(48 days)
Dimension Vista® Protein 3 Calibrator: PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the a1 -Microglobulin (A1MIC), Cystatin C(CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods. * For serum, plasma and cerebrospinal fluid.
Dimension Vista® Protein 3 Control: PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a 1-Microglobulin (A IMIC), specialty Albumin (sAlb)** and Microalbumin (MALB) on the Dimension Vista " System. ** For cerebrospinal fluid (CSF).
Dimension Vista® Protein 1 Control L: PROTI CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista 9 System in the quantitative determination of: a1-Acid Glycoprotein (A1AG), a - Antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB), soluble Transferrin Receptor (sTFR), specialty Albumin (sALB)***, Transferrin (TRF). *** For serum and plasma.
Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control H: PROT1 CON M and PROT1 CON H are assayed, mid-level and high level respectively, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of: α₁-Acid Glycoprotein (A1AG), α₁-Antitrypsin (A1AT), β₂-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB), specialty Albumin (sALB)***, soluble Transferrin Receptor (STFR), Transferrin (TRF). *** For serum and plasma.
Dimension Vista® Protein 3 Calibrator: PROT3 CAL is a multi-analyte, lyophilized, polygeline based product containing urinary a1-microglobulin, cystatin C and serum albumin of human origin.
Dimension Vista® Protein 3 Control: PROT3 CON is a multi-analyte, low level lyophilized, polygeline and rabbit albumin based product containing urinary a1 -microglobulin and serum albumin of human origin.
Dimension Vista® Protein 1 Control L: Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing: α1-acid glycoprotein, αι-antitrypsin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin M, prealbumin, soluble transferrin receptor, albumin, transferrin.
Dimension Vista® Protein 1 Control M and Dimension Vista® Protein 1 Control H: Protein I Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing: α₁-acid glycoprotein, α₁-antitrypsin, ß₂-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin M, prealbumin, soluble transferrin receptor, albumin, transferrin.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Dade Behring Dimension Vista® Protein Calibrator and Controls.
Important Note: The provided document is a 510(k) summary for calibrators and controls used in in-vitro diagnostic (IVD) devices. Unlike AI/ML diagnostic software, these products themselves do not typically involve 'AI' or 'algorithms' in the way common AI models do (e.g., image analysis, predictive analytics). Their "performance" relates to their ability to accurately calibrate and control other diagnostic systems, ensuring those systems provide precise and analytically unbiased results. Therefore, many of the typical AI/ML study questions (e.g., human-in-the-loop, standalone performance, training sets, expert ground truth) are not applicable in this context. The "study" described here is primarily a demonstration of "substantial equivalence" to previously cleared devices.
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for these devices revolve around demonstrating substantial equivalence in intended use to predicate devices, especially after modifications to include "specialty Albumin (sALB)". The purpose of these calibrators and controls is to ensure the Dimension Vista® System's assays for various proteins (like a1-Microglobulin, Cystatin C, Microalbumin, specialty Albumin, and other listed proteins) achieve appropriate precision and analytical bias.
The text does not present explicit numerical acceptance criteria for precision or bias of the calibrators/controls themselves (e.g., "bias must be less than X%"). Instead, the acceptance is based on the claim of substantial equivalence for their intended use as calibrators and quality controls for the Dimension Vista® System. The presumption is that if they are substantially equivalent to already cleared devices, they meet the necessary performance standards for their role.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The modified devices (Calibrator, Control L, M, H) must have an intended use substantially equivalent to their respective predicate devices. | Achieved Equivalence: "The modified Dimension Vista® Protein 3 Calibrator, Dimension Vista® Protein 3 Control and Dimension Vista® Protein 1 Control L, Dimension Vista® Protein 1 Control M and Dimension Vista Protein 1 Control H, are substantially equivalent to the legally marketed devices based on the information described above." |
Specifically, the intended use for the modified devices, including the addition of specialty Albumin (sALB) to the analyte list, aligns with the intended use of the predicate devices for calibration and quality control of protein assays on the Dimension Vista® System. |
| Material Composition (for Protein 3 Calibrator/Control): Maintain appropriate composition as a multi-analyte, lyophilized, polygeline-based product (or rabbit albumin for Control). | Described as:
- PROT3 CAL: "multi-analyte, lyophilized, polygeline based product containing urinary a1-microglobulin, cystatin C and serum albumin of human origin."
- PROT3 CON: "multi-analyte, low level lyophilized, polygeline and rabbit albumin based product containing urinary a1 -microglobulin and serum albumin of human origin." |
| Material Composition (for Protein 1 Control L, M, H): Maintain appropriate composition as multi-analyte, liquid human serum based products. | Described as: - Protein 1 Control L: "multi-analyte, low level liquid human serum based product containing" (list of proteins).
- Protein 1 Control M and H: "multi-analyte, mid and high level respectively, liquid human serum based products containing" (list of proteins). |
| Analytes Covered: The modified devices must include the specified analytes (including sALB) for their respective intended uses. | All listed analytes for each calibrator/control are reported in the "Device Descriptions" and "Intended Uses" sections. The key addition is "specialty Albumin (sALB)". |
Study Details to Prove Acceptance Criteria (Substantial Equivalence)
The document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence rather than providing detailed study protocols and results in the same way a clinical trial report would. The "study" here is primarily a comparison against predicate devices.
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Sample size used for the test set and the data provenance:
- The document does not specify a sample size for a test set. This type of submission would typically involve internal validation data (e.g., precision, linearity, stability studies) that show the new products perform comparably or meet acceptable standards, but these details are not provided in this summary. The "study" mentioned is the comparison to predicate devices.
- Data Provenance: Not explicitly stated, but for IVD products from Dade Behring Marburg GmbH and Newark, Delaware, the data would likely originate from their internal R&D and manufacturing sites, primarily in Germany and/or the US. It would be retrospective in the sense that they are comparing the characteristics of their new products against established predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For calibrators and controls, "ground truth" isn't established by experts in the context of diagnostic interpretation (like radiologists interpreting images). Instead, their "truth" is established through analytical methods (e.g., reference methods, certified values for analytes) during their manufacturing and quality control. The relevant "expertise" lies in the analytical chemistry and immunoassay fields for validating such products.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, typically for resolving discordant interpretations from human readers or comparing human interpretation to an AI output. This concept does not apply to the validation of IVD calibrators and controls.
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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:
- Not Applicable. This is an IVD calibrator/control device, not an AI/ML diagnostic algorithm for human interpretation. Therefore, an MRMC study and effects on human readers are irrelevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. These are chemical reagents used in an automated analyzer. There is no "algorithm" in the AI/ML sense to evaluate in standalone mode. Their performance is inherent in their analytical properties when used with the Dimension Vista® System.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For calibrators, the "ground truth" (assigned values) is typically established through a rigorous process traceable to international reference materials or definitive methods.
- For controls, the "ground truth" (expected range for analytes) is established by running the control material multiple times on a validated system using the relevant assays, often compared to the assigned values of the calibrator and typically with a statistical analysis to define the acceptable range. This is an analytical (chemical/biological) "truth," not a clinical "truth" from expert consensus or pathology.
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The sample size for the training set:
- Not Applicable. These are not AI/ML models that require a separate training set. Their "development" involves chemical formulation, manufacturing processes, and analytical validation.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it in this context.
§ 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.