(185 days)
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No
The summary describes a nucleic acid hybridization assay, which is a laboratory test, and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) assay used for identification of bacteria from blood cultures, aiding in diagnosis, not for treating a condition.
Yes
The device is stated to be "indicated in an aid in the diagnosis of bacteremia caused by enterococci." This clearly indicates its use in the diagnostic process.
No
The device is described as a "nucleic acid hybridization assay," which is a laboratory test involving physical reagents and procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and/or the detection of selected other enterococci on smears prepared from positive blood cultures." This describes a test performed in vitro (outside the body) on a biological sample (blood culture) to aid in diagnosis.
- Device Description: The description confirms it's a "qualitative nucleic acid hybridization assay," which is a common type of IVD technology.
- Anatomical Site: The sample is from "blood cultures," which is a biological specimen used in IVD testing.
- Indication: It's indicated as "an aid in the diagnosis of bacteremia caused by enterococci," which is a diagnostic purpose.
All these elements align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and/or the detection of selected other enterococci on smears prepared from positive blood cultures containing grampositive cocci in pairs and chains observed on Gram stain.
Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
Enterococcus QuickFISH BC is indicated in an aid in the diagnosis of bacteremia caused by enterococci.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.3740
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 and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
AdvanDx, Inc. c/o Benjamin S. Crystal Clinical and Regulatory Affairs Manager 400 Trade Center, Suite 6990 Woburn, MA 01801
JAN 2 9 2013
Re: K121991
Trade/Device Name: Enterococcus QuickFISH BC Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. serological reagents Regulatory Class: Class I Product Code: OAH Dated: December 10, 2012 Received: December 11, 2012
Dear Mr. Crystal:
This letter corrects our substantially equivalent letter of January 7, 2013.
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
1
CFR Part 807); labeling (21 CFR Part 801); 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 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Uwe Scherf for
Sally A. Hojvat, M. Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure: Indications for Use Statement
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510(k) Number (if known): K121991
Device Name: Enterococcus QuickFISH BC
Indications for Use:
Enterococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Enterococcus faecalis and/or the detection of selected other enterococci on smears prepared from positive blood cultures containing grampositive cocci in pairs and chains observed on Gram stain.
Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
Enterococcus QuickFISH BC is indicated in an aid in the diagnosis of bacteremia caused by enterococci.
Prescription Use X (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)
Ragu Lt, Acting Branch Chief, Bac!
Division Sign-Of
e of In Vitro Diagnostics and Radiological Health
510(k) K121991