APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE

K141220 · Thermo Fisher Scientific (Life Technologies Holdin · NSU · May 22, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141220
• Device Name: APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
• Applicant: Thermo Fisher Scientific (Life Technologies Holdin
• Product Code: NSU · Clinical Chemistry
• Decision Date: May 22, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

Intended Use

The Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument with the SDS Software is a real-time nucleic acid amplification and five color fluorescence detection system for use with FDA cleared or approved tests on human-derived specimens. The 7500 Fast Dx Real-Time PCR instrument and SDS Software are intended for use in combination with in vitro diagnostic tests labeled for use on this instrument. The 7500 Fast Dx instrument is intended for use by laboratory professionals trained in laboratory techniques, procedures, and on use of the system.

Device Story

Instrument integrates thermal cycler, fluorimeter, and PC-based Sequence Detection Software (SDS). Samples in tube strips or 96-well plates placed in Peltier-based thermal block. Halogen tungsten white light source provides excitation via 5 switchable filters; fluorescence emission detected via 5-color filter wheel to CCD camera. System performs quantitative RT-PCR in ~40 minutes. Operated by trained laboratory professionals in clinical settings. SDS software manages instrument control, data collection, and analysis; provides user-friendly setup wizard, cycle-by-cycle signal measurement, and instrument maintenance monitoring. Output used by clinicians to analyze diagnostic test results for clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical verification testing of the updated operating system.

Technological Characteristics

Real-time PCR instrument with Peltier-based thermal cycling and 5-color fluorescence detection. Excitation via halogen tungsten white source with 5 switchable filters; detection via CCD camera. Form factor: benchtop instrument with external PC. Connectivity: PC-based software (Windows 7).

Indications for Use

Indicated for laboratory professionals to perform real-time nucleic acid amplification and five-color fluorescence detection on human-derived specimens using FDA-cleared or approved in vitro diagnostic 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

• Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software version 1.4 (K082562)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for Thermo Fisher Scientific. The words "Thermo Fisher" are in bold, and the word "SCIENTIFIC" is in a smaller font below. The logo is simple and professional, and it is likely used on the company's website, products, and marketing materials.

# MAY 2 2 2014

Special 510(k) Summary

Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software

| Submitter: | Thermo Fisher Scientific<br>Life Sciences Solutions Group<br>Life Technologies Holdings Pte Ltd<br>Blk 33, #07-06, Marsiling Industrial Estate, Road 3<br>Singapore 739256 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Life Technologies Holdings Pte Ltd<br>Blk 33, #07-06, Marsiling Industrial Estate, Road 3<br>Singapore 739256 |
| Contact: | Nikki Arora, Engineer, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Alternate Contact: | Nicole Fisher, Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

Date Prepared: May 22, 2014

### Device Information:

Proprietary Trade Name: Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software

Common Name: 7500 Fast Dx

Device Class: Class II

Classification Name: Instrumentation for Clinical Multiplex Test Systems (21 CFR 862.2570)

Product Code: NSU

Predicate Device: K082562, Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software version 1.4

Device Description: The Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument integrates a thermal cycler, a fluorimeter and application specific software. The instrument houses the thermal cycler and the fluorimeter, while the application software is run on a PC that is attached to the instrument. Samples are placed in a tube strip or 96-well low-head space plate that is moved to a Peltier-based thermal block and positioned relative to the optics using a tray loading mechanism.

Excitation for all samples is provided by a halogen tungsten white source that passes

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

through 5 switchable excitation filters prior to reaching the sample. Fluorescence emission is then detected through 5 color emissions filter wheel to a charge coupled device (CCD) camera. The instrument is designed to complete quantitative RT-PCR runs in about 40 minutes.

The Sequence Detection Software (SDS) is used for instrument control, data collection and data analysis. The software provides a wizard for user-friendly set-up. The software measures cycleby-cycle real-time signals from the sample and provides a variety of tools to help the user analyze the data extracted from the samples. In addition, the software provides lamp-life monitoring and other instrument maintenance information. The software runs as an application on the Windows 7 platform.

Intended Use/Indications of Use: The Applied Biosystems® 7500 Fast Dx Real-Time PCR instrument with the SDS Software is a real-time nucleic acid amplification and five color fluorescence detection system for use with FDA cleared or approved tests on human-derived specimens. The 7500 Fast Dx Real-Time PCR instrument and SDS Software are intended for use in combination with in vitro diagnostic tests labeled for use on this instrument. The 7500 Fast Dx instrument is intended for use by laboratory professionals trained in laboratory techniques, procedures, and on use of the system.

