(297 days)
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No
The device description and performance studies focus on a standard immunoassay method (turbidity measurement) and do not mention any AI or ML components for data analysis or interpretation.
No
This device is an in vitro diagnostic (IVD) reagent and calibrator used to measure β2-microglobulin levels in human samples, which aids in the diagnosis of certain conditions, but it does not treat or prevent any disease, thus it is not a therapeutic device.
Yes
The reagent's intended use explicitly states it "aids in the diagnosis of active rheumatoid arthritis and kidney disease," indicating a diagnostic function.
No
The device description clearly indicates it is a reagent and calibrator for an in vitro diagnostic assay performed on a chemistry analyzer (ADVIA 1650). This involves physical components (reagents, calibrators) and a hardware system (the analyzer) to perform the test and measure results.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "for in vitro diagnostic use" for both the reagent and the calibrators. It also describes the intended use as the quantitative determination of β2-microglobulin in human serum or plasma, which is a diagnostic test performed outside of the body.
- Device Description: The description details a laboratory assay that measures a substance in a biological sample (serum or plasma) to aid in the diagnosis of specific medical conditions (rheumatoid arthritis and kidney disease). This is a hallmark of an in vitro diagnostic device.
- Performance Studies: The document describes performance studies conducted to demonstrate the analytical performance of the assay, which is a requirement for IVD devices.
The entire context of the document, including the description of the assay, the calibrators, and the performance data, clearly indicates that this device is intended for use in a laboratory setting to provide diagnostic information from biological samples.
N/A
Intended Use / Indications for Use
Reagent: for in vitro diagnostic use in the quantitative determination of β2-microglobulin in human serum or plasma (lithium heparin and potassium EDTA) on ADVIA® 1650 Chemistry systems. The ADVIA 1650 Chemistry 32-Microglobulin (B2M) assay aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Calibrators: for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry β2-Microglobulin method.
Product codes (comma separated list FDA assigned to the subject device)
JZG, JIT
Device Description
The ADVIA 1650 Chemistry 32-Microglobulin (B2M) assay sample is diluted and reacted with a buffer that contains latex particles coated with antibody specific for ß2microglobulin. The formation of the antibody-antigen complex during the reaction results in an increase in turbidity, the extent of which is measured as the amount of light absorbed at 545 nm. The ß2-Microglobulin concentration in a sample is determined by constructing a standard curve from the absorbance of a reagent blank and a single-level calibrator.
The ADVIA Chemistry B2-Microglobulin Calibrator is a single analyte, lyophilized, buffer based product containing bovine serum albumin and human ß2-Microglobulin. The kit consists of 3 vials of a single level calibrator. The calibrator requires reconstitution with 1 mL of distilled water prior to use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence for the ADVIA 1650 Chemistry ß2-Microglobulin assay to the predicate device was demonstrated by testing several method performance characteristics including analytical sensitivity, linearity, imprecision, method comparison and interfering substances. The following information summarize the analytical sensitivity, linearity, precision (total), interfering substances, serum / plasma equivalency and method comparison results.
All of the evaluation studies gave acceptable results compared to the predicate device. These studies support that the ADVIA 1650 Chemistry ß2-Microglobulin assay is substantially equivalent to the Siemens N Latex ß2 -Microglobulin (N B2M) that is currently marketed.
Analytical Sensitivity:
The Limit of Detection (LoD) and Limit of Blank (LoB) were determined by following CLSI quideline EP-17A. The study was performed by running 60 replicates of a blank (serum sample with a low concentration of ß2-Microglobulin at 10% is considered a significant interference. Ascorbic Acid showed -15.3% effect at 100 mg/dL (1.21 mg/L B2M) and -13.4% effect at 200 mg/dL (10.73 mg/L B2M). All other tested substances showed no significant interference (NSI).
Correlation:
A total of 88 samples serum samples were analyzed on the ADVIA 1650 Chemistry system using ß2-Microglobulin reagent and on the Siemens N Latex ß2 -Microglobulin (predicate device), in parallel on the same day to demonstrate the equivalence of the two methods.
r = 0.99, Slope = 1.03, Y-intercept = -0.38, n = 88.
