QUANTA FLASH CENTROMERE

K123880 · Inova Diagnostics, Inc. · LJM · Feb 7, 2014 · Immunology

Device Facts

• Record ID: K123880
• Device Name: QUANTA FLASH CENTROMERE
• Applicant: Inova Diagnostics, Inc.
• Product Code: LJM · Immunology
• Decision Date: Feb 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

QUANTA Flash Centromere is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-centromere protein B autoantibodies in human serum. The presence of anti-centromere protein B autoantibodies is used as an aid in the diagnosis of Systemic Sclerosis, in conjunction with clinical finding and other laboratory tests. QUANTA Flash Centromere Calibrators are intended for use with the QUANTA Flash Centromere Reagents for the determination of IgG anti-centromere protein B autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate the unit values. QUANTA Flash Centromere Controls are intended for use with the QUANTA Flash Centromere Reagents for quality control in the determination of IgG anti-centromere protein B autoantibodies in human serum.

Device Story

QUANTA Flash Centromere is a chemiluminescent immunoassay (CLIA) for detecting IgG anti-centromere protein B autoantibodies in human serum. The device consists of reagents, calibrators, and controls used on an automated instrument platform. It functions by measuring light emission proportional to the concentration of specific autoantibodies in the patient sample. Used in clinical laboratory settings by trained personnel, the output provides semi-quantitative results to assist clinicians in diagnosing Systemic Sclerosis. By identifying specific autoantibodies, the device supports clinical decision-making when combined with other laboratory tests and clinical findings, potentially facilitating earlier or more accurate diagnosis for patients suspected of having systemic sclerosis.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on analytical performance testing, including precision, linearity, and method comparison studies against the predicate ELISA device.

Technological Characteristics

Chemiluminescent immunoassay using paramagnetic beads coated with recombinant CENP-B antigen. Detection via isoluminol-conjugated anti-human IgG monoclonal antibody. Energy source: BIO-FLASH instrument optical system. Connectivity: Barcode-based reagent/master curve loading. Software: Instrument-specific firmware for RLU measurement and unit calculation. Sterilization: Not applicable (reagents). Form factor: Reagent cartridge system.

Indications for Use

Indicated for the semi-quantitative determination of IgG anti-centromere protein B autoantibodies in human serum as an aid in the diagnosis of Systemic Sclerosis in conjunction with clinical findings and other laboratory tests. For prescription use only.

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).

Predicate Devices

• QUANTA Lite Centromere ELISA (k003959)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

February 7, 2014

INOVA DIAGNOSTICS, INC. C/O MS. ANDREA SEAMAN SUPERVISOR, IMMUNOPATHOLOGY RESEARCH 9900 OLD GROVE RD. SAN DIEGO CA 92131-1638

Re: k123880

Trade/Device Name: Ouanta Flash Centromere Reagent Quanta Flash Centromere Calibrators Quanta Flash Centromere Controls Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: II Product Code: LJM, JIX, JJX Dated: February 3, 2014 Received: February 4, 2014

Dear Ms. Seaman:

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 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); 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

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Page 2-Ms. Andrea Seaman

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 regulations (21 CFR Parts 801 and 809), please contact 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. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Image /page/1/Picture/7 description: The image shows the name "Maria M. Chan -S" in a bold, sans-serif font. The letters are black against a white background. The letters "M. Chan" have a decorative border around them.

Maria M. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

## 51D(k) Number (if known) k123880

#### Device Name

QUANTA Flash Centromere Reagent

## Indications for Use (Describe)

QUANTA Flash Centromere is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-centromere protein B autoantibodies in human serum. The presence of anti-centromere protein B autoantibodies is used as an aid in the diagnosis Systemic Sclerosis, in conjunction with clinical finding and other laboratory tests.

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Elizabeth�@@afford -S

FORM FDA 3881 (1/14)

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

### 510(k) Number (if known) k123880

#### Device Name

QUANTA Flash Centromere Calibrators

## Indications for Use (Describe)

QUANTA Flash Centromere Calibrators are intended for use with the QUANTA Flash Centromere Reagents for the determination of IgG anti-Centromere autoantibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate the unit values.

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR FDA USE ONLY 23 2 3 2 2 2 2 2 2 2 2 2 2 3 2 2 3 2 2 3 2 3 2 2 3 2 3 2 3 2 3 2 3 2 3 2 3 3 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 . " Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Elizabeth AMStafford -S

FORM FDA 3881 (1/14)

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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

#### 510(k) Number (if known) k123880

### Device Name

#### QUANTA Flash Centromere Controls

## Indications for Use (Describe)

QUANTA Flash Centromere Controls are intended for use with the QUANTA Flash Centromere Reagents for quality control in the determination of IgG anti-centromere protein B autoantibodies in human serum.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY CARD THE FOR : "... . . . . -Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Elizabeth ADStafford -S

FORM FDA 3881 (1/14)