(289 days)
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No
The summary describes a nucleic acid hybridization assay, which is a biochemical test, and contains no mention of AI, ML, image processing, or computational analysis typically associated with AI/ML devices.
No
The device is a diagnostic assay for identifying specific Candida species from blood cultures, aiding in diagnosis rather than providing therapy.
Yes
The "Intended Use / Indications for Use" explicitly states that the assay is "intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis, and identification of Candida glabrata and/or Candida krusei on smears made from positive blood cultures" and "is indicated for use as an aid in the diagnosis of C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei fungemia." These are clear indicators of a diagnostic device.
No
The device is a nucleic acid hybridization assay, which is a laboratory test involving chemical reagents and physical processes, not solely software.
Yes, 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 Candida species on smears made from positive blood cultures." This describes a test performed in vitro (outside the body) on a biological sample (blood culture).
- Aid in Diagnosis: The intended use also states it is "indicated for use as an aid in the diagnosis of C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei fungemia." This directly aligns with the purpose of IVDs, which are used to provide information for the diagnosis of diseases or conditions.
- Sample Type: The test is performed on "smears made from positive blood cultures," which is a biological specimen.
These points strongly indicate that the Yeast Traffic Light PNA FISH is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis, and identification of Candida glabrata and/or Candida krusei on smears made from positive blood cultures containing yeasts observed on Gram stain or other microbiological stains. The test does not distinguish between C. albicans and C. parapsilosis. The test does not distinguish between C. qlabrata and C. krusei.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation between C. albicans and C. parapsilosis, differentiation between C. glabrata and C. krusei, and/or differentiation of mixed growth.
Yeast Traffic Light PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei fungemia.
Product codes
NZS
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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§ 866.2660 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.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
AdvanDx c/o Benjamin S. Crystal Clinical and Regulatory Affairs Manager 400 TradeCenter Suite 6990 Woburn MA 01801
JUL 15 2010
Re: K093024
| Trade/Device Name: | Yeast Traffic Light PNA FISH |
|---|---|
| Regulation Number: | 21CFR §866.2660 |
| Regulation Name: | FISH (FLUORESCENT IN SITU HYBRIDIZATION) KIT, |
| PROTEIN NUCLEIC ACID, RNA, YEAST | |
| Regulatory Class: | Class I, |
| Product Code: | NZS |
| Dated: | July 7, 2010 |
| Received: | July 8, 2010 |
Dear Mr. Crystal:
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, Trug, 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 class II (Special Controls), it may be subject to such 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
1
Page 2 – Benjamin S. Crystal
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 advice for your device on our labeling regulation (21 CFR Part 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Say, aAzi
A. Heintz, M.Sc., PhD
Sally A. Hojvat, M.S Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K093024
Device Name: Yeast Traffic Light PNA FISH®
Indications for Use:
Yeast Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Candida albicans and/or Candida parapsilosis, identification of Candida tropicalis, and identification of Candida glabrata and/or Candida krusei on smears made from positive blood cultures containing yeasts observed on Gram stain or other microbiological stains. The test does not distinguish between C. albicans and C. parapsilosis. The test does not distinguish between C. qlabrata and C. krusei.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing, differentiation between C. albicans and C. parapsilosis, differentiation between C. glabrata and C. krusei, and/or differentiation of mixed growth.
Yeast Traffic Light PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. parapsilosis, C. tropicalis, and C. glabrata and/or C. krusei fungemia.
Prescription Use (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)
Friedrich Rode
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093024