(64 days)
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the a1acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of a 1- acid glycoprotein (A1AG), C3 complement (C3), C4 complement (C4), haptoglobin (HAPT), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the antistreptolysin O (ASL), C-reactive protein (CRP), CardioPhase® high sensitivity CRP (hsCRP), and rheumatoid factors (RF) methods on the Dimension Vista® System.
Dimension Vista™ Protein 2 Control L and H: Protein 1 Control L and H are for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of antistreptolysin O (ASL). C-reactive protein (CRP), and rheumatoid factors (RF) on the Dimension Vista® System.
Dimension Vista™ Protein 3 Calibrator: Protein 3 Calibrator is an in vitro diagnostic product for the calibration of the armicroglobulin (A1MIC) and microalbumin (MALB) methods on the Dimension Vista® System.
Dimension Vista™ Protein 3 Control: Protein 3 Control is for use as assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of amicroglobulin (A1MIC) and microalbumin (MALB) on the Dimension Vista® System.
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing a1acid glycoprotein, C3 complement, C4 complement, haptoglobin, immunoglobulin A, immunoglobulin G, immunoglobulin M and prealbumin.
Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are multi-analyte, liquid human serum based products containing a1 - acid glycoprotein, C3 complement, C4 complement, haptoglobin, immunoglobulin A, immunoglobulin G, immunoglobulin M and prealbumin.
Dimension Vista™ Protein 2 Calibrator: Protein 2 Calibrator is a multi-analyte, liquid human serum based product containing antistreptolysin O, C-reactive protein, CardioPhase® high sensitivity CRP and rheumatoid factors.
Dimension Vista™ Protein 2 Control L and H: Protein 2 Control L and H are multi-analyte, liquid human serum based products containing antistreptolysin O, C-reactive protein, and rheumatoid factors.
Dimension Vista™ Protein 3 Calibrator: Protein 3 Calibrator is a multi-analyte, lyophilized, polygeline based product, with human source urinary and serum proteins, containing a - microglobulin and microalbumin.
Dimension Vista™ Protein 3Control: Protein 3 Control is a multi-analyte, lyophilized, polygeline, rabbit based albumin product, with human source urinary and serum proteins, containing a-microglobulin and microalbumin.
The provided 510(k) summary for the Dade Behring Inc. Dimension Vista™ Protein Calibrators and Controls does not contain the specific acceptance criteria or an explicit study section detailing performance against such criteria in the manner usually presented for more complex diagnostic devices like AI algorithms.
Instead, this submission is for calibrators and controls for assays, meaning the primary "performance" is about their ability to properly calibrate and control other assays, and their substantial equivalence to previously cleared devices. The document focuses on descriptions, intended uses, and claims of substantial equivalence to predicate devices, rather than detailed performance studies of the calibrators/controls themselves in terms of metrics like sensitivity, specificity, or reader improvement.
Based on the provided text, here’s an attempt to structure the information, with explanations for what is not present:
Acceptance Criteria and Device Performance Study for Dimension Vista™ Protein Calibrators and Controls
1. Table of Acceptance Criteria and Reported Device Performance
As this submission is for calibrators and controls, the "acceptance criteria" and "performance" are implicitly related to their ability to function as intended for the assays they support and their substantial equivalence to predicate devices. The document does not provide a table with explicit numerical acceptance criteria (e.g., specific thresholds for accuracy, precision, etc. for the calibrators/controls themselves) or detailed performance data for these products beyond their intended use.
The "performance" described is that these devices function for the calibration and quality control of specified protein methods on the Dimension Vista® System. The primary performance claim is Substantial Equivalence to legally marketed predicate devices, which implies that their performance characteristics are similar enough to the predicates.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Function as a Calibrator: | Successfully calibrates the specified protein methods (A1AG, C3, C4, HAPT, IGA, IGG, IGM, PREALB, ASL, CRP, hsCRP, RF, A1MIC, MALB). |
| Function as a Control: | Provides intralaboratory quality control for assessment of precision and analytical bias for the specified protein methods. |
| Substantial Equivalence: | Demonstrated to be substantially equivalent in intended use to previously cleared Dimension Vista™ Protein Calibrators and Controls (K062055, K062035, K061990), with modifications for additional analytes. |
| Safety and Effectiveness: | Determined safe and effective for their intended use through substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size or data provenance in the context of a performance study for these calibrators and controls. Their evaluation appears to be based on demonstrating their functionality within the Dimension Vista® system and substantial equivalence to existing products. If any testing involved biological samples, the details are not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or provided for this type of submission. The "ground truth" for calibrators and controls typically relates to their assigned values or their ability to produce accurate and precise results when used with an assay. This is usually established through manufacturing processes, reference methods, and validation, not through expert human review of a test set in the way an AI diagnostic device would be evaluated.
4. Adjudication Method for the Test Set
This information is not applicable or provided. Since there's no mention of a "test set" requiring expert review in the context of a diagnostic interpretation, an adjudication method is not described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
A MRMC comparative effectiveness study is not applicable and was not performed for this submission. MRMC studies are typically used to evaluate the diagnostic performance of devices, especially those involving human interpretation, often within the context of AI assistance. These calibrators and controls are reagents, not diagnostic interpretation devices.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
This concept is not applicable to these products. These are calibrators and controls for assays, not an algorithm, so a standalone study in this context is not relevant.
7. The type of ground truth used
The "ground truth" for calibrators and controls typically involves their precisely determined concentrations or activity levels, established during their manufacture and validation against reference methods or through rigorous assay development processes. The document does not explicitly state the type of ground truth used but implies that the effectiveness is demonstrated through their ability to calibrate and control the specified methods on the Dimension Vista® System.
8. The sample size for the training set
This information is not applicable or provided. These products are not machine learning algorithms and therefore do not have a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable or provided as there is no training set for these calibrators and controls.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.