(181 days)
Not Found
Not Found
No
The summary describes a standard in vitro diagnostic immunoassay for measuring a specific analyte and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic method used to measure a biomarker (B2-microglobulin) to aid in the management of patients with certain conditions (renal dysfunction and rheumatoid arthritis), not to treat them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "This in vitro diagnostic method is intended to quantitatively measure the concentration of B2-microglobulin in human serum and urine..." and "...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 directly identifies it as a diagnostic device.
No
The device description explicitly states it is an "in vitro, solid-phase enzyme immunoassay," which is a laboratory test involving physical reagents and a system (Technicon Immuno 1®) for measurement, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic method is intended to quantitatively measure the concentration of B2-microglobulin in human serum and urine..."
The "Device Description" also confirms this: "This is an in vitro, solid-phase enzyme immunoassay..."
These statements clearly indicate that the device is intended for use outside of the body to examine specimens (serum and urine) for diagnostic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JZG
Device Description
This is an in vitro, solid-phase enzyme immunoassay for the quantitative measurement of beta-2-Microglobulin in serum and urine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision (within-run):
Immuno 1 beta 2-Microglobulin
SERUM:
1.48 mg/L: 1.79%
2.57 mg/L: 1.25%
9.8 mg/L: 1.89%
URINE:
0.13 mg/L: 1.48%
0.91 mg/L: 1.10%
13.56 mg/L: 4.98%
Correlation:
SERUM:
A total of 97 serum samples were tested on the Abbott IMx (x) and the Immuno 1 (y).
The correlation equation according to Bablok-Passing was y = 0.99x + 0.11, r = 0.9917, Syx = 0.93 mg/L.
URINE:
A total of 24 urine samples were tested on the Abbott IMx (x) and the Immuno 1 (y).
The correlation equation according to Bablok-Passing was y = 1.05x - 0.05, r = 0.9956, Syx = 0.52 mg/L.
Sample Dilution:
Serum Samples (Calibrator Level 1 as diluent): Deviations ranged from -8.9% to 9.1%.
Urine Samples (Calibrator Level 1 as diluent): Deviations ranged from -10.6% to 11.1%.
Serum Samples (Sample Diluent B as diluent): Deviations ranged from -8.6% to 2.0%.
Urine Samples (Sample Diluent B as diluent): Deviations ranged from -2.1% to 4.6%.
Hook Effect:
A serum sample with a concentration of 126 mg/l was diluted. It was concluded that "even very high samples do not fall back into the assay range."
Recovery:
Known amounts of beta-2-microglobulin were spiked into two serum and one urine samples. Recoveries covered a range of 92.5 % to 106 % for serum.
Serum Sample 1: Recoveries ranged from 94.0% to 103.6%.
Serum Sample 2: Recoveries ranged from 92.5% to 101.4%.
Urine Samples: Recoveries ranged from 98.4% to 114.7%.
Expected Values:
Serum Samples:
262 healthy individuals measured. 95% had concentrations of 2.15 mg/L or less. Mean: 1.35 mg/L, Median: 1.28 mg/L.
Urine Samples:
72 healthy individuals measured. 95% had concentrations of 0.2 mg/L or less. Mean: 0.07 mg/L, Median: 0.04 mg/L.
Minimum Detectable Concentration:
Determined to be 0.01 mg/L based on 32 separate runs using 2 different lots of reagents and calibrators.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.01 mg/L
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 | T01-3669-51
T03-3670-01 | 2201-20 | |
| Minimum Detectable Conc. | 0.01 mg/L | | 0.005 mg/L | |
| Precision (within-run) | SERUM
1.48 mg/L
2.57 mg/L
9.8 mg/L | 1.79%
1.25%
1.89% | SERUM
1.7 mg/L
3.9 mg/L
9.7 mg/L | 6.0%
4.4%
4.9% |
| | URINE
0.13 mg/L
0.91 mg/L
13.56 mg/L | 1.48%
1.10%
4.98% | URINE
0.10 mg/L
0.30 mg/L
0.89 mg/L | 4.7%
5.5%
4.8% |
| Correlation | SERUM
y=0.99x+0.11
where
y=Immuno 1
x= Abbott IMX
n=97
r=0.99
Syx=0.93 mg/L | | URINE
y=1.05x-0.05
where
y=Immuno
x=Abbott IMX
n=24
r=0.99
Syx=0.52 mg/L | |
1
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Talds T
2
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 | Presi
1/2 |
|--------------------------|------|--------------|
| | | |
3
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
$$\begin{array}{l} \mathbf{y} = \mathbf{0.99} \times + \mathbf{0.11} \ \mathbf{r} = \mathbf{0.99} 17 \ \mathbf{Syx} = \mathbf{0.93 mg/L} \end{array}$$
4
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
$$\begin{array}{l} \textbf{y} =: \textbf{1.05} \times - \textbf{0.05} \ \textbf{r} = \textbf{0.9956} \ \textbf{Syx} = \textbf{0.52 mg/L} \end{array}$$
5
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 | ||
---|---|---|
ﺔ ﺍﻟﻤﺘﺤﺪﺓ |
6
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 |
7
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 |
oo
. ..
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 |
a market
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:
11
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-mid | |||
high | 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 |
12
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.
14
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.
15
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
16
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)