Serum / Plasma (lithium heparin and EDTA):
The ADVIA 1650 Chemistry Centaur (32-microglobulin assay was evaluated using different sample tube collection types. A matrix study was performed using matched specimens drawn in different tube types: potassium EDTA and lithium heparin. ß2-microglobulin values ranged from 0.97 to 17.75 mg/L. No significant differences between tube types were observed.
Plasma (K,EDTA) vs Serum: N=57, Regression Equation y = 1.00x - 0.04, Sy.x r=0.19 0.99
Plasma (Lithium Heparin) vs Serum: N=57, Regression Equation y = 1.01x + 0.01, Sy.x r=0.21 0.99
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
LoB = 0.20 mg/L LoD = 0.25 mg/L
| Level (mg/L) | Total CV (%) |
|---|---|
| 0.74 | 3.3 |
| 1.77 | 2.6 |
| 3.68 | 2.4 |
| 12.52 | 2.1 |
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.
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
510(k) Summary
JAN 2 0 2012
| Submitter information
Contact person: | Neil Parker
Senior Regulatory Affairs Specialist |
|------------------------------------------|------------------------------------------------------------------------------|
| Address: | Siemens Healthcare Diagnostics
511 Benedict Avenue
Tarrytown, NY 10591 |
| Phone: | 914-524-2477
914-524-2500 (fax) |
Date summary prepared: March 28, 2011
Device Trade or Proprietary Names:
ADVIA Chemistry β2-Microglobulin reagent ADVIA Chemistry β2-Microglobulin calibrator
Device Common/Usual Name or Classification Name:
Beta-2-Microglobulin Immunological Test System Calibrator
Classification Number / Class:
21 CFR 866.5630 - Beta-2-Microglobulin Immunological Test System Class II 21 CFR 862.1150 - Calibrator - Class II
Product code:
JZG - Beta-2-Microglobulin Immunological Test System JIT - Calibrator, Secondary
1
This 510/k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
The assigned 510(k) number is:
Assay Predicate Device:
| Predicate Device | ||
|---|---|---|
| Device Name | Siemens N Latex β2 – Microglobulin (N B2M) | |
| Common name | Beta-2-Microglobulin Immunological Test | |
| System – Class II | ||
| 510(k) Number | K002731 | |
| Manufacturer | Siemens (formerly Dade Behring, Inc) |
Calibrator Predicate Device
| Predicate Device | ||
|---|---|---|
| Device Name | Siemens N-protein standard SL | |
| Common name | Calibrator, multi-analyte mixture | |
| 510(k) Number | K052788 | |
| Manufacturer | Siemens (formerly Dade Behring, Inc) |
Device Description:
The ADVIA 1650 Chemistry 32-Microglobulin (B2M) assay sample is diluted and reacted with a buffer that contains latex particles coated with antibody specific for ß2microglobulin. The formation of the antibody-antigen complex during the reaction results in an increase in turbidity, the extent of which is measured as the amount of light absorbed at 545 nm. The ß2-Microglobulin concentration in a sample is determined by constructing a standard curve from the absorbance of a reagent blank and a single-level calibrator.
The ADVIA Chemistry B2-Microglobulin Calibrator is a single analyte, lyophilized, buffer based product containing bovine serum albumin and human ß2-Microglobulin. The kit consists of 3 vials of a single level calibrator. The calibrator requires reconstitution with 1 mL of distilled water prior to use.
Siemens Healthcare Diagnostics ADVIA 1650 Chemistry ß2-Microglobulin 510(k) Summary
2
Statements of Intended Use:
Reagent: for in vitro diagnostic use in the quantitative determination of β2-microglobulin in human serum or plasma (lithium heparin and potassium EDTA) on ADVIA® 1650 Chemistry systems. The ADVIA 1650 Chemistry 32-Microglobulin (B2M) assay aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Calibrators: for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry β2-Microglobulin method.
