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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the concordance percentages achieved in various patient cohorts. The document does not explicitly state numerical thresholds as "acceptance criteria" but rather presents the performance results.

Study Endpoint / Criteria	Reported Device Performance
MGUS Concordance (Overall): The ability of the device to correctly identify patients with MGUS based on FLC measurements.	50.4% Concordance across 121 MGUS samples (89 Non-IgM, 21 IgM, 11 LC MGUS).
LC MGUS Concordance: The ability of the device to correctly identify patients with Light Chain MGUS (LC MGUS) based on an abnormal FLC-Ratio and elevated iFLC.	90.9% Concordance across 11 LC MGUS samples when considering both criteria (abnormal FLC-Ratio and positive for iFLC elevation). 10 samples were positive for both criteria, and 1 for one criterion.
Polyclonal Immunostimulation Concordance: The ability of the device to correctly differentiate polyclonal immunostimulation from MGUS, yielding a low concordance for MGUS.	90.2% Concordance across 102 polyclonal immunostimulation samples. (This implies a high agreement that these samples are not MGUS, aligning with the expected performance of a device aiding in MGUS evaluation by not falsely classifying non-MGUS as MGUS).
Agreement with Clinical Diagnosis for Stable MGUS: The device's ability to show stability in FLC measurements consistent with clinically stable MGUS.	98.4% Agreement across 61 stable MGUS patients. Agreement was defined by: 1) κ/λ ratio within the reference interval of 0.53 - 1.51 at the last draw, AND 2) two consecutive assessments not showing a relative change of ≥ 25% for the involved free light chain (iFLC).
Agreement with Clinical Diagnosis for Progressive MGUS: The device's ability to show changes in FLC measurements consistent with progression from MGUS to MM.	75.0% Agreement across 4 progressive MGUS patients. Agreement was defined by: 1) κ/λ ratio outside the reference interval of 0.53 - 1.51 at the time of clinical MM diagnosis, AND 2) two consecutive assessments showing a relative change of ≥ 25% for the involved light chain (iFLC). (Note: The small sample size here for progressive cases should be considered when interpreting this percentage).

2. Sample Sizes Used for the Test Set and Data Provenance

MGUS Concordance:
- Test Set Sample Size: 121 MGUS samples (89 Non-IgM, 21 IgM, 11 LC MGUS)
- Data Provenance: Not explicitly stated, but the study was described as a "multi-center study," suggesting samples were collected from various clinical sites. It is implied to be retrospective as they are described as "clinically defined samples" and patients with "diagnosed" MGUS or polyclonal immunostimulation.
LC MGUS Concordance:
- Test Set Sample Size: 11 LC MGUS samples (subset of the 121 MGUS samples).
- Data Provenance: Same as above (multi-center, implied retrospective).
Polyclonal Immunostimulation Concordance:
- Test Set Sample Size: 102 specimens.
- Data Provenance: Same as above (multi-center, implied retrospective).
Evaluation of MGUS Patients (Stable Cohort):
- Test Set Sample Size: 61 patients.
- Data Provenance: Not explicitly stated, but patients were "initially diagnosed for MGUS" and "evaluated over different time periods" with "at least 4 sample draws at various time intervals," indicating a prospective or longitudinal study design over time.
Evaluation of MGUS Patients (Progressive Cohort):
- Test Set Sample Size: 4 patients.
- Data Provenance: Same as above (prospective/longitudinal).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It refers to "clinically defined samples" and "clinical diagnosis," implying that the ground truth was based on a comprehensive clinical assessment, likely by medical professionals (e.g., oncologists, hematologists), but the details are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing the ground truth of the test set (e.g., 2+1, 3+1). The ground truth appears to be based on pre-existing "clinical diagnosis" or "clinically defined samples."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic reagent, which provides quantitative measurements, not an imaging device that human readers interpret. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The studies described (concordance and evaluation of stable/progressive patients) assessed the performance of the N Latex FLC assays (the "device" or "algorithm" in this context) directly against clinical diagnoses and criteria. The results are reported as the "N Latex FLC κ/λ Ratio Concordance" and "N Latex FLC results," indicating an assessment of the device's output without direct human-in-the-loop interpretation of the assay results during the diagnostic process itself (though human interpretation of the FLC results in conjunction with other clinical findings is part of the intended use).

7. Type of Ground Truth Used

The ground truth used was expert consensus / clinical diagnosis / outcomes data.

"Clinically defined samples" with diagnoses of MGUS or polyclonal immunostimulation.
"Clinical diagnosis of MGUS" and "change in clinical diagnosis of MGUS to MM" for the stable and progressive cohorts, respectively. This implies that the ground truth was established by medical professionals using a combination of clinical findings, established diagnostic criteria, and other laboratory results, which could be considered a form of expert consensus or clinical outcomes.

