(106 days)
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No
The summary describes a quantitative assay kit for measuring light chains, which is a standard laboratory diagnostic technique. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a kit for the quantitation of light chains to aid in the diagnosis and monitoring of diseases, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurement "aids in the diagnosis and monitoring" of several diseases.
No
The device description is not provided, but the intended use clearly describes a "kit" for quantitation of substances using a "Nephelometer II (BNII)". This strongly suggests a physical kit containing reagents and a hardware instrument, 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 kit is for the "quantitation of kappa free light chains in serum and urine" and "quantitation of lambda free light chains in serum and urine." These are biological samples taken in vitro (outside the body).
- Purpose: The measurement of these light chains "aids in the diagnosis and monitoring" of various diseases. This is a key characteristic of IVDs – they are used to provide information for diagnostic or monitoring purposes.
- Device Type: The description refers to a "kit," which is a common format for IVD reagents and consumables used in laboratory testing.
- Instrument: It specifies use on a "Dade Behring Nephelometer II (BNII)," which is a laboratory instrument used for performing in vitro diagnostic tests.
- Care Setting: The "Prescription Use" indicates it's intended for use in a healthcare setting, typically a laboratory, under the direction of a healthcare professional.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FREELITE® Human Kappa Free Kit: "This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). 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 erythemoatosus."
FREELITE® Human Lambda Free Kit: "This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus."
Product codes (comma separated list FDA assigned to the subject device)
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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is rendered in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 6 2004
The Binding Site, Ltd. c/o Mr. Jay H. Geller West Tower, Suite 4000 2425 West Olympic Coulevard Santa Monica, CA 90404
Re: K031016
Trade/Device Name: FREELITE® Human Kappa Free Kit and FREELITE® Human Lambda Free Kit for use on the Dade Behring Nephelometer II
Regulation Number: 21 CFR 866.550
Regulation Name: Immunoglobulin (light chain specific) immunological test system
Regulatory Class: Class II
Product Code: DFH [Kappa]; DEH [Lambda] Dated: June 10, 2003 Received: June 13, 2003
Dear Mr. Geller:
This letter corrects our substantially equivalent letter of July 15, 2003, regarding the omission of the FREELITE® Human Lambda Free Kit from the trade name information above, and of the product code for the FREELITE® Human Kappa Free Kit, i.e., DFH.
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 [{{or 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 (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.
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Page 2 - Mr. Jay H. Geller
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-3084. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Fuen Antman, m.D.
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 / of 2
510(k) Number (if known): K031016
Device Name: FREELITE® Human Kappa Free Kit for Use on the Dade Behring Nephelometer II
This kit is intended for the quantitation of Indications for Use: kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). 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 erythemoatosus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| A.PReeves for J. Bautista | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
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Page 2 of 2
510(k) Number (if known): K03 /0 / L
FREELITE® Human Lambda Free Kit for Use on the Dade Device Name: Behring Nephelometer II
Indications for Use: This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer II (BNII). Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythemoatosus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| J.P.Reeves for J. Bautista | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K031016 |
| Prescription Use V
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use _ |
|---|---|---|
| (Optional Format 1-2-96) |
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