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. coliIP. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.

Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a diagnostic device. It does not contain the detailed study results, acceptance criteria, or performance metrics typically found in a clinical study report or a summary of safety and effectiveness.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be gathered and what cannot:

Information NOT available in the provided text:

A table of acceptance criteria and the reported device performance: This document is the clearance letter, not the study report.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not present.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is not an AI-assisted device for human readers; it's a diagnostic test for identifying bacteria.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a laboratory assay, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
The sample size for the training set: Not present.
How the ground truth for the training set was established: Not present.

Information that can be extracted or inferred:

Device Name: E. coli/P. aeruginosa PNA Fish™
Indications for Use (from the document):
- E. coli/P. 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. coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.
- Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.
Regulatory Class: Class I
Product Codes: JSS
Regulatory Regulation Number: 21 CFR §866.2660
Regulatory Regulation Name: Microorganism differentiation and identification device.

To obtain the detailed study information, one would typically need to consult the complete 510(k) submission summary, which is often publicly available on the FDA's website, or directly request it from the manufacturer. The provided document is merely the FDA's clearance letter stating that the device is substantially equivalent to a predicate device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

DEC 1 8 2009

AdvanDX, Inc. c/o Ms. Paula E. Bulger Director of Regulatory Affairs 10A Roessler Road Woburn, MA 01801

K092236 Re:

Trade Name: E. coli/P. aeruginosa PNA Fish™ Regulation Number: 21 CFR §866.2660 Regulation Name: Microorganism differentiation and identification device. Regulatory Class: Class I Product Codes: JSS Dated: November 03, 2009 Received: November 04, 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.

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

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Page 2- Ms. Bulger

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) 796-5455. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sak, autr

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):

Device Name: E. colilP. aeruginosa PNA FISH®

Indications for Use:

The E. coliIP. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia.

Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth.

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

sion Sien-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

SIANO K09236

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.