STAPHYLOCOCCUS QUICKFISH BC

K113371 · Advandx, Inc. · NXX · Apr 3, 2012 · Microbiology

Device Facts

• Record ID: K113371
• Device Name: STAPHYLOCOCCUS QUICKFISH BC
• Applicant: Advandx, Inc.
• Product Code: NXX · Microbiology
• Decision Date: Apr 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3700
• Device Class: Class 1

Intended Use

The Staphylococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or coagulasenegative staphylococci commonly isolated from human blood cultures, on smears prepared from positive blood cultures containing gram-positive cocci in clusters observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, and/or differentiation of mixed growth. Staphylococcus QuickFISH BC is indicated as an aid in the diagnosis of S. aureus bacteremia and/or coagulase-negative staphylococci commonly isolated from human blood cultures.

Device Story

Staphylococcus QuickFISH BC is a qualitative nucleic acid hybridization assay; utilizes fluorescent in situ hybridization (FISH) technology. Input: smears prepared from positive blood cultures containing gram-positive cocci in clusters. Process: multicolor hybridization to identify specific staphylococcal species. Output: visual identification of S. aureus and/or coagulase-negative staphylococci via fluorescence. Used in clinical laboratories by trained personnel. Results aid clinicians in diagnosing bacteremia; facilitates faster identification compared to traditional culture methods; enables earlier targeted therapy. Sub-culturing remains required for susceptibility testing and mixed growth differentiation.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Multicolor, qualitative nucleic acid hybridization assay (FISH). Utilizes fluorescent probes for identification of S. aureus and coagulase-negative staphylococci. Form factor: kit-based reagents for smear preparation and hybridization. Standalone diagnostic test.

Indications for Use

Indicated for identification of S. aureus and/or coagulase-negative staphylococci in human blood cultures for patients with positive blood cultures showing gram-positive cocci in clusters.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

APR - 3 2012

AdvanDx. Inc. c/o Mr. Benjamin S. Crystal Clinical and Regulatory Affairs Manager 400 TradeCenter, Suite 6990 Woburn, MA 01801

Re: K113371

Trade/Device Name: Staphylococcus QuickFISH™ BC Regulation Number: 21 CFR 866.3700 Regulation Name : FISH (Fluorescent in situ hybridization) kit, Protein Nuclei Acid, RNA, Staphylococcus aureus

Regulatory Class: Class I Product Code: NXX Dated: March 27, 2012 Received: March 29, 2012

Dear Mr. Crystal:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave toviewed your becalling 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 Connineres prior to May 20, 1978, the occordance with the provisions of the Federal Food, Drug, devices that have been receasined in access approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ap and COSMECE Act (1 tell that do not request to the general controls provisions of the Act. The You may, merciole, market the device, books of the universe for annual registration, listing of general Controls provisions of the recess labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 21 If your device is Classifica (see above) into exas ffecting your device can be found in Title 21, additional controls. Existing major regarations and to 895. In addition, FDA may publish further Cour of Pouchar concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuated or a baoines with other requirements of the Act
that FDA has made a determination that your device complies. You must that FDA has made a determination that your steers a goncered by other Federal agencies. You must or any Federal statutes and regulations annumbles, but not limited to: registration and listing (21
comply with all the Act's requirements, including, and seess reporting (re comply with an the Act s requirements, morating, on medical device reporting (reporting of

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## Page 2 - Benjamin S. Crystal

medical device-related adverse events) (21 CFR 803); and good manufacturing pactice modical device readed adverse creatity systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in keting your device as described in your Section 510(k) premarket will anow you to begal mation of substantial equivalence of your device to a legally marketed nonication. The I Driving of seation 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 Parts 801 and If you desire specific ad rice of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDA regulation (21 OF N Party/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may other other general meethances one 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,

Salgattyns

Sally A. Hojvat, M.Šc., 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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## 510(k) Number (if known): 113371

Device Name: Staphylococcus QuickFISH BC

Indications for Use:

The Staphylococcus QuickFISH BC is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Staphylococcus aureus and/or coagulasenegative staphylococci commonly isolated from human blood cultures, on smears prepared from positive blood cultures containing gram-positive cocci in clusters observed on Gram stain.

Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing, and/or differentiation of mixed growth.

Staphylococcus QuickFISH BC is indicated as an aid in the diagnosis of S. aureus bacteremia and/or coagulase-negative staphylococci commonly isolated from human blood cultures.

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)

Luedde h. Paole

Avision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113371