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.

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.

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 Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter pertains to in vitro diagnostic devices (reagents, calibrators, and controls) for detecting anti-centromere protein B autoantibodies. As such, the concept of a "device" in the context of an AI or imaging system, with acceptance criteria like sensitivity, specificity, and a detailed study report, is not directly applicable here.

However, I can extract the relevant information from the document in a way that aligns with your request's structure as much as possible, interpreting "device performance" as the intended use claims and "study" as the evidence supporting those claims.

Here's an interpretation based on the provided document:

Acceptance Criteria and Device Performance (Interpreted for IVD)

Acceptance Criteria (Implied)	Reported Device Performance (Summary of Indication)
QUANTA Flash Centromere Reagent: To accurately and semi-quantitatively determine IgG anti-centromere protein B autoantibodies in human serum as an aid in the diagnosis of Systemic Sclerosis.	QUANTA Flash Centromere Reagent: A chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-centromere protein B autoantibodies in human serum. The presence of these autoantibodies is used as an aid in the diagnosis of Systemic Sclerosis, in conjunction with clinical findings and other laboratory tests.
QUANTA Flash Centromere Calibrators: To establish a point of reference for the working curve with the reagents.	QUANTA Flash Centromere Calibrators: 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.
QUANTA Flash Centromere Controls: To be used for quality control with the reagents.	QUANTA Flash Centromere Controls: 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.

Study Details (Based on the nature of a 510(k) for an IVD kit)

Please note that this document is a 510(k) clearance letter, which affirms substantial equivalence to a predicate device. It usually does not contain the detailed study report itself, but rather references the successful submission of such data. Therefore, many of the specific quantitative details you requested are not present in this letter.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the clearance letter. For IVDs, this would typically involve a statistically significant number of patient samples (both positive and negative for the target autoantibody and disease state) and controls.
- Data Provenance: Not specified in the clearance letter. Clinical data would typically come from retrospective or prospective collections in various clinical settings.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. For IVDs detecting autoantibodies for diagnostic aid, "ground truth" often involves a combination of:
  - Clinical diagnosis by qualified physicians (e.g., rheumatologists) based on established criteria (e.g., ACR/EULAR criteria for Systemic Sclerosis).
  - Results from other established laboratory reference methods (e.g., IFA, Western Blot, or another cleared ELISA/CLIA).
  - Patient medical history and follow-up.
- The "experts" would be the clinicians and laboratory professionals involved in establishing the patient's true disease status or autoantibody presence.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified. Adjudication methods are more common in imaging studies. For IVDs, discrepancies between the investigational device and the ground truth (or predicate method) would typically be investigated per study protocol, potentially involving re-testing or review of clinical records.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an in vitro diagnostic (IVD) immunoassay kit, not an AI or imaging device involving human "readers." It provides a semi-quantitative measurement of an autoantibody.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Applicable in a different context. The "device" (reagent, calibrators, controls) provides a result (semi-quantitative determination of autoantibodies) without human interpretation of complex images or signals in the way an AI would. The human "in the loop" aspects for an IVD are the laboratory technician performing the test and the clinician interpreting the result in the context of other clinical findings. The performance demonstrated in the submission would be the "standalone" analytical and clinical performance of the assay system itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- As inferred above, the ground truth for the clinical utility claim ("aid in the diagnosis of Systemic Sclerosis") would likely be established by clinical diagnosis based on established criteria and other laboratory tests, potentially supported by long-term outcomes data or comparison to a reference method. For analytical performance, ground truth would be established by known positive/negative samples and spiked samples.
The sample size for the training set:
- Not explicitly mentioned. For an IVD, the concept of a "training set" in the context of machine learning isn't directly applicable in the same way. However, method development and optimization would involve numerous experiments with various samples (analogous to training/tuning) before final validation. The 510(k) submission would focus on the validation (test set) performance.
How the ground truth for the training set was established:
- Not applicable in the AI/ML context. For IVD development, "ground truth" during development involves using well-characterized samples (e.g., clinically confirmed SSc patients, healthy controls, disease controls) for analytical and early clinical studies to optimize the assay parameters and ensure it functions as intended.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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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)

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)

is 二十九 .

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

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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)

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)

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)

Regulation Number and Section

§ 866.5100 Antinuclear antibody immunological test system.

(a)
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).(b)
Classification. Class II (performance standards).