(52 days)
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No
The provided text describes a diagnostic kit for quantifying free light chains in serum and urine using an Olympus AU analyzer. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the intended use and the type of analysis performed, which is a standard laboratory assay.
No
The device is an in vitro diagnostic kit used for quantitation of specific light chains to aid in diagnosis and monitoring of various diseases, not for therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the quantity measurement of light chains "aids in the diagnosis and monitoring" of several diseases. This clearly indicates a diagnostic purpose.
No
The device is a kit intended for use on a specific analyzer, implying it includes reagents and likely other physical components, not just software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kits are "intended for the quantitation of kappa free light chains in serum and urine". This indicates that the device is used to test samples taken from the human body (serum and urine) in vitro (outside the body).
- Diagnostic Purpose: The intended use also clearly states that the measurement "aids in the diagnosis and monitoring of lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus." This confirms that the device is used for diagnostic purposes.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FREELITE® Human Kappa Free Kit For Use on the Olympus AU analyzer.
Indications for Use: This kit is intended for the quantitation of kappa free light chains in serum and urine on the Olympus AU series analysers. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of lymphocytic neoplasms, Waldenstrom's macroglobulinemia, multiple myeloma, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
FREELITE® Human Lambda Free Kit For Use on the Olympus AU analyzer.
Indications for Use: This kit is intended for the quantitation of kappa free light chains in serum and urine on the Olympus AU series analysers. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
Product codes (comma separated list FDA assigned to the subject device)
DEH, DFH
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 is a circular emblem with the department's name encircling a stylized caduceus symbol. The caduceus is represented by a stylized design of an eagle with its wings spread, with a staff entwined by two snakes below it. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
The Binding Site, Limited c/o Mr. Jay H. Geller 2425 West Olympic Boulevard West Tower, Suite 4000 Santa Monica, CA 90404
FEB 9 - 2004
Re: K033811 Trade/Device Name: FREELITE® Human Kappa and Lambda Free Kits for Use in the Olympus AUTM series Analyzers Regulation Number: 21 CFR § 866.5550 Regulation Name: Immunoglobulin (Light Chain Specific) Immunological Test System Regulatory Class: II Product Code: DEH, DFH Dated: December 5, 2003 Received: December 10, 2003
Dear Mr. Geller:
This letter corrects our substantially equivalent letter of January 30, 2004, regarding the omission of the Lambda Free Kit from the device information reference above and of the corresponding product code.
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 (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 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.
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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 (OS) 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) 594-1243. 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.
Joseph L. Hackett
Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _
Indications For Use:
FREELITE® Human Kappa Free Kit For Use on the Olympus Device Name: AU analyzer.
Indications for Use: This kit is intended for the quantitation of kappa free light chains in serum and urine on the Olympus AU series Measurement of the various amounts of the different analysers. types of light chains aids in the diagnosis and monitoring of lymphocytic neoplasms, Waldenstrom's myeloma, multiple macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
the clattDivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
K 033811
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
FREELITE® Human Lambda Free Kit For Use on the Device Name: Olympus AU analyzer.
Indications for Use: This kit is intended for the quantitation of kappa free light chains in serum and urine on the Olympus AU series analysers. Measurement of the various amounts of the different types of light chains aids in the diagnosis and monitoring of lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Thana Chan | |
|---|---|
| Division Sign-Off |
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K033811 |
|---|---|
| -------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)