(511 days)
No
The device description and performance studies focus on a particle-enhanced immunonephelometry assay, which is a traditional laboratory technique, and there is no mention of AI or ML in the document.
No.
Explanation: This device is an in-vitro diagnostic reagent used for diagnosis and monitoring of diseases, not for therapeutic purposes.
Yes
The device is described as "in-vitro diagnostic reagents" and its intended use is "as an aid in the diagnosis and monitoring of multiple myeloma (MM), immunoglobulin light-chain amyloidosis (AL), and for the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS)," which are all diagnostic applications.
No
The device is described as in-vitro diagnostic reagents and test systems based on particle-enhanced immunonephelometry, which are physical components used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in multiple sections:
- Intended Use / Indications for Use: "N Latex FLC kappa and lambda are in-vitro diagnostic reagents..."
- Device Description: "N Latex FLC kappa and lambda are in-vitro diagnostic reagents..."
These statements clearly identify the device as an in-vitro diagnostic product.
N/A
Intended Use / Indications for Use
N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA plasma. N Latex FLC kappa and lambda assays are used:
• as an aid in the diagnosis and monitoring of multiple myeloma (MM) on the BN Systems and Atellica® CH Analyzer.
• as an aid in the diagnosis of immunoglobulin light-chain amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer.
• as an aid in the monitoring of immunoglobulin light-chain amyloidosis (AL) on the BN Systems.
• as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) on the BN Systems.
Results of FLC measurements should always be interpreted in conjunction with other laboratory and clinical findings.
Product codes (comma separated list FDA assigned to the subject device)
DFH, DEH
Device Description
N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTAplasma. N Latex FLC kappa and lambda assays are used as an aid in the diagnosis and monitoring of multiple myeloma (MM) and immunoglobulin light-chain amyloidosis (AL) and as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS). Monitoring of immunoglobulin light-chain amyloidosis (AL) and evaluation of MGUS are cleared for use only on the BN Systems.
The N Latex FLC test systems are based upon the principles of particle-enhanced immunonephelometry. Polystyrene particles coated with monoclonal antibodies to human free light chains, type kappa or lambda, respectively, are agglutinated when mixed with samples containing free light chains. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
The devices in this submission have not materially changed since originally cleared under K171742. The purpose for this submission is to add monitoring of immunoglobulin light-chain amyloidosis (AL), on the BN Systems, to the intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
BN II (K943997) and BN ProSpec Systems (K001647)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
For the performance data for monitoring of immunoglobulin light-chain amyloidosis (AL) patients, the Latex FLC assays were evaluated on BN II Systems in a multicenter study. N Latex FLC kappa and lambda assays were compared to Freelite Kappa and Lambda assays (predicate devices) in a method comparison analysis. Additionally, both methods were compared to the patient's "clinical response," which considered all available clinical and laboratory information.
Response evaluation was performed by comparing changes between the initial sample draw and each consecutive blood draw independently, applying the NCCN Response Criteria as outlined in the provided table.
For the comparison to predicate devices, response categories were determined for free light chain testing by Siemens Healthcare N Latex FLC and TBS Freelite Kappa Free and Lambda Free. Response evaluation involved comparing changes between the initial sample draw and each consecutive blood draw independently. The response levels obtained by the two different test systems were compared in 5x5 contingency tables and relative agreement calculated. Sample size can be inferred from the contingency tables, which sum to 241 observations.
For the comparison to clinical status, response levels obtained by the two different test systems (N Latex FLC and predicate device) were compared to the clinical response level provided by the physician, taking into account all available clinical and laboratory information. Relative agreement between the clinical response (including further information in addition to serum testing) and the response level applying the clinical response criteria by either using N Latex FLC or the predicate device were calculated, also using 5x5 contingency tables, and compared. Sample size can be inferred from the contingency tables, which sum to 222 observations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Performance data for monitoring of immunoglobulin light-chain amyloidosis (AL) patients. Multi-center study.
Sample Size: 241 (for comparison to predicate devices), 222 (for comparison to clinical status)
Key Results:
Comparison to Predicate Devices:
Agreements (N Latex FLC versus Freelite) for Evaluation Mode 1:
Complete Response: 66.2% (95% CI: 51.6 – 83.6%)
VGPR: 82.8% (95% CI: 70.3 - 92.3%)
Partial Response: 55.6% (95% CI: 21.4 - 71.4%)
Stable Disease: 83.3% (95% CI: 77.4 – 96.7%)
Progressive Disease: 68.8% (95% CI: 47.4 - 92.3%)
Agreements (N Latex FLC versus Freelite) for Evaluation Mode 2:
Complete Response: 68.1% (95% CI: 53.6 – 86.3%)
VGPR: 81.8% (95% CI: 67.4 – 91.1%)
Partial Response: 45.5% (95% CI: 15.0 – 60.0%)
Stable Disease: 84.4% (95% CI: 76.5 – 95.4%)
Progressive Disease: 88.2% (95% CI: 70.0 – 100.0%)
Agreements (N Latex FLC versus Freelite) for Evaluation Mode 3:
Complete Response: 66.7% (95% CI: 52.0 – 83.9%)
VGPR: 84.2% (95% CI: 71.2 – 93.3%)
Partial Response: 57.7% (95% CI: 23.1 – 76.0%)
Stable Disease: 85.7% (95% CI: 77.0 – 96.1%)
Progressive Disease: 90.0% (95% CI: 77.8 – 100.0%)
Comparison to Clinical Status (N Latex FLC versus Clinical Status):
Concordances for Evaluation Mode 1:
Complete Response: 55.9% (95% CI: 28.6 – 75.7%)
VGPR: 71.4% (95% CI: 56.6 – 88.9%)
Partial Response: 26.8% (95% CI: 7.8 – 30.2%)
Stable Disease: 59.3% (95% CI: 39.6 – 75.0%)
Progressive Disease: 52.9% (95% CI: 28.6 – 78.9%)
Concordances for Evaluation Mode 2:
Complete Response: 52.9% (95% CI: 25.0 – 74.3%)
VGPR: 71.4% (95% CI: 56.6 – 88.9%)
Partial Response: 26.8% (95% CI: 8.0 – 30.3%)
Stable Disease: 57.6% (95% CI: 38.2 – 72.9%)
Progressive Disease: 70.6% (95% CI: 47.1 – 88.2%)
Concordances for Evaluation Mode 3:
Complete Response: 52.9% (95% CI: 24.0 – 74.2%)
VGPR: 71.4% (95% CI: 56.4 – 89.1%)
Partial Response: 26.8% (95% CI: 7.9 – 30.3%)
Stable Disease: 57.6% (95% CI: 37.5 – 72.3%)
Progressive Disease: 76.5% (95% CI: 52.9 – 93.8%)
Comparison to Clinical Status (Freelite versus Clinical Status):
Concordances for Evaluation Mode 1:
Complete Response: 61.8% (95% CI: 40.7 – 87.0%)
VGPR: 66.1% (95% CI: 54.9 – 85.4%)
Partial Response: 26.8% (95% CI: 6.2 – 29.2%)
Stable Disease: 54.2% (95% CI: 34.2 – 70.7%)
Progressive Disease: 64.7% (95% CI: 38.9 – 82.4%)
Concordances for Evaluation Mode 2:
Complete Response: 58.8% (95% CI: 33.3 – 84.0%)
VGPR: 60.7% (95% CI: 49.1 – 82.6%)
Partial Response: 28.6% (95% CI: 6.9 – 30.4%)
Stable Disease: 52.5% (95% CI: 32.7 – 68.8%)
Progressive Disease: 58.8% (95% CI: 28.6 – 80.0%)
Concordances for Evaluation Mode 3:
Complete Response: 64.7% (95% CI: 44.4 – 91.3%)
VGPR: 64.3% (95% CI: 52.6 – 84.6%)
Partial Response: 26.8% (95% CI: 6.4 – 29.3%)
Stable Disease: 50.8% (95% CI: 31.7 – 66.7%)
Progressive Disease: 64.7% (95% CI: 38.9 – 83.3%)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
N Latex FLC versus Clinical Status (Evaluation Mode 1):
Sensitivity: 52.9% (9/17) (95% CI: 28.6 – 78.9%)
Specificity: 96.6% (198/205) (95% CI: 95.2 — 99.5%)
N Latex FLC versus Clinical Status (Evaluation Mode 2):
Sensitivity: 70.6% (12/17) (95% CI: 47.1 – 88.2%)
Specificity: 96.1% (197/205) (95% CI: 94.8 - 99.0%)
N Latex FLC versus Clinical Status (Evaluation Mode 3):
Sensitivity: 76.5% (13/17) (95% CI: 52.9 – 93.8%)
Specificity: 95.6% (196/205) (95% CI: 93.3 – 99.0%)
Freelite versus Clinical Status (Evaluation Mode 1):
Sensitivity: 64.7% (11/17) (95% CI: 38.9 - 82.4%)
Specificity: 97.6% (200/205) (95% CI: 94.8 - 99.5%)
Freelite versus Clinical Status (Evaluation Mode 2):
Sensitivity: 58.8% (10/17) (95% CI: 28.6 – 80.0%)
Specificity: 96.6% (198/205) (95% CI: 94.2 - 99.5%)
Freelite versus Clinical Status (Evaluation Mode 3):
Sensitivity: 64.7% (11/17) (95% CI: 38.9 – 83.3%)
Specificity: 95.6% (196/205) (95% CI: 93.4 - 99.0%)
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) of N Latex FLC versus Freelite (Evaluation Mode 1):
PPA: 68.8% (11/16) (95% CI: 47.4 – 92.3%)
NPA: 97.8% (220/225) (95% CI: 96.8 - 100.0%)
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) of N Latex FLC versus Freelite (Evaluation Mode 2):
PPA: 88.2% (15/17) (95% CI: 70.0 – 100.0%)
NPA: 97.8% (219/224) (95% CI: 95.9 - 99.6%)
Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) of N Latex FLC versus Freelite (Evaluation Mode 3):
PPA: 90.0% (18/20) (95% CI: 77.8 – 100.0%)
NPA: 98.2% (217/221) (95% CI: 96.3 – 99.6%)
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.
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.
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).
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 29, 2021
Siemens Healthcare Diagnostics Products GmbH Kerstin Koenigs Official Correspondent Emil-von-Behring-Str. 76 Marburg, 35041 Germany
Re: K201496
Trade/Device Name: N Latex FLC kappa. N Latex FLC lambda Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (Light Chain Specific) Immunological Test System Regulatory Class: Class II Product Code: DFH, DEH Dated: July 29, 2021 Received: August 2, 2021
Dear Kerstin Koenigs:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ying (Katelin) Mao, Ph.D. Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201496
Device Name
N Latex FLC kappa and N Latex FLC lambda
Indications for Use (Describe)
N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA plasma. N Latex FLC kappa and lambda assays are used:
• as an aid in the diagnosis and monitoring of multiple myeloma (MM) on the BN Systems and Atellica® CH Analyzer. • as an aid in the diagnosis of immunoglobulin light-chain amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer.
· as an aid in the monitoring of immunoglobulin light-chain amyloidosis (AL) on the BN Systems.
· as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) on the BN Systems.
Results of FLC measurements should always be interpreted in conjunction with other laboratory and clinical findings.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots.
510(k) Summary per 21 CFR 807.92
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K201496
1. Submitter
Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 35041 Marburg, Germany
| Contact: | Kerstin Koenigs |
|---|---|
| Email: | kerstin.koenigs@siemens-healthineers.com |
| Phone: | +49 (173) 7318139 |
| Fax: | +49 (6421) 394977 |
| Date of Preparation: | October 20, 2021 |
2. Device Information
| Trade Name: | N Latex FLC kappa
N Latex FLC lambda |
|-----------------------|---------------------------------------------------------------------------------------|
| Common or Usual Name: | Light Chain immunological test system |
| Classification Name: | Immunoglobulin (light chain specific) immunological
test system per 21CFR 866.5550 |
| Product Code: | DFH (kappa)
DEH (lambda) |
| Regulatory Class: | II |
| 510(k) Review Panel: | Clinical Immunology (82) |
4
3. Predicate Devices
The Binding Site Freelite® Human Kappa Free Kit for use on the Siemens BN II - K031016
The Binding Site Freelite® Human Lambda Free Kit for use on the Siemens BN II - K031016
4. Device Description / Test Principle
N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTAplasma. N Latex FLC kappa and lambda assays are used as an aid in the diagnosis and monitoring of multiple myeloma (MM) and immunoglobulin light-chain amyloidosis (AL) and as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS). Monitoring of immunoglobulin light-chain amyloidosis (AL) and evaluation of MGUS are cleared for use only on the BN Systems.
The N Latex FLC test systems are based upon the principles of particle-enhanced immunonephelometry. Polystyrene particles coated with monoclonal antibodies to human free light chains, type kappa or lambda, respectively, are agglutinated when mixed with samples containing free light chains. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
The devices in this submission have not materially changed since originally cleared under K171742. The purpose for this submission is to add monitoring of immunoglobulin light-chain amyloidosis (AL), on the BN Systems, to the intended use.
5. Intended Use / Indications for Use
N Latex FLC kappa and N Latex FLC lambda assays
N Latex FLC kappa and lambda are in-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA plasma.
N Latex FLC kappa and lambda assays are used:
- as an aid in the diagnosis and monitoring of multiple myeloma (MM) on the BN Systems ● and Atellica® CH Analyzer.
- as an aid in the diagnosis of immunoglobulin light-chain amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer.
- . as an aid in the monitoring of immunoglobulin light-chain amyloidosis (AL) on the BN Systems.
- . as an aid in the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) on the BN Systems.
Results of FLC measurements should always be interpreted in conjunction with other laboratory and clinical findings.
5
Precaution
- . The performance of N Latex FLC kappa and lambda has not been thoroughly studied in IgM and Light Chain MGUS patients due to the low prevalence of these subtypes.
- . Patients with decreased renal function may have elevated FLC kappa and FLC lambda (Jacobs et al. N Latex FLC serum free light-chain assays in patients with renal impairment. Clin Chem Lab Med 2013, DOI 10.1515/cclm-2013-0864).
- . Sample populations excluded MGUS populations that were further diagnosed with a disease/disorder in subsequent testing with another medical device such as human immunodeficiency virus, hepatitis, and chronic lymphocytic leukemia. Thus, because the samples were enriched the specificity of the test may be inflated.
N FLC Supplementary Reagent
Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA).
Special Conditions for Use:
For prescription use only.
Special instrument requirements:
BN II (K943997) and BN ProSpec Systems (K001647)
6. Technical Characteristics
Similarities and Differences to the Predicate
A comparison of the similarities and differences between the proposed Siemens Healthcare Latex FLC kappa and lambda assays versus The Binding Site (TBS) Freelite Human Kappa Free Kit and Lambda Free Kit assays (predicate devices) is provided in the table below.
6
| Predicate Devices | Proposed Devices | |
|---|---|---|
| The Binding Site | Siemens Healthcare | |
| BN Systems | ||
| Freelite® Human Kappa Free Kit | ||
| and Freelite® Human Lambda | ||
| Free Kit on the Siemens BN II | N Latex FLC kappa | |
| N Latex FLC lambda | ||
| K031016 | K171742, K182098, K193047 | |
| Indications for | ||
| Use | Kappa: This kit is intended for the | |
| quantitation of kappa free light chains | ||
| in serum and urine on the Siemens | ||
| BN II. Measurement of free light | ||
| chains aids in the diagnosis and | ||
| monitoring of multiple myeloma, | ||
| lymphocytic neoplasms, | ||
| Waldenstrom's macroglobulinemia, | ||
| AL amyloidosis, light chain deposition | ||
| disease and connective tissue | ||
| diseases such as systemic lupus | ||
| erythematosus in conjunction with | ||
| other laboratory and clinical findings. | ||
| Lambda: This kit is intended for the | ||
| quantitation of lambda free light | ||
| chains in serum and urine on the | ||
| Siemens BNTM II. Measurement of | ||
| free light chains aids in the diagnosis | ||
| and monitoring of multiple myeloma, | ||
| lymphocytic neoplasms, | ||
| Waldenstrom's macroglobulinemia, | ||
| AL amyloidosis, light chain deposition | ||
| disease and connective tissue | ||
| diseases such as systemic lupus | ||
| erythematosus in conjunction with | ||
| other laboratory and clinical findings. | N Latex FLC kappa and lambda are in- | |
| vitro diagnostic reagents for the | ||
| quantitative determination of free light | ||
| chains (FLC), type kappa or type | ||
| lambda in human serum and EDTA | ||
| plasma. | ||
| N Latex FLC kappa and lambda assays | ||
| are used: | ||
| • as an aid in the diagnosis and | ||
| monitoring of multiple myeloma (MM) | ||
| on the BN Systems and Atellica® CH | ||
| Analyzer. | ||
| • as an aid in the diagnosis of | ||
| immunoglobulin light-chain amyloidosis | ||
| (AL) on the BN Systems and Atellica® | ||
| CH Analyzer. | ||
| • as an aid in the monitoring of | ||
| immunoglobulin light-chain amyloidosis | ||
| (AL) on the BN Systems. | ||
| • as an aid in the evaluation of | ||
