(88 days)
Not Found
No
The summary describes an automated system for nucleic acid extraction, amplification, and detection, but there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No
Explanation: The device is explicitly stated to be for "in vitro diagnostic (IVD) use" and performs "automated extraction of nucleic acids," "amplification," and "detection" of nucleic acids. These functions are for diagnostic purposes, not for treating or curing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "The BD Viper LT System is intended for in vitro diagnostic (IVD) use".
No
The device description explicitly states it is a "table-top instrument" and performs automated extraction, amplification, and detection, indicating it is a hardware system with integrated software, not a software-only device.
Yes, based on the provided text, the BD Viper LT System is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: Explicitly states "The BD Viper LT System is intended for in vitro diagnostic (IVD) use in clinical laboratories..."
- Device Description: Mentions it is used "when utilized with legally marketed in vitro diagnostic assays."
These statements clearly indicate the device's purpose is for diagnostic testing performed outside of the body (in vitro).
N/A
Intended Use / 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 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.
Product codes
OOI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Internal studies were conducted to validate the instrument specifications presented in Tables 2-3.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BD Viper TM System (K081825)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.2570 Instrumentation for clinical multiplex test systems.
(a)
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.(b)
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.
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
7 Loveton Circle
Sparks, MD 21152 |
|--------------------------------|----------------------------------------------------------------------------------------------|
| Establishment Registration No. | 1119779 |
| Contact Person | Sherma Winston, M.S., RAC
tel. 410-316-4145
fax. 410-316-4188
sherma_winston@bd.com |
| 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
(K081825) | BD Viper LT System
(K140447) |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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 package insert(s). | 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 |
| Technology | Strand Displacement
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 PRAStaff@fda.hhs.gov
"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."