← Product Code [OOI](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/OOI) · K140447 # BD VIPER LT SYSTEM (K140447) _Becton, Dickinson and Company · OOI · May 20, 2014 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94clinical-laboratory-instruments/OOI/K140447 ## Device Facts - **Applicant:** Becton, Dickinson and Company - **Product Code:** [OOI](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/OOI.md) - **Decision Date:** May 20, 2014 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.2570 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use The BD Viper LT System is intended for in vitro diagnostic (IVD) use in clinical laboratories to perform automated extraction of nucleic acids from multiple specimen types, amplification of target nucleic acid sequences by Strand Displacement Amplification (SDA), and detection of amplified nucleic acids using a two color fluorescence detection system. The BD Viper LT is for in vitro diagnostic use only with tests labeled for use on the system. Prescription use only. ## Device Story BD Viper LT System performs automated nucleic acid extraction, amplification, and detection for IVD testing. Input: clinical specimens. Process: specimens undergo pre-warming to lyse cells; DNA binds to FOX particles via pH-controlled magnetic extraction; purified DNA is eluted and neutralized. System performs Strand Displacement Amplification (SDA) in microwells; uses two-color fluorescence detection. Operated by laboratory personnel in clinical settings. Modes include Walkaway (continuous) and High Throughput (manual plate exchange). System uses barcode scanners for specimen tracking. Output: qualitative assay results reported automatically. Benefits: automates complex molecular diagnostic workflows, reducing manual labor and potential for error in pathogen detection. ## Clinical Evidence No clinical data provided for the instrument itself; clinical utility was assessed during the clearance of the BD ProbeTec GCQ Amplified DNA Assay (K140448). Instrument specifications were validated via internal bench testing. ## Technological Characteristics Bench-top instrument; utilizes Strand Displacement Amplification (SDA). Features thermal control systems (pre-warm, priming, and amplification heaters) with accuracy/uniformity of ±0.75°C. Optical system uses two-color fluorescence detection (Green Channel: 460-480nm excitation/505-515nm emission; Orange Channel: 575-597nm excitation/610-630nm emission). Maximum optical crosstalk ≤ 0.5%. ## Regulatory Identification Instrumentation for clinical multiplex test systems is a device intended to measure and sort multiple signals generated by an assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. Such instrumentation may be compatible with more than one specific assay. The device includes a signal reader unit, and may also integrate reagent handling, hybridization, washing, dedicated instrument control, and other hardware components, as well as raw data storage mechanisms, data acquisition software, and software to process detected signals. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.” See § 862.1(d) for the availability of this guidance document. The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems." ## Predicate Devices - BD Viper System ([K081825](/device/K081825.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K140447 B. Purpose for Submission: Clearance of BD Viper LT C. Manufacturer and Instrument Name: Becton, Dickinson and Company BD Viper LT System D. Type of Test or Tests Performed: Nucleic acid amplification by strand displacement with fluorescence detection E. System Descriptions: 1. Device Description: The BD Viper LT System is intended for *in vitro* diagnostic (IVD) use in clinical laboratories to perform automated extraction of nucleic acids from multiple specimen types, amplification of target nucleic acid sequences by Strand Displacement Amplification (SDA) and detection of amplified nucleic acid using a two color fluorescence detection system. The BD Viper LT is for use only with *in vitro* diagnostic tests labeled for use on the system. 2. Principles of Operation: The BD Viper LT system uses homogeneous Strand Displacement Amplification (SDA) as the amplification method and fluorescent energy transfer (ET) as the detection method to test for the presence of pathogens by their genetic content in clinical specimens. For both SDA and PCR assays, specimens are logged in and undergo a pre-warm step in the BD Prewarm heater. The pre-warm step disrupts cells and releases DNA. After cooling, the specimens are loaded onto the BD Viper LT instrument. The pre-warmed specimen is transferred to an extraction tube that contains FOX particles. High pH is used to lyse the bacterial cells and to liberate their DNA into solution. Acid is then added to lower the pH and induce a positive charge on the FOX particles, which in turn binds to the negatively charged DNA. The particles and bound DNA are then pulled to the sides of the extraction tube by magnets and the unbound material is aspirated to waste. The particles are washed and a high pH elution buffer is added to recover the purified DNA. Finally, a neutralization buffer is used to bring the pH of the extracted solution to optimum conditions for amplification of the target. The BD Viper LT instrument transfers extracted specimens and positive and negative assay controls to plates containing either SDA priming microwells. A warming step in each prime microwell ensures specific hybridization of SDA primers to target (if present) after which the reaction mixture is {1} transferred to a corresponding gray SDA amplification microwell. After the plate is sealed, the onboard reader door closes over the plate. Amplification and detection occur and results are reported automatically based on the algorithm identified in the assay specific package insert(s). 