(98 days)
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No
The summary describes a kit for protein electrophoresis and immunofixation, which are laboratory techniques, and does not mention any computational or algorithmic components indicative of AI/ML.
No
This device is for the qualitative identification of monoclonal gammopathies to aid in diagnosis, not for treating or preventing a disease state.
Yes
The "Intended Use / Indications for Use" section states that the kit is for the qualitative identification of monoclonal gammopathies and "could be a useful aid, in conjunction with other medical diagnostic tests, in the diagnosis of various disease states". This directly indicates a diagnostic purpose.
No
The 510(k) summary describes a "kit" intended for qualitative identification using protein electrophoresis and immunofixation, which are laboratory techniques involving physical components and reagents, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the kit is for the "qualitative identification of monoclonal gammopathies in urine using protein electrophoresis and immunofixation." This process is performed in vitro (outside the body) on a biological sample (urine) to provide information for the diagnosis of disease states.
- Sample Type: The device uses urine, which is a biological specimen.
- Diagnostic Purpose: The kit is intended to be a "useful aid, in conjunction with other medical diagnostic tests, in the diagnosis of various disease states." This directly aligns with the definition of an IVD, which is used to diagnose or aid in the diagnosis of disease.
The description explicitly describes a test performed on a biological sample in vitro for diagnostic purposes, which is the core definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This kit is intended for the qualitative identification of monoclonal gammopathies in urine using protein electrophoresis and immunofixation.
This kit could be a useful aid, in conjunction with other medical diagnostic tests, in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such gammopathies are multiple myeloma, collagen disorders and other chronic infections.
Product codes
DAO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).
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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 image of an eagle with its wings spread, and three human figures standing close together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image.
NOV 4 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Pat Franks Assistant Director, Regulatory Affairs Helena Laboratories 1530 Lindbergh Drive Beaumont, Texas 77704
к982639/51 Re : Trade Name: SPIFE – Urine Immunofixation Electrophoresis Kit Requlatory Class: II Product Code: DAO Dated: October 20, 1998 Received: October 22, 1998
Dear Ms. Franks:
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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will xerify 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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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 legally 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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): K982639
SPIFE Urine IFE Kit Device Name:
Indications for Use:
This kit is intended for the qualitative identification of monoclonal gammopathies in urine using protein electrophoresis and immunofixation.
This kit could be a useful aid, in conjunction with other medical diagnostic tests, in the diagnosis of various disease states which typically exhibit abnormal patterns. Examples of such gammopathies are multiple myeloma, collagen disorders and other chronic infections.
Peter E. Makin
(Division Sign-Off)
(Division Sign-Division of Clinical 510(k) Numbe
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. L.
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)