BD VIPER LT SYSTEM

K140447 · Becton, Dickinson and Company · OOI · May 20, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140447
• Device Name: BD VIPER LT SYSTEM
• Applicant: Becton, Dickinson and Company
• Product Code: OOI · Clinical Chemistry
• Decision Date: May 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

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 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.

Device Story

BD Viper LT System is a bench-top laboratory instrument for automated molecular diagnostics. It processes multiple specimen types to extract nucleic acids; performs Strand Displacement Amplification (SDA) of target sequences; and detects amplified products using a two-color fluorescence system. Operated by laboratory personnel in clinical settings, the device automates the workflow for IVD assays. Output consists of qualitative assay results, which clinicians use to aid in the detection of targeted organisms. The system benefits patients by providing standardized, automated diagnostic testing.

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%.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories for automated nucleic acid extraction, amplification via Strand Displacement Amplification (SDA), and two-color fluorescence detection of target sequences. For use only with compatible IVD tests.

Regulatory Classification

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)

Reference Devices

• BD ProbeTec GCQ Amplified DNA Assay (K140448)

Submission Summary (Full Text)

{0}------------------------------------------------

KIYOY47

# 510(k) Summary

Image /page/0/Picture/2 description: The image contains the BD logo. The logo consists of a stylized human figure with arms outstretched, surrounded by a sunburst. To the right of the figure are the letters "BD" in a bold, sans-serif font. Below the letters is the text "Helping all people live healthy lives" in a smaller font.

BD Viper™ LT System

MAY 2 0 2014

| Applicant | BD Diagnostic Systems<br>7 Loveton Circle<br>Sparks, MD 21152 |
|--------------------------------|----------------------------------------------------------------------------------------------|
| Establishment Registration No. | 1119779 |
| Contact Person | Sherma Winston, M.S., RAC<br>tel. [phone]<br>fax. [phone]<br>[e-mail] |
| Summary Date | May 15, 2014 |
| Proprietary Name | BD Viper ^TM LT System |
| Common Name | BD Viper LT |
| Classification | Class II |
| Classification Name | Instrumentation for clinical multiplex test systems |
| Regulation Number | 862.2570 |
| Product Code | OOI |
| Predicate Devices | BD Viper ^TM System (K081825) |

## Device Description

The BD Viper LT System is a table-top instrument that is designed to be fully contained on a standard laboratory bench-top. The system performs automated extraction of nucleic acids from multiple specimen types in addition to amplification and detection of target nucleic acid sequences when utilized with legally marketed in vitro diagnostic assays.

## 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 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.

A comparison of the BD Viper LT System with the predicate BD Viper System is summarized below.

{1}------------------------------------------------

# 510(k) Summary

Image /page/1/Picture/1 description: The image shows the BD logo, which consists of a stylized sun and human figure on the left, followed by the letters 'BD' in bold font. Below the letters, there is a tagline that reads 'Helping all people live healthy lives'. The logo is simple and conveys a message of health and well-being.

BD Viper™ LT System

#### Table 1 Comparison to Predicate Device

| | BD Viper System<br>(K081825) | BD Viper LT System<br>(K140447) |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BD Viper System, when<br>used with the BD ProbeTec<br>amplified nucleic assay(s), is<br>intended for the in vitro<br>detection of targeted<br>organisms from specimens as<br>identified in the assay-specific<br>reagent package insert(s). | The BD Viper LT System is intended for in<br>vitro diagnostic (IVD) use in clinical<br>laboratories to perform automated<br>extraction of nucleic acids from multiple<br>specimen types, amplification of target<br>nucleic acid sequences by Strand<br>Displacement Amplification (SDA), and<br>detection of amplified nucleic acids using a<br>two color fluorescence detection system.<br>The BD Viper LT is for in vitro diagnostic<br>use only with tests labeled for use on the<br>system |
| Technology | Strand Displacement<br>Amplification (SDA) | Strand Displacement Amplification (SDA) |
| Assay Results | Qualitative | Qualitative |

. 4

, ,

# Instrument Specifications

Internal studies were conducted to validate the instrument specifications presented in Tables 2-3.

{2}------------------------------------------------

# 510(k) Summary

Image /page/2/Picture/1 description: The image contains the BD logo. The logo consists of a stylized sun-like graphic on the left and the letters "BD" on the right. Below the letters, there is some text that reads "Helping all people live healthy lives."

BD Viper™ LT System

#### Thermal Specifications Table 2

| Pre-warm heater fluid temperature | 100°c >=9 min. not to exceed 115°c > 8 min | |
|----------------------------------------------------------------|--------------------------------------------|--|
| Priming heater fluid temperature | 70°c ±2.0°c | |
| Amplification heater fluid temperature | 52.5°c ± 1.0°c | |
| Temperature Accuracy: ±0.75°c; Temperature Uniformity: ±0.75°c | | |

・・・・

#### Table 3 Optical Specifications

| WaveLength | Set 1 (Green Channel) | Set 2 (Orange Channel) |
|----------------------------------|-----------------------|------------------------|
| Excitation | 460-480 nm | 575-597 nm |
| Emission | 505-515 nm | 610-630 nm |
| Maximum optical crosstalk ≤ 0.5% | | |

## Clinical Performance Characteristics

Clinical utility of the BD Viper LT System was assessed during clearance of the BD ProbeTec GCQ Amplified DNA Assay as presented in a separate premarket submission (K140448).

# Conclusions

The submitted information for the BD Viper LT System supports the determination of substantial equivalence in accordance with the intended use as stated in the product labeling.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.

Public Health Service .

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

BECTON, DICKINSON AND COMPANY SHERMA WINSTON, M.S. REGULATORY AFFAIRS PROJECT MANAGER 7 LOVETON CIRCLE SPARKS MD 21152

May 20, 2014

Re: K140447

Trade/Device Name: BD Viper LT System Regulation Number: 21 CFR 862.2570 Regulation Name: Instrumentation for clinical multiplex test systems Regulatory Class: II Product Code: OOI Dated: February 20, 2014 Received: February 21, 2014

Dear Ms. Winston:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not musicading,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major repulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registred. - Tou hilast CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

Page 2-Ms. Winston

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

John Hobson -S for

Sally A. Hoivat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K140447

Device Name BD Viper™ LT System

### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

ال Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

12 14 6 1 1 6 1 1 2 1 2 1 2 1 5 FOR FDA USE ONLY 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

John Hobson -S 2014.05.20 09:36:58 -04

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."