(183 days)
Not Found
None
No
The summary describes a qualitative nucleic acid hybridization assay and does not mention any AI or ML components or processes.
No
The device is a diagnostic assay intended for identification of C. albicans and/or C. glabrata and as an aid in diagnosis, not for treating any condition.
Yes
The device is intended for use as "an aid in the diagnosis of C. albicans and/or C. glabrata fungemia."
No
The device is a fluorescence qualitative nucleic acid hybridization assay, which is a laboratory test method involving physical reagents and procedures, not solely software.
Based on the provided information, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "fluorescence qualitative nucleic acid hybridization assay intended for identification of C. albicans and/or C. glabrata on smears made from yeast positive blood cultures." and "indicated for use as an aid in the diagnosis of C. albicans and/or C. glabrata fungemia." This clearly describes a test performed in vitro (outside the body) on a biological sample (blood culture) to provide diagnostic information.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The description perfectly aligns with this definition.
N/A
Intended Use / Indications for Use
C. albicans/C. glabrata PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of C. albicans and/or C. glabrata on smears made from yeast positive blood cultures. Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. C. albicans/C. glabrata PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. glabrata fungemia.
Product codes
NZS
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
Prescription Use
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
§ 866.2660 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the seal is a stylized image of a human figure, represented by three curved lines that suggest a head, body, and legs.
10903 New Hampshire Avenue Silver Spring, MD 20993
Advan Dx, Inc. c/o Henrik Stender Vice President Research and Development 400 Trade Center, Suite 6990 Woburn, MA 01801-7476
MAR 13 2012
Re: K092784
Trade/Device Name: C. albicans/C.glabrata PNA FISH™ Regulation Number: 21 § CFR 866.2660 Regulation Name: Microorganism differentiation and identification device Regulatory Class: Class I Product Code: NZS Dated: January 28, 2010 Received: March 2, 2010
Dear Mr. Stender:
This letter corrects our substantially equivalent letter of March 12, 2010.
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 (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 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 Part 801); medical
1
Page 2 - Henrik Stender
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 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Say actquino
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
2
INDICATIONS FOR USE STATEMENT 2A.
510(k) Number (if known):
Device Name: C. albicans/C. glabrata PNA FISH®
Indications for Use:
C. albicans/C. glabrata PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of C. albicans and/or C. glabrata on smears made from yeast positive blood cultures.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
C. albicans/C. glabrata PNA FISH is indicated for use as an aid in the diagnosis of C. albicans and/or C. glabrata fungemia.
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)
Lucille M. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Only tion and Safety
Evaluation and
K092784
:10(k)