S. AUREUS PNA FISH

K060099 · Advandx, Inc. · NXX · May 8, 2006 · Microbiology

Device Facts

• Record ID: K060099
• Device Name: S. AUREUS PNA FISH
• Applicant: Advandx, Inc.
• Product Code: NXX · Microbiology
• Decision Date: May 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3700
• Device Class: Class 1

Intended Use

S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for presumptive identification of Staphylococcus aureus from blood cultures.

Device Story

S. aureus PNA FISH is a qualitative nucleic acid hybridization assay; utilizes peptide nucleic acid (PNA) probes to target specific ribosomal RNA sequences in Staphylococcus aureus. Input: positive blood culture samples. Process: hybridization of fluorescently labeled PNA probes to target RNA within fixed cells; visualization via fluorescence microscopy. Output: visual identification of S. aureus based on fluorescence pattern. Used in clinical microbiology laboratories by trained laboratory personnel. Provides rapid identification of S. aureus from blood cultures, enabling faster targeted antimicrobial therapy and improved patient management.

Clinical Evidence

Bench testing and multi-site clinical laboratory evaluations. Compared against standard culture identification procedures across 1,438 samples using BacT/Alert, ESP, and BACTEC systems. Overall sensitivity 99.2% (513/517) and specificity 99.5% (916/921). Reproducibility >95%. Analytical specificity 100% for S. aureus strains; potential for false positives with S. schleiferi due to single base mismatch.

Technological Characteristics

Nucleic acid hybridization assay using peptide nucleic acid (PNA) probes. Employs fluorescence in situ hybridization (FISH) technology. Requires fluorescence microscopy for visualization. Qualitative detection method.

Indications for Use

Indicated for presumptive identification of Staphylococcus aureus from positive blood cultures. For prescription use only.

Regulatory Classification

Identification

Staphylococcus aureus serological reagents are devices that consist of antigens and antisera used in serological tests to identify enterotoxin (toxin affecting the intestine) producing staphylococci from cultured isolates. The identification aids in the diagnosis of disease caused by this bacterium belonging to the genus Staphylococcus and provides epidemiological information on these diseases. Certain strains of Staphylococcus aureus produce an enterotoxin while growing in meat, dairy, or bakery products. After ingestion, this enterotoxin is absorbed in the gut and causes destruction of the intestinal lining (gastroenteritis).

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV . 3 2006

AdvanDx Inc. c/o Ms. Amy Aulwes Vice President Health Policy Associates, Inc. 690 Canton Street, Suite 302 Westwood, MA 02090

k060099 Re: Trade/Device Name: S. aureus PNA FISH Regulation Number: 21 CFR 866.3700 Regulation Name: Staphylococcus Aureus Serological Reagents Regulatory Class: Class I Product Code: NXX Dated: April 7, 2006 Received: April 10, 2006

Dear Ms. Aulwes:

This letter corrects our substantially equivalent letter of May 8, 2006.

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 CFR Part 807); labeling (21 CFR Part 801); 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.

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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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally, anton

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 2A.

510(k) Number (if known): K060099

Device Name: S. aureus PNA FISH

Indications for Use:

S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for presumptive identification of Staphylococcus aureus from blood cultures.

Prescription Use (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 Ln Poole

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**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K060099