(69 days)
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No
The summary describes a diagnostic kit for quantifying light chains using standard laboratory instruments, with no mention of AI or ML.
No
The device is intended for the diagnosis and monitoring of various medical conditions, not for treating them.
Yes
The text explicitly states that the "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 disorders such as systemic lupus erythematosus." This indicates its use in diagnosing diseases.
No
The device is described as a "kit" intended for the "quantitation of kappa free light chains in serum and urine" on specific laboratory instruments (Nephelometer II, IMMAGE, Hitachi). This strongly suggests it is a reagent kit or similar consumable used with hardware, not a standalone software device.
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 kit is intended for the "quantitation of kappa free light chains in serum and urine" and "quantitation of lambda free light chains in serum and urine." It also clearly states that the measurement "aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, amyloidosis, light chain deposition disease and connective tissue disorders such as systemic lupus erythematosus."
- Sample Type: The device analyzes biological samples (serum and urine).
- Purpose: The purpose is to provide information that aids in the diagnosis and monitoring of specific medical conditions.
These are all key characteristics of an In Vitro Diagnostic device, which is defined as a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BN™II). 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 disorders such as systemic lupus erythematosus.
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Dade Behring Nephelometer II (BN™II). 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 disorders such as systemic lupus erythematosus.
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Beckman Coulter IMMAGE™. 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 disorders such as systemic lupus erythematosus.
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Beckman Coulter IMMAGE™. 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 disorders such as systemic lupus erythematosus.
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Hitachi 911/912/917/Modular P. 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 disorders such as systemic lupus erythematosus.
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Hitachi 911/912/917/Modular P. 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 disorders such as systemic lupus erythematosus.
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures.
MAR 1 1 2004
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, California 90404
Re: K040009
Trade/Device Names: FREELITE™ Human Kappa Free Kit for use on the Dade Behring Nephelometer "11 II FREELITE™ Human Lambda Free Kit for use on the Dade Behring Nephelometer 11 FREELITE™ Human Kappa Free Kit for use on the Beckman Coulter IMMAGE™ FREELITE™ Human Lambda Free Kit for use on the Beckman Coulter IMMAGE™ FREELITE™ Human Kappa Free Kit for use on the HITACHI 911/912/917/Modular P FREELITE™ Human Lambda Free Kit for use on the HITACHI 911/912/917/Modular P Regulation Number: 21 CFR § 866.5550 Regulation Name: Immunoglobulins (Light Chain Specific) Immunological Test System Regulatory Class: II Product Code: DFH, DEH Dated: December 29, 2004 Received: January 2, 2004
Dear 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 recuirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
1
Page 2 - Jay H. Geller
will allow you to begin 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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 Division of Small Manufacturers, International and Consumer 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,
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
2
510(k) Number (if known):
FREELITE™ Human Kappa Free kit for use on the Dade Behring Device Name: Nephelometer™ II
Indications For Use:
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Dade Behring Nephelometer II (BN™II). 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 disorders such as systemic lupus erythematosus.
e Clan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040009
Prescription Use ____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
3
510(k) Number (if known): Ko 4000 9
FREELITE™ Human Lambda Free kit for use on the Dade Behring Device Name: 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 (BN™II). 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 disorders such as systemic lupus erythematosus.
ia chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Ko40009
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
4
510(k) Number (if known): Ko 40009
FREELITE™ Human Kappa Free kit for use on the Beckman Device Name: Coulter IMMAGE™
Indications For Use:
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Beckman Coulter IMMAGE™. 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 disorders such as systemic lupus erythematosus.
Maria Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040009
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
5
510(k) Number (if known): Ko 4000 9
FREELITE™ Human Lambda Free kit for use on the Beckman Device Name: Coulter IMMAGE™
Indications For Use:
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Beckman Coulter IMMAGE™. 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 disorders such as systemic lupus erythematosus.
Maria Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040009
Prescription Use 1 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
6
510(k) Number (if known): Ko40009
FREELITE™ Human Kappa Free kit for use on the Hitachi Device Name: 911/912/917/Modular P
Indications For Use:
This kit is intended for the quantitation of kappa free light chains in serum and urine on the Hitachi 911/912/917/Modular P. 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 disorders such as systemic lupus erythematosus.
Mana Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040009
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
7
510(k) Number (if known): Ko 40009
FREELITE™ Human Lambda Free kit for use on the Hitachi Device Name: 911/912/917/Modular P
Indications For Use:
This kit is intended for the quantitation of lambda free light chains in serum and urine on the Hitachi 911/912/917/Modular P. 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 disorders such as systemic lupus erythematosus.
Maria Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040009
1 Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)