(245 days)
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No
The provided text does not mention AI, ML, or related concepts like image processing, deep neural networks, or training/test sets, which are typically associated with AI/ML-powered medical devices.
No
The device is described as a "clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample," and is intended for use with "IVD cleared or approved assays to measure multiple similar analytes that establish a single indicator to aid in diagnosis." This indicates it is for diagnostic purposes, not therapeutic.
Yes
The 'Intended Use / Indications for Use' section states that the system is intended "to aid in diagnosis," which is a key characteristic of a diagnostic device. It also mentions "in vitro diagnostic assay from a clinical sample."
No
The device description explicitly mentions the "Luminex® FLEXMAP 3D® system," which is a hardware instrument, in addition to the software. Therefore, it is not a software-only medical device.
Yes, based on the provided text, the Luminex® FLEXMAP 3D® system with xPONENT® software version 4.0 SP1 is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "...is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample."
- "This instrumentation is intended for use with specific IVD cleared or approved assays citing its use..."
These statements clearly indicate that the device is designed to be used in an in vitro diagnostic context, analyzing samples outside of the body to aid in diagnosis.
N/A
Intended Use / Indications for Use
The Luminex® FLEXMAP 3D® system with xPONENT® software version 4.0 SP1 is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.
Product codes
NSU
Device Description
FLEXMAP 3D® Instrument System with Luminex® xPONENT 4.0 SP1 Software; FLEXMAP 3D® IVD Calibration Kit, and FLEXMAP 3D® IVD Performance Verification Kit
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
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2013
Luminex, Inc. c/o Oliver Meek Vice President, Quality Assurance and Regulatory Affairs 12212 Technology Blvd. AUSTIN, TX 78727
Re: K121399
Trade/Device Name: FLEXMAP 3D® Instrument System with Luminex® xPONENT 4.0 SP1 Software; FLEXMAP 3D® IVD Calibration Kit, and FLEXMAP 3D® IVD Performance Verification Kit Regulation Number: 21 CFR 862.2570
Regulation Name: Instrumentation for Clinical Multiplex Test Systems Regulatory Class: Class II Product Code: NSU Dated: December 7, 2012 Received: December 10, 2012
Dear Mr. Oliver Meek:
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 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.
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Page 2 - Mr. Oliver Meek
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 Part 801); 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 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 regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip -S
Maria M. Chan, Ph.D.
Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ K121399
Device Name: Luminex® FLEXMAP 3D®
The Luminex® FLEXMAP 3D® system with xPONENT® software version 4.0 SP1 is a clinical multiplex test system intended to measure and sort multiple signals generated in an in vitro diagnostic assay from a clinical sample. This instrumentation is intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics Evaluation and Safety (OIVD)
Karen E. Bijwaard -S 2013.01.04,17:28:43 -05'00'
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121399
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