MADx REF 31-0800-02 Quality Xplorer RUO Instructions

MADx REF 31-0800-02 Quality Xplorer RUO

Product Information

Specifications

• Product Name: QualityXplorer (RUO)
• Basic UDI-DI: 91201229231JX
• REF: 31-0800-02

Product Usage Instructions

Description

• This Instruction for Use applies to the QualityXplorer product.

Intended Purpose

• For correct use, carefully read and follow the instructions provided. The manufacturer holds no liability for improper use or modifications.

Shipment and Storage

• QualityXplorer is intended for one determination per vial. Spin down the liquid before opening. Use immediately after opening for analysis.

Waste Disposal

• Dispose of used samples with laboratory chemical waste following disposal regulations.

Glossary of Symbols

• Includes symbols and meanings for reference during usage.

Reagents and Material

• The QualityXplorer includes reagents stored separately with expiration dates and storage temperatures indicated on the label.

Warnings and Precautions

• Wear protective gear and follow good laboratory practices when handling reagents and samples. Treat all human source material as potentially infectious.

Frequently Asked Questions

Can the QualityXplorer be used multiple times?

No, the QualityXplorer is intended for single-use per vial.

What should I do if the kit components are damaged upon delivery?

If any component is damaged, do not use it as it may affect kit performance. Contact MADx or your distributor for assistance.

DESCRIPTION

The QualityXplorer is a product for research use only (RUO) and is to be used as quality control for monitoring specified limits (process control charts) in combination with the ALEX² test procedure.

This Instruction for Use is applicable to the following product:

INTENDED PURPOSE

• The QualityXplorer is a product for research use only (RUO) to examine and monitor the processing of ALEX² Allergy Xplorer.
• The product contains a mixture of antibodies that react with defined allergens on the ALEX² Allergy Xplorer and is used by trained laboratory staff.

Important information for users!

• For the correct use of the QualityXplorer, it is necessary for the user to carefully read and follow these instructions for use.
• The manufacturer assumes no liability for any use of this product that is not described in this document or for modifications by the user of the product.

SHIPMENT AND STORAGE

• The shipment of the QualityXplorer takes place at ambient temperature conditions. Nevertheless, the QualityXplorer must be stored, after spinning down the liquid, in an upright position immediately upon delivery at 2-8°C.
• Stored correctly it can be used until the indicated expiration date.
• The QualityXplorer is only intended for one determination per vial. Before opening, briefly spin down the liquid in the vials. After opening the vials, they are to be used immediately for analysis.
• The human blood components used in the manufacture of the QualityXplorer have been tested and found negative for HBsAg, HCV, and antibodies to the HI virus.

WASTE DISPOSAL

• Dispose of the used QualityXplorer sample with laboratory chemical waste. Follow all national, state, and local regulations regarding disposal.

GLOSSARY OF SYMBOLS

| For Research Use Only
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| Catalog number
| Sufficient for tests
| Indicates a control material that is intended to verify the results in the expected positive range
| Do not use if packaging is damaged
| Batch code
| Consult instructions for use
| Manufacturer
| Do not re-use
| Use-by date
---|---
| Temperature limit
| Important note
| MacroArray Diagnostics (MADx)

REAGENTS AND MATERIAL

• The QualityXplorer is packaged separately. The expiration date and storage temperature are indicated on the label. The reagents are not to be used after their expiry date.
• The use of the QualityXplorer is not batch-dependent and can therefore be used independently of the ALEX² Kit batch used.

Ready to use. Store at 2-8°C until expiry date.

• The composition of the QualityXplorer and the corresponding acceptance intervals of the individual antibodies are stored in the RAPTOR SERVER Analysis Software for each lot of the QualityXplorer.
• Using the QC module in RAPTOR SERVER Analysis Software, the results of the QualityXplorer measurements can be displayed in tabular or graphical form.
• After a minimum number of measurements (e.g. 20 measurements), instrument-specific intervals (2 and 3 standard deviations) can be displayed via the QC module in RAPTOR SERVER Analysis Software.
• In this way, the laboratory-specific intervals for each allergen can be determined more precisely.

WARNINGS AND PRECAUTIONS

• It is recommended to wear hand and eye protection as well as lab coats and follow good laboratory practices (GLP) when preparing and handling reagents and samples.
• In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions as patient samples.
• The starting material is partially prepared from human blood sources. The product was tested non-reactive for Hepatitis B Surface Antigen (HBsAg), antibodies to Hepatitis C (HCV), and antibodies to HIV-1 and HIV-2.
• The reagents are for research use only (RUO). They are not to be used for internal or external use in humans or animals.
• Upon delivery, the containers must be checked for damage. If any component is damaged (e.g., buffer container), please contact MADx (support@madx.com) or your local distributor.
• Do not use damaged kit components, this may affect kit performance.
• Do not use expired kit components.

WARRANTY

• The herein presented performance data were obtained using the procedure outlined in this Instructions for Use. Any change or modification in the procedure may affect the results and MacroArray Diagnostics disclaims all warranties expressed (including the implied warranty of merchantability and fitness for use) in such an event. Consequently, MacroArray Diagnostics and its local distributors shall not be liable for damages indirect or consequential in such an event.
• © Copyright by MacroArray Diagnostics
• MacroArray Diagnostics (MADx)
• Lemböckgasse 59, Top 4
• 1230 Vienna, Austria
• +43 (0)1 865 2573
• www.madx.com
• Version number: 31-IFU-02-EN-04
• Released: 06-2024
• MacroArray Diagnostics · Lemböckgasse 59, Top 4 · 1230 Vienna · madx.com · CRN 448974 g

CHANGE HISTORY

Chapter 2: Intended Purpose instead of Intended Use; Address updated acc. ÄA_01022023; URL changed to madx.com; Change history added

| 3.0

• MacroArray Diagnostics
• Lemböckgasse 59, Top 4
• 1230 Vienna
• madx.com
• CRN 448974 g
• www.madx.com

Documents / Resources

| MADx REF 31-0800-02 Quality Xplorer RUO [pdf] Instructions
Basic UDI-DI 91201229231JX, REF 31-0800-02, REF 31-0800-02 Quality Xplorer RUO, REF 31-0800-02, Quality Xplorer RUO, Xplorer RUO, RUO
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