(352 days)
No
The description mentions a "software algorithm" for image processing and interpreting results based on a "preset cutoff value," which is typical of traditional rule-based or deterministic algorithms, not necessarily AI/ML. There is no mention of learning, training data, or adaptive behavior characteristic of AI/ML.
No
This device is an immunochromatographic test for detecting Oxycodone in urine samples, which is a diagnostic tool, not a therapeutic one.
Yes
The device is described as an "immunochromatographic test" intended for "qualitative detection of Oxycodone in urine samples" and for "clinical laboratory use only," indicating its use in diagnosing or detecting a substance in the body for medical purposes.
No
The device description clearly states that the system includes a physical test device (immunochromatographic test) and a reader (DXpress™ Reader) which captures an image. While software is used for interpretation, the system is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of Oxycodone in urine samples" and is "intended for clinical laboratory use only." This clearly indicates it's used to examine specimens derived from the human body (urine) to provide information for clinical purposes.
- Device Description: The description details a "simple immuno-chromatographic test" that detects substances in human urine. This aligns with the definition of an in vitro diagnostic device.
- Performance Studies: The performance studies compare the device to a predicate device (MedTox Oxycodone) which is also an in vitro rapid qualitative test for detecting Oxycodone in urine. This comparison within the context of performance studies further confirms its classification as an IVD.
The fact that it analyzes a human specimen (urine) to provide a diagnostic result (detection of Oxycodone) for clinical use is the primary indicator that it is an IVD.
N/A
Intended Use / Indications for Use
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 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.
Product codes
DJG
Device Description
The Status DSTM OXY test device is a simple immunochromatographic 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.
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It is intended for clinical laboratory use only.
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
Not Found
Summary of Performance Studies
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.
Key Metrics
98% agreement for positive samples (Status DS OXY)
96% agreement for negative samples (Status DS OXY)
96% agreement for positive samples (MedTox Oxycodone)
97% agreement for negative samples (MedTox Oxycodone)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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Date of Summary: January 10, 2014
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Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 Phone: 732-274-1000 Fax: 732-274-1010
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- Device Trade Names: Status DS™ OXY
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- 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)
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- 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.
1
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- 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.
3
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)
Status DS™ OXY
Indications for Use (Describe)
Device Name
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.
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)