E.COLI/P. AERUGINOSA PNA FISH by ADVANDX, INC.

E. colilP. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The E. colifP. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E.coli and/or P. aeruginosa.

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided text regarding the E. coli/P. aeruginosa PNA FISH Culture Identification Kit, focusing on the acceptance criteria and study details:

Unfortunately, the provided text is a 510(k) clearance letter from the FDA and does not contain the specific details of the acceptance criteria nor the study results that proved the device met those criteria. The letter acknowledges that a 510(k) premarket notification was submitted and reviewed, determining the device is "substantially equivalent" to legally marketed predicate devices. This means that AdvanDx Inc. provided data demonstrating safety and effectiveness, likely including performance studies, but those study details are not present in this document.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of your specific questions about the study design.

However, based on the context of FDA device clearance and the nature of an "Identification Kit," I can infer some general aspects and what kind of information would typically be found in the actual study reports.

Based on the provided document, I cannot answer the following questions as the information is not present:

A table of acceptance criteria and the reported device performance
Sample sizes used for the test set
Data provenance (country of origin, retrospective/prospective)
Number of experts used to establish ground truth for the test set
Qualifications of those experts
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
If a standalone (algorithm only) performance was done (as this is a lab kit, not an AI algorithm)
The type of ground truth used
Sample size for the training set
How the ground truth for the training set was established

What can be inferred or stated from the provided document:

Device Name: E. coli/P. aeruginosa PNA FISH Culture Identification Kit
Intended Use: "identification of Escherichia coli and Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods. The E. coli/P. aeruginosa PNA FISH assay is indicated for use in conjunction with positive blood subcultures as an aid in the identification of E.coli and/or P. aeruginosa."
Regulatory Class: Class I (indicated by the 510(k) process and the lack of mention of Special Controls or PMA). This generally means a lower regulatory burden and often substantial equivalence is based on comparisons to well-established predicate devices.
Nature of the Device: It's a "qualitative nucleic acid hybridization assay." This means it likely uses probes (PNA FISH - Peptide Nucleic Acid Fluorescent In Situ Hybridization) to bind to specific RNA sequences of the target bacteria (E. coli and P. aeruginosa) within a sample, and the binding is detected qualitatively (e.g., presence/absence of fluorescence under a microscope).

Hypothetical Information (what would typically be found in the supporting 510(k) submission but is not in this letter):

For a device like this, the acceptance criteria would most likely revolve around:

Sensitivity: The ability of the test to correctly identify E. coli or P. aeruginosa when they are present in the sample.
Specificity: The ability of the test to correctly identify when E. coli or P. aeruginosa are not present (i.e., not cross-reacting with other common blood culture pathogens).
Accuracy: Overall agreement with a gold standard method.
Reproducibility/Repeatability: Consistency of results when tested multiple times under the same or varying conditions.

The study would typically involve:

Test Set: A collection of positive blood culture samples (either contrived or clinical) known to contain E. coli, P. aeruginosa, other Gram-negative rods, or other bacteria/no bacteria.
Ground Truth: For a microbiology identification kit, the ground truth would almost certainly be established by culture and biochemical identification methods (e.g., Vitek, API, or 16S rRNA gene sequencing) performed by trained microbiologists. This is the "gold standard" for bacterial identification. Pathology or outcomes data would not be relevant here.
Standalone Performance: For a diagnostic kit, the performance is almost always "standalone" – the kit itself processes the sample and gives a result. There isn't typically an "algorithm only" or a "human-in-the-loop" aspect in the same way there would be for an AI imaging device. Human interpretation might be involved in reading a fluorescent signal under a microscope, but the "performance" is tied to the chemical reaction of the kit.
Training Set: While not explicitly mentioned, during the development of such an assay, "training" might involve optimizing probe design, hybridization conditions, and interpretation criteria using a smaller set of known positive and negative samples before large-scale validation. The ground truth for this would also be established by culture.

Summary

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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 features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Paula E. Bulger Director of Regulatory Affairs AdvanDx Inc. 10A Roessler Road Woburn, MA 01801, USA

DEC 1 9 2008

Re: K081309

Trade/Device Name: E. coli/P aeruginosa PNA FISH Culture Identification Kit Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganisms differentiation and identification device Regulatory Class: Class I Product Code: JSS Dated: December 5, 2008 Received: December 8, 2008

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.

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitto 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 vours,

Sally attaym

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): K081309

Device Name: E. coli/ P. aeruginosa PNA FISH

Indications for Use:

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 L. Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081309

Regulation Number and Section

§ 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.