3
Comparisons to the Predicate Devices: Assay Similarities
| Items | ADVIA 1650 Chemistry β2-
Microglobulin (B2M) assay | Siemens N Latex β2 -
Microglobulin (N B2M)
(Predicate Device) K002731 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indication for
use | for in vitro diagnostic use in the
quantitative determination of β2-
microglobulin in human serum or
plasma (lithium heparin and
potassium EDTA) on ADVIA®
1650 Chemistry systems. The
ADVIA 1650 Chemistry β2-
Microglobulin (B2M) assay aids
in the diagnosis of active
rheumatoid arthritis and kidney
disease. | Similar
The Siemens N Latex β2 -
Microglobulin (N B2M) is
In vitro diagnostic reagent for
the quantitative determination
of β2-microglobulin in human
serum, plasma (EDTA and
heparinized), as well as in
urine by means of particle-
enhanced immuno-
nephelometry on the BN
Systems. This assay aids in
the diagnosis of renal
dysfunction. |
| Measurement | Quantitative | Same |
| Reagent storage temperature | 2-8°C | Same |
| Format | Liquid | Same |
| Use of Calibrators | Yes | Same |
| Reference Range | 1.0 to 2.4 mg/L | Similar
1.09 to 2.53 mg/L |
Assay Differences
| Items | ADVIA 1650 Chemistry β2-
Microglobulin (B2M) assay | Siemens N Latex β2 -
Microglobulin (N B2M)
(Predicate Device) K002731 |
|--------------------|-------------------------------------------------------|-----------------------------------------------------------------------------|
| Differences | | |
| Platform | ADVIA 1650 Chemistry System | BN system |
| Assay principle | turbidimetric | nephelometric |
| On Board stability | 21 days | Minimum 5 days |
| Sample Type | Serum, plasma | Serum, plasma, urine |
| Assay Range | 0.25 - 18.0 mg/L | 0.7 - 23.0 mg/L
(serum/plasma) |
| Antibody Source | goat | mouse |
4
Calibrator Similarities
| Items | ADVIA Chemistry β2-Microglobulin Calibrator | Siemens N Protein Standard SL (Predicate Device) K052788 |
|---|---|---|
| Similarities | ||
| Intended Use/Indication for use | for in vitro diagnostic use the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry β2-Microglobulin method. | Similar |
| For in vitro diagnostic use for establishment of reference curves for the determination of 27 analytes including β2-Microglobulin on the BN Systems. | ||
| Number of calibrators | 1 | Same |
| Calibrator storage temperature | 2-8°C | Same |
| Fill volume | 1.0mL | Same |
| Traceability | WHO 1st International Standard | Same |
Calibrator Differences
| Items | ADVIA Chemistry β2-Microglobulin
Calibrator | Siemens N Protein Standard
SL (Predicate Device)
K052788 |
|-------------|------------------------------------------------|----------------------------------------------------------------|
| Differences | | |
| Analyte | Single | Multi |
| Format | Lyophilized - buffer based | Liquid - serum based |
| Stability | 30 days after reconstitution | 14 days after opening |
| Instrument | ADVIA 1650 Chemistry System | BN Systems |
5
Performance:
Substantial equivalence for the ADVIA 1650 Chemistry ß2-Microglobulin assay to the predicate device was demonstrated by testing several method performance characteristics including analytical sensitivity, linearity, imprecision, method comparison and interfering substances. The following information summarize the analytical sensitivity, linearity, precision (total), interfering substances, serum / plasma equivalency and method comparison results.
All of the evaluation studies gave acceptable results compared to the predicate device. These studies support that the ADVIA 1650 Chemistry ß2-Microglobulin assay is substantially equivalent to the Siemens N Latex ß2 -Microglobulin (N B2M) that is currently marketed.
Analytical Sensitivity
The Limit of Detection (LoD) and Limit of Blank (LoB) were determined by following CLSI quideline EP-17A. The study was performed by running 60 replicates of a blank (serum sample with a low concentration of ß2-Microglobulin at 10% is considered a significant interference.