8. Sample Size for the Training Set

The document does not report on a separate training set or its sample size. The performance data provided is for the evaluation of the device, implying the device was already developed. For an in-vitro diagnostic assay like this (which is a reagent test and analytical system), the "training" typically refers to the development and optimization of the assay's chemical and biological components, calibration, and establishment of analytical performance characteristics, rather than machine learning model training on a distinct labeled dataset. The document refers to prior submissions (K171742 and K182098) for "previously documented analytical and clinical studies," which likely covered the initial development and analytical validation.

9. How the Ground Truth for the Training Set Was Established

As no explicit "training set" for an AI/ML model is mentioned, this question is not directly applicable. For a traditional diagnostic assay, the "ground truth" during development involves rigorous analytical validation (e.g., using reference materials, spiked samples, and comparison to established methods) and initial clinical studies to define normal ranges and characteristic responses in different disease states. These would have been established through standard laboratory and clinical practices, likely involving certified reference materials, reference methods, and clinical expert assessment of patient samples.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K193047

Device Name

N Latex FLC kappa, N Latex FLC lambda

Indications for Use (Describe)

· 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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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)

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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

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

• 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,

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· 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)

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Freelite Human Kappa Free and Lambda Free assays (predicates) is provided in the table below.

Comparison ofTechnologicalCharacteristics	Predicate Devices	Proposed Device
	The Binding Site	Siemens HealthcareBN Systems
	Freelite® Human Kappa FreeFreelite® Human LambdaFree onSiemens BN™II(K031016)	N Latex FLC kappaN Latex FLC lambda(K193047)
Indications for Use	Kappa: This kit is intended forthe quantitation of kappa freelight chains in serum and urineon the Siemens BN™ II.Measurement of free lightchains aids in the diagnosisand monitoring of multiplemyeloma, lymphocyticneoplasms, Waldenstrom'smacroglobulinemia, ALamyloidosis, light chaindeposition disease andconnective tissue diseasessuch as systemic lupuserythematosus in conjunctionwith other laboratory andclinical findings.Lambda: This kit is intendedfor the quantitation of lambdafree light chains in serum andurine on the Siemens BN™ II.Measurement of free lightchains aids in the diagnosisand monitoring of multiplemyeloma, lymphocyticneoplasms, Waldenstrom'smacroglobulinemia, ALamyloidosis, light chaindeposition disease andconnective tissue diseasessuch as systemic lupuserythematosus in conjunctionwith other laboratory andclinical findings.	N Latex FLC kappa andlambda are in-vitro diagnosticreagents for the quantitativedetermination of free lightchains (FLC), type kappa ortype lambda in human serumand EDTA-plasma. N LatexFLC kappa and lambdaassays are used:• as an aid in thediagnosis and monitoring ofmultiple myeloma (MM) onthe BN Systems andAtellica® CH Analyzer,• as an aid in thediagnosis of amyloidosis (AL)on the BN Systems andAtellica® CH Analyzer.• as an aid in theevaluation of MonoclonalGammopathy ofUndetermined Significance(MGUS) on the BN Systems.Results of FLCmeasurements should alwaysbe interpreted in conjunctionwith other laboratory andclinical findings.
Sample Type	Human serum and urine	Human serum and EDTAplasma
Units	mg/L	Same
Comparison ofTechnologicalCharacteristics	Predicate Devices	Proposed Device
	The Binding Site
	Freelite® Human Kappa FreeFreelite® Human LambdaFree onSiemens BN™II(K031016)	Siemens HealthcareBN SystemsN Latex FLC kappaN Latex FLC lambda(K193047)
Detection Mode	Nephelometry	Same
Measurement	Quantitative	Same
Detection Antibody	Polyclonal mouse anti-humanFLC KappaPolyclonal mouse anti-antibodyFLC Lambda	Monoclonal mouse anti-human FLC kappaMonoclonal mouse anti-antibody FLC lambda
Reagent Composition	Polystyrene particles coatedwith polyclonal antibodies	Polystyrene particles coatedwith monoclonal antibodies
Traceability	Internal reference preparation	Internal reference plasma pool
Calibrators	One level	Same
Instrument System	Siemens BN II System	Siemens BN II and BNProSpec Systems
Analytical measuringrange	Kappa: 5.9 to 190 mg/LLambda: 5.0 to 160 mg/L	Typical range:kappa: 3.4 to 110 mg/Llambda: 1.9 to 60 mg/L
Reference Interval	Kappa: 3.30 to 19.40 mg/LLambda: 5.71 to 26.30 mg/LRatio: 0.26 to 1.65	kappa: 8.24 to 28.9 mg/Llambda: 9.10 to 32.6 mg/LRatio: 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 ●

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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 =	ConcordanceObtained(%)
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:

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LC MGUS Disease Group Concordance

Disease Group	N=	Positive forboth criteria	Positive forone criterion	Concordanceobtained(%)
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 =	Concordanceobtained(%)
PolyclonalImmunostimulation	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).

END OF SUMMARY

Regulation Number and Section

§ 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).