(29 days)
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No
The description details a standard turbidimetric immunoassay reagent kit and its performance characteristics, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic reagent used for the quantitative determination of a specific substance in human serum, not for treating or preventing a disease.
Yes
This device is a diagnostic device as indicated by "For In Vitro Diagnostic use only" in the "Intended Use / Indications for Use" section. It quantitatively determines ß-2-Microglobulin, which is a common diagnostic marker.
No
The device is a reagent kit, which is a physical product containing liquid reagents for laboratory testing. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic use only."
- Nature of the Device: The device is a "System reagent for the quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum". This describes a product used to test a biological sample (human serum) outside of the body (in vitro) to obtain diagnostic information (quantitative determination of a substance).
- Mechanism: The description of the device and its mechanism (turbidimetry based on antigen-antibody reaction) is consistent with an in vitro diagnostic assay.
Therefore, based on the provided information, this device is definitively an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
System reagent for the quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum on Beckman Coulter AU analyzers. For In Vitro Diagnostic use only.
Product codes
JZG
Device Description
The Beta-2-Microglobulin reagent kit is a System Reagent for the Quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum on Beckman Coulter AU analyzers.
The ßeta-2-Microglobulin kit is a liquid, ready to use and consists of 4 x 10mL R1 reagent vials and 4 x 8mL R2 reagent vials. Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter.
In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
The ßeta-2-Microglobulin reagent is designed for optimal performance on Beckman Coulter AU analyzers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum
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
Stability: On-Board and Calibration Frequency. Testing was performed using one reagent lot. Calibration was performed on the first day. Controls were run to check calibration and the reagent. Linearity was run on the last number of shots of reagent. The maximum time point exceeded the claim. Calibration was performed again at day 90. A 90 day reagent on-board claim and a 90-day calibration frequency claim was established.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 8, 2016
Beckman Coulter Ireland, Inc. Ms. Eimear Carr Regulatory Affairs Specialist Lismeehan, O'Callaghan's Mills, Co. Clare, Ireland
Re: K161297
Trade/Device Name: Beta-2-Microglobulin Regulation Number: 21 CFR 866.5630 Regulation Name: Beta-2-microglobulin immunological test system Regulatory Class: II Product Code: JZG Dated: May 5, 2016 Received: May 9, 2016
Dear Ms. Carr:
This letter corrects our substantially equivalent letter of June 7, 2016.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kelly Oliner -S/A
For Leonthena Carrington, MS, MBA, MT (ASCP) Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name Beta-2-Microglobulin
Indications for Use (Describe)
System reagent for the quantitative determination of (9-2-Microglobulin (62M) in human serum on Beckman Coulter AU analyzers
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510k Summary ßeta-2-Microglobulin
1.0
Submitted By:
Eimear Carr Regulatory Affairs Specialist Beckman Coulter Ireland, Inc. Lismeehan, O'Callaghan's Mills Co. Clare, Ireland Telephone: +353-65-683-1483 Fax: +353-65-683-1122 Email: ecarr@beckman.com
2.0 Date of Preparation:
05th May, 2016
3.0 Device Identifications
| Proprietary Name: | βeta-2-Microglobulin |
|---|---|
| Common Name: | βeta-2-Microglobulin |
| Classification: | Class II |
| Product Codes: | JZG |
| Regulation Number: | 21 CFR 866.5630 |
4.0 Predicate Device:
| Proposed Device | Predicate | Manufacturer | Docket
Number |
|----------------------|-------------------|--------------|-----------------------------------------------------|
| Beta-2-Microglobulin | β-2-Microglobulin | K991136 | Olympus
America Inc./
Beckman
Coulter Inc. |
The ßeta-2-Microglobulin reagent is substantially equivalent to the Beckman Coulter product listed above currently in commercial distribution.
5.0 Description:
The Beta-2-Microglobulin reagent kit is a System Reagent for the Quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum on Beckman Coulter AU analyzers.
The ßeta-2-Microglobulin kit is a liquid, ready to use and consists of 4 x 10mL R1 reagent vials and 4 x 8mL R2 reagent vials. Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter.
4
In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
The ßeta-2-Microglobulin reagent is designed for optimal performance on Beckman Coulter AU analyzers.
6.0 Intended Use:
System reagent for the quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum on Beckman Coulter AU analyzers. For In Vitro Diagnostic use only.
Clinical Significance:
ß-2-Microglobulin occurs in serum, urine, cerebrospinal and other body fluids in low concentrations. Increased concentrations of ß2M in serum are found in patients with renal diseases (due to reduced glomerular filtration) and active rheumatoid arthritis.
7.0 Comparison to Predicate(s):
The following tables shows similarities and differences between the predicate identified in Section 4.0 of this summary.
| Test System | Predicate | Proposed Device |
|---|---|---|
| Proprietary | ||
| and | ||
| Established | ||
| Names | β 2-microglobulin | |
| (K991136) | Beta-2-Microglobulin | |
| Similarities | ||
| Intended use | System reagent for the | |
| quantitative determination of | ||
| β-2-Microglobulin | ||
| (β2M) in human serum on | ||
| OLYMPUS analyzers. | Similar | |
| System reagent for the | ||
| quantitative determination of β-2- | ||
| Microglobulin | ||
| (β2M) in human serum on Beckman | ||
| Coulter AU analyzers. | ||
| Instrument | ||
| Platforms | Olympus AU400, AU600, AU640 | |
| or AU1000 Chemistry analyzers | Similar | |
| Beckman Coulter analyzers | ||
| AU400/400°/480. | ||
| AU600/640/640°/680 and | ||
| AU2700/5400/AU5800 | ||
| Quality | ||
| Control | At least two levels of | |
| appropriate β-2-Microglobulin | ||
| control material such as Bio- | ||
| Rad Liquichek should be tested | ||
| a minimum of once a day. | Similar | |
| At least two levels of an appropriate | ||
| quality control material should be | ||
| tested a minimum of once a day. | ||
| Specificity | ||
| (Interferences) | AU400: | |
| Ascorbate: |