← Product Code [CZW](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW) · K962199

# QUANTEX C3 (K962199)

_Instrumentation Laboratory CO · CZW · Sep 25, 1996 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K962199

## Device Facts

- **Applicant:** Instrumentation Laboratory CO
- **Product Code:** [CZW](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW.md)
- **Decision Date:** Sep 25, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5240
- **Device Class:** Class 2
- **Review Panel:** Immunology

## 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.

## Regulatory 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](/device/K920007.md)/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 (617) 861-4182
fax (617) 861-4464

![img-0.jpeg](img-0.jpeg)

## Contact Person:
Betty Lane
phone (617) 861-4182

## 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)
Page 1 of 1

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K962199](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/CZW/K962199)

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