LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)

K961828 · Bio-Rad · JJT · Jun 11, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961828
• Device Name: LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
• Applicant: Bio-Rad
• Product Code: JJT · Clinical Chemistry
• Decision Date: Jun 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Cardiac Markers Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory’s specific cardiac marker procedures.

Device Story

Liquichek Cardiac Markers Control; liquid quality control serum; human serum base with human/non-human additives. Used in clinical laboratories by laboratory personnel to monitor precision of cardiac marker assays. Product serves as reference material to verify analytical performance of diagnostic testing procedures. Provides stability for 20 days at 2-8°C (10 days for Troponin T).

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence established through comparison of physical form, matrix, storage conditions, and stability performance.

Technological Characteristics

Liquid human serum matrix; additives of human and non-human origin. Storage: -10 to -20°C. Open vial stability: 20 days at 2-8°C (10 days for Troponin T).

Indications for Use

Indicated for use as an assayed quality control serum in clinical laboratories to monitor the precision of cardiac marker testing procedures. No specific patient population, age, or gender restrictions apply as this is an in vitro diagnostic control material.

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

• Liquichek CK/LD Isoenzyme Control (K903430)

Submission Summary (Full Text)

{0}

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

K961828

JUN 11 1996

## 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 8, 1996

**Device (Trade & Common Name)**
Liquichek Cardiac Markers Control

**Classification Name**
CFR 862.1660: Quality Control Material
(Assayed and Unassayed)

**Devices to Which Substantial Equivalence is Claimed**
Liquichek CK/LD Isoenzyme Control
Bio-Rad Laboratories, Anaheim, CA
K903430

**Statement of Intended Use**
Liquichek Cardiac Markers Control is intended for use as an assayed quality control serum to monitor the precision of an individual laboratory’s specific cardiac marker procedures.

35

{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 Cardiac Markers 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 Cardiac Markers Control and the devices to which substantial equivalence is claimed.

| | Bio-Rad Liquichek Cardiac Markers Control | Bio-Rad CK/LD Isoenzyme Control |
| --- | --- | --- |
| Intended Use | To monitor the precision of a laboratories specific cardiac markers procedures. | To monitor the precision of a laboratories CK (Creatine Kinase), LD (Lactate Dehydrogenase) and serum protein testing procedures. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Storage | -10 to -20°C | -10 to -20°C |
| Open Vial Claim | 20 Days at 2-8°C for all analytes; except Troponin T which is stable for 10 Days at 2-8°C | 10 Days at 2-8°C |