LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P

K121399 · Luminex Corp. · NSU · Jan 9, 2013 · Clinical Chemistry

Device Facts

• Record ID: K121399
• Device Name: LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
• Applicant: Luminex Corp.
• Product Code: NSU · Clinical Chemistry
• Decision Date: Jan 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

Intended 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.

Device Story

FLEXMAP 3D system is an instrumentation platform for clinical multiplex testing; processes in vitro diagnostic (IVD) assays from clinical samples. Device measures and sorts multiple signals generated by assays to quantify multiple analytes simultaneously. Operated by laboratory personnel in clinical settings. System includes FLEXMAP 3D instrument, xPONENT 4.0 SP1 software, and associated calibration/verification kits. Output provides quantitative data for analytes, aiding clinicians in diagnostic decision-making. System performance is verified through specific IVD assays that cite its use.

Clinical Evidence

No clinical data provided; substantial equivalence established through bench testing and performance verification of the instrumentation system using calibration and verification kits.

Technological Characteristics

Flow cytometry-based analyzer; utilizes xMAP microspheres. Optics: two lasers, avalanche photo diodes (APDs), and photomultiplier tubes (PMTs). Fluidics: syringe-driven sample uptake and positive-pressure sheath fluid path. Software: xPONENT 4.0 SP1. Dimensions: 64.8 cm footprint. Power: electronic subsystem control. Sterilization: N/A (instrument). Connectivity: supports barcode reader for sample ID.

Indications for Use

Indicated for use as a clinical multiplex test system to measure and sort signals from in vitro diagnostic assays to aid in the diagnosis of conditions by measuring multiple analytes. Intended for prescription use with specific IVD cleared or approved assays.

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."

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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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