(26 days)
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.
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 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.
This 510(k) summary (K082562) for the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument does not contain the detailed information required to describe the acceptance criteria and the specific study that proves the device meets those criteria.
The document primarily focuses on:
- Device Identification: Name, classification, submitter information.
- Predicate Device: Identifies the Affymetrix GeneChip Microarray instrument System as the predicate.
- Device Description: Explains the physical components and basic functionality of the instrument and its software.
- Intended Use/Indications for Use: States what the device is designed to do.
- FDA Correspondence: The FDA letter confirming substantial equivalence.
Crucially, it lacks the following information that would be necessary to answer the prompt directly:
- Specific performance metrics: No mention of sensitivity, specificity, accuracy, precision, limit of detection, or any other quantitative measure.
- Defined acceptance criteria: There are no thresholds or targets stated for any performance metric.
- Study design details: No description of any clinical or analytical study, including sample sizes, data collection methods, ground truth establishment, or expert involvement.
- Results of a study: No reported device performance values are provided against any criteria.
Therefore, I cannot populate the requested table or answer most of the specific questions based on the provided text.
Here's a breakdown of what cannot be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Not specified | Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document does not describe any test set or study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified. No information on ground truth establishment or expert involvement.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. No test set described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an RT-PCR instrument, not an AI-assisted diagnostic tool that would involve human readers interpreting images. The document does not mention any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This device is an instrument with software for data analysis, not an "algorithm" in the sense of an AI model. The document does not provide details on standalone performance testing in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not specified. No ground truth information provided.
8. The sample size for the training set:
- Not applicable/Not specified. This is an instrument and software, not a machine learning model that would have a separate "training set" in the common sense. If it refers to data used to develop the algorithms for the SDS software, that information is not provided.
9. How the ground truth for the training set was established:
- Not applicable/Not specified. See point 8.
Conclusion:
The provided 510(k) summary is a high-level document intended to demonstrate substantial equivalence, not a detailed technical report of performance studies. To obtain the requested information, one would typically need to consult a more detailed submissions, such as an FDA review memo, or the full 510(k) submission, which would include the performance data and methodology.
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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 iohn.dangelo@appliedbiosystems.com
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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes on its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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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Page 2 -
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 (800) 638-2041 or (240) 276-3150 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
§ 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.