(158 days)
The IMMAGE™ Immunochemistry System Albumin (ALB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human albumin concentrations in human serum and CSF samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.
The IMMAGE Immunochemistry System Albumin (ALB) Reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human albumin concentrations in human serum and cerebrospinal fluid (CSF) samples. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.
Here's an analysis of the provided text regarding the Beckman Instruments IMMAGE™ Immunochemistry System Albumin (ALB) Reagent, structured according to your request:
Acceptance Criteria and Device Performance Study
The provided document describes a 510(k) premarket notification for a medical device. In this context, "acceptance criteria" are not explicitly stated as quantitative thresholds for this specific device's performance. Instead, the primary goal of this study is to demonstrate substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implicitly met if the performance characteristics (method comparison, stability, and imprecision) are comparable to, or within acceptable limits relative to, the legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria are not provided in terms of specific numeric thresholds for parameters like slope, intercept, r-value, or %CV, the table below will present the reported device performance and infer the implicit acceptance being "comparable to the predicate device."
| Performance Characteristic | Implicit Acceptance Criteria (Comparative to Predicate) | Reported Device Performance (IMMAGE ALB Reagent) |
|---|---|---|
| Method Comparison (vs. Beckman Albumin Reagent (ALB) on ARRAY® Systems) | ||
| Serum Samples | ||
| Slope | Close to 1.000 | 1.020 |
| Intercept | Close to 0.00 | 10.3 |
| Correlation Coefficient (r) | Close to 1.000 | 0.997 |
| CSF Samples | ||
| Slope | Close to 1.000 | 0.990 |
| Intercept | Close to 0.00 | 0.692 |
| Correlation Coefficient (r) | Close to 1.000 | 0.994 |
| Stability Study | ||
| Shelf-life | 24 months | 24 months |
| Open Container Stability | 14 days | 14 days |
| Calibration Stability | 14 days | 14 days |
| Precision Study (Serum) | ||
| %CV (Within Run, Level 1) | Low %CV | 1.8% |
| %CV (Within Run, Level 2) | Low %CV | 1.6% |
| %CV (Within Run, Level 3) | Low %CV | 2.3% |
| %CV (Total Precision, Level 1) | Low %CV | 2.4% |
| %CV (Total Precision, Level 2) | Low %CV | 1.9% |
| %CV (Total Precision, Level 3) | Low %CV | 2.4% |
| Precision Study (CSF) | ||
| %CV (Within Run, Level 1) | Low %CV | 4.4% |
| %CV (Within Run, Level 2) | Low %CV | 4.2% |
| %CV (Within Run, Level 3) | Low %CV | 3.4% |
| %CV (Total Precision, Level 1) | Low %CV | 6.9% |
| %CV (Total Precision, Level 2) | Low %CV | 4.6% |
| %CV (Total Precision, Level 3) | Low %CV | 4.2% |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison Study:
- Serum: n = 164 samples
- CSF: n = 101 samples
- Precision Study (Serum):
- 80 replicates for each of 3 levels for "Within Run Precision" and "Total Precision" (Total individual measurements = 80 x 3 x 2 = 480).
- Precision Study (CSF):
- 30 replicates for each of 3 levels for "Within Run Precision" and "Total Precision" (Total individual measurements = 30 x 3 x 2 = 180).
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state whether the data was retrospective or prospective, but performance studies for 510(k) submissions are typically prospective studies conducted specifically for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (an immunoassay reagent) determines a quantitative value for a specific analyte. "Ground truth" is established by the reference method or comparative method itself, not typically by expert review in the way it would be for imaging or diagnostic interpretation.
- The ground truth for the method comparison study was established by another assay: Beckman Albumin Reagent (ALB) on the ARRAY® Systems (the predicate device).
- There were no "experts" in the sense of human adjudicators for establishing the ground truth; it was a direct comparison to an established laboratory method.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the ground truth is established by a quantitative measurement from a comparative method, not by human adjudication of qualitative findings.
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 a quantitative diagnostic reagent, not an AI-powered image analysis or diagnostic interpretation device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This device (reagent for an immunochemistry system) operates as a standalone quantitative measurement system. Its performance data (method comparison, stability, precision) reflect its intrinsic capabilities without human interpretation influencing the final analyte concentration reported.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation was:
- Comparative Quantitative Measurement: For the method comparison study, the results from the Beckman Albumin Reagent (ALB) on the ARRAY® Systems served as the comparative ground truth.
- Defined Standards/Reference Materials: For stability and precision studies, control materials with known or expected values were used, enabling the assessment of accuracy and reproducibility.
8. The Sample Size for the Training Set
The document does not specify a "training set" in the context of machine learning. This device is an immunoassay reagent, not a machine learning algorithm that requires a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the machine learning sense for this device. The development of such a reagent involves chemical formulation and optimization, followed by validation against known standards and comparative methods.
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(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 § 866.9.