Beta-2-Microglobulin

K161297 · Beckman Coulter Ireland, Inc. · JZG · Jun 7, 2016 · Immunology

Device Facts

• Record ID: K161297
• Device Name: Beta-2-Microglobulin
• Applicant: Beckman Coulter Ireland, Inc.
• Product Code: JZG · Immunology
• Decision Date: Jun 7, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Intended Use

The βeta-2-Microglobulin assay is an in vitro diagnostic test for the quantitative determination of βeta-2-microglobulin in human serum and urine. Measurement of βeta-2-microglobulin is used in the diagnosis and management of renal impairment and in the assessment of renal tubular function.

Device Story

In vitro diagnostic assay; measures βeta-2-microglobulin levels in human serum and urine; used by clinical laboratory personnel; provides quantitative results to clinicians for renal function assessment; modification involves updated on-board stability claims and calibration frequency; fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

Bench testing only; verification and validation activities performed to assess impact of stability and calibration frequency changes; no clinical data required for this modification.

Technological Characteristics

Liquid, ready-to-use reagent kit. Principle: Immunoturbidimetric assay. Reagents: Phosphate buffer, latex particles coated with rabbit IgG anti-ß-2-Microglobulin antibodies, Polyethylene Glycol, preservatives. Form factor: 4x10mL R1 and 4x8mL R2 vials. Compatible with Beckman Coulter AU series analyzers. Calibration: Serum Protein Multi-calibrator 2.

Indications for Use

Indicated for the quantitative determination of ß-2-Microglobulin (ß-2-M) in human serum to aid in the assessment of patients with renal diseases or active rheumatoid arthritis.

Regulatory Classification

Identification

A beta-2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques beta-2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement of beta-2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

Special Controls

*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.

Predicate Devices

• ß-2-Microglobulin (K991136)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------|
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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: [phone] Fax: [phone] Email: [e-mail]

#### 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<br>Number |
|----------------------|-------------------|--------------|-----------------------------------------------------|
| Beta-2-Microglobulin | β-2-Microglobulin | K991136 | Olympus<br>America Inc./<br>Beckman<br>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.

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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 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary<br>and<br>Established<br>Names | β 2-microglobulin<br>(K991136) | Beta-2-Microglobulin |
| Similarities | | |
| Intended use | System reagent for the<br>quantitative determination of<br>β-2-Microglobulin<br>(β2M) in human serum on<br>OLYMPUS analyzers. | Similar<br>System reagent for the<br>quantitative determination of β-2-<br>Microglobulin<br>(β2M) in human serum on Beckman<br>Coulter AU analyzers. |
| Instrument<br>Platforms | Olympus AU400, AU600, AU640<br>or AU1000 Chemistry analyzers | Similar<br>Beckman Coulter analyzers<br>AU400/400°/480. |
| | | AU600/640/640°/680 and<br>AU2700/5400/AU5800 |
| Quality<br>Control | At least two levels of<br>appropriate β-2-Microglobulin<br>control material such as Bio-<br>Rad Liquichek should be tested<br>a minimum of once a day. | Similar<br>At least two levels of an appropriate<br>quality control material should be<br>tested a minimum of once a day. |
| Specificity<br>(Interferences) | AU400:<br>Ascorbate: <3% up to 20mg/dL<br>Ascorbate<br>Bilirubin: <3% up to 40 mg/dL<br>Bilirubin<br>Hemolysis:< 3% up to 500<br>mg/dL Hemolysate<br>Lipemia: <10% up to 500 mg/dL<br>Intralipid<br>AU600/AU640:<br>Ascorbate: <3% up to 20mg/dL<br>Ascorbate<br>Bilirubin: <3% up to 40 mg/dL<br>Bilirubin<br>Hemolysis:< 3% up to 500<br>mg/dL Hemolysate<br>Lipemia: <3% up to 1000 mg/dL<br>Intralipid<br>AU1000:<br>Ascorbate: <3% up to 20mg/dL<br>Ascorbate<br>Bilirubin: <3% up to 40 mg/dL<br>Bilirubin<br>Hemolysis:<4% up to 500<br>mg/dL Hemolysate<br>Lipemia: <4% up to 1000 mg/dL<br>Intralipid | Similar<br>Within ± 10 % NSI for the<br>following(NSI = No Significant<br>Interference)<br>Ascorbate 20 mg/dL<br>Bilirubin 40 mg/dL<br>Hemolysis 500 mg/dL<br>Lipemia 500 mg/dL |
| Specimen<br>Storage and<br>Stability | Serum is the recommended<br>specimen. Allow the sample to<br>clot for 15-30 minutes at room<br>temperature, then for 30 - 60<br>minutes at 4°C. Centrifuge,<br>separate the serum from the<br>clot and store the serum in<br>plastic tubes. Serum should be | Similar<br>Literature reference<br>A fasting serum specimen, free from<br>hemolysis, is the recommended<br>specimen. Avoid highly lipemic<br>samples, which may produce |
| | stored in multiple aliquots to<br>avoid thawing and refreezing. | excessively high scatter signals. |
| Measurement | Quantitative | Same |
| Reagent | Liquid, ready to use | Same |
| Technology | Immunological test system | Same |
| Operating<br>Principle | Turbidimetric Method | Same |
| Reagent<br>Formulation | Phosphate buffer, Latex<br>particles coated with rabbit IgG<br>anti-β-2-Microglobulin<br>antibodies, Polyethylene Glycol,<br>also contains preservatives | Same |
| Sample Types | Serum | Same |
| Reagent<br>Storage /<br>Closed Shelf<br>life | 2-8°C until expiration date | Same |
| Calibrator | Serum Protein Multi-calibrator 2<br>(ODR3023) | Same |
| Reference<br>Interval | 0.097 - 0.184 mg/dL | Same |
| Reagent<br>Material:<br>Antibodies | Rabbit IgG anti-β-2-<br>Microglobulin antibodies | Same |
| Reagent<br>Material:<br>Buffer | Phosphate buffer | Same |
| Dynamic<br>Range /<br>Linearity | 0.05 - 1.6 mg/dL | Same |
| Precision<br>Within Run | ≤ 5% CV | Same |
| Precision<br>Total | ≤ 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<br>(K991136) | βeta-2-Microglobulin |
| Differences | | |
| Reagent<br>On-Board Stability | 60 days | 90 days |
| Calibration<br>Frequency | 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.