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510(k) Data Aggregation
(181 days)
This in vitro diagnostic method is intended to quantitatively measure the concentration of B2-microglobulin in human serum and urine using the Technicon Immuno 1® system. B2-Microglobulin assay values obtained should be used in conjunction with information available from clinical and other diagnostic procedures in the management of patients with renal dysfunction and rheumatoid arthritis. This diagnostic method is not intended for use on any other system.
This is an in vitro, solid-phase enzyme immunoassay for the quantitative measurement of beta-2-Microglobulin in serum and urine.
The Acceptance Criteria and Study for the Beta-2-Microglobulin Method for Bayer Technicon Immuno 1® System are detailed below:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a dedicated section. However, it presents performance characteristics of the Immuno 1 beta-2-Microglobulin method and compares them to those of the predicate device (Abbott IMX beta-2-Microglobulin Assay). The "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device and meeting general performance expectations for such assays.
| Performance Metric | Acceptance Criteria (Implied by Predicate Device/General Expectation) | Reported Device Performance (Immuno 1 beta-2-Microglobulin) | Conclusion |
|---|---|---|---|
| Minimum Detectable Conc. | Comparable to predicate device (Abbott IMX: 0.005 mg/L) | 0.01 mg/L | Deemed acceptable for intended use, though slightly higher than predicate. |
| Precision (Within-Run) | Comparable to predicate device (Abbott IMX: Serum 4.4-6.0%, Urine 4.7-5.5%) | SERUM: 1.79%, 1.25%, 1.89% URINE: 1.48%, 1.10%, 4.98% | Better than or comparable to predicate device. |
| Correlation (Serum) | Strong correlation with predicate device (Abbott IMX) | y=0.99x+0.11, r=0.99, Syx=0.93 mg/L (n=97) | Strong correlation. |
| Correlation (Urine) | Strong correlation with predicate device (Abbott IMX) | y=1.05x-0.05, r=0.99, Syx=0.52 mg/L (n=24) | Strong correlation. |
| Interferences | Beta-2-Microglobulin recoveries within acceptable range (not explicitly defined, but shown in Table 3) | Recoveries for spiked interferants are shown in Table 3. Generally, values are close to the unspiked sample. | Appears acceptable, no significant interferences reported. |
| Sample Dilution | Calculated concentrations should be close to measured concentrations (low deviation %) | Deviations vary but are generally within acceptable limits for a quantitative assay (Tables 4-7, e.g., <10-15%). | Acceptable dilution performance. |
| Hook Effect | High concentrations should not lead to falsely low readings (no "hook effect") | Even very high samples (126 mg/L) do not fall back into the assay range (Fig. 3) | No hook effect observed. |
| Recovery | Recoveries within an acceptable percentage range (e.g., 90-110%) | 92.5% to 106% for serum and urine samples (Tables 8 & 9, with one low urine recovery at 114.7% for low spike) | Generally acceptable. |
| Expected Values (Serum) | Establish a reference range for healthy individuals | 95% of healthy individuals ≤ 2.15 mg/L. Mean: 1.35 mg/L, Median: 1.28 mg/L (n=262) | Reference range established. |
| Expected Values (Urine) | Establish a reference range for healthy individuals | 95% of healthy individuals ≤ 0.2 mg/L. Mean: 0.07 mg/L, Median: 0.04 mg/L (n=72) | Reference range established. |
| Sensitivity | Statistically distinguishable from zero calibrator | 0.01 mg/L | Confirmed sensitivity. |
2. Sample Size Used for the Test Set and Data Provenance
- Correlation Study (Serum):
- Sample Size: 97 serum samples (n=97).
- Data Provenance: Not explicitly stated, but clinical samples are typically used for such studies. It is retrospective in the sense that the samples are analyzed on two different assays for comparison. The country of origin is not specified.
- Correlation Study (Urine):
- Sample Size: 24 urine samples (n=24).
- Data Provenance: Not explicitly stated, likely clinical samples. Retrospective for comparison. Country of origin not specified.
- Precision Study (Within-run):
- Sample Size: Controls were analyzed for 5 days. Specific number of runs/replicates per day isn't explicitly given beyond "within-run".
- Data Provenance: Human serum and urine controls. Country of origin not specified.
- Interference Study:
- Sample Size: One pool was spiked with various interferants. It refers to "Beta-2-Microglobulin recoveries for interference pools".
- Data Provenance: Not specified, likely laboratory-prepared samples.
- Sample Dilution Study:
- Sample Size: 6 serum samples and 4 urine samples were diluted.
- Data Provenance: Serum and urine samples. Not specified.
- Recovery Study:
- Sample Size: 2 serum samples and 1 urine sample were spiked.
- Data Provenance: Serum and urine samples. Not specified.
- Expected Values Study:
- Serum: 262 healthy individuals.
- Urine: 72 healthy individuals.
- Data Provenance: Samples from healthy individuals. Country of origin not specified.
- Minimum Detectable Concentration:
- Sample Size: Measured in 32 separate runs using 2 different lots of reagents and calibrators.
- Data Provenance: Laboratory determined using reagents and calibrators.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is an in vitro diagnostic device for quantitative measurement of a biomarker. The "ground truth" for the test set is established by the comparative method (Abbott IMX beta-2-Microglobulin Assay) and by controlled laboratory experiments with known concentrations/spikes, not by expert consensus or adjudication of qualitative data.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used for studies involving subjective human interpretation of images or clinical cases that require a consensus "ground truth." This device measures a quantitative biomarker, and its performance is compared to a predicate device or known concentrations in laboratory settings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices, often in medical imaging, where human readers interpret results and AI might assist or replace them. The Immuno 1 beta-2-Microglobulin method is a laboratory assay that provides a quantitative value, not a system that assists human readers in interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, the studies conducted demonstrate the standalone performance of the Immuno 1 beta-2-Microglobulin method. The device performs the quantitative measurement of beta-2-Microglobulin directly, without human intervention in the measurement process itself, and its performance is validated through various analytical studies (precision, correlation, interference, dilution, recovery, etc.).
7. Type of Ground Truth Used
The "ground truth" for evaluating the performance of this quantitative assay is established through several methods:
- Comparative Method: The primary method for establishing substantial equivalence for correlation studies is comparison against a legally marketed predicate device (Abbott IMX beta-2-Microglobulin Assay) which serves as the reference standard.
- Known Concentrations/Spiked Samples: For studies like interference, dilution, recovery, and minimum detectable concentration, the ground truth is established by using samples with known, prepared concentrations or by spiking samples with known amounts of beta-2-Microglobulin.
- "Zero" Calibrator: For sensitivity, the ground truth is the "zero calibrator" statistical distinction.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI models. This device is an enzyme immunoassay, and its development would typically involve optimization of reagents, antibodies, and assay parameters rather than training a machine learning algorithm on a specific dataset. The samples referred to in the performance studies (correlation, precision, etc.) are used for validation and characterization of the assay's performance, not for "training" an algorithmic model.
9. How the Ground Truth for the Training Set Was Established
N/A, as there is no mention of a "training set" for an AI/ML model for this assay. The establishment of performance characteristics relies on analytical validation against predicate methods, known controls, and biological samples from defined populations (e.g., healthy individuals).
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