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510(k) Data Aggregation
(272 days)
The Kappa light chains assay is an in vitro diagnostic test used for the quantitative determination of immunoglobulin bound and free kappa light chains (KAPPA) in serum and in Li-heparin plasma by immunoturbidimetry on Synchron LX20 System. Measurement of type 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, in conjunction with other clinical and laboratory findings.
The Kappa light chains assay is an in vitro diagnostic test used for the quantitative determination of immunoglobulin bound and free kappa light chains (KAPPA) in serum and in Li-heparin plasma by immunoturbidimetry on Synchron LX20 System. The determination of Kappa light chains is based on the specific turbidimetric reaction, which occurs between a polyclonal antiserum against human Immunoglobulin Kappa light chains and its corresponding antigen under optimal pH conditions and in the presence of polyethylene glycol (PEG). The turbidity of the immune complex is proportional to the concentration of the analyte in the sample.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Kappa light chains assay (Sentinel)
Predicate Device: Beckman IMMAGE Immunochemistry System Kappa light chain (K964260)
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device, primarily through performance similarities rather than explicit, pre-defined quantitative acceptance criteria with thresholds for accuracy, sensitivity, or specificity against a clinical ground truth. The acceptance is implied by acceptable correlation and precision compared to its own internal metrics and the overall 'similar performance characteristics' to the predicate.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison (Correlation with Predicate) | "Acceptable correlation" with Beckman Kappa light chain (K964260) on IMMAGE nephelometer Analyzer. | Correlation coefficient (r): 0.985 |
| Slope (implied close to 1) | Slope: 0.900 | |
| Y-intercept (implied close to 0) | Y-intercept: 134 mg/dL | |
| Precision (Total Imprecision) | "Acceptable" %CV values. | Ranges from 2.4% to 6.8% CV across 6 levels. |
| Precision (Between Days) | "Acceptable" %CV values. | Ranges from 1.7% to 5.5% CV across 6 levels. |
| Precision (Repeatability) | "Acceptable" %CV values. | Ranges from 1.5% to 4.1% CV across 6 levels. |
| Analytical Measurement Range (AMR) - Lower Limit | Not explicitly stated but expected to be within a clinically relevant range. | Found lower limit: 31.2 mg/dL. Claimed: 35 mg/dL. |
| Analytical Measurement Range (AMR) - Upper Limit | Not explicitly stated but expected to be within a clinically relevant range. | Found upper limit: 750.13 mg/dL. Claimed: 750 mg/dL. |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison: The document states "Comparative performance studies were conducted," but does not explicitly mention the sample size of patient samples used for the method comparison study. It does mention that the Kappa light chains assay on Synchron LX20 System was compared using "calibrator material with assigned Kappa Light chains concentration based on definition of Kappa Light chains as Whole IgG content (MW 150000)." This suggests that at least part of the comparison involved characterized calibrator samples rather than solely patient samples.
- Precision Studies: Two levels for 20x2x2 test (day x run x rep) on 6 levels implies:
- 20 days x 2 runs/day x 2 replicates/run = 80 measurements for each of the 6 levels.
- Total tests for precision: 6 levels * 80 tests/level = 480 tests.
- AMR Studies: Not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of in-vitro diagnostic (IVD) device (quantitative biochemical assay) does not typically rely on "experts" to establish ground truth in the same way an imaging or pathology device might. The "ground truth" for method comparison is the measurement obtained by the predicate device (Beckman IMMAGE Immunochemistry System Kappa light chain), which is itself a quantitative assay.
4. Adjudication Method for the Test Set
Not applicable. This is a comparison of quantitative measurements between two instruments/assays, not an interpretation that requires adjudication (like reading medical images).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices where human readers interpret outputs (e.g., medical images), and the AI either assists or replaces human interpretation. This device is a quantitative diagnostic assay.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies presented (method comparison, precision, AMR) are all standalone performance evaluations of the device (Kappa light chains assay on Synchron LX20 System). There is no "human-in-the-loop" component described for its operation or result generation; it's an automated in vitro diagnostic test system.
7. The Type of Ground Truth Used
The primary "ground truth" for the method comparison study was the measurements obtained from the predicate device (Beckman IMMAGE Immunochemistry System Kappa light chain, K964260). For precision and AMR, the ground truth refers to the intrinsic analytical performance characteristics of the new device itself, often evaluated against known concentrations or through repeated measurements, rather than an external clinical "ground truth" (e.g., pathology or outcomes data). The assays are also traceable to ERM-DA 470 (European Reference Material) from BCR (EG Community Bureau of Reference), corresponding to RPPHS (Reference Preparation for Protein in Human Serum), which serves as a metrological ground truth for standardization.
