(236 days)
Not Found
Not Found
No
The device description details a manual or semi-automated electrophoresis process followed by visual evaluation of the results. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.
No
The device is used for detection and identification of Bence Jones proteins, serving as a qualitative aid in the identification of monoclonal gammopathies, which is a diagnostic purpose, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the kits are "designed for qualitative detection and identification of Bence Jones proteins... The detection of Bence Jones proteins serves as a qualitative aid in the identification of monoclonal gammopathies," which is a diagnostic purpose.
No
The device description clearly outlines a kit containing physical components like agarose gels, antisera, and stains, used in a manual or semi-automated electrophoresis apparatus. There is no mention of software as the primary or sole component.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the kits are designed for "qualitative detection and identification of Bence Jones proteins (monoclonal free light chains) in urine and serum." This involves testing samples taken from the human body (urine and serum) in vitro (outside the body) to provide information about a person's health status (identification of monoclonal gammopathies).
- Device Description: The description details a laboratory procedure involving electrophoresis and immunofixation of biological samples (urine and serum) to analyze proteins. This is a typical process for in vitro diagnostic testing.
The core function of the device is to analyze biological samples to aid in a medical diagnosis, which is the definition of an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JKM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urine and serum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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): 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.
Not Found
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.
Not Found
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).
Not Found
§ 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).
0
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.
1
Page 2
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
2
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)