(52 days)
FREELITE® Human Kappa Free Kit For Use on the Olympus AU analyzer. 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.
FREELITE® Human Lambda Free Kit For Use on the Olympus AU analyzer. 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.
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This document is a FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, not a study report or scientific publication describing acceptance criteria and a study to prove a device meets them. Therefore, many of the requested items are not present in this type of document.
The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA reviewed performance data provided by the manufacturer and determined that the new device performs as well as, or is sufficiently similar to, a device already on the market. The specific acceptance criteria and the detailed study proving equivalence are typically included in the 510(k) submission itself, which is not fully provided here.
However, based on the information that is available in this clearance letter, here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
This information is not provided in this FDA clearance letter. The letter confirms that The Binding Site, Limited’s FREELITE® Human Kappa and Lambda Free Kits for Use in the Olympus AU series Analyzers are substantially equivalent to predicate devices. The specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) and their acceptance criteria would have been part of the 510(k) submission, which is not contained within this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in this FDA clearance letter. Such details would be found within the 510(k) submission document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in this FDA clearance letter. For IVD devices like this, ground truth is typically established through reference methods or clinical diagnosis, not by experts reviewing images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in this FDA clearance letter. As above, adjudication methods like 2+1 or 3+1 are more relevant to image-based diagnostic aids and not typically for quantitative IVD tests where results are numerical values.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable/Not provided. This is an in vitro diagnostic (IVD) device for quantitating kappa and lambda free light chains in serum and urine. It is not an AI-assisted diagnostic tool for human readers; therefore, an MRMC comparative effectiveness study involving human readers would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device is inherently standalone. This is an automated in vitro diagnostic test performed on an analyzer. The "algorithm" is the reagent and analyzer system itself, producing quantitative results. Its performance is evaluated in a standalone manner. The FDA's substantial equivalence determination is based on the performance of the device as a system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used is not explicitly stated in this letter. For an IVD device quantifying biomarkers, the ground truth would typically be established by:
- Reference methods: A highly accurate and precise analytical method.
- Clinical diagnosis/Patient outcomes: Correlating the device's results with the ultimate clinical diagnosis of conditions like "lymphocytic neoplasms, multiple myeloma, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus."
8. The sample size for the training set
Not applicable/Not provided. This device is a reagent/analyzer system, not an AI model that requires a "training set" in the conventional machine learning sense. The development of such a system involves analytical validation and clinical validation, but not typically a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable/Not provided. As explained in point 8, this is not an AI-based device that relies on a "training set" and corresponding ground truth for algorithm development.
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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)
§ 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).