(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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Summary of Safety and Effectiveness
Beta-2-Microglobulin Method for Bayer Technicon Immuno 1® System
1. Intended Use
到明星期
This is an in vitro, solid-phase enzyme immunoassay for the quantitative measurement of beta-2-Microglobulin in serum and urine. Measurements of beta-2-Microglobulin are used in monitoring inflammatory conditions and in diagnosing and managing patients with renal diseases.
Listed below is a comparison of the performance between the Immuno 1 beta-2-Microglobulin method and a similar device that was granted FDA clearance of substantial equivalence (The Abbott IMX beta-2-Microglobulin Assay). The information used in this Summary of Safety and Effectiveness was extracted from the Immuno 1@ beta-2-Microglobulin method sheet, from data on file at Bayer Corporation, and from the Abbott IMX beta-2-Microglobulin method sheet.
| METHOD | Immuno 1 beta 2-Microglobulin | Abbott IMX(predicate Device) | ||
|---|---|---|---|---|
| Part No. | Reagents | T01-3669-51T03-3670-01 | 2201-20 | |
| Minimum Detectable Conc. | 0.01 mg/L | 0.005 mg/L | ||
| Precision (within-run) | SERUM1.48 mg/L2.57 mg/L9.8 mg/L | 1.79%1.25%1.89% | SERUM1.7 mg/L3.9 mg/L9.7 mg/L | 6.0%4.4%4.9% |
| URINE0.13 mg/L0.91 mg/L13.56 mg/L | 1.48%1.10%4.98% | URINE0.10 mg/L0.30 mg/L0.89 mg/L | 4.7%5.5%4.8% | |
| Correlation | SERUMy=0.99x+0.11wherey=Immuno 1x= Abbott IMXn=97r=0.99Syx=0.93 mg/L | URINEy=1.05x-0.05wherey=Immunox=Abbott IMXn=24r=0.99Syx=0.52 mg/L |
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b) Urine Samples
Imprecision data for urine samples was obtained by analyzing human urine controls on an Immuno 1 over 5 days. The concentrations of serum controls were calculated from a calibration curve genrated on day 1 of the study. (Table 2)
| specimen | Mean (mg/l) | Total SD (mg/l) | Total CV (%) | Within-Run SD (mg/l) | Within-Run CV (%) |
|---|---|---|---|---|---|
| sample 1 | 0.13 | 0.005 | 3.46 | 0.002 | 1.48 |
| sample 2 | 0.91 | 0.012 | 1.31 | 0.010 | 1.10 |
| sample 3 | 13.56 | 0.676 | 4.98 | 0.676 | 4.98 |
| ్టింగ్ స్టేషన్లు మూలాలు | able | Presi1/2 |
|---|---|---|
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Correlation मुं
a) Serum Samples
A total of 97 serum samples were tested on the Abbott IMx (x) and the Immuno 1 (y). The correlation results are shown in Figure 1.
Image /page/3/Figure/3 description: This image is a scatter plot comparing two different immunoassays, Immuno 1 and Abbott IMx. The x-axis represents the values from the Abbott IMx assay, ranging from 0 to 20. The y-axis represents the values from the Immuno 1 assay, also ranging from 0 to 20. The plot shows a strong positive correlation between the two assays, with data points clustered around a central trend line and two dashed lines.
Fig 1: Serum Sample Correlation of Immuno 1 vs. Abbott IMX for beta-2-Microglobulin The correlation equation according to Bablok-Passing was
$$\begin{array}{l} \mathbf{y} = \mathbf{0.99} \times + \mathbf{0.11} \ \mathbf{r} = \mathbf{0.99} 17 \ \mathbf{Syx} = \mathbf{0.93 mg/L} \end{array}$$
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b. Urine Samples
A total of 24 urine samples were tested on the Abbott IMx (x) and the Immuno 1 (y). The correlation results are shown in Figure 2.
Image /page/4/Figure/2 description: This image is a scatter plot comparing "Immuno 1" on the y-axis and "Abbott IMx" on the x-axis. The plot contains data points scattered around a diagonal line, indicating a correlation between the two variables. The axes range from 0 to 20, and there are several data points clustered near the origin, with a few points extending towards the upper right corner of the plot.
