(27 days)
EK/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made 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.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
The EK/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the AdvanDx EK/P. aeruginosa PNA FISH device. It confirms the device's substantial equivalence to a legally marketed predicate device. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it include details about sample sizes, ground truth establishment, or expert qualifications.
The letter primarily focuses on:
- Device Name: AdvanDx EK/P. aeruginosa PNA FISH
- Regulation Number/Name: 21 CFR 866.2660, Microorganism differentiation and identification device
- Regulatory Class: Class I
- Product Code: JSS, JSZ
- Indications for Use: Multicolor, qualitative nucleic acid hybridization assay for identification of Escherichia coli and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. It also states that the test does not distinguish between E. coli and K. pneumoniae and serves as an aid in diagnosis.
To answer your specific questions, one would need access to the actual 510(k) submission or the study report that was cited in the submission. The information requested falls under the detailed performance data and clinical evidence typically presented in such submissions, which are not part of this clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
SEP - 1 2009
Paula E. Bulger Director, Regulatory Affairs AdvanDx, Inc. 10A Roessler Road Woburn, MA 01801
K092393 Re:
Trade/Device Name: AdvanDx EK/P. aeruginosa PNA FISH Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism differentiation and identification device Regulatory Class: Class I Product Code: JSS, JSZ Dated: August 4, 2009 Received: August 5, 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 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.
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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). 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 (301) 594-3084. 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.
Vay attyr
Sally A. Hoivat. 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 2A.
510(k) Number (if known): KO92393
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 and/or Klebsiella pneumoniae and Pseudomonas aeruginosa on smears made 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.
Subculturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
The EK/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or K. pneumoniae and P. aeruginosa bacteremia.
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)
Freddie tu. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092393
EK/PAER PNAFISH: 00026 (08/04/09) ADX
§ 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.