QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(

K964767 · R&D Systems, Inc. · JZG · May 29, 1997 · Immunology

Device Facts

• Record ID: K964767
• Device Name: QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
• Applicant: R&D Systems, Inc.
• Product Code: JZG · Immunology
• Decision Date: May 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5630
• Device Class: Class 2

Intended Use

The Quantikine IVD β₂-microglobulin EIA kit is intended for the quantitative determination of β₂ microglobulin concentration in human serum and urine as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases.

Device Story

Quantikine IVD β₂ microglobulin enzyme immunoassay (EIA) is a competitive binding assay for quantitative measurement of β₂ microglobulin in human serum and urine. Device utilizes colorimetric detection to determine concentration, serving as an aid in diagnosing active rheumatoid arthritis and kidney diseases. Intended for professional use in clinical laboratory settings. Performance relies on competitive binding between sample β₂ microglobulin and labeled analyte; signal intensity inversely proportional to concentration. Healthcare providers use quantitative results to assess disease activity or renal function. Benefits include standardized diagnostic support for specific inflammatory and renal conditions.

Clinical Evidence

Bench testing only. Performance attributes evaluated include accuracy, precision, and stability. Sensitivity reported as < 0.2 µg/mL. Precision (intra-assay) based on 10 replicates of three in-house controls typically < 8%. Acceptance criteria included specific absorbance thresholds for standards (Standard 0 > 1.5 AU; Standard 5 < 0.35 AU) and curve fitting requirements (replicates within ±10-15% of nominal values).

Technological Characteristics

Competitive binding enzyme immunoassay (EIA). Colorimetric detection method. Form factor: kit-based reagents. Storage requirements: 2-8°C. Shelf life: 26 weeks. Reagent stability: 4 weeks after opening/dilution.

Indications for Use

Indicated for quantitative determination of β₂ microglobulin in human serum and urine to aid in diagnosis of active rheumatoid arthritis and kidney diseases.

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

• Pharmacia’s β₂ Micro RIA

Submission Summary (Full Text)

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MAY 29 1997
K 964767

# 510(k) Summary

## Quantikine™ IVD™ β₂ microglobulin enzyme immunoassay

| Date of Summary: | November 27, 1996 |
| --- | --- |
| Company Name: | R&D Systems, Inc.
614 McKinley Place N.E.
Minneapolis, MN 55413 |
| Contact name: | Kenneth T. Edds, Ph.D.
612-379-2956, FAX [phone] |
| Classification name: | β₂ microglobulin immunological test system |
| Product name: | Quantikine IVD β₂ microglobulin enzyme immunoassay |
| CFR section: | 866.5630 |
| Device Class: | Class II |

Device to which substantial equivalence is claimed:
Pharmacia’s β₂ Micro RIA currently being marketed by Pharmacia Diagnostics, Fairfield, N.J. 07006.

The product is a competitive binding enzyme immunoassay (EIA) for β₂ microglobulin.

It is intended for the quantitative determination of β₂ microglobulin concentration in human serum and urine as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases.

R&amp;D Systems’ Quantikine IVD β₂-microglobulin enzyme immunoassay has an intended use that is similar to the predicate device. The technologies of the two devices are similar in that both are competitive binding based assays. They differ in the “reporter” moiety attached to assayed molecule. R&amp;D System’s assay is colorimetric and Pharmacia’s is radiometric.

Nonclinical testing centered on the performance attributes of accuracy, precision and stability. In addition to demonstrating acceptable performance for the above attributes Quantikine IVD β₂-microglobulin enzyme immunoassay passed the additional acceptance criteria that all parameters met their individual specifications. Those criteria are:

1. Signal generated by standard 0 to be greater than 1.5 absorbance units
2. Signal generated by standard 5 to be less than 0.35 absorbance units
3. Curve fitting - individual replicates of Standard 1 to fit within ±15% of nominal value and the Mean value of Standard 1 to fit within ±10% of nominal value. Individual replicates and Mean values of Standards 2 -5 to fit within ±10% of nominal value.
4. In house control and kit control values to be within the ranges quoted on the appropriate control data sheets.

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5) Sensitivity to be less than 0.2 µg/mL.
6) Precision - based on 10 replicates of three in-house controls, to be typically less than 8%.

All other performance parameters were similar to the predicate device. Expiration dating has been established as 26 weeks when stored at 2-8°C and handled according to instructions for use. Opened or diluted reagents are good for up to 4 weeks when stored at 2-8°C provided that this is within the expiration date.

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DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

MAY 29 1997

Kenneth T. Edds, Ph.D.
Regulatory Affairs
R&amp;D Systems, Inc.
614 McKinley Place N.E.
Minneapolis, Minnesota 55413

Re: K964767/S1
Trade Name: β₂ Microglobulin Immunological Test System
Regulatory Class: II
Product Code: JZG
Dated: March 24, 1997
Received: March 25, 1997

Dear Dr. Edds:

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 submission 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 [phone].

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

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

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510(k) Number: K964767

Device Name: Quantikine™ IVD™ β₂ Microglobulin Enzyme Immunoassay Kit

Indications for Use: The Quantikine IVD β₂-microglobulin EIA kit is intended for the quantitative determination of β₂ microglobulin concentration in human serum and urine as an aid in the diagnosis of active rheumatoid arthritis and kidney diseases.


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