QUANTA FLASH ENA7

K122923 · Inova Diagnostics, Inc. · LLL · May 7, 2013 · Immunology

Device Facts

• Record ID: K122923
• Device Name: QUANTA FLASH ENA7
• Applicant: Inova Diagnostics, Inc.
• Product Code: LLL · Immunology
• Decision Date: May 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

QUANTA Flash ENA7 is a chemiluminescent immunoassay for the qualitative screening of IgG autoantibodies to Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum. The presence of these autoantibodies is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc), polymyositis (PM), dermatomyositis (DM), sjogren's syndrome (SjS) and mixed connective tissue disease (MCTD) in conjunction with clinical findings and other laboratory tests. QUANTA Flash ENA7 Calibrators are intended for use with the QUANTA Flash ENA7 Reagents for the determination of IgG autoantibodies to Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate the unit values. QUANTA Flash ENA7 Controls are intended for use with the QUANTA Flash ENA7 Reagents for quality control in the determination of IgG autoantibodies to Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum.

Device Story

QUANTA Flash ENA7 is a chemiluminescent immunoassay (CLIA) used to detect IgG autoantibodies in human serum. The device processes patient serum samples to identify specific autoantibodies (Sm, RNP, Ro60, Ro52/TRIM21, SS-B, Scl-70, Jo-1). It is intended for professional use in clinical laboratory settings. The system utilizes reagents, calibrators, and controls to perform the assay. Results are interpreted by clinicians alongside clinical findings and other laboratory tests to assist in diagnosing systemic autoimmune rheumatic diseases. The device provides qualitative screening results, aiding in the clinical decision-making process for patients presenting with symptoms of connective tissue disorders.

Technological Characteristics

Chemiluminescent immunoassay (CLIA) system; includes reagent kit, calibrator kit, and control kit; designed for detection of IgG autoantibodies; utilizes human serum samples; class II medical device.

Indications for Use

Indicated for qualitative screening of IgG autoantibodies to Sm, RNP, Ro60, Ro52/TRIM21, SS-B, Scl-70, and Jo-1 in human serum to aid diagnosis of SLE, SSc, PM, DM, SjS, and MCTD in patients suspected of connective tissue diseases.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 7, 2013

INOVA Diagnostics Inc. c/o Dr. Michael Mahler, Ph.D. 9900 Old Grove Road San Diego, CA 92131

Re: k122923

Trade/Device Name:

Regulation Number:

Regulation Name:

Regulatory Class:

Product Code:

QUANTA Flash ENA7 Reagent Kit QUANTA Flash ENA7 Calibrator Kit QUANTA Flash ENA7 Control Kit 21 CFR 8866.5100 Antinuclear antibody immunological test system Class II LLL, JIX, JJX April 2, 2013 April 5, 2013 : ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・

#### Dear Dr. Mahler:

Dated: Received:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{1}------------------------------------------------

Page 2 - Dr. Michael Mahler

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 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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

### Reena Phillips-S for

Maria M. Chan, Ph.D.

Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health (OIR)

: Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use Form

510(k) Number (if known): k122923 ·

Device Name: QUANTA Flash® ENA7 Reagents

Indications for Use:

QUANTA Flash ENA7 is a chemiluminescent immunoassay for the qualitative screening of IgG autoantibodies to Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum. The presence of these autoantibodies is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc), polymyositis (PM), dermatomyositis (DM), sjogren's syndrome (SjS) and mixed connective tissue disease (MCTD) in conjunction with clinical findings and other laboratory tests.

(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 In Vitro Diagnostics and Radiological Health (OIR)

## Reena የሕዝብ የሚጠርቅ - S

Prescription Use _

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

k122923 510(k)__

Page 1 of _ 1

{3}------------------------------------------------

### Indications for Use Form

510(k) Number (if known): k122923

QUANTA Flash® ENA7 Calibrator Kit Device Name:

Indications for Use:

QUANTA Flash ENA7 Calibrators are intended for use with the QUANTA Flash ENA7 Reagents for the determination of IgG autoantibodies to Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate the unit values.

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 In Vitro Diagnostics and Radiological Health (OlR)

# Reena Piիilijo - S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health k122923 510(k).

Page 1 of _ 1

{4}------------------------------------------------

## Indications for Use Form

510(k) Number (if known): k122923

Device Name: QUANTA Flash® ENA7 Control Kit

Indications for Use:

QUANTA Flash ENA7 Controls are intended for use with the QUANTA Flash ENA7 Reagents for quality control in the determination of IgG autoantibodies to Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum.

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 In Vitro Diagnostics and Radiological Health (OIR)

# Reena Philip -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

k122923 510(k)__

Page 1 of 1