Fig 2: Urine Samples Correlation of Immuno 1 vs. Abbott IMX for beta-2-Microglobulin
The correlation equation according to Bablok-Passing was
$$\begin{array}{l} \textbf{y} =: \textbf{1.05} \times - \textbf{0.05} \ \textbf{r} = \textbf{0.9956} \ \textbf{Syx} = \textbf{0.52 mg/L} \end{array}$$
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5. Interferences
For all interference measurements, a pool was spiked with potentially interfering substances and I or an interference measurements) on containing no interferants. Beta-2-Microglobulin recoveries for interference pools are summarized in Table 3.
| Interferants | Interferant Conc. (mg/dL) | B2-M Recovery mg/L |
|---|---|---|
| Alburnin | 0 | 2.56 |
| 1625 | 2.58 | |
| 3250 | 2.57 | |
| 4875 | 2.56 | |
| 6500 | 2.58 | |
| Bilirubin | 0 | 2.53 |
| 6.25 | 2.46 | |
| 12.50 | 2.40 | |
| 18.75 | 2.45 | |
| 25 | 2.41 | |
| Urea | 0 | 2.70 |
| 50 | 2.69 | |
| 100 | 2.69 | |
| 175 | 2.70 | |
| 200 | 2.56 | |
| Hemoglobin | 0 | 2.61 |
| 300 | 2.60 | |
| 600 | 2.75 | |
| 800 | 2.63 | |
| 1200 | 2.69 | |
| Heparin | 0 | 2.64 |
| 12.5 | 2.60 | |
| 25 | 2.41 | |
| 37.5 | 2.56 | |
| 50 | 2.78 | |
| Human IgG | 0 | 2.40 |
| 1325 | 2.50 | |
| 2650 | 2.40 | |
| 3975 | 2.50 | |
| 5300 | 2.54 | |
| Triglycerides | 0 | 3.31 |
| 250 | 3.36 | |
| 500 | 3.56 | |
| 750 | 3.56 | |
| 1000 | 3.43 |
| Table | ||
|---|---|---|
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6. Sample Dilution
The find of the many
Serum and urine samples were diluted with beta-2-Microglobulin Calibrator Level 1 and with Semple Diluent B was carried out. For data analysis a linear regression was calculated from the Sample Dildent is was Carried out. For usta and risk togers in the deviation from the measured values were calculated from this equation; these are shown in Tables 4-7.
I. Results obtained with Calibrator Level 1 as diluent
a) Serum Samples
| sample | dilution (%) | conc. (meas.) | conc. (calc.) | deviation (%) |
|---|---|---|---|---|
| 1 | 0 | 0 | 0.04 | - |
| 10 | 1.19 | 1.12 | 5.6 | |
| 25 | 2.72 | 2.75 | -1.0 | |
| 50 | 5.39 | 5.45 | -1.2 | |
| 75 | 8.62 | 8.16 | 5.3 | |
| 100 | 11.06 | 10.87 | 1.8 | |
| 2 | 0 | 0 | 0.03 | - |
| 10 | 1.16 | 1.10 | 4.8 | |
| 25 | 2.69 | 2.71 | -0.8 | |
| 50 | 5.01 | 5.39 | -7.6 | |
| 75 | 8.65 | 8.07 | 6.7 | |
| 100 | 11.68 | 10.75 | 8.0 | |
| 3 | 0 | 0 | 0.08 | - |
| 10 | 1.62 | 1.49 | 8.0 | |
| 25 | 3.56 | 3.61 | -1.4 | |
| 50 | 7.10 | 7.15 | -0.6 | |
| 75 | 11.64 | 10.68 | 8.2 | |
| 100 | 14.39 | 14.21 | 1.2 | |
| 4 | 0 | 0 | 0.02 | - |
| 10 | 1.05 | 1.02 | 2.6 | |
| 25 | 2.52 | 2.53 | -0.4 | |
| 50 | 5.07 | 5.05 | 0.5 | |
| 75 | 7.95 | 7.56 | 4.9 | |
| 100 | 11.06 | 10.07 | 8.9 | |
| 5 | 0 | 0 | 0.04 | - |
| 10 | 1.74 | 1.67 | 4.2 | |
| 25 | 4.07 | 4.10 | -0.7 | |
| 50 | 8.97 | 8.15 | 9.1 | |
| 75 | 13.4 | 12.2 | 8.9 | |
| 100 | 17.11 | 16.27 | 4.9 | |
| 6 | 0 | 0 | 0.08 | - |
| 10 | 2.03 | 1.92 | 5.4 | |
| 25 | 4.66 | 4.70 | -0.9 | |
| 50 | 8.58 | 9.34 | -8.9 | |
| 75 | 15.21 | 13.98 | 8.1 | |
| 100 | 18.89 | 18.61 | 1.4 |
