(30 days)
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No
The summary describes an ELISA test kit, which is a laboratory assay for measuring a specific substance. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an in vitro diagnostic test kit used for diagnosis, not for treating a condition.
Yes
Explanation: The device is used for the "diagnosis and treatment of DHEA-secreting adrenal carcinomas," which directly indicates its role in diagnosing a medical condition.
No
The device is an ELISA test kit, which is a laboratory diagnostic assay and involves physical reagents and laboratory equipment, not solely software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The key phrase that indicates this is:
- "The IBL DHEA-S ELISA test kit is intended for the in vitro determination of DHEA-S (dehydroepiandrosterone sulphate) in human serum and plasma."
"In vitro" means "in glass" or "outside the body," and IVD devices are specifically designed to perform tests on samples taken from the human body (like serum and plasma in this case) to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
The IBL DHEA-S ELISA test kit is intended for the in vitro determination of DHEA-S (dehydroepiandrosterone sulphate) in human serum and plasma. DHEA measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
Product codes
JKC
Device Description
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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
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1245 Dehydroepiandrosterone (free and sulfate) test system.
(a)
Identification. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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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 a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mark A. Kowal President/CEO KMI Diaqnostics, Inc. 818 5185 Avenue, N.E. Suite 101 Minneapolis, Minnesota 55421
NOV 1 3 1997
K973897 Re : Trade Name: IBL DHEA-S ELISA Test Kit Regulatory Class: I Tier: I Product Code: JKC Dated: October 10, 1997 Received: October 14, 1997
Dear Mr. Kowal:
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, Druq, and Cosmetic Act (Act). 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 (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 requirement, as set forth in the Quality System Regulation (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 Reqister. 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 leqally 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
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Sincerely yours,
Steven Putman
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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Image /page/2/Picture/3 description: The image shows the letters KMI in a stylized, bold font. The letters are black and appear to be slightly distressed or textured. The letters are arranged horizontally, with the K on the left, followed by the M, and then the I on the right.
KMI Diagnostics, Inc. 818 51st Ave. NE Suite 101 Minneapolis, MN 55421 USA
Attachment I
Device Name: DHEA-S ELISA Test Kit
Indications for Use ------------------
The IBL DHEA-S ELISA test kit is intended for the in vitro determination of DHEA-S (dehydroepiandrosterone sulphate) in human serum and plasma. DHEA measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.
Marke P. Krouf
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K973897
(Per 21 CFR 801.109)