QUANTEX IGM

K962201 · Instrumentation Laboratory CO · DFT · Sep 25, 1996 · Immunology

Device Facts

• Record ID: K962201
• Device Name: QUANTEX IGM
• Applicant: Instrumentation Laboratory CO
• Product Code: DFT · Immunology
• Decision Date: Sep 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

This product permits the quantitative in vitro diagnostic determination of Immunoglobulin M in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents.

Device Story

Turbidimetric immunoassay for quantitative IgM determination in serum/plasma; utilizes ILab Clinical Chemistry System. Reagents include anti-human IgM and buffer. Used in clinical laboratory settings by trained personnel. Output provides IgM concentration levels; assists clinicians in diagnosing protein metabolism disorders and immune system function. Benefits include standardized, automated quantification of IgM levels for clinical assessment.

Clinical Evidence

Bench testing only. Comparative performance study evaluated 48 serum samples using subject device on ILab Clinical Chemistry System versus predicate on Monarch Clinical Chemistry System. Correlation coefficient (r) reported as 0.9912.

Technological Characteristics

Turbidimetric immunoassay; reagents include anti-human IgM and buffer. Designed for use on ILab Clinical Chemistry System. No specific materials or software algorithms described.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of Immunoglobulin M in serum and plasma to aid in diagnosis of abnormal protein metabolism and immune resistance to infectious agents.

Regulatory Classification

Identification

An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Predicate Devices

• IL Test™ IgM (K920008/B)

Submission Summary (Full Text)

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# SECTION 3
quantex IgM - 510(k) SUMMARY
(Summary of Safety and Effectiveness)

## Submitted by:
Betty Lane
Director, Regulatory Affairs
Instrumentation Laboratory Company
113 Hartwell Avenue
Lexington, MA 02173
phone [phone]
fax [phone]


## Contact Person:
Betty Lane
phone [phone]

## Summary Prepared:
May 29, 1996

## Name of the device:
quantex IgM:
8 x 6 mL anti-human IgM P/N 3000-22135
2 x 100 mL Buffer P/N 3000-22130

## Classification name(s):
866.5510 Immunoglobulins A, G, M, D and E immunological test systems Class II

## Identification of predicate device(s):
IL Test™ IgM #K920008/B

## Description of the device/intended use(s):
This product permits the quantitative *in vitro* diagnostic determination of Immunoglobulin M in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body’s lack of ability to resist infectious agents.

## Statement of how the Technological Characteristics of the Device compare to the Predicate device:
Biokit’s quantex IgM is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ IgM -- 510(k) #K920008/B.

## Summary of Performance Data:
A comparative performance study was performed with IL Test™ IgM on a Monarch Clinical Chemistry System and Biokit’s quantex IgM on an ILab Clinical Chemistry System. Method comparison studies evaluated IgM levels of forty-eight serum samples on the respective instruments. The correlation $(r)$ in these studies was 0.9912.

Section 3
quantex IgM 510(k)
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