HYDRAGEL CSF ISOFOCUSING KITS

K033277 · Morax · CFF · Nov 4, 2003 · Immunology

Device Facts

Record IDK033277
Device NameHYDRAGEL CSF ISOFOCUSING KITS
ApplicantMorax
Product CodeCFF · Immunology
Decision DateNov 4, 2003
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 866.5510
Device ClassClass 2

Indications for Use

The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are designed for the qualitative detection of oligoclonal bands in the electrophoretic patterns of cerebrospinal fluid (CSF) and confirmation of their immunoglobulin character. The use of anti-IgG antisera permits to prove or disprove the "true" IgG character of oligoclonal banding. Visual, comparative interpretation of immunofixation patterns of IgG in high resolution isoelectric separations of CSF and serum proteins from the same patient allows detection of oligoclonal banding that represents intrathecal synthesis of immunoglobulins. The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are indicated when certain diseases of the central nervous system (CNS), such as multiple sclerosis, are suspected and the detection of oligoclonal banding and inflammatory processes (intrathecal synthesis of immunoglobulins) can aid to the diagnosis. The use of enzyme labeled antibodies increases the sensitivity of detection so that the analysis can be generally performed on unconcentrated CSF.

Device Story

The HYDRAGEL 3/9 CSF ISOFOCUSING kits are in vitro diagnostic assays for qualitative detection of oligoclonal bands in CSF. The device utilizes high-resolution isoelectric focusing (IEF) to separate CSF and serum proteins, followed by immunofixation using anti-IgG antisera to confirm the immunoglobulin character of the bands. Enzyme-labeled antibodies are employed to enhance sensitivity, allowing analysis of unconcentrated CSF. The procedure is performed in a clinical laboratory setting by trained laboratory personnel. Results are obtained via visual, comparative interpretation of the electrophoretic patterns of paired CSF and serum samples. The presence of oligoclonal bands in CSF, not present in the corresponding serum, indicates intrathecal synthesis of immunoglobulins, aiding clinicians in the diagnosis of CNS inflammatory processes like multiple sclerosis.

Clinical Evidence

No clinical data provided. The submission relies on bench testing and performance characteristics inherent to the established isoelectric focusing and immunofixation methodology for CSF protein analysis.

Technological Characteristics

In vitro diagnostic kit utilizing high-resolution isoelectric focusing (IEF) on agarose gels. Employs immunofixation with anti-IgG antisera and enzyme-labeled antibodies for detection. The system is manual/semi-automated for laboratory use. No electronic components, software, or connectivity features. Sterilization not applicable to the chemical/reagent-based assay components.

Indications for Use

Indicated for qualitative detection of IgG oligoclonal bands in cerebrospinal fluid (CSF) to aid in the diagnosis of neurological disorders. Requires minimum 2 mg/dL total IgG concentration for analysis.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Related Devices

Submission Summary (Full Text)

{0} SPECIAL 510(k): Device Modification ODE Review Memorandum (Decision Making Document is Attached) To: THE FILE RE: DOCUMENT NUMBER K033277 HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 6 CSF ISOFOCUSING This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary): 1. HYDRAGEL 3 CSF and HYDRAGEL 6 CSF (k981048) 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials. 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. The changes were 1) isoelectric focusing replaces zonal electrophoresis for protein separation, 2) chemical compositions of the agarose gels and electrophoretic buffer, 3) voltage, 4) requires 2 mg/dL instead of 1 mg/dL total IgG for analysis, 5) detects IgG oligoclonal bands and not IgG, IgA and IgM and 6) for the HYDRAGEL 9 CSF ISOFOCUSING kit, the agarose gel has 18 tracks instead of 12 tracks. 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, indication for use, methodology, kit component specification, packaging and analytical performance. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis – Fault Tree analysis (see pg. 3) b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied (see pgs. 3, 4, 6 and 8) c) A declaration of conformity with design controls. The declaration of conformity should include: i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met (see pg. 18), and ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review (see pg. 19). 6. A Truthful and Accurate Statement, a 510(k) Statement and the Indications for Use Enclosure. The labeling for these modified subject devices have been reviewed to verify that the indication/intended uses for these devices are unaffected by the modifications. In addition, the submitter's description of these particular modifications and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend these devices be determined substantially equivalent to the previously cleared devices. (Reviewer's Signature) (Date)
Innolitics

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