QUANTEX IGA

K962200 · Instrumentation Laboratory CO · CZP · Sep 25, 1996 · Immunology

Device Facts

• Record ID: K962200
• Device Name: QUANTEX IGA
• Applicant: Instrumentation Laboratory CO
• Product Code: CZP · Immunology
• Decision Date: Sep 25, 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 A in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgA 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 IgA determination in serum/plasma; utilizes ILab Clinical Chemistry System; reagent kit includes anti-human IgA and buffer; used in clinical laboratory settings by trained personnel; provides quantitative IgA concentration values; aids clinicians in assessing protein metabolism and immune function.

Clinical Evidence

Bench testing only. Method comparison study evaluated 45 serum samples comparing quantex IgA on ILab system vs. IL Test™ IgA on Monarch system. Correlation coefficient (r) = 0.9905.

Technological Characteristics

Turbidimetric immunoassay; reagents include anti-human IgA and buffer; designed for use on ILab Clinical Chemistry System; quantitative measurement principle.

Indications for Use

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

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™ IgA (K920014/B)

Submission Summary (Full Text)

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# SECTION 3

## quantex IgA - 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]

*K962200*

**SEP 26 1996**

**Contact Person:**

Betty Lane
phone [phone]

**Summary Prepared:**

May 29, 1996

**Name of the device:**

quantex IgA:
8 x 6 mL anti-human IgA P/N 3000-22133
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™ IgA #K920014/B

**Description of the device/intended use(s):**

This product permits the quantitative *in vitro* diagnostic determination of Immunoglobulin A in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. Measurement of IgA 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 IgA is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ IgA -- 510(k) #K920014/B.

**Summary of Performance Data:**

A comparative performance study was performed with IL Test™ IgA on a Monarch Clinical Chemistry System and Biokit’s quantex IgA on an ILab Clinical Chemistry System. Method comparison studies evaluated IgA levels of forty-five serum samples on the respective instruments. The correlation $(r)$ in these studies was 0.9905.

Section 3
quantex IgA 510(k)
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