QUANTEX C3

K962199 · Instrumentation Laboratory CO · CZW · Sep 25, 1996 · Immunology

Device Facts

• Record ID: K962199
• Device Name: QUANTEX C3
• Applicant: Instrumentation Laboratory CO
• Product Code: CZW · Immunology
• Decision Date: Sep 25, 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 3 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C3 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 C3.

Device Story

Turbidimetric immunoassay for quantitative C3 determination in serum/plasma; utilizes anti-human C3 reagent and buffer on ILab Clinical Chemistry System. Used in clinical laboratory settings by trained personnel. Output is quantitative C3 concentration; aids clinicians in diagnosing immunologic disorders and C3 deficiencies.

Clinical Evidence

Bench-only; method comparison study of 50 serum samples comparing quantex C3 on ILab system vs. IL Test™ C3 on Monarch system. Correlation coefficient (r) = 0.9842.

Technological Characteristics

Turbidimetric immunoassay; reagents include anti-human C3 and buffer. Designed for use on ILab Clinical Chemistry System. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for quantitative in vitro diagnostic determination of Complement 3 (C3) in serum and plasma to aid in the diagnosis of immunologic disorders associated with C3 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™ C3 (K920007/B)

Submission Summary (Full Text)

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# SECTION 3
quantex C3 - 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 C3:
8 x 6 mL anti-human C3 P/N 3000-22136
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™ C3 #K920007/B

## Description of the device/intended use(s):
This product permits the quantitative *in vitro* diagnostic determination of Complement 3 in serum and plasma on the ILab Clinical Chemistry System by turbidimetric immunoassay method. C3 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 C3.

## Statement of how the Technological Characteristics of the Device compare to the Predicate device:
Biokit’s quantex C3 is substantially equivalent in performance, intended use, safety and effectiveness to the predicate, IL Test™ C3 -- 510(k) #K920007/B.

## Summary of Performance Data:
A comparative performance study was performed with IL Test™ C3 on a Monarch Clinical Chemistry System and Biokit’s quantex C3 on an ILab Clinical Chemistry System. Method comparison studies evaluated C3 levels of fifty serum samples on the respective instruments. The correlation $(r)$ in these studies was 0.9842.

Section 3
quantex C3 510(k)
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