(29 days)
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.
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.
The provided text describes the Beckman Coulter Beta-2-Microglobulin reagent, but it does not contain information about a study proving that a device meets acceptance criteria in the context of AI/ML or medical imaging analysis.
The document is a 510(k) summary for an in vitro diagnostic reagent used to measure Beta-2-Microglobulin in human serum. This type of product is different from a "device" in the context of AI/ML, which typically refers to software or hardware that assists in diagnosis or treatment based on complex data analysis (like image interpretation).
Therefore, I cannot provide an answer based on the detailed requirements you outlined, such as multireader multidevice studies, expert adjudication for ground truth, or training set details, as these are not relevant to the type of product described in the input.
However, I can extract the acceptance criteria and performance data that are present for this specific reagent:
Acceptance Criteria and Reported Reagent Performance (for Beta-2-Microglobulin Reagent)
| Acceptance Criteria Category | Specific Metric (Criteria) | Reported Reagent Performance |
|---|---|---|
| Stability | Reagent On-Board Stability | 90 days |
| Calibration Frequency | 90 days | |
| Analytical Performance | Specificity (Interferences) | Within ± 10 % NSI for: - Ascorbate 20 mg/dL - Bilirubin 40 mg/dL - Hemolysis 500 mg/dL - Lipemia 500 mg/dL |
| Dynamic Range / Linearity | 0.05 - 1.6 mg/dL | |
| Precision Within Run | ≤ 5% CV | |
| Precision Total | ≤ 10% CV |
Further details from the document (as far as applicable):
- Sample size used for the test set and data provenance: Not explicitly stated as "test set" in the context of an AI device. For stability testing, "one reagent lot" was used. The document refers to "human serum" generally for the intended use and does not specify geographical origin or if it was retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for a reagent. The "ground truth" for a reagent's performance is typically established through analytical methods and comparison to existing validated methods or reference materials.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a reagent.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for an in vitro diagnostic reagent, not an AI medical device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For analytical performance (e.g., linearity, precision), analytical validation is the ground truth (e.g., comparing results to known concentrations, reference methods, or statistical limits). The document mentions "controls" and "calibration" as part of the stability testing.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable.
Study Proving Device Meets Acceptance Criteria:
The document describes a non-clinical study to demonstrate that the Beta-2-Microglobulin system reagent is as safe, effective, and performs as well as the predicate device.
- Study type: Analytical performance study, focusing on stability (on-board and calibration frequency).
- Methodology for Stability: "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."
- Conclusion: The tests established a 90-day reagent on-board claim and a 90-day calibration frequency claim, indicating the proposed device meets the stability performance of the predicate.
- Other performance characteristics (Specificity (Interferences), Dynamic Range / Linearity, Precision Within Run, Precision Total): The table states "Similar" for the proposed device compared to the predicate, implying that these characteristics were either demonstrated to be equivalent through testing or are inherent to the described technology and formulation which are similar to the predicate. Specific details of how these were proven beyond "similar" are not provided in this summary but would be in the full submission.
In summary, the provided document details the analytical performance and stability of a laboratory reagent, not an AI or imaging device, thus many of your specific questions are not applicable.
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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
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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 | DocketNumber |
|---|---|---|---|
| Beta-2-Microglobulin | β-2-Microglobulin | K991136 | OlympusAmerica Inc./BeckmanCoulter 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.
