(70 days)
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No
The summary describes a nucleic acid hybridization assay, which is a laboratory test, and there is no mention of AI or ML in the provided text.
No
This device is an in vitro diagnostic (IVD) assay used for identification, not for treating any condition.
Yes
The device is used to identify specific microorganisms (Enterococcus faecalis and other enterococci) from patient samples (blood cultures), which is a diagnostic function.
No
The summary describes a qualitative nucleic acid hybridization assay, which is a laboratory test involving chemical reagents and biological samples, not a software-only device.
Based on the provided information, the device 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 Enterococcus faecalis and selected other enterococci (OE) from blood cultures." This describes a test performed in vitro (outside the body) on a biological sample (blood cultures) to provide diagnostic information (identification of specific bacteria).
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The description perfectly aligns with this definition.
N/A
Intended Use / Indications for Use
E. faecalis PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures.
Product codes
OAH
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
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§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney 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 U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AdvanDx, Inc c/o Mr. Juan Carlos Serna Health Policy Associates, Inc. 690 Canton Street, Suite 302 Westwood, MA 02090
DEC 2 2 2 2006
Re: K063127 Trade/Device Name: E. faecalis PNA FISH Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. Serological reagents Regulatory Class: Class I Product Code: OAH Dated: November 15, 2006 Received: November 16, 2006
Dear Mr. Serna:
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, anton
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): ____________________________________________________________________________________________________________________________________________________
Device Name: E. faecalis PNA FISH
Indications for Use:
E. faecalis PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Enterococcus faecalis and selected other enterococci (OE) from blood cultures.
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)
Ludmila Poole
Division Sign Off
Asion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety