(170 days)
Not Found
Not Found
No
The summary describes a simple in vitro diagnostic test that provides visual, qualitative results. There is no mention of any computational analysis, image processing, or AI/ML terms.
No.
The device is an in vitro screening test for detecting oxycodone in urine, providing diagnostic information, not a treatment or therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The devices are intended for professional in vitro diagnostic use only."
No
The device is described as a "Cassette Test" and "Dipstick Test," which are physical, in vitro diagnostic devices used for chemical analysis of urine. The description focuses on the chemical detection method and does not mention any software component.
Yes, the provided text explicitly states that the device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section clearly says:
The devices are intended for professional in vitro diagnostic use only.
N/A
Intended Use / Indications for Use
The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are in vitro screening test devices for the rapid detection of Oxycodone in human urine. The tests are standardized to detect Oxycodone at a cut-off concentration of 100 ng/mL. The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are used to obtain visual, qualitative results. The assays provide only preliminary results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method. The devices are intended for professional in vitro diagnostic use only. They are not intended for over-the-counter sale to lay users.
Product codes
DJG
Device Description
Not Found
Mentions image processing
Not Found
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
professional in vitro diagnostic use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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
§ 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 2 2003
2 2003
Dr. Raphael Wong President Branan Medical Corporation 10015 Muirlands Road - Suite E Irvine, CA 92618
Re: K030113 Trade/Device Name: Monitect® Oxycodone Drug Screen Cassette Test Fastect 110 Oxycodone Drug Screen Dipstick Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: May 8, 2003 Received: May 20, 2003
Dear Dr. Wong:
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).
1
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
KO3643 510(k) Number (if known):
Monitect® Oxycodone Drug Screen Cassette Test Device Name: Fastect™ Oxycodone Drug Screen Dipstick Test
Indications For Use:
The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are in vitro screening test devices for the rapid detection of Oxycodone in human urine. The tests are standardized to detect Oxycodone at a cut-off concentration of 100 ng/mL. The Monitect® Oxycodone Drug Screen Cassette Test and Fastect™ Oxycodone Drug Screen Dipstick Test are used to obtain visual, qualitative The assays provide only preliminary results. Clinical consideration and results. professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method. The devices are intended for professional in vitro diagnostic use only. They are not intended for over-the-counter sale to lay users.
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K030113
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) | ✓ |
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |