(621 days)
No
The device description and performance studies describe a standard immunoassay method and statistical analysis of results, with no mention of AI or ML techniques.
No
The device is described as an "in-vitro diagnostic reagent" used to aid in the diagnosis and monitoring of conditions like multiple myeloma and amyloidosis by quantitative determination of free light chains. It does not directly treat or prevent a disease, which is the primary function of a therapeutic device.
Yes
The device is an in-vitro diagnostic reagent designed for the quantitative determination of free light chains, which is used as an aid in the diagnosis and monitoring of multiple myeloma, amyloidosis, and the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS). This directly falls under the definition of a diagnostic device.
No
The device is described as in-vitro diagnostic reagents for the quantitative determination of free light chains, which are physical substances used in laboratory testing, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the N Latex FLC kappa and lambda are "in-vitro diagnostic reagents" and describes their use for the quantitative determination of substances in human samples (serum and EDTA-plasma) to aid in the diagnosis and monitoring of specific medical conditions (multiple myeloma, amyloidosis, and evaluation of MGUS). This directly aligns with the definition of an in vitro diagnostic device.
- Device Description: The description further clarifies that these are "in vitro diagnostic reagents" used for quantitative determination in human samples.
- Performance Studies: The document details performance studies conducted to evaluate the device's performance in a clinical setting, which is typical for IVD devices.
- Predicate Device(s): The mention of predicate devices with K numbers (K031016) indicates that this device is being compared to previously cleared IVD devices.
All these points strongly support the classification of this device as an In Vitro Diagnostic.
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 amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer, · 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
DFH, DEH
Device Description
The N Latex FLC (free light chain) assays are in vitro diagnostic reagents for the quantitative determination of free light chains, type kappa or type lambda, in human serum and EDTA plasma by means of particle-enhanced immunoassay determination. Used in conjunction with other clinical and laboratory findings, FLC measurements are used as an aid in the diagnosis and monitoring of multiple myeloma (MM), as an aid in the diagnosis of amyloidosis (AL) and on the BN Systems, as an aid in the evaluation of MGUS. Polystyrene particles coated with antibodies to human free light chains, type kappa or lambda, are agglutinated when mixed with samples containing FLC. 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 are not materially changed from those cleared under K171742. The purpose for this submission is to add evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) 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
For prescription use only.
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
The cohort of MGUS samples consisted of 121 samples (89 Non-IgM, 21 IgM and 11 LC MGUS).
The cohort of polyclonal immunostimulation samples consisted of 102 specimens.
Patients initially diagnosed for MGUS were evaluated over different time periods. At least 4 sample draws at various time intervals were obtained from each participant. The overall population consisted of 61 patients with clinically stable MGUS diagnosis (stable cohort) and 4 patients that demonstrated a progressive clinical status by converting from MGUS to MM (progressive cohort).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data is provided for the extended indication for evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS). The Latex FLC assays were evaluated on BN II Systems in a multi-center study to evaluate performance to support a claim for the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) patients.
MGUS Concordance Study:
- Study Type: Clinical study for MGUS concordance.
- Sample Size: 121 MGUS samples (89 Non-IgM, 21 IgM, 11 LC MGUS).
- Key Results: Overall MGUS concordance was 50.4%. For LC MGUS, concordance was 90.9% (10 out of 11 positive for both criteria, 1 out of 11 positive for one criterion).
Polyclonal Immunostimulation Concordance Study: - Study Type: Clinical study for polyclonal immunostimulation concordance.
- Sample Size: 102 polyclonal immunostimulation samples.
- Key Results: Concordance was 90.2%.
MGUS Stable Cohort Study: - Study Type: Evaluation of stable MGUS patients.
- Sample Size: 61 patients.
- Key Results: Agreement with clinical diagnosis was 98.4%, defined by a κ/λ ratio within 0.53-1.51 at the last draw and two consecutive assessments not showing a relative change of ≥ 25% for the involved free light chain (iFLC).
Progressive Cohort Study: - Study Type: Evaluation of progressive MGUS patients (converting to MM).
- Sample Size: 4 patients.
- Key Results: Agreement with clinical diagnosis was 75.0%, defined by a κ/λ ratio outside 0.53-1.51 at MM diagnosis and two consecutive assessments showing a relative change of ≥ 25% for the involved light chain (iFLC).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- MGUS Concordance: 50.4%
- LC MGUS Disease Group Concordance: 90.9%
- Polyclonal Immunostimulation Concordance: 90.2%
- Agreement with clinical (Stable MGUS): 98.4%
- Agreement with clinical (Progressive MGUS): 75.0%
Predicate Device(s)
Reference Device(s)
BN II (K943997), BN ProSpec Systems (K001647)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 14, 2021
Siemens Healthcare Diagnostics Products GmbH Sanja Matern Regulatory Affairs Manager Emil-von-Behring-Str. 76 Marburg, 35041 De
Re: K193047
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: October 2, 2020 Received: October 5, 2020
Dear Sanja Matern:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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 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) K193047
Device Name
N Latex FLC kappa, 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 amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer,
· 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image contains 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 words 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: K193047
1. Submitter Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 35041 Marburg, Germany Contact: Sanja Matern Email: sanja.matern@siemens-healthineers.com Phone: +49 176 34939948 Date of Preparation: July 12, 2021 2. Device Information Trade Name: N Latex FLC kappa assay N Latex FLC lambda assay Common or Usual Name: Light Chain immunological test system Classification Name: lmmunoglobulin specific) (light chain 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
Even though TBS' Freelite assays are cited as predicate devices in this submission, they do not contain an MGUS evaluation claim in the product package insert intended use statement. Siemens has received guidance from FDA in an email dated October 5, 2018, stating that Siemens may use the Freelite assays as predicate devices with the understanding that FDA will determine Substantial Equivalence based on clinical performance.
4. Device Description / Test Principle
The N Latex FLC (free light chain) assays are in vitro diagnostic reagents for the quantitative determination of free light chains, type kappa or type lambda, in human serum and EDTA plasma by means of particle-enhanced immunoassay determination. Used in conjunction with other clinical and laboratory findings, FLC measurements are used as an aid in the diagnosis and monitoring of multiple myeloma (MM), as an aid in the diagnosis of amyloidosis (AL) and on the BN Systems, as an aid in the evaluation of MGUS.
Polystyrene particles coated with antibodies to human free light chains, type kappa or lambda, are agglutinated when mixed with samples containing FLC. 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 are not materially changed from those cleared under K171742. The purpose for this submission is to add evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) to the intended use.
5. 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 amyloidosis (AL) on the BN Systems and Atellica® CH Analyzer,
5
· 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.
Special Conditions for Use:
For prescription use only.
The result of the FLC kappa or FLC lambda in a given specimen determined with assays and/or instrument platforms from different manufacturers can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the FLC kappa or FLC lambda assay used. Values obtained with different assay methods cannot be used interchangeably. The values of FLC kappa or FLC lambda on BN systems and on Atellica® CH Analyzer should not be used interchangeably.
If, in the course of serially monitoring a patient, the assay method used for determining the FLC kappa and FLC lambda levels is changed, additional sequential testing should be carried out. Prior to changing assays, the laboratory MUST confirm baseline values for patients being serially monitored.
- o Precautions:
- . 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.
- 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.
Special instrument requirements:
BN II (K943997)
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 assay versus The Binding Site (TBS)
6
Freelite Human Kappa Free and Lambda Free assays (predicates) is provided in the table below.
| Comparison of
Technological
| Characteristics | Predicate Devices | Proposed Device |
|---|---|---|
| The Binding Site | Siemens Healthcare | |
| BN Systems | ||
| Freelite® Human Kappa Free | ||
| Freelite® Human Lambda | ||
| Free on | ||
| Siemens BN™II | ||
| (K031016) | N Latex FLC kappa | |
| N Latex FLC lambda | ||
| (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 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. | 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 amyloidosis (AL)
on the BN Systems and
Atellica® CH Analyzer.
• 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 |
| Comparison of
Technological
Characteristics | Predicate Devices | Proposed Device |
| | The Binding Site | |
| | Freelite® Human Kappa Free
Freelite® Human Lambda
Free on
Siemens BN™II
(K031016) | Siemens Healthcare
BN Systems
N Latex FLC kappa
N Latex FLC lambda
(K193047) |
| Detection Mode | Nephelometry | Same |
| Measurement | Quantitative | Same |
| Detection Antibody | Polyclonal mouse anti-human
FLC Kappa
Polyclonal mouse anti-antibody
FLC Lambda | Monoclonal mouse anti-
human FLC kappa
Monoclonal mouse anti-
antibody FLC lambda |
| Reagent Composition | Polystyrene particles coated
with polyclonal antibodies | Polystyrene particles coated
with monoclonal antibodies |
| Traceability | Internal reference preparation | Internal reference plasma pool |
| Calibrators | One level | Same |
| Instrument System | Siemens BN II System | Siemens BN II and BN
ProSpec Systems |
| Analytical measuring
range | Kappa: 5.9 to 190 mg/L
Lambda: 5.0 to 160 mg/L | Typical range:
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 to 28.9 mg/L
lambda: 9.10 to 32.6 mg/L
Ratio: 0.53 to 1.51 |
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This submission is to add a claim for evaluation of MGUS to the intended use statement.
