LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363

K961941 · Bio-Rad · JJY · Sep 16, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961941
• Device Name: LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of a laboratory testing procedures for the analytes listed in this package insert.

Device Story

Liquichek Immunoassay Plus Control; liquid-form quality control serum; derived from human serum with added human/non-human constituents. Used in clinical laboratories to monitor precision of immunoassay testing procedures. Provides known concentration samples to verify assay performance. Healthcare providers use results to assess analytical stability and precision of laboratory testing; ensures reliability of patient diagnostic results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid-form control; matrix: human serum with added human/non-human constituents. Storage: -10 to -20°C; open vial stability: 14 days at 2-8°C (7 days for folate).

Indications for Use

Indicated for use as an assayed quality control serum to monitor precision of laboratory testing procedures for specified analytes in clinical settings.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Tri-Point Liquimmune Control (K954322)

Submission Summary (Full Text)

{0}

BIO-RAD
Bio-Rad Laboratories
SEP 16 1996
ECS Division
3726 E. Miraloma Avenue
Anaheim, CA 92806
Telephone [phone]
Toll Free [phone]
K 96/541

# 510(k) Summary

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

## Contact Person
Elizabeth Platt

## Date of Summary Preparation
May 17, 1996

## Device (Trade & Common Name)
Liquichek Immunoassay Plus Control

## Classification Name
CFR 862.1660: Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

## Devices to Which Substantial Equivalence is Claimed
Tri-Point Liquimmune Control
Medical Analysis Systems, Inc.
Camarillo, CA
K954322

## Statement of Intended Use
Liquichek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of a laboratory testing procedures for the analytes listed in this package insert.

49

{1}

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

## Description of the Device

Liquichek Immunoassay Plus Control is prepared from human serum with added constituents of human and non-human origin. The control is provided in liquid form for convenience.

## Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Bio-Rad Liquichek Immunoassay Plus Control and the devices to which substantial equivalence is claimed.

| | Bio-Rad Liquichek Immunoassay Plus Control | MAS Tri-Point Liquimmune Control |
| --- | --- | --- |
| Intended Use | To monitor the precision of a laboratory testing procedures for the analytes listed in the package insert. | A consistent test sample of known concentration for monitoring assay conditions in many immunological determinations. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Customer Storage | 1) -10 to -20°C;
2) 30 days at 2-8°C for all analytes except folate and T3Total which are stable for 14 days | 1) 90 Days from receipt at 2-8°C |
| Open Vial Claim | 14 Days at 2-8°C for all analytes; except Folate which is stable for 7 Days at 2-8°C | 30 Days at 2-8°C |