(60 days)
Not Found
Not Found
No
The summary describes a qualitative nucleic acid hybridization assay for identifying a specific bacterium and does not mention any AI or ML components.
No
The device is described as a qualitative nucleic acid hybridization assay intended for identification of Staphylococcus aureus, functioning as an aid in diagnosis. It does not directly treat or prevent a disease, which is characteristic of a therapeutic device.
Yes
The intended use explicitly states, "S. aureus PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia."
No
The device is a nucleic acid hybridization assay, which is a laboratory test involving chemical reagents and physical processes, not solely software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "qualitative nucleic acid hybridization assay intended for identification of Staphylococcus aureus on smears made from positive blood cultures..." and "intended as an aid in the diagnosis of S. aureus bacteremia." This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Specimen Type: It uses "smears made from positive blood cultures," which are specimens taken from the human body.
- Purpose: The purpose is to identify a specific pathogen (Staphylococcus aureus) to aid in diagnosis.
The lack of information in other sections (Device Description, Performance Studies, etc.) does not negate its classification as an IVD based on the clear intended use.
N/A
Intended Use / Indications for Use
S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Staphylococcus aureus on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
S. aureus PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.
Product codes
NXX
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
§ 866.3700
Staphylococcus aureus serological reagents.(a)
Identification. Staphylococcus aureus serological reagents are devices that consist of antigens and antisera used in serological tests to identify enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genusStaphylococcus and provides epidemiological information on these diseases. Certain strains ofStaphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).(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 the limitations in § 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AUG 1 8 2009
Ms. Paula E. Bulger Director, Regulatory Affairs AdvanDx, Inc. 10A Roessler Road Woburn, MA 01801
Re: K091827
Trade/Device Name: S. aureus PNA FISH® Culture Identification Kit Regulation Number: 21 CFR § 866.3700 Regulation Name: Staphylococcus aureus serological reagents Regulatory Class: I Product Code: NXX Dated: August 12, 2009 Received: August 13, 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,
Freddie Poole, MS
Acting for:
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):
Device Name: S. aureus PNA FISH®
Indications for Use:
S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Staphylococcus aureus on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
S. aureus PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.
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)
Yuedith Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091827