(81 days)
Not Found
No
The summary describes a standard RT-PCR based diagnostic test for detecting GBS nucleic acid. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No.
The device is an in vitro diagnostic test designed to detect Group B Streptococcus nucleic acid, not to diagnose, treat, or monitor a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is a "qualitative in vitro diagnostic test" designed to "detect Group B Streptococcus (GBS) nucleic acid." This indicates its purpose is to aid in diagnosis by identifying the presence of a specific pathogen. Although it also states it is "not intended to diagnose or monitor treatment of a GBS infection," this likely refers to a complete medical diagnosis, while the test itself provides diagnostic information.
No
The device is described as an "in vitro diagnostic test" that performs "real-time polymerase chain reaction (RT-PCR)". This indicates a laboratory-based test involving physical reagents and equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The ARIES GBS Assay, performed on ARIES Systems, is a real-time polymerase chain reaction (RT-PCR) based qualitative in vitro diagnostic test."
N/A
Intended Use / Indications for Use
The ARIES GBS Assay, performed on ARIES Systems, is a real-time polymerase chain reaction (RT-PCR) based qualitative in vitro diagnostic test. The ARIES GBS Assay is designed to detect Group B Streptococcus (GBS) nucleic acid from 18-24 hour Lim broth enrichments of vaginal-rectal specimen swabs obtained from pregnant women.
The ARIES GBS Assay is intended for use as a method for detection in antepartum women. It is not intended to diagnose or monitor treatment of a GBS infection.
The ARIES GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
Product codes
NJR, OOI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal-rectal
Indicated Patient Age Range
pregnant women (ante partum women)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2016
LUMINEX CORPORATION CHRISTIE HUGHES SENIOR MANAGER, REGULATORY AFFAIRS 12212 TECHNOLOGY BLVD. AUSTIN, TX 78727
Re: K162772
Trade/Device Name: ARIES GBS Assav Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. serological reagents Regulatory Class: I Product Code: NJR, OOI Dated: October 3, 2016 Received: October 4, 2016
Dear Ms. Hughes:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801 and 809); 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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Noel J. Gerald -S
For Uwe Scherf, M.Sc., Ph.D. 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) K162772
Device Name ARIES GBS Assay
Indications for Use (Describe)
The ARIES GBS Assay, performed on ARIES Systems, is a real-time polymerase chain reaction (RT-PCR) based qualitative in vitro diagnostic test. The ARIES GBS Assay is designed to detect Group B Streptococcus (GBS) nucleic acid from 18-24 hour Lim broth enrichments of vaginal-rectal specimen swabs obtained from pregnant women.
The ARIES GBS Assay is intended for use as a method for detection in antepartum women. It is not intended to diagnose or monitor treatment of a GBS infection.
The ARIES GBS Assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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