QUANTEX C4

K962198 · Instrumentation Laboratory CO · DBI · Sep 26, 1996 · Immunology

Device Facts

• Record ID: K962198
• Device Name: QUANTEX C4
• Applicant: Instrumentation Laboratory CO
• Product Code: DBI · Immunology
• Decision Date: Sep 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

This product permits the quantitative in vitro diagnostic determination of Complement 4 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C4 is one of a group of serum proteins which destroy infectious agents. Measurement of this protein aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of C4.

Device Story

Turbidimetric immunoassay for quantitative C4 determination in serum/plasma; performed on ILab Clinical Chemistry System. Input: patient serum/plasma samples. Principle: antigen-antibody reaction causing turbidity proportional to C4 concentration. Output: quantitative C4 levels. Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in diagnosing immunologic disorders and C4 deficiencies.

Clinical Evidence

Method comparison study; 38 serum samples; compared quantex C4 on ILab system vs. IL Test™ C4 on Monarch system. Correlation coefficient (r) = 0.9791.

Technological Characteristics

Turbidimetric immunoassay; reagents include anti-human C4 and buffer. Designed for use on ILab Clinical Chemistry System. Quantitative measurement of serum proteins.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of Complement 4 (C4) in serum and plasma to aid in diagnosis of immunologic disorders associated with C4 deficiencies.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Predicate Devices

• IL Test™ C4 (K920010/B)

Submission Summary (Full Text)

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# SECTION 3

## quantex C4 - 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]

*K962198*

**SEP 26 1996**

**Contact Person:**

Betty Lane
phone [phone]

**Summary Prepared:**

May 29, 1996

**Name of the device:**

quantex C4:
8 x 6 mL anti-human C4 P/N 3000-22137
2 x 100 mL Buffer P/N 3000-22130

**Classification name(s):**

866.5240 Complement components immunological test systems Class II

**Identification of predicate device(s):**

IL Test™ C4 #K920010/B

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

This product permits the quantitative *in vitro* diagnostic determination of Complement 4 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C4 is one of a group of serum proteins which destroy infectious agents. Measurement of this protein aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of C4.

**Statement of how the Technological Characteristics of the Device compare to the Predicate device:**

Biokit’s quantex C4 is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ C4 -- 510(k) #K920010/B.

**Summary of Performance Data:**

A comparative performance study was performed with IL Test™ C4 on a Monarch Clinical Chemistry System and Biokit’s quantex C4 on an ILab Clinical Chemistry System. Method comparison studies evaluated C4 levels of thirty-eight serum samples on the respective instruments. The correlation $(r)$ in these studies was 0.9791.

Section 3
quantex C4 510(k)
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