(41 days)
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K/DEN number:
No
The summary describes an ELISA test kit for measuring estradiol, a standard laboratory assay, with no mention of AI or ML.
No.
The IBL Estradiol ELISA test kit is intended for in vitro determination of estradiol in human serum and plasma for diagnostic purposes, not for treating a condition.
Yes
The text explicitly states, "Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy," indicating its use for diagnostic purposes.
No
The device is described as an "ELISA test kit," which is a laboratory assay involving physical reagents and equipment, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that the kit is for the "in vitro determination of estradiol... in human serum and plasma." This means the test is performed outside of the living body, using biological samples.
- Purpose: The intended use also states that the measurements are used in the "diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy." This indicates the test is used for diagnostic purposes.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Product codes
CHP
Device Description
Estradiol ELISA Test Kit
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1260 Estradiol test system.
(a)
Identification. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.(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/2 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "U.S. DEPT. OF HEALTH & HUMAN SERVICES. USA" is arranged in a semi-circle above the symbol, following the curve of the logo.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 24 1997
Mark A. Kowal . President KMI Diagnostics, Inc. 818 51st Avenue, NE Suite 101 55421 Minneapolis, Minnesota
Re : K973901 17 ß-Estradiol (ELISA) Regulatory Class: I .. . Product Code: CHP October 10, 1997 Dated: 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, 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 Regulations, 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 Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 requlations.
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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 requlation (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 Litman
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/0 description: The image shows a logo with the letters "KMI" in a bold, stylized font. The letters are connected and appear to be slightly slanted to the right. The logo is in black and stands out against a white background. The font style gives the logo a dynamic and modern look.
KMI Diagnostics; Inc. ---------818 Sist Ave. NE Suite 101 Minneapolis, MN 55421 USA
Attachment I
Device Name: Estradiol ELISA Test Kit
Indications for Use
The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
(Division Sign-Off)
Division of Clinical Laboratory Degies
510(k) Number. K973930
Mark Q. Kousf
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
rrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Phone: 1 (612) 572-9354
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