S. AUREUS PNA FISH

K091827 · Advandx, Inc. · NXX · Aug 18, 2009 · Microbiology

Device Facts

• Record ID: K091827
• Device Name: S. AUREUS PNA FISH
• Applicant: Advandx, Inc.
• Product Code: NXX · Microbiology
• Decision Date: Aug 18, 2009
• 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 the identification of S. aureus on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain. Subculturing of positive blood cultures is necessary for susceptibility testing and/or differentiation of mixed growth. S. aureus PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.

Device Story

In vitro diagnostic assay; utilizes peptide nucleic acid (PNA) fluorescence in situ hybridization (FISH) technology. Input: smears prepared from positive blood cultures containing Gram-positive cocci in clusters. Process: PNA probes hybridize to specific ribosomal RNA sequences within the organism; fluorescently labeled probes allow visualization. Output: fluorescent signal indicating presence or absence of S. aureus. Used in clinical microbiology laboratories by trained technicians. Results aid clinicians in rapid identification of S. aureus bacteremia, facilitating targeted antimicrobial therapy and potentially improving patient outcomes by reducing time to appropriate treatment.

Clinical Evidence

No clinical data provided in the summary document; substantial equivalence based on technological characteristics and performance comparison to predicate.

Technological Characteristics

Nucleic acid hybridization assay using PNA probes. Fluorescence microscopy detection. Qualitative result. Standalone diagnostic kit.

Indications for Use

Indicated for identification of Staphylococcus aureus in patients with positive blood cultures showing Gram-positive cocci in clusters on Gram stain. Used as an aid in diagnosing S. aureus bacteremia. Requires subculturing for susceptibility testing.

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).

Predicate Devices

• S. aureus PNA FISH (K060099)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

## AUG 1 8 2009

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

Re: k091827

Trade/Device Name: S. aureus PNA FISH® Culture Identification Kit Regulation Number: 21 CFR § 866.3700 Regulation Name: Staphylococcus aureus serological reagents Regulatory Class: I Product Code: NXX Dated: August 12, 2009 Received: August 13, 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

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Freddie Poole, MS
Acting for:

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: S. aureus PNA FISH®

Indications for Use:

S. aureus PNA FISH is a qualitative nucleic acid hybridization assay intended for identification of Staphylococcus aureus on smears made from positive blood cultures containing Gram-positive cocci in clusters observed on Gram stain.

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

S. aureus PNA FISH is intended as an aid in the diagnosis of S. aureus bacteremia.

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)

Yuedith Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k091827