(25 days)
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Not Found
No
The description focuses on a laboratory kit for electrophoretic analysis and visual interpretation, with no mention of AI or ML technologies.
No
This device is for the qualitative detection of oligoclonal bands in CSF to aid in diagnosis, not for treating any condition.
Yes
The device is designed for the qualitative detection of oligoclonal bands in CSF and confirmation of their immunoglobulin character, specifically aiding in the diagnosis of CNS diseases like multiple sclerosis. This directly relates to identifying a health condition.
No
The device description is not found, but the intended use describes "kits" and "electrophoretic patterns," which strongly suggests a physical laboratory test kit and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kits are designed for the "qualitative detection of oligoclonal bands in the electrophoretic patterns of cerebrospinal fluid (CSF)" and "confirmation of their immunoglobulin character." This involves testing a sample (CSF and serum) taken from the human body.
- Purpose: The kits are used to "aid to the diagnosis" of certain diseases of the central nervous system, such as multiple sclerosis, by detecting "oligoclonal banding and inflammatory processes (intrathecal synthesis of immunoglobulins)." This directly relates to providing information for diagnostic purposes.
- Sample Type: The device analyzes "cerebrospinal fluid (CSF) and serum proteins," which are biological samples from the human body.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / 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.
The only difference between the 3 CSF and 6 CSF kits is in the intended number of samples per gel: 3 and 9 CSF/serum sample pairs, respectively.
Product codes
CFF
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Central nervous system (CNS)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
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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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is in a bold, sans-serif font and is centered horizontally. The words are arranged on a single line, with the word "DEPARTMENT" appearing first, followed by "OF HEALTH & HUMAN SERVICES".
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized caduceus symbol, featuring a staff with a serpent entwined around it.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Sebia, Inc. c/o Borek Janik, Ph.D. Morax-Official Correspondent 13805 Waterloo Chelsea, Michigan 48118
NOV - 4 2003
Re: K033277 Trade/Device Name: HYDRAGEL 3 CSF ISOFOCUSING PN 4353 HYDRAGEL 9 CSF ISOFOCUSING PN 4355 Regulation Number: 21 CFR § 866.5510 Regulation Name: Immunoglobulins A, G, M, D, E Immunological Test System Regulatory Class: II Product Code: CFF Dated: October 4, 2003 Received: October 10, 2003
Dear Dr. Janik:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K033277
(Special 510(k): Device Modification)
| Device name: | HYDRAGEL 3 CSF ISOFOCUSING | PN 4353 |
|---|---|---|
| Device name: | HYDRAGEL 9 CSF ISOFOCUSING | PN 4355 |
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.
The only difference between the 3 CSF and 6 CSF kits is in the intended number of samples per gel: 3 and 9 CSF/serum sample pairs, respectively.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office, of Device Evaluatio leves Jor
Division Sim : Off
Office of in Vita Diagnostic Device Evaluation and Salety
Prescription Use
(Per 21 CFR 801.109) /
500 k) - - Over-The Counter Use ______________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)