(10 days)
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No
The document describes standard PCR instrument functionality and data analysis software without mentioning AI or ML.
No
The device is a real-time PCR instrument used for nucleic acid amplification and fluorescence detection with in vitro diagnostic tests, primarily for data collection and analysis, not for direct therapeutic intervention.
Yes
The device is intended for use with FDA cleared or approved tests on human-derived specimens, in combination with in vitro diagnostic tests, which directly points to its role in diagnosing conditions based on biological samples.
No
The device description clearly states that the system includes a physical instrument (thermal cycler, fluorimeter, tray loading mechanism, optics, CCD camera) in addition to the software. While the software is a critical component, it is integrated with and controls hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the instrument is for use with "FDA cleared or approved tests on human-derived specimens" and is "intended for use in combination with in vitro diagnostic tests labeled for use on this instrument." This directly aligns with the definition of an IVD, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a system that performs real-time nucleic acid amplification and fluorescence detection on samples, which are common techniques used in IVD tests.
- Anatomical Site: The device is used with "human-derived specimens," which is a key characteristic of IVDs.
- Intended User: The intended users are "laboratory professionals," which is typical for devices used in clinical diagnostic settings.
The information provided strongly indicates that this device is designed and intended to be used as part of an in vitro diagnostic process.
N/A
Intended Use / Indications for 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.
Product codes
NSU
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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Human-derived specimens
Indicated Patient Age Range
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Intended User / Care Setting
Laboratory professionals trained in laboratory techniques, procedures, and on use of the system.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
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.
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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
Life Sciences Solutions Group
Life Technologies Holdings Pte Ltd
Blk 33, #07-06, Marsiling Industrial Estate, Road 3
Singapore 739256 |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Life Technologies Holdings Pte Ltd
Blk 33, #07-06, Marsiling Industrial Estate, Road 3
Singapore 739256 |
| Contact: | Nikki Arora, Engineer, Regulatory Affairs
Phone: 650-554-2268
Fax: 240-379-4673
Email: nikki.arora@thermofisher.com |
| Alternate Contact: | Nicole Fisher, Manager, Regulatory Affairs
Phone: 240-379-4602
Fax: 240-379-4673
Email: nicole.fisher@thermofisher.com |
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 | |
| 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 | Applied Biosystems® 7500 | |
| Fast Dx Real-Time PCR | ||
| instrument with the SDS | ||
| Software version 1.4 is a real- | ||
| time nucleic acid amplification | ||
| and detection system that | ||
| measures nucleic acid signals | ||
| from reverse transcribed RNA | ||
| and converts them to | ||
| comparative quantitative | ||
| readouts using fluorescent | ||
| detection of dual-labeled |
Table 1: Predicate Comparison Table
2
| | 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. | hydrolysis probes. The 7500
Fast Dx instrument is to be
used only by technologists
trained in laboratory
techniques, procedures, and
on use of the analyzer. |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental Technology | Real-Time PCR | Same |
| Instrument Computer
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
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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 (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 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
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