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b) Urine Samples
Table 5
| sample | dilution (%) | conc. (meas.) | conc. (calc.) | deviation (%) |
|---|---|---|---|---|
| 1 | 0 | 0 | 0 | - |
| 10 | 0.87 | 0.88 | -0.8 | |
| 25 | 2.2 | 2.2 | 0 | |
| 50 | 4.33 | 4.40 | -1.6 | |
| 75 | 6.76 | 6.60 | 2.4 | |
| 100 | 9.08 | 8.80 | 3.1 | |
| 2 | 0 | 0 | -0.3 | - |
| 10 | 1.64 | 1.69 | -2.9 | |
| 25 | 4.28 | 4.26 | 0.4 | |
| 50 | 8.89 | 8.55 | 3.8 | |
| 75 | 13.59 | 12.84 | 5.5 | |
| 100 | 17.34 | 17.13 | 1.2 | |
| 3 | 0 | 0 | 0.03 | - |
| 10 | 1.13 | 1.09 | 3.84 | |
| 25 | 2.66 | 2.68 | -0.7 | |
| 50 | 4.82 | 5.33 | -10.6 | |
| 75 | 7.62 | 7.98 | -4.7 | |
| 100 | 11.16 | 10.63 | 4.7 | |
| 4 | 0 | 0 | 0.07 | - |
| 10 | 1.53 | 1.41 | 7.7 | |
| 25 | 3.38 | 3.43 | -1.4 | |
| 50 | 7.63 | 6.78 | 11.1 | |
| 75 | 11.23 | 10.14 | 9.7 | |
| 100 | 12.73 | 13.50 | -6.0 |
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{8}------------------------------------------------
II. Results obtained with Sample Diluent B
a) Serum Samples
Table 6
| sample | dilution (%) | conc. (meas.) | conc. (calc.) | deviation (%) |
|---|---|---|---|---|
| 1 | 0 | 0 | -0.01 | - |
| 10 | 1.45 | 1.44 | 1.0 | |
| 25 | 3.57 | 3.58 | -0.2 | |
| 50 | 7.07 | 7.14 | -1.0 | |
| 75 | 10.48 | 10.71 | -2.2 | |
| 100 | 13.15 | 14.28 | -8.6 | |
| 2 | 0 | 0 | -0.01 | - |
| 10 | 1.11 | 1.14 | -2.5 | |
| 25 | 2.88 | 2.87 | 0.4 | |
| 50 | 5.84 | 5.75 | 1.5 | |
| 75 | 8.25 | 8.64 | -4.7 | |
| 100 | 11.76 | 11.53 | 2.0 |
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{9}------------------------------------------------
b) Urine Samples
్ ప్రజ
| Table | ang |
|---|
| sample | dilution (%) | conc. (meas.) | conc. (calc.) | deviation (%) |
|---|---|---|---|---|
| 1 | 0 | 0 | 0.03 | - |
| 10 | 1.81 | 1.75 | 3.1 | |
| 25 | 4.31 | 4.33 | -0.5 | |
| 50 | 8.64 | 8.63 | 0.1 | |
| 75 | 13.12 | 12.93 | 1.4 | |
| 100 | 16.92 | 17.22 | -1.8 | |
| 2 | 0 | 0 | 0.03 | - |
| 10 | 2.04 | 2.00 | 2.2 | |
| 25 | 4.93 | 4.95 | -0.4 | |
| 50 | 9.94 | 9.87 | 0.7 | |
| 75 | 15.51 | 14.79 | 4.6 | |
| 100 | 19.31 | 19.71 | -2.1 |
-....
{10}------------------------------------------------
7。 Hook Effect
อนไลน์
A serum sample with a concentration of 126 mg/l was diluted with calibrator level 1 and the rate values and calculated concentrations were compared to L.6 calibrators. It can be concluded that even very high samples do not fall back into the assay range. (Fig. 3)
Image /page/10/Figure/2 description: This image is a graph titled "Hook Study". The x-axis is labeled "concentration", and the y-axis is labeled "rate value (AU/min)". The graph shows a curve that increases and then plateaus, with data points ranging from approximately 0 to 5.2 on the y-axis and 0 to 140 on the x-axis.
Fig. 3:
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8. Recovery
Known amounts of beta-2-microglobulin were spiked into two senum and one urine samples. The first and 9 Known amounts of beta-2-microglobulin were spiked. recoveries cover a range of 92.5 % to 106 % are shown in Tables 8 and 9.
