APPLIED BIOSYSTEMS 7500 FAST DX

K082562 · Applied Biosystems, Inc. · NSU · Sep 30, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082562
• Device Name: APPLIED BIOSYSTEMS 7500 FAST DX
• Applicant: Applied Biosystems, Inc.
• Product Code: NSU · Clinical Chemistry
• Decision Date: Sep 30, 2008
• Decision: SESE
• Submission Type: Traditional
• 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 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 hydrolysis probes. The 7500 Fast Dx is to be used only by technologists trained in laboratory techniques, procedures and on use of the analyzer.

Device Story

The Applied Biosystems 7500 Fast Dx is a real-time PCR instrument integrating a thermal cycler, fluorimeter, and PC-based software. It accepts samples in tube strips or 96-well plates. A Peltier-based thermal block performs cycling while a halogen tungsten light source and 5-filter excitation/emission system enable fluorescence detection via a CCD camera. The Sequence Detection Software (SDS) v1.4 controls the instrument, collects real-time cycle-by-cycle signals, and performs data analysis. Used in clinical laboratory settings by trained technologists, the system provides quantitative readouts to assist in diagnostic decision-making. The device benefits patients by enabling rapid (approx. 40-minute) nucleic acid amplification and detection.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Peltier-based thermal block; halogen tungsten excitation source; 5 switchable excitation filters; 5-color emission filter wheel; CCD camera detector. Form factor: 96-well plate or tube strip capacity. Connectivity: PC-attached (Windows XP). Software: SDS v1.4 for instrument control and data analysis. Calibration: background calibration performed by user.

Indications for Use

Indicated for use by trained laboratory technologists as a real-time nucleic acid amplification and detection system for reverse transcribed RNA, providing comparative quantitative readouts via fluorescent detection of dual-labeled hydrolysis probes. Prescription use only.

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

• Affymetrix GeneChip Microarray instrument System

Submission Summary (Full Text)

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K082562

Image /page/0/Picture/1 description: The image shows the logo for Applied Biosystems. The logo consists of the letters AB in a stylized font on the left, followed by the words "Applied Biosystems" in a bold, sans-serif font on the right. The letters AB are in a lighter shade than the words "Applied Biosystems".

SEP 3 0 2008

## 510(k) Summary

### Summary of Safety and Effectiveness

### Submitter Information:

- Applied Biosystems Submitter: 850 Lincoln Centre Drive Foster City, CA 94404
- John D'Angelo Contact: Vice President of Regulatory and Quality Affairs 650-554-2005 [e-mail]

## Name of Device and Classification:

Applied Biosystems 7500 Fast Dx Name:

Class II Classification:

### Predicate Devices:

Applied Biosystems is submitting this application under 21 CFR Part 862.2570 Instrumentation for clinical multiplex test systems, Class II. The predicate device is the Affymetrix GeneChip Microarray instrument System.

Description of Device:

The AB 7500 Fast Dx RT-PCR instrument integrates a thermal cycler, a fluorimeter and application specific software. The instrument houses the thermal cycler and the

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Image /page/1/Picture/0 description: The image shows the logo for Applied Biosystems. The logo consists of the letters "AB" in a stylized font on the left, with the words "Applied Biosystems" in a bold, sans-serif font on the right. The letters "AB" are in a lighter color, while the words "Applied Biosystems" are in black.

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) version 1.4 for the 7500 Fast Dx Instrument is used for instrument control, data collection and data analysis. The software can measure cycle-by-cycle real-time signals from the sample. The software provides a variety of tools to help the user analyze the data extracted from the samples. The software also provides lamp-life monitoring and other instrument maintenance information. The software runs as an application on Windows XP platform. Changes to the Dx software are subject to change control in accordance with 21 CFR Part 820.40.

### Intended Use / Indications for Use:

The 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 hydrolysis probes. The 7500 Fast Dx is to be used only by technologists trained in laboratory techniques, procedures and on use of the analyzer.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. John D'Angelo Vice President of Regulatory Affairs Applied Biosystems 850 Lincoln Centre Drive Foster City, CA 94404

SEP 30 2008

Re: K082562 Trade/Device Name: Applied Biosystems 7500 Fast Dx Regulation Number: 21 CFR 862. 2570 Regulation Name: Instrumentation for clinical multiplex test systems Regulatory Class: Class II . Product Code: NSU Dated: September 2, 2008 Received: September 4, 2008

Dear Mr. D'Angelo:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attayma

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Applied Biosystems. The logo consists of the letters AB in a stylized font on the left, with the words "Applied Biosystems" in a bold, sans-serif font on the right. The letters AB are made up of small dots, giving them a textured appearance.

Indications for Use Statement

510(k) Number (if known): K082562

Applied Biosystems 7500 Fast Dx Device Name:

Indications For Use:

The 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 hydrolysis probes. The 7500 Fast Dx is to be used only by technologists trained in laboratory techniques, procedures and on use of the analyzer.

OR Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use _

Uve Schuf
Division Sign-Off

Division Sign-Off

(Optional Format 1-2-96)

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k082562