(108 days)
The IMMAGE Immunochemistry System Kappa (KAP) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of kappe light chains (free and bound) by rate nephelometry.
The IMMAGE Immunochemistry System Lambda (LAM) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is Intended for the quantitative determination of lambda light chains (free and bound) by rate nephelometry.
The IMMAGE Immunochemistry System KAP and LAM Reagents in conjunction with Beckman Callbrator 1, are intended for use in the quantitative determination of kappa and lambda light chain concentrations respectively in human serum and urine samples on Beckman's IMMAGE Immunochemistry System.
This document describes the safety and effectiveness summary for the IMMAGE™ Immunochemistry System Kappa (KAP) and Lambda (LAM) Light Chain Reagents.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the IMMAGE™ Immunochemistry System KAP and LAM Reagents are based on demonstrating equivalence to predicate devices already on the market through method comparison, stability, and imprecision studies. While specific numerical acceptance criteria (e.g., minimum r-value, maximum acceptable %C.V.) are not explicitly stated as "acceptance criteria" in the provided text, the reported performance values are presented to support the claim of equivalence.
| Performance Metric | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (IMMAGE™ System) |
|---|---|---|
| Method Comparison | Equivalence to Beckman KAP/LAM Reagent (Predicate) | |
| KAP Reagent (Serum) | Slope, Intercept, r-value comparable to predicate | Slope: 1.037, Intercept: -9.16, r: 0.987 |
| KAP Reagent (Urine) | Slope, Intercept, r-value comparable to predicate | Slope: 0.970, Intercept: 1.36, r: 0.980 |
| LAM Reagent (Serum) | Slope, Intercept, r-value comparable to predicate | Slope: 1.020, Intercept: -23.5, r: 0.991 |
| LAM Reagent (Urine) | Slope, Intercept, r-value comparable to predicate | Slope: 1.009, Intercept: -0.08, r: 0.954 |
| Stability | Equivalent claims to predicate | 24 month shelf-life, 14 day open container stability, 14 day calibration stability |
| Imprecision (Kappa Serum) | Low %C.V. (implicitly comparable to predicate) | Level 1: 2.9% C.V., Level 2: 2.2% C.V., Level 3: 2.6% C.V. |
| Imprecision (Kappa Urine) | Low %C.V. (implicitly comparable to predicate) | Level 1: 2.5% C.V., Level 2: 2.5% C.V., Level 3: 1.3% C.V. |
| Imprecision (Lambda Serum) | Low %C.V. (implicitly comparable to predicate) | Level 1: 2.1% C.V., Level 2: 1.9% C.V., Level 3: 3.0% C.V. |
| Imprecision (Lambda Urine) | Low %C.V. (implicitly comparable to predicate) | Level 1: 2.4% C.V., Level 2: 1.2% C.V., Level 3: 3.0% C.V. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only discusses "Method Comparison Study Results" and "Estimated Within-Run Imprecision" which can be considered as test sets for performance evaluation.
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Method Comparison Study:
- KAP Reagent (Serum): 220 samples (n=220)
- KAP Reagent (Urine): 103 samples (n=103)
- LAM Reagent (Serum): 236 samples (n=236)
- LAM Reagent (Urine): 40 samples (n=40)
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the context of a regulatory submission for a diagnostic device, it is typically assumed these are clinical samples.
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Estimated Within-Run Imprecision:
- Kappa Light Chain (KAP) Serum: 80 replicates per level (3 levels)
- Kappa Light Chain (KAP) Urine: 30 replicates per level (3 levels)
- Lambda Light Chain (LAM) Serum: 80 replicates per level (3 levels)
- Lambda Light Chain (LAM) Urine: 30 replicates per level (3 levels)
- Data Provenance: Not explicitly stated. Typically, imprecision studies use assayed control materials or pooled patient samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The device is an immunochemistry system designed to quantitatively measure specific analytes (kappa and lambda light chains) in biological samples. The "ground truth" for method comparison and imprecision studies is established by comparing the device's measurements to a reference method (the predicate device) or by assessing the repeatability and reproducibility of its own measurements. It does not involve expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
This information is not applicable. The studies involve quantitative measurements, not subjective evaluations that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases. This device is an automated immunochemistry system.
6. Standalone Performance
Yes, a standalone performance was done. The entire summary of performance data (method comparison, stability, imprecision) represents the standalone performance of the IMMAGE™ Immunochemistry System KAP and LAM Reagents, as they are automated systems that provide quantitative results without human interpretation of raw data in the context of the study. The comparison is done against a predicate device, not against human interpretation.
7. Type of Ground Truth Used
The ground truth for the method comparison studies was established by using measurements from the predicate devices (Beckman Kappa Light Chain (KAP) Reagent and Beckman Lambda Light Chain (LAM) Reagent). For imprecision studies, the "ground truth" is the statistically derived mean of repeated measurements, reflecting the device's inherent precision.
8. Sample Size for the Training Set
The provided text does not specifically mention a "training set". For devices like this (immunochemistry systems), "training" is typically inherent in the development and calibration process using standards and controls, rather than a distinct "training set" of patient samples in the way that machine learning algorithms are trained. The data provided focuses on validation (performance) of the already developed and calibrated device.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is identified, this information is not applicable. Calibration and quality control procedures during development would establish the accuracy of the device against known standards, which serves a similar function to establishing "ground truth" for a training phase.
§ 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).