# K972591: Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones Kit

- Pathway: 510(k) (Traditional)
- Applicant: Morax
- Decided: Mar 4, 1998 after 236 days
- Product code: JKM (Immunochemical, Bence-Jones Protein)
- Device class: 2
- Regulation: 21 CFR 866.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 monocional 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 alpha, gamma & mu heavy chain trivalent antiserum, 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 MAX! 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 each kit, 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.

Source page: https://510kreport.com/device/K972591
Methodology: https://510kreport.com/methodology