(114 days)
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No
The summary describes a system for measuring fluorescence signals from microarrays and does not mention any AI or ML components or functionalities.
No
The device is described as an instrumentation system intended to measure fluorescence signals of labeled DNA and RNA, which suggests it is for diagnostic or research purposes, not for treating a condition.
No
The stated intended use is to "measure fluorescence signals of labeled DNA and RNA target hybridized to GeneChip® arrays," which describes a measurement tool, not a device that provides diagnostic information.
No
The device description explicitly lists hardware components (scanner, fluidics station) in addition to the software.
Based on the provided information, the Affymetrix GeneChip® Microarray Instrumentation System is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for measuring fluorescence signals of labeled DNA and RNA target hybridized to GeneChip® arrays. This process involves analyzing biological samples (DNA and RNA) outside of the body (in vitro) to obtain information about a person's health or condition.
- Device Description: The description details the components of a system used for this in vitro analysis.
- Prescription Use: The indication for "Prescription Use" further suggests it's a medical device used in a clinical or laboratory setting, which is common for IVDs.
While the information doesn't explicitly state "In Vitro Diagnostic" in the intended use, the nature of the analysis (measuring signals from labeled DNA and RNA hybridized to arrays) and the context of "Prescription Use" strongly align with the definition of an IVD.
The lack of information about image processing, AI/ML, anatomical site, patient age range, training/test sets, performance studies, and key metrics is not unusual for a device description and doesn't negate its likely IVD status. These details are often found in more comprehensive regulatory submissions or technical documentation.
N/A
Intended Use / Indications for Use
The Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software is intended to measure fluorescence signals of labeled DNA and RNA target hybridized to GeneChip® arrays.
Product codes
NSU
Device Description
Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software.
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
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned above a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is presented in black and white.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
JUL 3 0 2008
Affymetrix, Inc. C/O Maureen J. Mende Director, Regulatory Affairs and Clinical Trials 3420 Central Expressway Santa Clara, CA 95051
Re: K080995
Trade/Device Name: Affymetrix Genechip Microarray Instrumentation System Regulation Number: 21CFR § 862.2570 Regulation Name: Instrumentation for clinical multiplex test systems Regulatory Class: Class II Product Code: NSU Dated: July, 23 2008 Received: July 24, 2008
Dear Ms. Mende:
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indication for Use
510(k) Number (if known): K080995
Device Name: Affymetrix GeneChip® Microarray Instrumentation System Indication For Use:
The Affymetrix GeneChip® Microarray Instrumentation System consisting of GeneChip® 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDx software is intended to measure fluorescence signals of labeled DNA and RNA target hybridized to GeneChip® arrays.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080995