I. Serum Samples
| Claim Ocailing | Table 8 | ||
|---|---|---|---|
| sample | |||
| sample 1 base | 2.32 | ి రాజాల్లో విద్యాలయం విద్యాలయం గ్రామం నుండి | 100 |
| low | 4.07 | িন্দ মানুষ্ঠান বাংলাদেশ মৃত্যু বিশ্ববিদ্যালয় মৃত্যু বিশ্ববিদ্যালয় মহাট্যমান | 101.2 |
| low-mid | 5.44 | க்கு இது இது இருக்கு இது இருக்கு இது இருக்கு இது இருக்கு மேற்கு இது இருக்கு ம | 102.0 |
| mid | 6.81 | 7.03 | 103.2 |
| 8.18 | 7.69 | 94.0 | |
| high-midhigh | 9.55 | ్రి. 89 | 103.6 |
| 9.9 | 100 | ||
| sample 2 base | 2.29 | ||
| low | 4.06 | 4.00 | 98.5 |
| low-mid | 5.43 | ရွာ၊ မိုင်းမျိုးများ မြို့နယ်ရှိ ရွာများ BotUpload Books (၂၆) ရက် (၂၂) ရက် (၂၂) ရက် (၂၂) ရက် (၂၂) ရက် (၂၂) ရက် (၂၂) ရက် (၂၂) ရက် (၂၂) ရက် (၂၂) ရက် (၂၂) ရက် (၂၂) ရက် (၂၂) ရက် | 98.0 |
| mid | 6.80 | 6 58 | તેરું જ |
| 7.56 | 92.5 | ||
| high-mid | 8.17 | 101.4 | |
| high | 9.54 | 9.67 |
II. Urine Samples
Table 9
| sample | conc. (calculated) | conc. (measured) | recovery (%) |
|---|---|---|---|
| sample 1 base | 0.1 | 0.04 | - |
| low | 1.90 | 2.18 | 114.7 |
| low-mid | 3.80 | 3.74 | 98.4 |
| mid | 5.70 | 5.66 | 99.3 |
| high-mid | 7.60 | 7.63 | 100.4 |
| high | 9.50 | 9.58 | 100.8 |
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9. Expected Values
I. Serum Samples
Serum samples from 262 healthy individuals were measured and gave the distribution of results , shown in Fig. 4.
95 % of these serum samples were found to have concentrations of 2.15 mg/L or less. The calculated mean of this distribution is 1.35 mg/L, the median is 1.28 mg/L.
Image /page/12/Figure/4 description: This image shows a frequency distribution of beta-2-microglobulin in serum. The x-axis represents the concentration of beta-2-microglobulin in mg/L, ranging from 0 to 5. The y-axis represents the frequency, ranging from 0 to 25. The distribution appears to be approximately normal, with a peak around 1.25-1.5 mg/L, and the sample size is 262.
Fig. 4: Normal Distribution of beta-2-Microglobulin in Serum Samples
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II. Urine Samples
Urine samples from 72 healthy individuals were measured; 95 % of these urine samples were found to have concentrations of 0.2 mg/L or less. The calculated mean of this distribution is 0.07 mg/L, the median is 0.04 mg/L. The distribution of results are shown in Fig. 5.
Image /page/13/Figure/2 description: This image shows a frequency distribution of beta-2-Microglobulin in urine. The x-axis represents the concentration of beta-2-Microglobulin in mg/L, ranging from 0 to 0.6. The y-axis represents the frequency, ranging from 0 to 12. The distribution appears to be skewed to the right, with most values concentrated between 0 and 0.1 mg/L.
Fig. 5: Normal Distribution of beta-2-Microglobulin in Urine Samples
10. Minimum Detectable Concentration
Sensitivity or Minimum Detectable Concentration of the assay is defined as the beta-2-Microglobulin concentration that can be statistically distinguished for the zero calibrator - the mean zero absorbance + 2SD. The sensitivity measured in 32 seprate runs using 2 different lots of reagents and calibrators was determined to be 0.01 mg/L.
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Image /page/14/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 29 1997
Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation Diagnostics Division 511 Benedict Avenue Tarrytown, New York 10591
Re: K964791/S1 Trade Name: B2 Microglobulin Assay for the Technicon Immuno 1@ System Regulatory Class: II Product Code: JZG Dated: March 25, 1997 Received: March 26, 1997
Dear Mr. Muraca, Jr .:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please note: this response to your premarket notification does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809-10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 7
Page 1 of 1
510(K) Number (if known): K 96 479 /
Technicon Immuno 1® System ß2-Microglobulin (B2S / B2U) Device Name:
Indications For Use:
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.
Peter E. Marin
ase do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
Concurrence of CDRH, Office of Device Evaluation (ODE
Prescription Use (Per 21 CFR 801.109)
ીને
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.