(125 days)
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No
The summary describes a nucleic acid hybridization assay for identifying bacteria, which is a laboratory technique and does not mention any computational or algorithmic components indicative of AI/ML.
No.
The device is intended as an aid in diagnosis, not for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states: "S. aureus/CNS PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia." This explicitly indicates its diagnostic purpose.
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, the device described is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures..." This clearly indicates that the device is used to examine specimens (blood cultures) taken from the human body to provide information for diagnostic purposes (identifying specific bacteria).
- Diagnostic Aid: The statement "S. aureus/CNS PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia" further reinforces its role in the diagnostic process.
- In Vitro: The assay is performed on "smears made from positive blood cultures," which are samples taken outside of the living organism (in vitro).
Therefore, the device fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
S. aureus/CNS PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Grampositive cocci in clusters observed on Gram stain.
Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.
S. aureus/CNS PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.
Product codes
NXX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 eagle with three lines forming its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in all capital letters. The text is arranged around the circumference of the circle.
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
NOV 2 3 2009
Re: K092166
Trade/Device Name: S. aureus and/or other Staphylococcus species PNA FISH® Culture Identification Kit Regulation Number: 21 CFR § 866.3700 Regulation Name: Staphylococcus aureus serological reagents Regulatory Class: I Product Code: NXX Dated: November 19, 2009 Received: November 20, 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.
1
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).
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,
Jay attagne
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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K0921663
Device Name: S. aureus/CNS PNA FISH®
Indications for Use:
S. aureus/CNS PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or selected other Staphylococcus species on smears made from positive blood cultures containing Grampositive cocci in clusters observed on Gram stain.
Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.
S. aureus/CNS PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Souastyn
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092166-3