AESKUSLIDES ANA HEP-2

K120889 · Aesku Diagnostics · DHN · Oct 15, 2012 · Immunology

Device Facts

• Record ID: K120889
• Device Name: AESKUSLIDES ANA HEP-2
• Applicant: Aesku Diagnostics
• Product Code: DHN · Immunology
• Decision Date: Oct 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

AESKUSLIDES ANA-HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA-HEp-2 is intended for use as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

Device Story

Indirect immunofluorescence assay for detection of antinuclear antibodies (ANA) in human serum. Input: patient serum samples applied to HEp-2 tissue culture slides. Process: patient antibodies bind to antigens on slide; FITC-labeled goat anti-human IgG conjugate added; binding visualized via fluorescence microscopy. Output: qualitative/semi-quantitative fluorescence intensity (1+ to 4+) and staining pattern (e.g., homogenous, speckled). Used in clinical laboratories; operated by trained technicians. Healthcare providers use results to aid diagnosis of systemic rheumatic diseases. Benefits: assists in identifying autoimmune conditions through visual pattern recognition and titer determination.

Clinical Evidence

No clinical trials; performance established via method comparison study. 138 clinical samples (rheumatic disease patients and healthy donors) compared against predicate. Results: 100% positive agreement (95% CI: 96.8–100%) and 100% negative agreement (95% CI: 85.1–100%). Pattern agreement was 100%. Precision studies (intra-assay, inter-assay, lot-to-lot, between-technician) showed high reproducibility with titer variations within ±1 dilution.

Technological Characteristics

Indirect immunofluorescence assay. Components: HEp-2 cell-coated 12-well slides, FITC-labeled goat anti-human IgG conjugate, positive/negative human serum controls, mounting medium (glycerol/PBS), sample/wash buffer (BSA/PBS/sodium azide). Requires fluorescence microscope (mercury/tungsten-halogen source, 390–490nm excitation, 515–520nm barrier filter, 400x magnification). Manual procedure.

Indications for Use

Indicated for the qualitative and/or semi-quantitative detection of antinuclear antibodies (ANA) in human serum to aid in the diagnosis of systemic rheumatic diseases. Intended for prescription use.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

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

OCT 15 2012

AESKU Diagnostics, Inc. c/o Dr. Helene Paxton Bioguidance, LLC 87 Pedrick - Woodstown Road . Pedrickstown, NJ 08067

Re: k120889

Trade/Device Name: AESKUSLIDES ANA-HEp-2 Regulation Number: 21 CFR §866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: DHN Dated: September 24, 2012 Received: September 25, 2012

Dear Dr. Paxton:

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 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); medical device reporting (reporting of medical

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## Page 2 - Dr. Helene Paxton

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health 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 http://www.fda.gov/MedicalDevices/Safety/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 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,

Reena Philip

on Maria Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

K120889 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

AESKUSLIDES ANA-HEp-2 is an indirect fluorescent antibody assay utilizing HEp-2 tissue culture cells as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. AESKUSLIDES ANA-HEp-2 Test System is intended for use as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reeve Philip

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k120889

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