| Monoclonal Gammopathy of | ||
| Undetermined Significance (MGUS) on | ||
| the BN Systems. | ||
| Results of FLC measurements should | ||
| always be interpreted in conjunction | ||
| with other laboratory and clinical | ||
| findings. | ||
| Sample Type | Human serum and urine | Human serum and EDTA plasma |
| Units | mg/L | Same |
| Technology | Nephelometry | |
| Polystyrene particles coated with | ||
| polyclonal monospecific antibodies | Nephelometry | |
| Polystyrene particles coated with | ||
| monoclonal antibodies | ||
| Traceability | Internal reference preparation | Internal Reference Plasma Pool |
| Calibrators | One level | Same |
| Predicate Devices | Proposed Devices | |
| The Binding Site | ||
| Freelite® Human Kappa Free Kit | ||
| and Freelite® Human Lambda | ||
| Free Kit on the Siemens BN II | Siemens Healthcare | |
| BN Systems | ||
| N Latex FLC kappa | ||
| N Latex FLC lambda | ||
| K031016 | K171742, K182098, K193047 | |
| Instrument | ||
| System | Siemens BN II System | Siemens BN II and BN ProSpec |
| Systems | ||
| Analytical | ||
| Measuring | ||
| Range | ||
| (Calibrator lot | ||
| dependent) | Kappa: 5.9 to 190 mg/L | |
| Lambda: 5.0 to 160 mg/L | kappa: 3.4 to 110 mg/L | |
| lambda: 1.9 to 60 mg/L | ||
| Reference | ||
| Interval | Kappa: 3.30 to 19.40 mg/L | |
| Lambda: 5.71 to 26.30 mg/L | ||
| Ratio: 0.26 to 1.65 | kappa: 8.24 – 28.90 mg/L | |
| lambda: 9.10 – 32.60 mg/L | ||
| Ratio: 0.53 to 1.51 |
Comparison of Technological Characteristics
7
510(k) Premarket Notification for Addition of immunoglobulin light-chain amyloidosis (AL) Monitoring Claim to N Latex FLC kappa and lambda
The differences between the predicate devices and proposed reagents do not result in a change to the intended use, the indications for use, or the safety and efficacy when used according to the product labeling.
7. Performance Data
Performance Data: Extended indication for monitoring of immunoqlobulin light-chain amyloidosis (AL).
See submissions K171742, K182098 and K193047 for previously documented analytical and clinical studies:
- Precision and Reproducibility ●
- Linearity / Assay Measuring Range ●
- Antigen Excess ●
- Stability ●
- Detection Capabilities ●
- . Analytical Specificity / Interferences
- Expected Values ●
- Clinical Specificity and Sensitivity ●
- Method Comparison to Predicate Devices ●
7.1 Performance data for monitoring of immunoglobulin light-chain amyloidosis (AL) patients
The Latex FLC assays were evaluated on BN II Systems in a multi-center study to evaluate performance in monitoring immunoglobulin light-chain amyloidosis (AL) patients. N Latex FLC kappa and lambda assays were compared to Freelite Kappa and Lambda assays (predicate
8
devices) in a method comparison analysis. In addition, both methods were compared to the patient's "clinical response", taking into account all available clinical and laboratory information.
For each of the comparisons these three evaluation modes were applied to all immunoglobulin light-chain amyloidosis (AL) data sets, respectively:
- Evaluation Mode 11 ●
- Evaluation Mode 2² .
- . Evaluation Mode 33-4
Response evaluation was done by comparing changes between the initial sample draw and each consecutive blood draw independently, applying the rules as outlined in the table below.
| NCCN Response
Criteria | Serum M Protein
/ IFE | Evaluation Mode
1 | Evaluation Mode
2 | Evaluation Mode
3 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CR
(Complete Response) | Serum and Urine
IFE negative | FLC levels and
ratio normal | FLC levels and
ratio normal | FLC levels and
ratio normal |
| VGPR
(Very Good Partial
Response) | n/a | Reduction in the
dFLC to 0.5g/dL or 50% | From CR,
abnormal FLC
ratio (light chain
must at least
double)
From PR, Serum
FLC increase of
≥ 50% to iFLC | From CR,
abnormal FLC
ratio (light chain
must at least
double)
From PR, Serum
FLC increase of
≥ 50% to dFLC | From CR,
abnormal FLC
ratio (light chain
must at least
double)
From PR, Serum
FLC increase of
≥ 50% to dFLC |
| | increase in urine
M protein to > 200
mg/dL | > 100 mg/L | > 50 mg/L | > 20 and 20%
increase of
baseline |
Therapy Response Criteria
- Note:-For dFLC