LUMINEX LX 100/200 INSTRUMENT

K073506 · Luminex Corp. · NSU · Mar 7, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073506
• Device Name: LUMINEX LX 100/200 INSTRUMENT
• Applicant: Luminex Corp.
• Product Code: NSU · Clinical Chemistry
• Decision Date: Mar 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2570
• Device Class: Class 2

Intended Use

The Luminex LX 100/200 Instrument 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 used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals.

Device Story

Luminex LX 100/200 is a clinical multiplex test system; functions as a signal reader for In Vitro Diagnostic assays. Device accepts clinical samples; measures and sorts multiple signals generated by assays to detect multiple analytes. System comprises signal reader unit, raw data storage, data acquisition software, and signal processing software. Used in clinical laboratory settings by trained personnel. Output provides processed signal data to aid clinicians in diagnosis. Benefits include high-throughput, simultaneous measurement of multiple analytes from a single sample, facilitating efficient diagnostic workflows.

Clinical Evidence

No independent clinical trial data provided for the instrument itself. Performance characteristics (accuracy, precision, linearity, carryover, interfering substances) were established via previously cleared assays: Luminex Id-Tag Respiratory Viral Panel (k063765), Inova Quanta Plex Celiac IgA Profile (k063818), and Inova Quanta Plex ANCA Profile (k050715).

Technological Characteristics

System utilizes xMAP technology (flow cell fluorometry). Components: polystyrene microspheres (internally labeled with fluorescent dyes), two-laser optics assembly, avalanche photo diodes, photomultiplier tubes, syringe-driven fluidics, and heater block. Connectivity: barcode reader for sample ID. Software: IS 2.3. Sterilization: N/A. Energy: electrical. Form factor: compact benchtop analyzer.

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 clinical diagnosis. No specific patient population, age, or gender restrictions are defined.

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

• Luminex 100 System (K030558)

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with its wings spread, along with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Luminex Corporation c/o Mr. Dave D. Smith Director of Regulatory Affairs 12212 Technology Blvd. Austin, TX 78727

MAR - 7 2008

k073506 Trade/Device Name: Luminex LX 100/200 Instrument Regulation Number: 21 CFR 862.2570 Regulation Name: Instrumentation for clinical multiplex test system. Regulatory Class: Class II Product Code: NSU Dated: December 11, 2007 Received: December 13, 2007

Dear Mr. Smith:

Re:

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 [phone]. 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 than the [phone] or [phone] 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.

Jéan 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

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## Indications for Use

510(k) Number (if known):____k073506

Device Name:___Luminex LX 100/200 Instrument

Indications For Use:

The Luminex LX 100/200 Instrument 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 used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Linton Sign-Off

e of In Vitro Diegnostic Device on and St

073506

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