Gene Sequencer_NMPA Approval in December 2017
Product Name: Gene Sequencer
Category: Domestic Class III
Registration Pathway: Priority
NMPA Approval Time: December 2017
Product Structure and Composition: The gene sequencer consists of a main unit and gene sequencer control software (integrated within the main unit, version number: V1), with the main unit including main architecture, operating system unit, optical system, XYZ platform, chip platform, gas-liquid system, electronic control system, reagent storage system, power system, and display system.
Scope of Application: This product uses combinatorial probe anchor synthesis sequencing technology and is used in clinical settings for sequencing deoxyribonucleic acid (DNA) samples from human sources to detect gene sequences that may lead to diseases or susceptibility to diseases. The instrument is only intended for clinical use in conjunction with in vitro diagnostic reagents and software approved by the food and drug supervision and administration department, not for whole human genome sequencing or de novo sequencing.
Model/Specification: BGISEQ-50
Working Principle: The gene sequencer utilizes DNA nanoballs(DNB) and combinatorial probe anchor synthesis (cPAS) sequencing core technology, employing a specially surface-modified regular array chip where each modification site anchors only one DNA nanoball, ensuring uniform spacing of modification sites on the array chip to prevent interference between different nanoballs' optical signals, thereby enhancing signal processing accuracy. Sequencing reagents and fluorescently labeled probes with different emission wavelengths are pumped into the sequencing chip flow cell through the instrument's fluidic system. Each DNA nanoball binds only one fluorescent label per sequencing cycle, which is then excited by a laser to emit light. The emitted light signals from different fluorescent labels are captured by a complementary metal oxide semiconductor (CMOS) camera. The light signals on the regular array chip are processed by random software into digital signals, transmitted to a computer for analysis to obtain the base sequence information of the sample.
Safety Research: 1. Gene sequencer safety requirements: comply with the requirements of GB 4793.1-2007, GB 4793.9-2013, YY 0648-2008,and GB7247.1-2012; 2. Gene sequencer electromagnetic compatibility requirements: comply with the requirements of GB/T 18268.1-2010 and GB/T18268.26-2010; 3. Gene sequencer environmental test requirements: comply with the provisions of GB/T 14710-2009 for climate environmental test group I and mechanical environmental test group I.
Performance Research: 1. Sample type validation; 2. Mutation detection research; 3. Sequencing data quality control research; 4. Accuracy research; 5. Precision research; 6. Detection upper/lower limit research; 7.Clinical application project research; 8. Instrument limitations
Product Service/Shelf Life and Packaging: A validation report for service life is provided, with accelerated aging tests conducted, including product stability and packaging integrity. Based on factors affecting service life, a lifespan assessment and testing were conducted from the most stringent foreseeable application scenarios to ensure user safety and testing accuracy, determining the product's service life to be 7 years. The packaging has been verified through environmental testing to meet transportation and storage requirements.
Software Research: The product has been submitted in accordance with the requirements of the "Technical Review Guidelines for Medical Device Software Registration," including software description documents and software version naming rules declaration. The complete software version number consists of four parts, with software version naming rules following the principle of risk prioritization, treating major software updates differently from minor updates, and prioritizing enhancement updates over corrective updates.
Clinical Evaluation: Clinical evaluation is conducted based on the "Guidelines for Clinical Evaluation of Medical Devices,"analyzing and evaluating data obtained from clinical trials and clinical use of the predicate of medical device. The predicate refers to the gene sequencer(BGISEQ-500). The gene sequencer (BGISEQ-50) is largely consistent with the gene sequencer (BGISEQ-500) in terms of basic principles, safety assessment, core software functions, compliance with national/industry standards, scope of application, instructions for use, contraindications, precautions, and warnings. Additionally, clinical trial data and data obtained from clinical use of the same type of medical device "gene sequencer (BGISEQ-500)" have been submitted, including scientific publications publicly available in China and abroad, as well as legally obtained corresponding data, comprising clinical literature data and clinical experience data. Following the requirements of the "Guidelines for Clinical Evaluation of Medical Devices," an analysis and evaluation of the above data were conducted (quality assessment of data, establishment of data sets, statistical analysis of data), synthesizing the results of different data sets to form a clinical evaluation report.