7
| Table | 3 |
|---|---|
| ------- | --- |
| Substance in Serum | Concentration Tested | Interference |
|---|---|---|
| Acetone | up to 250 mg/dL | NSI* |
| Cholesterol | up to 500 mg/dL | NSI* |
| Creatinine | up to 125 mg/dL | NSI* |
| Ethanol | up to 1000 mg/dL | NSI* |
| Glucose | up to 2000 mg/dL | NSI* |
| Immunoglobulin G | up to 5000 mg/dL | NSI* |
| Immunoglobulin M | up to 1600 mg/dL | NSI* |
| Riboflavin | up to 15 mg/dL | NSI* |
| Total protein | up to 12 g/dL | NSI* |
| Urea | up to 60 mg/dL | NSI* |
| Uric acid | up to 12 mg/dL | NSI* |
*NSI = No Significant Interference. A percentage effect ≥ 10% is considered a significant interference.
Correlation
A total of 88 samples serum samples were analyzed on the ADVIA 1650 Chemistry system using ß2-Microglobulin reagent and on the Siemens N Latex ß2 -Microglobulin (predicate device), in parallel on the same day to demonstrate the equivalence of the two methods.
Table 4 summarizes the data.
Table 4 - ADVIA 1650 Chemistry ß2-microglobulin assay vs. Siemens N Latex ß2 -Microglobulin (N B2M) method
| Siemens N Latex β2 -Microglobulin vs ADVIA 1650 Chemistry B2M
| Assay | |||||
|---|---|---|---|---|---|
| X Axis | Y Axis | n | r | Slope | Y-int |
| Siemens N | |||||
| Latex β2 - | |||||
| Microglobulin | ADVIA 1650 | ||||
| Chemistry | |||||
| B2M | 88 | 0.99 | 1.03 | -0.38 |
8
Serum / Plasma (lithium heparin and EDTA)
The ADVIA 1650 Chemistry Centaur (32-microglobulin assay was evaluated using different sample tube collection types. A matrix study was performed using matched specimens drawn in different tube types. potassium EDTA and lithium heparin. 82microglobulin values ranged from 0.97 to 17.75 mg/L. Linear regression analysis was performed using the following:
· serum (x) vs. potassium EDTA (v1)
· serum (x) vs. lithium heparin (y2)
No significant differences between tube types was observed. The following results were obtained:
Table 5
| Specimen
Type | Comparison Assay
(x) | N | Regression
Equation | Sy.x r | Sample Range |
|--------------------------------|--------------------------------|----|------------------------|-----------|-----------------|
| Plasma
(K,EDTA)
| ADVIA 1650/1800
B2M Reagent | 57 | $y = 1.00x - 0.04$ | 0.19 0.99 | 0.97-17.75 mg/L |
| Plasma
(Lithium
Heparin) | ADVIA 1650/1800
B2M Reagent | 57 | $y = 1.01x + 0.01$ | 0.21 0.99 | 0.97-17.75 mg/L |
Conclusions:
The Siemens Healthcare Diagnostics ADVIA 1650 Chemistry Centaur 02-microglobulin assay ADVIA is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Siemens N Latex ß2 -Microglobulin (N B2M) K002731.
The Siemens Healthcare Diagnostics ADVIA Chemistry β2-Microglobulin calibrator is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Siemens N Protein Standard SL K052788.
9
Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics, Inc. c/o Mr. Neil Parker Sr. Regulatory Affairs Specialist 511 Benedict Ave Tarrytown, NY 10591
JAN 2 0 2012
Re: K110874
ADVIA® Chemistry ß2-Microglobulin Reagent Regulation Number: 21 CFR §866.5630 Regulation Name: Beta-2-Microglobulin Immunological Test System Regulatory Class: II Product Code: JZG, JIT Dated: January 10, 2012 Received: January 12, 2012
Dear Mr. Parker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
10
Page 2 – Mr. Neil Parker
will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Reeva Philip
C 0%
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
11
Indication for Use
K 110874 510(k) Number (if known): Device Name: ADVIA 1650 Chemistry ß2-microglobulin (B2M) method Indication for Use:
Reagent: for in vitro diagnostic use in the quantitative determination of ß2-microglobulin in human serum or plasma (lithium heparin and potassium EDTA) on ADVIA 1650 Chemistry systems. The ADVIA 1650 Chemistry ß2-Microglobulin (B2M) assay aids in the diagnosis of active rheumatoid arthritis and kidney disease.
Calibrator: for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry ß2-Microglobulin method
Prescription Use X_ (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
KII0874 510(k)
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