(186 days)
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No
The description focuses on immunoassay techniques (radioimmunoassay, EMIT, FPIA) for chemical analysis, with no mention of AI or ML.
No.
The device is an in vitro diagnostic device used to screen and identify newborn infants exposed to drugs, not to treat them.
Yes
The document explicitly states: "MECTEST is an in vitro diagnostic device intended to prospectively screen and identify newborn infants exposed to drugs (cocaine, opiate and cannabinoid) in utero. Meconium drug testing via MECTEST is an idea and important diagnostic tool for clinical and research applications."
No
The device is described as a "kit" for processing and analysis using laboratory techniques like radioimmunoassay, enzyme immunoassay, and fluorescence polarization, which are hardware-based methods.
Yes, based on the provided information, MECTEST is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The description explicitly states "MECTEST is an in vitro diagnostic device intended to prospectively screen and identify newborn infants exposed to drugs (cocaine, opiate and cannabinoid) in utero." This directly aligns with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description details a "kit for the processing and semiquantitative analysis of meconium," which is a biological specimen. The analysis is performed using laboratory techniques (radioimmunoassay, enzyme immunoassay, fluorescence polarization).
- Anatomical Site: The device analyzes "Meconium," which is a specimen taken from the human body (specifically, newborn infants).
- Intended User/Care Setting: The device is for "hospital and laboratory use only," which are typical settings for performing in vitro diagnostic tests.
The information provided clearly indicates that MECTEST is a device used to analyze a human specimen (meconium) outside of the body (in vitro) to provide diagnostic information about drug exposure in newborn infants.
N/A
Intended Use / Indications for Use
MECTEST is a kit for the processing and semiquantitative analysis of meconium for cocaine, opiate and cannabinoid by radioimmunoassay and for the processing and semiquantitative analysis of cocaine and opiate by enzyme immunoassay (EMIT) and by fluorescence polarization (FPIA). MECTEST is for hospital and laboratory use only.
MECTEST is an in vitro diagnostic device intended to prospectively screen and identify newborn infants exposed to drugs (cocaine, opiate and cannabinoid) in utero. Meconium drug testing via MECTEST is an idea and important diagnostic tool for clinical and research applications. MECTEST offers a positive alternative to urine analysis because (1) it is highly sensitive and specific, (2) the test can be performed using commong laboratory techniques for purposes of mass screening with capabilities of GC/MS confirmation, (3) collection of meconium is easy and non invasive, (4) analysis of serial meconium can reflect the type, chronology and amount of in utero drug exposure of the infant, and, (5) drugs in meconium are present up to the third day after birth; thus late testing of the infant for drugs is possible.
Product codes
DIO, LAT, DJG
Device Description
MECTEST is a kit for the processing and semiquantitative analysis of meconium for cocaine, opiate and cannabinoid by radioimmunoassay and for the processing and semiquantitative analysis of cocaine and opiate by enzyme immunoassay (EMIT) and by fluorescence polarization (FPIA).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Newborn infants
Intended User / Care Setting
Hospital and laboratory use only
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of a human figure in profile, with three wavy lines representing the head, body, and legs. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 4 1998
Eugene A. Esguerra . President Meco Industries P.O. Box 468 Walnut, California 91788-0468
K973986 Re : MECTEST Regulatory Class: II Product Code: DIO, LAT, DJG February 11, 1998 Dated: Received: February 24, 1998
Dear Mr. Esquerra:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act "" 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set ... forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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THE PERSELLAND POSTER
Acres
510(k) Number (if known): K973986
Device Name: MECTEST
Indications For Use:
MECTEST is a kit for the processing and semiquantitative analysis of meconium for cocaine, opiate and cannabinoid by radioimmunoassay and for the processing and semiquantitative analysis of cocaine and opiate by enzyme immunoassay (EMIT) and by fluorescence polarization (FPIA). MECTEST is for hospital and laboratory use only.
MECTEST is an in vitro diagnostic device intended to prospectively screen and identify newborn infants exposed to drugs (cocaine, opiate and cannabinoid) in utero. Meconium drug testing via MECTEST is an idea and important diagnostic tool for clinical and research applications. MECTEST offers a positive alternative to urine analysis because (1) it is highly sensitive and specific, (2) the test can be performed using commong laboratory techniques for purposes of mass screening with capabilities of GC/MS confirmation, (3) collection of meconium is easy and non invasive, (4) analysis of serial meconium can reflect the type, chronology and amount of in utero drug exposure of the infant, and, (5) drugs in meconium are present up to the third day after birth; thus late testing of the infant for drugs is possible.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K173986
OR
Over-The-Counter Use
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
O