(63 days)
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No
The summary describes a qualitative nucleic acid hybridization assay, which is a traditional laboratory technique 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 Candida albicans from blood cultures. This indicates a diagnostic purpose (identifying a pathogen) rather than a therapeutic one (treating or alleviating a disease).
Yes
Explanation: The device is described as a "qualitative nucleic acid hybridization assay intended for identification of Candida albicans from blood cultures," which identifies a specific pathogen from a biological sample, fitting the definition of a diagnostic device.
No
The description clearly states the device is a "qualitative nucleic acid hybridization assay," which is a laboratory test involving physical reagents and processes, not solely software.
Based on the provided information, the device "C. albicans PNA FISH" is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative nucleic acid hybridization assay intended for identification of Candida albicans from blood cultures." This describes a test performed on a biological sample (blood cultures) outside of the body to provide information about a medical condition (presence of Candida albicans). This is the core definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
C. albicans PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Candida albicans from blood cultures.
Product codes (comma separated list FDA assigned to the subject device)
NZS, JXB
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of 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 shows the logo for the Department of Health & Human Services (USA). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AdvanDx Inc. c/o Ms. Amy Aulwes Vice President Health Policy Associates, Inc. 690 Canton Street, Suite 302 Westwood, MA 02090
OCT 2 5 2006
Re: K062461
Trade/Device Name: C albicans PNA FISH Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Code: NZS, JXB Dated: October 17, 2006 Received: October 18, 20()6
Dear Ms. Aulwes:
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 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).
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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)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Sally attom
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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2A. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ KO62461
Device Name: C. albicans PNA FISH
Indications for Use:
C. albicans PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Candida albicans from blood cultures.
Over-The-Counter Use Prescription Use X Prescription 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 W. Pool
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safet 510(k