(236 days)
HYDRAGEL BENCE JONES, MAXI KIT HYDRAGEL BENCE JONES, HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for qualitative detection and identification of Bence Jones proteins (monoclonal free light chains) in urine and serum. The detection of Bence Jones proteins serves as a qualitative aid in the identification of monoclonal gammopathies.
The analysis is generally performed on unconcentrated urine or on diluted serum. All these kits utilize the same composition of alkaline buffered HYDRAGEL BENCE JONES agarose gels and the same procedure which is carried out in two stages:
· electrophoresis of the sample on multi-track agarose gel to separate the individual urinary or serum proteins.
· the separated proteins in the reference track are fixed, the remaining tracks are subjected to respective immunofixation with anti aloha, gamma & mu heavy chain trivalent anti kappa and anti lambda free & bound light chains antisera; anti kappa and anti lambda free light chains antisera. The fixed and immunoprecipitated proteins are then stained with acid violet. The electrophoregrams are evaluated visually. The suspect band (in the reference track) is identified from the positive reaction, or lack of, with the individual antisera.
The HYDRAGEL BENCE JONES kit and MAXI KIT HYDRAGEL BENCE JONES are designed for use with a manual electrophoresis apparatus. The only difference between these two kits is the total number of tests which can be performed with i.e., 10 and 100, respectively. Each agarose gel in the HYDRAGEL BENCE JONES kit and MAXI-KIT HYDRAGEL BENCE JONES is intended to run one sample.
The HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus.
Each agarose gel in the HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits is intended to run two and four samples, respectively.
This document is an FDA 510(k) clearance letter for the HYDRAGEL BENCE JONES Kit. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.
Specifically, the document states that the device is "substantially equivalent" to predicate devices, which means it met the regulatory requirements for clearance based on comparison to existing devices, rather than necessarily performing a specific study to meet pre-defined acceptance criteria for a novel device.
Here's what is not present in the provided document:
- A table of acceptance criteria and the reported device performance: This document only lists the indications for use and a general description of the test procedure. It doesn't present performance metrics like sensitivity, specificity, accuracy, or any specific numerical acceptance thresholds.
- Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or the origin of any data.
- Number of experts used to establish the ground truth for the test set and their qualifications: No information about expert review or ground truth establishment is provided.
- Adjudication method for the test set: Not applicable as no test set or expert review is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This type of study is not mentioned. The device is a diagnostic kit, not an AI-assisted interpretation tool, so MRMC studies are generally not applicable in this context.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a lab kit requiring human interpretation, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
- The sample size for the training set: Not applicable as this is not an AI/ML device with a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, this FDA clearance letter confirms the device's substantial equivalence to existing devices for its intended use, but it does not provide the kind of detailed study results and performance metrics that would be present in a clinical trial report or a more extensive submission for a novel device or an AI/ML product.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird design.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Borek Janik Official Correspondent MORAX 13805 Waterloo MAR - 4 1998 Chelsea, Michigan 48118 Re : K972591/S1 HYDRAGEL BENCE JONES KIT/ MAXI KIT HYDRAGEL BENCE Trade Name: JONES/ HYDRAGEL 2 BENCE JONES KIT/ HYDRAGEL 4 BENCE JONES KIT Requlatory Class: II Product Code: JKM Dated: January 5, 1998 Received: January 6, 1998
Dear Dr. Janik:
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 Regulations, 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 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 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"
Sincerely yours,
Steven Butman
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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510(k) Number (if known):
Device name:
HYDRAGEL BENCE JONES Kit MAXI KIT HYDRAGEL BENCE JONES HYDRAGEL 2 BENCE JONES Kit HYDRAGEL 4 BENCE JONES Kit
Indications For Use:
HYDRAGEL BENCE JONES, MAXI KIT HYDRAGEL BENCE JONES, HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for qualitative detection and identification of Bence Jones proteins (monoclonal free light chains) in urine and serum. The detection of Bence Jones proteins serves as a qualitative aid in the identification of monoclonal gammopathies.
The analysis is generally performed on unconcentrated urine or on diluted serum. All these kits utilize the same composition of alkaline buffered HYDRAGEL BENCE JONES agarose gels and the same procedure which is carried out in two stages:
· electrophoresis of the sample on multi-track agarose gel to separate the individual urinary or serum proteins.
· the separated proteins in the reference track are fixed, the remaining tracks are subjected to respective immunofixation with anti aloha, gamma & mu heavy chain trivalent anti kappa and anti lambda free & bound light chains antisera; anti kappa and anti lambda free light chains antisera. The fixed and immunoprecipitated proteins are then stained with acid violet. The electrophoregrams are evaluated visually. The suspect band (in the reference track) is identified from the positive reaction, or lack of, with the individual antisera.
The HYDRAGEL BENCE JONES kit and MAXI KIT HYDRAGEL BENCE JONES are designed for use with a manual electrophoresis apparatus. The only difference between these two kits is the total number of tests which can be performed with i.e., 10 and 100, respectively. Each agarose gel in the HYDRAGEL BENCE JONES kit and MAXI-KIT HYDRAGEL BENCE JONES is intended to run one sample.
The HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus.
Each agarose gel in the HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits is intended to run two and four samples, respectively.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of D
Ketu E. Kaur
(Division Sign-Off)
Division of Clinical Laboratory Devices K972591
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use ......
(Optional Format 1-2-96)
§ 866.5150 Bence-Jones proteins immunological test system.
(a)
Identification. A Bence-Jones proteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of polypeptide chains (subunits) of unequal size (light chains and heavy chains) bound together by several disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody-producing cell) with excess production of light chains of one specific kind (monoclonal light chains). These free homogeneous light chains not associated with an immunoglobulin molecule can be found in urine and plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination that they are monoclonal aid in the diagnosis of multiple myeloma (malignant proliferation of plasma cells), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins by spleen and bone marrow cells), leukemia (cancer of the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).(b)
Classification. Class II (performance standards).