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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 |
|---|---|---|
| ProprietaryandEstablishedNames | β 2-microglobulin(K991136) | Beta-2-Microglobulin |
| Similarities | ||
| Intended use | System reagent for thequantitative determination ofβ-2-Microglobulin(β2M) in human serum onOLYMPUS analyzers. | SimilarSystem reagent for thequantitative determination of β-2-Microglobulin(β2M) in human serum on BeckmanCoulter AU analyzers. |
| InstrumentPlatforms | Olympus AU400, AU600, AU640or AU1000 Chemistry analyzers | SimilarBeckman Coulter analyzersAU400/400°/480. |
| AU600/640/640°/680 andAU2700/5400/AU5800 | ||
| QualityControl | At least two levels ofappropriate β-2-Microglobulincontrol material such as Bio-Rad Liquichek should be testeda minimum of once a day. | SimilarAt least two levels of an appropriatequality control material should betested a minimum of once a day. |
| Specificity(Interferences) | AU400:Ascorbate: <3% up to 20mg/dLAscorbateBilirubin: <3% up to 40 mg/dLBilirubinHemolysis:< 3% up to 500mg/dL HemolysateLipemia: <10% up to 500 mg/dLIntralipidAU600/AU640:Ascorbate: <3% up to 20mg/dLAscorbateBilirubin: <3% up to 40 mg/dLBilirubinHemolysis:< 3% up to 500mg/dL HemolysateLipemia: <3% up to 1000 mg/dLIntralipidAU1000:Ascorbate: <3% up to 20mg/dLAscorbateBilirubin: <3% up to 40 mg/dLBilirubinHemolysis:<4% up to 500mg/dL HemolysateLipemia: <4% up to 1000 mg/dLIntralipid | SimilarWithin ± 10 % NSI for thefollowing(NSI = No SignificantInterference)Ascorbate 20 mg/dLBilirubin 40 mg/dLHemolysis 500 mg/dLLipemia 500 mg/dL |
| SpecimenStorage andStability | Serum is the recommendedspecimen. Allow the sample toclot for 15-30 minutes at roomtemperature, then for 30 - 60minutes at 4°C. Centrifuge,separate the serum from theclot and store the serum inplastic tubes. Serum should be | SimilarLiterature referenceA fasting serum specimen, free fromhemolysis, is the recommendedspecimen. Avoid highly lipemicsamples, which may produce |
| stored in multiple aliquots toavoid thawing and refreezing. | excessively high scatter signals. | |
| Measurement | Quantitative | Same |
| Reagent | Liquid, ready to use | Same |
| Technology | Immunological test system | Same |
| OperatingPrinciple | Turbidimetric Method | Same |
| ReagentFormulation | Phosphate buffer, Latexparticles coated with rabbit IgGanti-β-2-Microglobulinantibodies, Polyethylene Glycol,also contains preservatives | Same |
| Sample Types | Serum | Same |
| ReagentStorage /Closed Shelflife | 2-8°C until expiration date | Same |
| Calibrator | Serum Protein Multi-calibrator 2(ODR3023) | Same |
| ReferenceInterval | 0.097 - 0.184 mg/dL | Same |
| ReagentMaterial:Antibodies | Rabbit IgG anti-β-2-Microglobulin antibodies | Same |
| ReagentMaterial:Buffer | Phosphate buffer | Same |
| DynamicRange /Linearity | 0.05 - 1.6 mg/dL | Same |
| PrecisionWithin Run | ≤ 5% CV | Same |
| PrecisionTotal | ≤ 10% CV | Same |
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Differences between the Predicate Device and the Proposed Device:
| Test System | Predicate | Proposed Device |
|---|---|---|
| Feature | β 2-microglobulin(K991136) | βeta-2-Microglobulin |
| Differences | ||
| ReagentOn-Board Stability | 60 days | 90 days |
| CalibrationFrequency | 14 days | 90 days |
8.0 Performance Characteristics - Analytical Performance
a. Stability: On-Board and Calibration Frequency
On-Board (OB) stability and calibration frequency testing was assessed in accordance with internal procedures. The aim was to establish a 90 day reagent onboard claim and a 90 day calibration frequency claim.
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, a 90-day calibration frequency claim was established.
9.0 Conclusion:
The conclusions drawn from the nonclinical tests (discussed above) demonstrate that the Beta-2-Microglobulin system reagent is as safe, as effective and performs as well as the predicate device. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
§ 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.