(109 days)
The B2MIC method is an in vitro diagnostic test for the quantitative measurement of ß₂microglobulin in human serum, heparinized plasma, EDTA plasma and urine using the B2MIC Flex® reagent cartridge on the Dimension Vista® Systems. Measurement of ß 2 -microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.
PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: αγ-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), IS2-Microglobulin (B2MIC, B2MU**), 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*, ICC-U**), Immunoglobulin G subclass 1(IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF)
*For cerebrospinal fluid
** For urine
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: α-Acid Glycoprotein (A1AG), α-- Antitrypsin (A1AT), a2 -- Macroglobulin (A2MAC), ß2-Microglobulin (B2MIC-U *), 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), Immunoglobulin G subclass 4 (IGG4), Immunodlobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB), soluble Transferrin Receptor (STFR) and Transferrin (TRF).
*For serum and plasma
** For Urine
PROT1 CON M is an assayed, mid-level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: : α -- Acid Glycoprotein (A1AG), α -- Antitrypsin (A1AT), α 2 -- Macroglobulin (A2MAC), ß2-Microglobulin (B2MIC*,B2MIC-U**), 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), lmmunoqlobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR), and Transferrin (TRF),
*For serum and plasma
** For urine
Dimension Vista® B2MIC 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: a+acid glycoprotein, a1 -antitrypsin, a1-macroglobulin, 132 -microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunodlobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, 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 : q-acid glycoprotein, α-- antitrypsin, α 2-macroglobulin, ß-microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoqlobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealburnin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin
Dimension Vista® Protein 1 Control M: Protein 1 Control M is a multi-analyte, mid level, liquid human serum based product containing: Q -- acid glycoprotein, a -- antitrypsin, as -macroglobulin, 13-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3. immunodobulin G subclass 4. immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor, and transferrin.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® B2MIC Flex® reagent cartridge:
The document describes a 510(k) submission for an in vitro diagnostic device, primarily focusing on showing substantial equivalence to a legally marketed predicate device. This type of submission usually doesn't involve the same kind of acceptance criteria as AI/ML-based medical devices for image interpretation or diagnosis. Instead, the "acceptance criteria" here are typically performance characteristics that demonstrate the new device is comparable to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (a reagent cartridge for quantitative measurement), the key performance characteristic evaluated is method comparison against a predicate device. The performance is assessed using regression analysis.
| Acceptance Criteria (Implied) | Reported Device Performance (B2MIC Flex® vs. BN ProSpec®) |
|---|---|
| Correlation Coefficient | 0.988 |
| Slope | 0.952 |
| Intercept | -0.0008 mg/dL (-0.008 mg/L) |
Note: The acceptance criteria are "implied" because in a 510(k) for a quantitative assay, the goal is to show acceptable agreement with a predicate. While explicit numerical acceptance thresholds aren't stated here (e.g., "slope must be between 0.9 and 1.1"), the high correlation coefficient (0.988) and a slope close to 1 with an intercept close to 0 demonstrate substantial equivalence and acceptable performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 82 urine samples
- Data Provenance: The document does not explicitly state the country of origin. It is a retrospective study as it's a "Method Comparison Study" where samples are analyzed by both the new device and a predicate device. The samples are collected and then tested on both systems.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For this type of in vitro diagnostic device measuring a biomarker concentration, the "ground truth" isn't established by human experts in the same way it would be for an imaging AI. Instead, the "ground truth" is typically the result obtained from the legally marketed predicate device, which is considered the reference method for comparison.
- Number of "Experts": Not applicable in the traditional sense. The predicate device (Siemens N Latex to Human ß₂-microglobulin on the BN ProSpec® System) served as the reference.
- Qualifications of "Experts": Not applicable. The predicate device itself is the standard against which the new device is compared.
4. Adjudication Method for the Test Set
Not applicable. As described above, the comparison is against the predicate device's results; there is no human adjudication process involved for establishing ground truth for individual samples.
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 an in vitro diagnostic (IVD) device for quantitative measurement, not an AI/ML device for image interpretation or human assistance. Therefore, MRMC studies and "human reader improvement with/without AI" are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The described "Method Comparison Study" is a standalone evaluation of the device's analytical performance (i.e., its ability to accurately measure ß₂-microglobulin concentrations) against a reference method. It assesses the device's output numerically without direct human interpretation within the measurement process.
7. The Type of Ground Truth Used
The ground truth used for the method comparison study was the quantified measurement of ß₂-microglobulin obtained from the legally marketed predicate device (Siemens N Latex to Human ß₂-microglobulin on the BN ProSpec® System). This is a form of "reference method" ground truth.
8. The Sample Size for the Training Set
Not applicable. This is a traditional IVD device, not an AI/ML algorithm that undergoes a training phase with a specific training set. The device's performance is based on its chemical reactions and optical detection, not on learning from a dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/ML device, there is no "training set" or ground truth establishment for such a set.
§ 866.5630
Beta -2-microglobulin immunological test system.(a)
Identification. Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.(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 § 866.9.