【Case Study】Colloidal Gold Immunochromatography Reader Registration in China

1. Introduction

Product Name: colloidal gold test paper reader, colloidal gold immunochromatography reader, lateral flow immunoassay analyzer, gold standard detector, immunoassay instrument, gold standard reader, etc.

Related Products: supporting reagents, usually XX test reagents/test papers (colloidal gold method)

Range of Application: This product is suitable for qualitative/semi-quantitative/quantitative interpretation of sample results by measuring the reflectance of the strips in the reaction zone of the colloidal gold reagent card in a medical laboratory. Other similar products can also be used for rapid immunoassays using fluorescent labels or other labeling methods.

Working Principle: The colloidal gold reader is an instrument for interpreting the results of the colloidal gold reagent card test. The reagent card to be detected is placed in the instrument, and the reflectivity characteristic of the detection reagent card is converted into a photoelectric signal by the sensor, and the photoelectric signal is converted into a corresponding concentration value by the calibration curve information, and the object to be tested is analyzed. Colloidal gold analyzers can be divided into three types according to different light sensors: CCD (Charge Coupled Device), CMOS (Complementary Metal Oxide Semiconductor), and photodiode.

Typical Structure: Generally composed by the host (including photoelectric detection module, mechanical scanning control module, control board module, liquid crystal display module, housing, etc.), information acquisition module (such as: 2D barcode scanner, IC chip reader), power supply, random software, etc.

Product Type:

1) According to the size of the device can be divided into desktop devices, portable (handheld) devices

2) According to the type of power supply, it is divided into internal power supply and network power supply equipment.

3) According to the number of simultaneous tests, it can be divided into multi-channel devices and single-channel devices.

4) According to the test performance can be divided into qualitative, semi-quantitative or quantitative equipment

Desktop multi-channel,Desktop single-channel,Portable

     Desktop multi-channel        Desktop single-channel               Portable

Product Features:

1) The sample processing method is simple, the reagent usage method is simple, and the instrument operation process is simple.

2) The operating environment is low in requirements and fast in response, and POCT (Point-Of-Care Testing) can be realized.

3) Due to the limitations of reagent technology, the quasi-determination and sensitivity of the product are not as high as those of chemiluminescence.

2. Classification

Classification Code: 22-04-04 Class II immunochromatographic analysis instrument

Product Description: It usually consists of photoelectric detection module, mechanical scanning control module, control board module, information acquisition module and so on. The principle is generally that the reflectance signal of the detection reagent card is converted into a photoelectric signal by a sensor, and the photoelectric signal is converted into a corresponding concentration value or threshold value by the calibration information, and the object to be tested is analyzed.

Expected Usage: Used in conjunction with an adaptation reagent for qualitative and/or quantitative analysis of the analyte in a human sample.

3. Registration Unit

In principle, the registration unit of the colloidal gold reader is based on the technical principle, structural composition, performance index and applicable scope.

1) Different signal acquisition principles should be considered into different registration units, such as CCD, CMOS and photodiode;

2) Different types of electric shock protection should be considered for different registration units;

3) Different degrees of automation should be considered into different registration units;

4) Qualitative, semi-quantitative, quantitative detection functions can be considered to be assigned to the same registration unit.

4. Clinical Trials

Animal Test or Small Sample Test: not required

Clinical Trials: not required

In ‘Medical Device Catalog Exempted from Clinical Trials’

Usually consists of photoelectric detection module, mechanical scanning control module, control board module, information acquisition module and so on. The principle is generally that the reflectance signal of the detection reagent card is converted into a photoelectric signal by a sensor, and the photoelectric signal is converted into a corresponding concentration value or threshold value by the calibration information, and the object to be tested is analyzed. Used in conjunction with an adaptation reagent for qualitative and/or quantitative analysis of the analyte in a human sample.

5. Technical Requirements

Table 1 Relevant Product Standards

Standard Number

Standard Name

GB/T 191-2008

Packaging storage and transportation icon

GB 4793.1-2007

Safety of electrical equipment for measurement, control and laboratory use - Part 1: General requirements

GB 4793.9-2013

Safety of electrical equipment for measurement, control and laboratory use - Part 9: Particular requirements for automatic and semi-automatic equipment for laboratory analysis and other purposes

GB 4943.1-2011

Information technology equipment - Safety - Part 1: General requirements

GB/T 14710-2009

Medical electrical environment requirements and test methods

GB/T 18268.1-2010

Electrical equipment for measurement, control and laboratory use - Electromagnetic compatibility - Part 1: General requirements

GB/T 18268.26-2010

Electrical equipment for measurement, control and laboratory use - Electromagnetic compatibility - Part 26: Particular requirements In vitro diagnostic (IVD) medical devices

GB/T 29791.3-2013

In vitro diagnostic medical devices - Information provided by manufacturers (indicators) - Part 3: Professional in vitro diagnostic equipment

YY/T 0316-2016

Medical device risk management for medical devices

YY/T 0466.1-2016

Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1: General requirements

YY 0648-2008

Safety of electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical devices

YY/T 1582-2018

Colloidal gold immunochromatography reader

 

Guidelines of Colloidal gold immunochromatography reader registration technical review (draft for comments)

6. Registration Cost and Duration

1) Product Testing

Test items

Testing duration(90 working days total)

Testing fee(USD)

Safety Performance

90

4,500

EMC

90

3,500

Notes:

1. The price of EMC is only the price of one operating mode. If there are multiple operating modes, it needs to be re-priced;

2) Technology Approval

60 working days

Another 60 working days if the 1-year supplement is required

3) Administrative Approval

20 working days


If you would like to get the detailed registration proposal, please contact us via md@cirs-group.com.

Contact Us
CIRS China

Ms. Shuo Wang (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mr. Edwin Wen (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Bryan Zhou
Tel:  +353 (1)477 3710

Email: md@cirs-group.com

CIRS Korea
Mr. Junho Lee 
Tel: +82 2 6347 8801 
Email: md@cirs-group.com