for negative samples" directly reflects this standalone device performance.

7. Type of Ground Truth Used

Ground Truth Type: A legally marketed predicate device (MedTox Oxycodone, K060351) served as the reference standard. The text states: "Status DS OXY test showed 98% agreement for positive samples and 96% for negative samples compared to the reference test, while MedTox Oxycodone showed 96% and 97% agreement, respectively, indicating the two test devices are substantially equivalent." While the predicate device itself is for "qualitative detection," the ultimate confirmatory method mentioned for clinical use is Gas chromatography/mass spectrometry (GC/MS). However, for the purpose of demonstrating substantial equivalence to the FDA, the predicate device served as the comparison standard.

8. Sample Size for the Training Set

Not explicitly mentioned. The provided text describes a performance study for demonstrating substantial equivalence. It does not detail the development or training of any underlying algorithms, only the performance of the final device against a predicate.

9. How Ground Truth for the Training Set Was Established

Not applicable, as details about a training set are not provided. The information focuses on the performance of the final product in comparison to a predicate device. If there was an internal training process for the DXpress™ Reader's algorithm, the method for establishing ground truth for that training is not described in this document.

Summary

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K130650

FEB 2 6 2014

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: K130650

Date of Summary: January 10, 2014
Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 Phone: 732-274-1000 Fax: 732-274-1010

1. Device Trade Names: Status DS™ OXY
1. Regulatory Information:
- 4.1. Regulation section: 21 CFR 862.3650, Enzyme Immunoassay, Opiates
- 4.2. Classification: Class II
- 4.3. Product Code: DJG
- 4.4. Panel: Toxicology (91)
1. Identification of legally marketed devices to which claims of equivalence are made: K060351: MedTox Oxycodone by MedTox Diagnostics

Device Description: The Status DSTM OXY test device is a simple immuno-

chromatographic test for the rapid, qualitative detection of oxycodone and/or their metabolites in human urine. The test may be read visually or by using a DXpress™ Reader. The DXpress reader captures an image of an inserted compatible test device and uses a software algorithm to calculate the intensity of the test line. The DXpress reader interprets test result automatically by comparing the intensity of the test line to the preset cutoff value. In addition, the software will use the presence of the control line to determine whether or not the test result is valid.

The Status DSTM OXY is an immunochromatograhic test for the qualitative 7. Intended Use: detection of Oxycodone in urine samples. The detection cut-off concentration of Oxycodone is 100 ng/mL. The test may be read visually or by using a DXpress™ Reader. It is intended for clinical laboratory use only. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to the test result, particularly when preliminary positive results are obtained.

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1. Substantial Equivalence: The Status DS™ OXY test was compared to the MedTox Oxycodone, K060351 by MedTox Diagnostics. Both tests are in vitro rapid qualitative tests that detect Oxycodone in urine and use the same cutoff concentration. The scientific principle of both devices is a solid phase chromatographic immunoassay. In the performance study. Status DS OXY test showed 98% agreement for positive samples and 96% for negative samples compared to the reference test, while MedTox Oxycodone showed 96% and 97% agreement, respectively, indicating the two test devices are substantially equivalent.
Conclusion: The Status DXM OXY test is substantially equivalent in assay principle and performance to the MedTox Oxycodone, K060351 by MedTox Diagnostics. The test is safe and effective for professional and laboratory use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2014

PRINCETON BIOMEDITECH CORP. KYUNG-AH KIM DIRECTOR, OPERATIONS/QUALITY SYSTEMS 4242 U.S. HIGHWAY 1 MONMOUTH JUNCTION NJ 08852-1905

Re: K130650

Trade/Device Name: Status DS OXY Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG Dated: January 10, 2014 Received: January 13, 2014

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFF). Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510{k) Number (if known)

K130650

Status DS™ OXY

Indications for Use (Describe)

Device Name

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Avis T. Danishefsky

FORM FDA 3881 (1/14)

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).