7. Performance Data
Performance data is provided for the extended indication for evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS). See submissions K171742 and K182098 for previously documented analytical and clinical studies:
- Precision and Reproducibility ●
- Linearity / Assay Measuring Range ●
- Antigen Excess .
- Stability ●
8
- Detection Capabilities ●
- Analytical Specificity / Interferences ●
- Expected Values ●
- Clinical Sensitivity / Specificity for MM and AL diagnosis and MM monitoring . claims
- Method comparison to the Predicate Devices for MM and AL diagnosis and . MM monitoring claims
7.1 Performance data for evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) patients
The Latex FLC assays were evaluated on BN II Systems in a multi-center study to evaluate performance to support a claim for the evaluation of Monoclonal Gammopathy of Undetermined Significance (MGUS) patients. The following studies were performed in support of the proposed claim
7.1.1 Aid in Evaluation of MGUS
Concordances were evaluated using clinically defined samples including a panel of samples from patients with defined MGUS diagnosis and a panel of samples from patients with the diagnosis of polyclonal immunostimulation to evaluate for MGUS.
7.1.1.1 MGUS Concordance
The cohort of MGUS samples consisted of 121 samples (89 Non-IgM, 21 IgM and 11 LC MGUS).
| Disease Group | N = | Concordance
Obtained
(%) |
|---------------|-----|--------------------------------|
| MGUS | 121 | 50.4 |
N Latex FLC κ/λ Ratio Concordance
In order to demonstrate the capability of N Latex FLC to detect this subgroup of MGUS patients, the group of LC MGUS samples was evaluated separately using the currently defined criteria:
LC MGUS is defined as an abnormal FLC-Ratio with complete lack of IgH (Heavy-Chain) expression, plus an elevation in the appropriate involved FLC. The following table contains the % concordance for the LC MGUS evaluated population:
9
LC MGUS Disease Group Concordance
| Disease Group | N= | Positive for
both criteria | Positive for
one criterion | Concordance
obtained
(%) |
|---------------|----|-------------------------------|-------------------------------|--------------------------------|
| LC MGUS | 11 | 10 | 1 | 90.9 |
7.1.1.2 Polyclonal Immunostimulation Concordance
Evaluation used a panel of samples from patients with the diagnosis of polyclonal immunostimulation to evaluate for MGUS.
The cohort of polyclonal immunostimulation samples consisted of 102 specimens.
N Latex FLC κ/λ Ratio Concordance
| Disease Group | N = | Concordance
obtained
(%) |
|---------------------------------|-----|--------------------------------|
| Polyclonal
Immunostimulation | 102 | 90.2 |
7.1.2 Evaluation of MGUS patients
Patients initially diagnosed for MGUS were evaluated over different time periods. At least 4 sample draws at various time intervals were obtained from each participant. The overall population consisted of 61 patients with clinically stable MGUS diagnosis (stable cohort) and 4 patients that demonstrated a progressive clinical status by converting from MGUS to MM (progressive cohort).
7.1.2.1 MGUS Stable Cohort
Evaluation criteria: Agreement of the N Latex FLC results with the clinical diagnosis of MGUS was defined if the two following criteria were both fulfilled:
- a) The к/л ratio must be within the reference interval of 0.53 - 1.51 at the time of the last draw
- Two consecutive assessments did not show a relative change of ≥ 25% for b) the involved free light chain (iFLC)
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Results in Stable Patient Cohort
| Disease Group | N = | Agreement with clinical
(%) |
|---------------|-----|--------------------------------|
| Stable MGUS | 61 | 98.4 |
7.1.2.2 Progressive Cohort
Evaluation criteria: Agreement of the N Latex results with a change in clinical diagnosis of MGUS to MM defined if the two following criteria were both fulfilled:
The к/λ ratio must be outside the reference interval of 0.53 - 1.51 at the time of clinical MM diagnosis
Two consecutive assessments must show a relative change of ≥ 25% for the involved light chain (iFLC).
Results in Progressive Patient Cohort
| Disease Group | N = | Agreement with clinical
(%) |
|------------------|-----|--------------------------------|
| Progressive MGUS | 4 | 75.0 |
8. Proposed Labeling
The labeling is adequate and satisfies the requirements of 21 CFR Part 809.10.
9. Conclusion
The completed studies demonstrate that the N Latex FLC kappa and lambda assays can be used to evaluate Monoclonal Gammopathy of Undetermined Significance (MGUS).