3. Modes of Operation: The BD Viper LT Instrument has two modes, Walkaway and High Throughput. The user may enable or disable Walkaway mode through use of a check box on the screen. Walkaway mode enables the instrument to perform a complete run without pausing to allow the user to enter additional consumables prior to the prime to amplification plate transfer. In High Throughput mode, the instrument pauses prior to the prime to amplification transfer to allow the user to remove the tested amplification plates from the previous run and load new amplification plates for the next run. In High Throughput mode, the user must acknowledge a message before the instrument will perform the prime to amplification transfer. In either mode, the user may setup and begin a new run while the plates are being tested in the readers. Specimen Identification: Two barcode scanners are located on the instrument deck: one at the specimen rack station and one at the extraction reagent trough. There is also a built-in barcode scanner on the Pre-warm heater that reads the specimen rack barcode. A separate hand-held scanner is provided to help automate specimen login and identification 5. Specimen Sampling and Handling: See K140446 and K140448 6. Calibration: The instrument is calibrated at the time of manufacturing. The thermal and optical systems are under closed loop feedback control therefore no user performed calibration is needed. 8. Software: FDA has reviewed applicant's Hazard Analysis and Software Development processes for this line of product types: Yes ☐ X or No ☐ Level of Concern: Moderate Device Hazard Analysis: Acceptable {2} The Hazard Analysis for the BD ProbeTec CT & GC Q₄ Amplified DNA Assays on the BD Viper LT System is presented in Appendix B: Risk Management Documentation. **Architecture Design Chart**: Acceptable The relationship between the hardware and the data flow are presented in Appendix A. **Software Specifications**: Acceptable A summary of the implementation of the product requirements is provided in Appendix A. Software design specifications for the heater, QC, Start Run/User Assistance, Consumables, Run Status, System Data, System Alert, Configuration Screen, Consumable Management, Login, Main Screen, Reports and Results, Specimen Rack, System Alert, related to SDA assays is presented in Appendix A. **Development Environment**: Acceptable The software development plan was presented including procedures for developing requirements and specifications, change control, design approach, risk management, configuration control plan, V&V and a summary of the design deliverables. **Verification and Validation Testing**: Acceptable Software verification and validation plans describe the software review process to be followed and the total scope of software testing to be performed. The plan describes the software design verification activities that will occur during development and establish the pan for conducting software tests to complete V&V testing. **Revision Level History**: Acceptable Release notes for revisions of the software previous to 1.01D were provided. **Unresolved Anomalies**: Acceptable Anomalies left unresolved in software revision 1.01D were reported along with an analysis of the impact on the device and plans/timeframe for addressing each line item. **EMC and Electrical Testing**: Acceptable Third party vendor reports are provided stating that the system complies with EN 61326-2-6: 2006, IEC 61010-1:2001 and IEC 61326-2-6-2005. **F. Regulatory Information**: 1. Regulation section: 862.2570 {3} 2. Classification: Class II 3 Product code: OOI 4. Panel: Clinical Chemistry ## G. Intended Use: 1. Indication(s) for Use: The BD Viper LT System is intended for in vitro diagnostic (IVD) use in clinical laboratories to perform automated extraction of nucleic acids from multiple specimen types, amplification of target nucleic acid sequences by Strand Displacement Amplification (SDA), and detection of amplified nucleic acids using a two color fluorescence detection system. The BD Viper LT is for in vitro diagnostic use only with tests labeled for use on the system 2. Special Conditions for Use Statement(s): Prescription use only. ## H. Substantial Equivalence Information: 1. Predicate Device Name(s) and 510(k) numbers: BD Viper LT System (K081825) 2. Comparison with Predicate Device: | Similarities | | | | --- | --- | --- | | Item | BD Viper LT | Predicate Device BD Viper System (K081825) | | Intended Use | The BD Viper LT System is intended for in vitro diagnostic (IVD) use in clinical laboratories to perform automated extraction of nucleic acids from multiple specimen types, amplification of | The BD Viper System, when used with the BD ProbeTec amplified nucleic assay(s), is intended for the in vitro detection of targeted organisms from specimens as identified in the assay-specific reagent | {4} | Similarities | | | | --- | --- | --- | | Item | BD Viper LT | Predicate Device BD Viper System (K081825) | | | target nucleic acid sequences by Strand Displacement Amplification (SDA), and detection of amplified nucleic acids using a two color fluorescence detection system. The BD Viper LT is for in vitro diagnostic use only with tests labeled for use on the system | package insert(s). | | Technology | Strand displacement amplification (SDA) | Same | | Assay Results | Qualitative | Same | | Sample Login | Manual barcode scan | Same | | Nucleic Acid Extraction Method | FOX Extraction | Same | | Optical Channels | Green and Orange | Same | | Pipetting Volume Range | 50 – 1000 μL | Same | | Differences | | | | --- | --- | --- | | Item | BD Viper LT | Predicate Device BD Viper System (K081825) | | Sample Rack Capacity | 48 | 96 | | Optical System | Filtered CCD camera fluorescent detection | Fiber optic bundles lead to individual PMT fluorescent detection | | Thermal Control | Conductive heating via Peltier-based thermal system. | Conductive heating via resistive heating system. | I. Special Control/Guidance Document Referenced (if applicable): FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005. J. Performance Characteristics: 1. Analytical Performance: {5} a. Accuracy: See K140446 and K140448 b. Precision/Reproducibility: See K140446 and K140448 c. Linearity: See K140446 and K140448 d. Carryover: See K140446 and K140448 e. Interfering Substances: See K140446 and K140448 2. Other Supportive Instrument Performance Data Not Covered Above: None K. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. L. Conclusion: The submitted information in this premarket notification along with the performance data submitted in K140446 and K140448 is complete and supports a substantial equivalence decision. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94clinical-laboratory-instruments/OOI/K140447](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94clinical-laboratory-instruments/OOI/K140447) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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