QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA

K120817 · Inova Diagnostics, Inc. · MID · Feb 26, 2013 · Immunology

Device Facts

• Record ID: K120817
• Device Name: QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
• Applicant: Inova Diagnostics, Inc.
• Product Code: MID · Immunology
• Decision Date: Feb 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

QUANTA Flash β2GP1 IgA: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-β2 glycoprotein-1 (β2GP1) IgA antibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome, when used in conjunction with other laboratory and clinical findings. QUANTA Flash β2GP1 IgA Controls: The QUANTA Flash β2GP1 IgA Controls are intended for the quality control purposes of the QUANTA Flash β2GP1 IgA assay performed on the BIO-FLASH® instrument. QUANTA Flash aCL IgA: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgA antibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings. QUANTA Flash aCL IgA Controls: The QUANTA Flash aCL IgA Controls are intended for quality control purposes of the QUANTA Flash aCL IgA assay performed on the BIO-FLASH® instrument.

Device Story

Device is a fully automated chemiluminescent immunoassay (CIA) for semi-quantitative measurement of IgA antibodies to β2-glycoprotein-1 or cardiolipin in human serum/citrated plasma. Operates on BIO-FLASH instrument; uses magnetic particles coated with purified human β2GP1 or bovine cardiolipin/human β2GP1. Patient sample mixed with beads and assay buffer; incubated; washed; isoluminol-conjugated anti-human IgA tracer added. After further incubation and washing, triggers (catalyst/oxidant) added to induce chemiluminescence. Light output (RLU) measured by optical system; proportional to antibody concentration. Results calculated via 4-parameter logistic curve (4PLC) against lot-specific master curve. Used in clinical laboratories to aid diagnosis of thrombotic disorders associated with APS. Output provides semi-quantitative values (CU) to assist clinicians in diagnostic decision-making.

Clinical Evidence

Clinical validation performed on 632 patient samples (APS and non-APS controls). Sensitivity for total APS: 33.6% (β2GP1 IgA) and 31.5% (aCL IgA). Specificity (excluding SLE): 99.1% for both assays. Method comparison against predicate ELISAs showed overall percent agreement of 87.8% (β2GP1 IgA) and 89% (aCL IgA) in clinical validation sets. Analytical performance included precision (total CVs generally <15%), linearity, and interference testing.

Technological Characteristics

Solid phase: paramagnetic beads coated with β2GP1 or cardiolipin. Detection: isoluminol-conjugated monoclonal anti-human IgA. Energy source: BIO-FLASH instrument (chemiluminescence). Dimensions/form factor: reagent cartridge system. Connectivity: BIO-FLASH instrument system. Sterilization: N/A (reagents). Software: BIO-FLASH system software. Algorithm: 4-parameter logistic curve (4PLC) data reduction.

Indications for Use

Indicated for use as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS) in patients, when used in conjunction with other laboratory and clinical findings. For prescription use only.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Predicate Devices

• QUANTA Lite β2GP1 IgA ELISA (k973006)
• QUANTA Lite ACA III IgA ELISA (k953366)

Submission Summary (Full Text)

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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

October 31. 2013

INOVA DIAGNOSTICS, INC. C/O MS. ROSANNA KEIVENS DIRECTOR OF QUALITY SYSTEMS 9900 OLD GROVE ROAD SAN DIEGO, CA 92131

Re: k120817

Trade/Device Name: OUANTA Flash™ B2GP1 IgA OUANTA Flash™ aCL IgA OUANTA Flash™ B2GP] IgA Controls OUANTA Flash™ aCL IgA Controls Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: MID, MSV, JJX Dated: February 20, 2013 Received: February 21, 2013

Dear Ms. Keivens:

This letter corrects our substantially equivalent letter of February 26, 2013.

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. Iisting 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.

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Page 2 - Ms. Rosanna Keivens

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 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 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 (2 I 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 vours.

## Reena Philip -S

for 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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## Indications for Use

510(k) Number (if known): K120817

QUANTA Flash™ aCL IgA Device Name:

Indications For Use:

QUANTA Flash aCL IgA: Fully automated chemiluminescent immunoassay for the semiquantitative measurement of anti-cardiolipin (aCL) In human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings.

QUANTA Flash™ aCL IgA Controls Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The QUANTA Flash aCL IgA Controls are intended for quality control purposes of the QUANTA Flash aCL IgA assay performed on the BIO-FLASH® instrument.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

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Reena Philip -S 2013.03.04 12:24:33 -05'00'

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## Indications for Use

510(k) Number (if known): K120817

QUANTA Flash™ B2GP1 IgA Device Name:

Indications For Use:

Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 glycoprotein-1 ((S2GP1) IgA antibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome, when used in conjunction with other laboratory and clinical findings.

QUANTA Flash™ B2GP1 IgA Controls Device Name: Indications For Use: The QUANTA Flash \$2GP1 IgA Controls are intended for the quality control purposes of the QUANTA Flash B2GP1 IgA assay performed on the BIO-FLASH® instrument.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

Reena Philip -S 2013.03.04 12:25:36 -05'00' Page 1 of ____________________________________________________________________________________________________________________________________________________________________