8. The Sample Size for the Training Set
The document does not specify a separate training set. For IVD submissions like this, the development process for an assay involves calibration and optimization, but typically, the pre-market submission focuses on the validation or test data for the final, locked-down assay. If there was an implicit "training" or development phase, the data used for that is not explicitly detailed as a distinct 'training set' in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" is mentioned in the context of machine learning, this question isn't directly applicable. The assay's development (which could be considered analogous to training) would involve establishing appropriate calibration curves and reagent formulations based on known standards and reference materials (e.g., ERM-DA 470).
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(199 days)
The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. Measurement of the different types of light chains aids in the diagnosis of multiple myeloma. Iymphocytic 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 in conjunction with other clinical and laboratory findings.
The Lambda light chains assay is an in vitro diagnostic test used for the quantitative determination of Immunoglobulin bound and free Lambda light chains (LAMBDA) in serum and Li-heparin plasma by immunoturbidimetry. It is intended to measure Immunoglobulin Lambda light chains (bound and free) using Synchron LX20 System. The determination of Lambda light chains is based on the specific turbidimetric reaction, which occurs between a polyclonal antiserum against human Immunoglobulin Lambda light chains and its corresponding antigen under optimal pH conditions and in the presence of polyethylene glycol (PEG). The turbidity of the immune complex is proportional to the concentration of the analyte in the sample.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Method Comparison | Acceptable correlation with predicate device (Beckman IMMAGE Lambda light chain, K964260) | Correlation coefficient (r) = 0.981 |
| Slope = 0.928 | ||
| Y-intercept = 58.59 mg/dL | ||
| Precision (Total CV%) | Not explicitly stated, but typical regulatory expectations for assays of this type are excellent to good precision. | Varies by concentration level: |
| 67.7 mg/dL: 4.7% | ||
| 243.6 mg/dL: 2.9% | ||
| 168.7 mg/dL: 3.4% | ||
| 387.0 mg/dL: 4.3% | ||
| 415.9 mg/dL: 4.3% | ||
| Analytical Measurement Range (AMR) | Not explicitly stated as a numerical criterion for acceptance, but a claimed range is provided. | Lower limit found: 20 mg/dL |
| Upper limit found: 423 mg/dL | ||
| Claimed AMR: 20 to 400 mg/dL |
Study Details:
The primary study conducted was a performance characteristic study for the Lambda light chains assay on the Synchron LX20 System. The goal was to demonstrate substantial equivalence to a predicate device, the Beckman IMMAGE Immunochemistry System Lambda light chain (K964260).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the total number of patient samples used for the method comparison study. It only mentions that precision studies were conducted on "5 levels (N=80 for each level)," totaling 400 precision test samples. For method comparison, it refers to "acceptable correlation," implying a comparison of results from unknown patient samples run on both devices.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (in vitro diagnostic assay verification) does not typically involve human experts establishing "ground truth" in the same way an image analysis or diagnostic AI study would. The ground truth for this assay is the quantitative concentration of Lambda light chains, as determined by the accepted scientific methods and calibration standards.
For the method comparison, the "truth" for the comparison samples would have been the results obtained from the predicate device (Beckman IMMAGE Immunochemistry System Lambda light chain). The predicate device itself (K964260) would have undergone its own validation to establish its accuracy.
4. Adjudication Method for the Test Set
Not applicable. As this is an in vitro diagnostic assay comparing quantitative measurements to a predicate device, there is no human adjudication process involved in establishing the "ground truth" for individual test results. The comparison is based on numerical agreement and statistical correlation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic study or an imaging study involving human readers. It's an in vitro diagnostic assay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the device performance described (method comparison, precision, AMR) represents the standalone performance of the Lambda light chains assay on the Synchron LX20 System. It measures the analytical capabilities of the assay itself, independent of a human interpretation loop required for diagnostic imaging or similar applications.
7. The Type of Ground Truth Used
The ground truth for the method comparison was established by the results from the legally marketed predicate device (Beckman IMMAGE Immunochemistry System Lambda light chain, K964260). The predicate device's results are considered the established "truth" for the purpose of demonstrating substantial equivalence of the new device.
For the assay's own internal calibration and reference, it is stated that "Both assays are traceable to ERM-DA 470 (European Reference Material) from BCR (EG Community Bureau of Reference), corresponding to RPPHS (Reference Preparation for Protein in Human Serum)." This indicates the use of certified reference materials and established scientific standards to define the quantitative values.
8. The Sample Size for the Training Set
Not applicable in the context of this traditional in vitro diagnostic assay. There isn't a "training set" in the machine learning sense. The assay is developed and validated based on chemical and immunological principles, not by training an algorithm on a dataset. The calibration material used ("calibrator material with assigned Lambda Light chains concentration based on definition of Lambda Light chains as Whole IgG content (MW 150000)") could be considered analogous, but it's not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable for a "training set" in the AI sense. For the calibrator material, its "ground truth" or assigned concentration is established by its traceability to ERM-DA 470 and RPPHS (Reference Preparation for Protein in Human Serum), which are internationally recognized reference materials.
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