XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX

K121894 · Luminex Molecular Diagnostics, Inc. · PCH · Mar 21, 2013 · Microbiology

Device Facts

• Record ID: K121894
• Device Name: XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX
• Applicant: Luminex Molecular Diagnostics, Inc.
• Product Code: PCH · Microbiology
• Decision Date: Mar 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3990
• Device Class: Class 2

Indications for Use

The xTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. The following pathogen types, subtypes and toxin genes are identified using the xTAG GPP: Campylobacter (C. jejuni, C. coli and C. lari only) . Clostridium difficile (C. difficile) toxin A/B ● Cryptosporidium (C. parvum and C. hominis only) ● Escherichia coli (E. coli) 0157 . Enterotoxigenic Escherichia coli (ETEC) LT/ST ● Giardia (G. lamblia only also known as G. intestinalis and G. duodenalis) . Norovirus GI/GII . Rotavirus A . Salmonella ● Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 . Shigella (S. boydii, S. sonnei, S. flexneri and S. dysenteriae) ● The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation, laboratory findings and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks. xTAG® GPP positive results are presumptive and must be confirmed by FDAcleared tests or other acceptable reference methods. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out coinfection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAG® Gastrointestinal Pathogen Panel results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. xTAG GPP is not intended to monitor or guide treatment for C. difficile infections. The xTAG GPP is indicated for use with the Luminex® MAGPIX® instrument.

Device Story

Multiplexed nucleic acid test for qualitative detection of gastrointestinal pathogens (viral, parasitic, bacterial) in human stool. Input: stool specimens. Process: nucleic acid extraction and amplification followed by detection on Luminex MAGPIX instrument. Output: identification of specific pathogens/toxin genes. Used in clinical laboratory settings by trained personnel. Results aid diagnosis of infectious colitis/gastroenteritis and outbreak identification. Results are presumptive; require confirmation by reference methods. Not for sole diagnostic use or C. difficile treatment monitoring.

Technological Characteristics

Multiplexed nucleic acid-based assay. Designed for use with the Luminex MAGPIX instrument. Qualitative detection of viral, parasitic, and bacterial nucleic acids.

Indications for Use

Indicated for individuals with signs and symptoms of infectious colitis or gastroenteritis. Used for qualitative detection and identification of viral, parasitic, and bacterial nucleic acids in human stool specimens. Not intended to monitor or guide treatment for C. difficile infections.

Regulatory Classification

Identification

A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

Special Controls

*Classification.* Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002

March 21, 2013

Luminex Molecular Diagnostics, Inc. Lubna Syed Director, Regulatory Affairs 439 University Ave., Suite 900 Toronto, Canada M5G 1Y8

Re: k121894

Trade/Device Name: xTAG® Gastrointestinal Pathogen Panel (GPP) Regulation Number: 21 CFR 866.3990 Regulation Name: Gastrointestinal microorganism multiplex nucleic acid-based assay Regulatory Class: Class II Product Code: PCH, NSU, JJH Dated: January 25, 2013 Received: January 28, 2013

Dear Ms. Syed:

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.

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

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Page 2 - Lubna Syed

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,

# Sally Aೃଖି djyat

Sally Hojvat Director Division of Microbiology 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): k121894

121894

Device Name: xTAG® Gastrointestinal Pathogen Panel (GPP)

The xTAG® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis. The following pathogen types, subtypes and toxin genes are identified using the xTAG GPP:

- Campylobacter (C. jejuni, C. coli and C. lari only) .
- Clostridium difficile (C. difficile) toxin A/B ●
- Cryptosporidium (C. parvum and C. hominis only) ●
- Escherichia coli (E. coli) 0157 .
- Enterotoxigenic Escherichia coli (ETEC) LT/ST ●
- Giardia (G. lamblia only also known as G. intestinalis and G. duodenalis)
- . Norovirus GI/GII
- . Rotavirus A
- Salmonella ●
- Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 .
- Shigella (S. boydii, S. sonnei, S. flexneri and S. dysenteriae) ●

The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation, laboratory findings and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

## xTAG® GPP positive results are presumptive and must be confirmed by FDAcleared tests or other acceptable reference methods.

The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out coinfection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAG® Gastrointestinal Pathogen Panel results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.

### xTAG GPP is not intended to monitor or guide treatment for C. difficile infections.

The xTAG GPP is indicated for use with the Luminex® MAGPIX® instrument.

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Prescription Use X (Part 21 CFR 801 Subpart D)

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

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John Hoppsons -09:51 -04'00'