Minor changes were made to the intended use in order to remove the specific software version. to modernize, and to implement consistency. The changes are not substantive changes in the use of the device and do not affect the safety and effectiveness of the device when used as labeled.

# Summary of technological characteristics of the device compared to the predicate device:

The Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software is substantially equivalent to the predicate device Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software version 1.4 (K082562). A comparison table is provided below:

| Item | Subject Device: Applied | Predicate Device: Applied |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Biosystems® 7500 Fast Dx | Biosystems® 7500 Fast Dx |
| | Real-Time PCR Instrument | Real-Time PCR Instrument |
| | with SDS Software | with SDS Software version 1.4 |
| Indications for Use | The Applied Biosystems 7500<br>Fast Dx Real-Time PCR<br>instrument with the SDS<br>Software is a real-time nucleic<br>acid amplification and five<br>color fluorescence detection<br>system for use with FDA<br>cleared or approved tests on<br>human-derived specimens.<br>The 7500 Fast Dx Real-Time<br>PCR instrument and SDS<br>Software are intended for use | Applied Biosystems® 7500<br>Fast Dx Real-Time PCR<br>instrument with the SDS<br>Software version 1.4 is a real-<br>time nucleic acid amplification<br>and detection system that<br>measures nucleic acid signals<br>from reverse transcribed RNA<br>and converts them to<br>comparative quantitative<br>readouts using fluorescent<br>detection of dual-labeled |

### Table 1: Predicate Comparison Table

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

| | in combination with in vitro<br>diagnostic tests labeled for<br>use on this instrument. The<br>7500 Fast Dx instrument is<br>intended for use by laboratory<br>professionals trained in<br>laboratory techniques,<br>procedures, and on use of the<br>system. | hydrolysis probes. The 7500<br>Fast Dx instrument is to be<br>used only by technologists<br>trained in laboratory<br>techniques, procedures, and<br>on use of the analyzer. |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental Technology | Real-Time PCR | Same |
| Instrument Computer<br>Operating System | Windows 7 | Windows XP |

Non-clinical Testing Performed for Determination of Substantial Equivalence: Based on the risk analysis evaluation results, verification testing was conducted to support the modifications in the instrument computer operating system. The verification testing report included in the submission supports substantial equivalence to the predicate device.

Conclusion: The Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software has the same operating principle and technological characteristics as the previously cleared device. The changes in intended use were made only to remove the software version and to modernize the language; there is no change in the use of the device. In summary, the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software is substantially equivalent to the predicate device.

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

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered horizontally and appears to be the heading of a document or a sign. The font is a serif typeface, and the overall impression is formal and official.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Public Health Service

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

THERMO FISHER SCIENTIFIC (LIFE TECHNOLOGIES HOLDINGS PTE LTD.) NIKKI ARORA REGULATORY AFFAIRS ENGINEER May 22, 2014 BLK 33, MARSILING INDUSTRIAL ESTATE ROAD 3, NO. 07-06 SINGAPORE 739256

Re: K141220

Trade/Device Name: Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument with SDS Software Regulation Number: 21 CFR 862.2570 Regulation Name: Instrumentation for clinical multiplex test systems Regulatory Class: II Product Code: NSU Dated: May 13, 2014 Received: May 14, 2014

Dear Ms. Arora:

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 contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 regulations 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 or any I odotal Juliates and registanents, including, but not limited to: registration and listing (21 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

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

Page 2-Ms. Arora

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Hojvat, 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) K141220

Device Name

Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software

#### Indications for Use (Describe)

The Applied Biosystems 7500 Fast Dx Real-Time PCR instrument with the SDS Software is a real-time nucleic acid amplification and five color fluorescence detection system for use with FDA cleared or approved tests on human-derived specimens. The 7500 Fast Dx Real-Time PCR instrument and SDS Software are intended for use in combination with in vitro diagnostic tests labeled for use on this instrument. The 7500 Fast Dx instrument is intended for use by laboratory professionals trained in laboratory techniques, procedures, and on use of the system.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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

John Hobson -S
2014.05.22 12:33:44 -04:00

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."

EF

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.