(311 days)
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No
The summary describes a quantitative assay kit for measuring light chains in serum, which is a laboratory test. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is for the quantitation of specific biomarkers to aid in diagnosis and monitoring, not for treating any condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the "Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring" of several diseases, directly indicating a diagnostic purpose.
No
The provided text describes a kit for the quantitation of kappa and lambda free light chains in serum using The Binding Site SpaPlus. This clearly indicates a laboratory assay kit involving reagents and a specific hardware instrument (SpaPlus), not a software-only device.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is intended for the quantitation of kappa and lambda free light chains in serum. This involves testing a biological sample (serum) outside of the body (in vitro).
- Purpose: The purpose of this testing is to aid in the diagnosis and monitoring of various diseases like multiple myeloma, lymphocytic neoplasms, etc. This aligns directly with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
The text clearly describes a product designed to perform a diagnostic test on a biological sample in a laboratory setting, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
This kit is intended for the quantitation of kappa free light chains in serum on The Binding Site SpaPlus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.
This kit is intended for the quantitation of lambda free light chains in serum on The Binding Site SpaPlus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.
Product codes
DFH, DEH
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design. The eagle is facing left.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 1 2007
The Binding Site, Ltd. C/O Jay H. Geller West Tower, Suite 4000 2425 West Olympic Boulevard Santa Monica, California 90404
Re: K062372
Trade/Device Name: FREELITE Human Kappa Free Kit for use on the SPAPLUS FREELITE Human Lambda Free Kit for use on the SPAPLUS Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (light chain specific) immunological test system Regulatory Class: Class II Product Code: DFH, DEH Dated: August 16, 2006 Received: August 17, 2006
Dear Mr. Geller:
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
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Page 2 – Jay H. Geller
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as be form inrketing your device as described in your Section 510(k) premarket wifi anow you to begin mating of substantial equivalence of your device to a legally marketed nourteate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, 11 you don't bp the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. 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 Four may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Polo D. Baker Jr.
Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number : K 062372
Device Name: FREELITE Human Kappa Free kit for use on the SPAPLUS
Indications for Use: This kit is intended for the quantitation of kappa free light chains in serum on The Binding Site SpaPlus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Attachment H1
Division Sign-Off
Attachment H1
Office of In Vitro Dlagnostic Device Evaluation and Safety
510(k) 2-06672
Page 1 of 1
3
Indications for Use
510(k) Number : K 062372
Device Name: FREELITE Human Lambda Free kit for use on the SPAPLUS
Indications for Use: This kit is intended for the quantitation of lambda free light chains in serum on The Binding Site SpaPlus. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus in conjunction with other laboratory and clinical findings.
Prescription Use ___X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Attachment H1
Division Sign-Off
Office of In Vitro Diagno Device Evaluation an
510(k) K062372
Page 1 of 1