(309 days)
EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli /Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The test does not distinguish between E. coli and K. pneumoniae. Further testing is needed to differentiate E. coli and K. pneumoniae. The EK/P. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E. coli/K. pneumoniae, and/or P. aeruginosa.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called EK/P. aeruginosa PNA FISH. It does not contain the detailed study information required to answer the prompt thoroughly.
Here's why and what's missing:
The provided text informs AdvanDx, Inc. that their device EK/P. aeruginosa PNA FISH has received 510(k) clearance. It specifies the regulation number, name, class, and product code. It also includes the indications for use.
Crucially, it does not include the results of any clinical studies, performance data, or detailed acceptance criteria. A 510(k) clearance letter acknowledges substantial equivalence to a predicate device, but the supporting data for that claim is typically found in the 510(k) submission itself, not the clearance letter.
Therefore,Based on the provided FDA 510(k) clearance letter for the EK/P. aeruginosa PNA FISH device, the following information regarding acceptance criteria and supporting studies cannot be extracted:
- Table of acceptance criteria and reported device performance: This document only states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not present the specific acceptance criteria or the performance metrics of the new device.
- Sample size used for the test set and data provenance: No details are provided about the test set size, nor where the data originated (country, retrospective/prospective).
- Number of experts used to establish ground truth and their qualifications: The document does not discuss the methodology of ground truth establishment for any studies.
- Adjudication method for the test set: There is no mention of adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: The document does not describe any MRMC studies or human-in-the-loop performance.
- Standalone (algorithm only) performance study: This document does not describe standalone performance. The device is a "qualitative nucleic acid hybridization assay," implying it's a lab-based test, not a standalone algorithm in the typical sense of AI imaging.
- Type of ground truth used: No information is given about how ground truth was established for any study (e.g., pathology, outcomes data, expert consensus).
- Sample size for the training set: There is no mention of a training set, as this is a diagnostic assay, not an AI/ML device in the context of the prompt's typical questions.
- How the ground truth for the training set was established: No information is available for a training set.
Summary of available information from the document:
- Device Name: EK/P. aeruginosa PNA FISH
- Intended Use: Qualitative nucleic acid hybridization assay for identification of Escherichia coli / Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods.
- Regulatory Status: 510(k) clearance, found substantially equivalent to predicate devices.
- Key Indication Note: The test does not distinguish between E. coli and K. pneumoniae; further testing is needed. It is indicated for use in conjunction with positive blood subcultures.
To answer your prompt comprehensively, one would need to access the full 510(k) submission documentation, which would contain the detailed study reports and performance data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Paula Bulger Director, Regulatory Affairs AdvanDx, Inc. 10A Rossler Road Woburn, MA 01901
MAR 2 6 2009
Re: K081433
Trade/Device Name: EK/P aeruginosa PNA FISH Regulation Number: 21 CFR § 866.2660 Regulation Name: Microorganism differential and identification device Regulatory Class: Class I Product Code: JSS Dated: January 23, 2009 Received: January 27, 2009
Dear Ms. Bulger:
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 misburanding 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 aft the Act or any Federal statutes and regulations administered by other Federal agencies. Your 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 advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attym
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K081433
Device Name: EK/ P. aeruginosa PNA FISH
Indications for Use:
EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli IKlebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The test does not distinguish between E. coli and K. pneumoniae. Further testing is needed to differentiate E. coli and K. pneumoniae. The EK/P. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E. colilK. pneumoniae, and/or P. aeruginosa.
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)
Freddie H. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
$\partial(k)$ K081433
§ 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.