(282 days)
Not Found
Not Found
No
The summary describes a nucleic acid hybridization assay, which is a laboratory test based on molecular biology techniques, not AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is intended for identification and detection of bacteria from blood cultures, which serves a diagnostic purpose rather than a therapeutic one. Therapeutic devices are used for treatment or prevention of diseases.
Yes
The device is an assay intended for the "identification of Enterococcus faecalis and the detection of selected other enterococci (OE) on smears made from positive blood cultures." This directly identifies a pathogen, which is a diagnostic function.
No
The 510(k) summary describes a nucleic acid hybridization assay, which is a laboratory test involving chemical reagents and physical processes, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and the detection of selected other enterococci (OE) on smears made from positive blood cultures". This describes a test performed in vitro (outside the body) on a biological sample (blood culture) to provide diagnostic information (identification of specific bacteria).
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
E. faecalis/OE PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and the detection of selected other enterococci (OE) on smears made from positive blood cultures containing Grampositive cocci in pairs and chains observed on Gram stain.
Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.
Product codes
OAH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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.
0
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 depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Ms. Paula E. Bulger Director, Regulatory Affairs AdvanDx, Inc. 10A Roessler Road Woburn, MA 01801
JUL 2 4 2009
Re: K083074
Trade/Device Name: E. faecalis PNA FISH® Culture Identification Kit Regulation Number: 21 CFR § 866.3740 Regulation Name: FISH, Protein nucleic acid, Enterocuccous faecalis Regulatory Class: I Product Code: OAH Dated: July 13, 2009 Received: July 15, 2009
Dear Ms. Bulger:
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
1
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).
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 (240) 276-0484. 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Salla Attepnis
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): $0830/4
Device Name: E. faecalis/OE PNA FISH
Indications for Use:
E. faecalis/OE PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and the detection of selected other enterococci (OE) on smears made from positive blood cultures containing Grampositive cocci in pairs and chains observed on Gram stain.
Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Freddie M. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K08 3074