(231 days)
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No
The summary describes an in vitro diagnostic kit for measuring a specific biomarker and does not mention any AI or ML components.
No
The device is described as an "in vitro measurement" kit, which means it is used for diagnostic purposes (measuring B2-Microglobulin to aid in diagnosis), not for treating or preventing disease directly. Therapeutic devices are used for treatment.
Yes
The device is described as aiding "in the diagnosis of active rheumatoid arthritis and kidney disease," which explicitly states a diagnostic purpose.
No
The intended use explicitly states the device is a "kit" for "in vitro measurement" using a "Minineph," which are terms associated with hardware components and laboratory equipment, not software-only devices.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- "in vitro measurement": The intended use explicitly states that the kit is for "in vitro measurement," meaning it is used to test samples taken from the body (like serum and urine) outside of the body. This is a key characteristic of IVDs.
- "human B2-Microglobulin in serum and urine": It specifies the biological samples being tested (serum and urine) and the analyte being measured (human B2-Microglobulin).
- "to aid in the diagnosis of active rheumatoid arthritis and kidney disease": The intended use clearly states that the results are used to "aid in the diagnosis" of specific medical conditions. This diagnostic purpose is a defining feature of IVDs.
The combination of these elements strongly indicates that this kit falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This kit is designed for the in vitro measurement of human B2-Microglobulin in serum and urine using the Minineph, to aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Product codes
JZG, JZW
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and is on a white background. The text is centered in the image.
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 eagle or bird-like figure with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
The Binding Site Limited c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, California 90404
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 5 2002
K014270 Re:
Trade/Device Name: MININEPH® Human Beta-2 Microglobulin Kit Regulation Number: 21 CFR § 866.5630 Regulation Name: Beta-2 Microglobulin Immunological Test System Regulatory Class: II Product Code: JZG, JZW Dated: August 6, 2002 Received: August 8, 2002
Dear Mr. Geller:
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 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 Part 801); 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.
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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 Jegally 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Autman
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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INDICATIONS FOR USE STATEMENT
Minineph Human B2 Microglobulin Kit Device Name:
Indications for Use: This kit is designed for the in vitro measurement of human B2-Microglobulin in serum and urine using the Minineph, to aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Sousan, Alta.e
(Division Sign-Off) (Division of Clinical Laboratory Devices
510(k) Number K014270
Prescription Use ✓
(Per 21 CFR 801.109)
ATTACHMENT >