QUANTEX IGG

K962202 · Instrumentation Laboratory CO · DEW · Sep 26, 1996 · Immunology

Device Facts

• Record ID: K962202
• Device Name: QUANTEX IGG
• Applicant: Instrumentation Laboratory CO
• Product Code: DEW · Immunology
• Decision Date: Sep 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5510
• Device Class: Class 2

Intended Use

This product permits the quantitative in vitro diagnostic determination of Immunoglobulin G in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgG 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 determination of Immunoglobulin G (IgG) in serum and plasma; performed on ILab Clinical Chemistry System. Reagents include anti-human IgG and buffer. Used in clinical laboratory settings by trained personnel. Output provides quantitative IgG concentration levels; assists clinicians in diagnosing protein metabolism disorders and immune system function. Results interpreted by healthcare providers to assess patient ability to resist infectious agents.

Clinical Evidence

Method comparison study using 47 serum samples; compared Biokit quantex IgG on ILab Clinical Chemistry System vs. IL Test™ IgG on Monarch Clinical Chemistry System. Correlation coefficient (r) = 0.9644.

Technological Characteristics

Turbidimetric immunoassay reagent kit; includes anti-human IgG and buffer. Designed for use on ILab Clinical Chemistry System. Quantitative measurement principle based on light scattering/turbidity.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of Immunoglobulin G in serum and plasma to aid in diagnosis of abnormal protein metabolism and immune deficiency in patients.

Regulatory Classification

Identification

An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Predicate Devices

• IL Test™ IgG (K920006/B)

Submission Summary (Full Text)

{0}

# SECTION 3

## quantex IgG - 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]


SEP 26 1996

### Contact Person:
Betty Lane
phone [phone]

### Summary Prepared:
May 29, 1996

### Name of the device:
quantex IgG: 8 x 6 mL anti-human IgG P/N 3000-22134
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™ IgG #K920006/B

### Description of the device/intended use(s):
This product permits the quantitative *in vitro* diagnostic determination of Immunoglobulin G in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgG 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 IgG is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ IgG -- 510(k) #K920006/B.

### Summary of Performance Data:
A comparative performance study was performed with IL Test™ IgG on a Monarch Clinical Chemistry System and Biokit’s quantex IgG on an ILab Clinical Chemistry System. Method comparison studies evaluated IgG levels of forty-seven serum samples on the respective instruments. The correlation $(r)$ in these studies was 0.9644.

Section 3
quantex IgG 510(k)
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