(112 days)
Dimension Vista® KAPPA Flex® reagent cartridge: The KAPPA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® Systems. Measurements of the various amounts of the different types of light chains aid 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.
Dimension Vista® LAMBDA Flex® reagent cartridge: The LAMBDA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type lambda in human serum and plasma on the Dimension Vista® Systems. Measurements of the various amounts of the differant types of light chains aid in the diagnosis of multiple myeloma cancer of antibody-forming cells) lymphocytic neoplasms ( cancer of lymohoid tissue), Waldenstom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.
Dimension Vista® PROT 1 CAL: PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2 -macroglobulin (A2MAC), b2 -Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG, IGG-C*. IGG-U**), Immunoglobulin G subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunglobulin (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF) *For cerebrospinal fluid ** For urine
Dimension Vista® Protein 1 Control L: PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® Systems in the quantitative determination of: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2 -Macroglobulin (A2MAC), C3 Complement (C3), C4 Complement (C4), Ccruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin G subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF). *For serum and plasma
Dimension Vista® Protein 1 Control M and H: PROT1 CON M and PROT1 CON H are assayed, mid-level and high level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a2-Acid Glycoprotein (A1AG), a1 -Antitrypsin (A1AT), a2-Macroglobulin (A2MAC), b2 -Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4),Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA),Immunoglobulin E (IGE), Immunoglobulin G (IGG),Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), lmmunoglobulin G subclass 4 (IGG4), Immunoglobulin light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP),soluble Transferrin Receptor (STFR), specialty Albumin (sALB) and Transferrin (TRF). *For scrum and plasma
Dimension Vista® KAPPA Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes 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.
Dimension Vista® LAMBDA Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes 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.
Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a1acid glycoprotein, a1 -antitrypsin, az- macroglobulin,b2-microglobulin, C3 complement, C4 complement, ccruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin light chains type kappa, immunoglobulin light chains type lambda, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin.
Dimension Vista® Protein 1 Control L: Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : a1-acid glycoprotein, a1 -antitrypsin, a-- macroglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, i mmunoglobulin light chains type kappa, immunoglobulin light chains type lambda, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin
Dimension Vista® Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing: a1 -acid glycoprotein, a1 -antitrypsin, a2macroglobulin, b2 -Microglobulin (B2MIC), C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M. immunoglobulin light chains type kappa, immunoglobulin light chains type lambda. prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.
Here's a breakdown of the acceptance criteria and study details for the Dimension Vista® KAPPA Flex® and LAMBDA Flex® reagent cartridges, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the Dimension Vista® KAPPA Flex® and LAMBDA Flex® reagent cartridges are implicitly established by their comparison to legally marketed predicate devices. The study aims to demonstrate substantial equivalence, meaning the new device performs comparably to the existing devices. While explicit numerical acceptance criteria (e.g., minimum correlation coefficient or defined acceptable slope/intercept ranges) aren't directly stated as "acceptance criteria," the reported performance metrics (slope, intercept, correlation coefficient) are the basis for demonstrating this equivalence.
| Performance Metric | Acceptance Criteria (Implicit from Predicate Performance History) | Dimension Vista® KAPPA Flex® Performance | Dimension Vista® LAMBDA Flex® Performance |
|---|---|---|---|
| Slope | Demonstrated substantial equivalence to predicate device | 1.105 | 1.045 |
| Intercept | Demonstrated substantial equivalence to predicate device | -4.2 mg/dL [-0.042 g/L] | -1.5 mg/dL [-0.015 g/L] |
| Correlation | Demonstrated substantial equivalence to predicate device | 0.998 | 0.993 |
Note: The acceptance criteria are "demonstrated substantial equivalence." The reported performance metrics are what the manufacturer presented to show this equivalence. In submissions like this, a high correlation coefficient (close to 1) and a slope close to 1 with an intercept close to 0 typically indicate good agreement and thus substantial equivalence.
Study Details
Here's the information regarding the study:
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 66 serum samples for the KAPPA assay and 66 serum samples for the LAMBDA assay.
- Data Provenance: Not explicitly stated regarding country of origin. The study is retrospective as it involves evaluating existing serum samples that covered a range of concentrations.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth appears to be the results obtained from the predicate devices, not an expert panel reviewing cases.
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Adjudication method for the test set:
- None described. The comparison is directly between the new device's readings and the predicate device's readings.
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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:
- No, a MRMC comparative effectiveness study was not done. This study is for an in vitro diagnostic reagent cartridge, not an AI-assisted diagnostic tool that involves human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The performance reported is that of the Dimension Vista® KAPPA and LAMBDA assays themselves, operating independently to measure immunoglobulin light chains in serum samples.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for correlation and equivalence purposes was the measurements obtained from the legally marketed predicate devices:
- Dade Behring N Antisera to Human Immunoglobulin/L-chains, kappa type assay on the BN ProSpec® System (for KAPPA)
- Dade Behring N Antisera to Human Immunoglobulin/L-chains, lambda type assay on the BN ProSpec® System (for LAMBDA)
- The "ground truth" for correlation and equivalence purposes was the measurements obtained from the legally marketed predicate devices:
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The sample size for the training set:
- This information is not provided in the document. For in vitro diagnostic reagents, there might not be a "training set" in the sense of machine learning algorithms. Instead, method development and optimization would occur using various samples, but these are typically not documented as a formalized "training set" with a specific size in 510(k) summaries.
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How the ground truth for the training set was established:
- Not applicable as the concept of a "training set" with established ground truth in the context of this type of diagnostic reagent study is not detailed. Method development relies on established analytical techniques and reference methods, but the specific validation of a "training set ground truth" is not a typical component of these summaries.
§ 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).