LIQUICHEK RHEUMATOID FACTOR CONTROL

K960987 · Bio-Rad · DHR · Jun 4, 1996 · Immunology

Device Facts

• Record ID: K960987
• Device Name: LIQUICHEK RHEUMATOID FACTOR CONTROL
• Applicant: Bio-Rad
• Product Code: DHR · Immunology
• Decision Date: Jun 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory’s rheumatoid factor testing methodologies.

Device Story

Liquichek Rheumatoid Factor Control; human serum-based quality control material; used to monitor precision of laboratory rheumatoid factor testing methodologies; provides trilevel product for multi-point calibration/verification; stored at 2-8°C; used by laboratory personnel to ensure assay performance; assists in clinical decision-making by validating test accuracy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Human serum matrix; trilevel product configuration; storage at 2-8°C. No specific materials or software algorithms described.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of rheumatoid factor testing methodologies in clinical laboratory settings.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

Predicate Devices

• Liquichek Rheumatoid Factor Control (K923578)

Submission Summary (Full Text)

{0}

BIO-RAD
Bio-Rad Laboratories
ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
Telephone [phone]
Toll Free [phone]

# 510(k) Summary

K960987
JUN - 4 1996

## Submitter
Bio-Rad Laboratories, ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
[phone]
Fax [phone]

## Contact Persons
Elizabeth Platt

## Date of Summary Preparation
May 2, 1996

## Device (Trade & Common Name)
Liquichek Rheumatoid Factor Control

## Classification Name
Class II
CFR 866.5775, Rheumatoid Factor Immunological Test System
82DHR

## Devices to Which Substantial Equivalence is Claimed
Liquichek Rheumatoid Factor Control
K923578

## Statement of Intended Use
Liquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory’s rheumatoid factor testing methodologies.

## Description of the Device
Liquichek Rheumatoid Factor Control is prepared from human serum with added constituents of human origin.

{1}

BIO-RAD
Bio-Rad Laboratories
ECS Division
3726 E. Miratoma Avenue
Anaheim, CA 92806
Telephone [phone]
Toll Free [phone]

# Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the technological characteristics between Liquichek Rheumatoid Factor Control and the original device to which substantial equivalence is claimed.

| | Liquichek Rheumatoid Factor Control (original submission) | Liquichek Rheumatoid Factor Control (additional information submitted in 1996) |
| --- | --- | --- |
| Intended Use | assayed control for rheumatoid factor testing methodologies | assayed control for rheumatoid factor testing methodologies |
| Matrix | Human Serum | Human Serum |
| Product Levels | single level product | trilevel level product (two additional levels added) |
| Storage | 2-8°C | 2-8°C |