The ADVIA Centaur HAV IgM assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human serum or plasma (EDTA, lithium heparinized, or sodium heparinized) using the ADVIA Centaur® System. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, infants, or children. WARNING: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. United States federal law restricts this device to sale by or on the order of a physician.

Device Description

The modified ADVIA Centaur® HAV IgM Assay is comprised of the following:

ADVIA Centaur HAV IgM ReadyPack primary reagent pack is composed of three components:

Lite Reagent - Mouse anti-HAV human IgM monoclonal antibody labeled with acridinium ester in . buffer with bovine serum albumin and preservatives. The modified device uses the fab2 fragment of the monoclonal antibody

Solid Phase Streptavidin coated paramagnetic microparticles with bovine serum albumin and . preservatives
Ancillary Well Reagent Inactivated purified hepatitis A virus (<0.1 ug/ml) in buffer with bovine . serum albumin and preservatives

ADVIA Centaur HAV IgM Readypack ancillary reagent pack containing ADVIA Centaur HAV IgM Ancillary Reagent which is composed of biotinylated mouse monoclonal to anti-human IgM in buffer with bovine serum albumin and preservatives.
ADVIA Centaur HAV IgM Calibrators

AI/ML Overview

This looks like a 510(k) premarket notification for an in vitro diagnostic immunoassay, not an AI/ML medical device. Therefore, many of the requested fields related to AI/ML device studies (e.g., MRMC studies, number of experts for ground truth, training set information) are not applicable.

Here's the information as best as can be extracted from the provided text, focusing on the device's performance and the study details that are relevant to this type of diagnostic assay:

Acceptance Criteria and Device Performance for ADVIA Centaur® HAVM Assay

The provided text does not explicitly state "acceptance criteria" in a table format with specific quantifiable thresholds for this 510(k) submission. However, for diagnostic assays, acceptance criteria are generally established during internal validation and analytical performance studies to demonstrate that the assay consistently meets performance specifications (e.g., sensitivity, specificity, precision, accuracy). The 510(k) summary typically includes a comparison to a predicate device and demonstrates that the new device is "substantially equivalent" in performance.

The provided document focuses on describing the device, its intended use, and affirming its substantial equivalence to a predicate device without listing detailed performance metrics or the specific studies used to demonstrate those metrics for the modified device. The document explicitly states:

"The modified ADVIA Centaur HAV IgM assay has the same operating principles, design, method of manufacture, assay performance characteristics and intended use as the predicate device. The modified ADVIA Centaur HAV IgM assay is substantially equivalent to the predicate ADVIA Centaur HAV IgM assay."

This statement implies that the "acceptance criteria" are effectively met by demonstrating performance equivalent to the predicate device. Without further documentation (e.g., a detailed performance study report), specific numerical acceptance criteria and reported device performance cannot be extracted from the provided text.

Therefore, a table of acceptance criteria and reported device performance cannot be formulated from the given text.

Here's an attempt to answer the other questions based on the available information:

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text.
Data Provenance: Not specified in the provided text. For an in vitro diagnostic, this would typically involve human serum or plasma samples. The country of origin and whether data was retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable / Not Specified: For an immunoassay like this, ground truth is typically established by established diagnostic methods (e.g., other validated assays, clinical diagnosis based on a combination of tests and patient history) rather than expert consensus on image interpretation. The document does not provide details on how the ground truth for any validation samples was established.

4. Adjudication method for the test set:

Not Applicable / Not Specified: Adjudication methods are more relevant for subjective interpretations (e.g., radiology reads). For a quantitative or qualitative immunoassay result, the "adjudication" is typically the result of the reference method used to establish ground truth.

5. 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 is an in vitro diagnostic immunoassay, not an AI-assisted device that involves human readers interpreting cases. Therefore, an MRMC study and AI assistance effect size are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes (Implied): The ADVIA Centaur® HAVM Assay is an automated immunoassay system. Its performance characteristics (like sensitivity and specificity) are inherently "standalone" in the sense that the assay itself generates the result without human intervention in the result determination beyond running the sample on the instrument. No "human-in-the-loop" is involved in interpreting the assay's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not Specified: The document does not detail how the ground truth for establishing assay performance (e.g., sensitivity, specificity) was determined. For diagnostic assays, it is typically established using a highly accurate reference method or a composite reference standard (e.g., a combination of other serological tests, clinical diagnosis, and follow-up).

8. The sample size for the training set:

Not Applicable / Not Specified: For an immunoassay, there isn't a "training set" in the sense of AI/ML models. Assay development involves optimizing reagents and conditions, and then validating performance with a series of characterized clinical samples. The document does not provide details on sample sizes used during assay development or validation.

9. How the ground truth for the training set was established:

Not Applicable / Not Specified: As there isn't a "training set" in the AI/ML context, this question is not directly applicable. If referring to samples used during assay development and optimization, their "ground truth" would likely be established through reference methods.

Summary

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Siemens Healthcare Diagnostics Inc. 510(k) Premarket Notification - ADVIA Centaur® HAVM Assay

K081716

510(k) Summary ADVIA Centaur® HAVM Assay

JUL 1 7 2008

1. Manufacturer's Name, Address, Telephone, and Contact Person

Manufacturer

Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, New York 10591-5097

Contact Information:

Mary Seeger Manager, Requlatory Affairs Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, New York 10591-5097

Phone: 914-524-2908 Fax : 914-524-2500

2. Date Summary Prepared:

June 10, 2008

3. Device Trade Name / Common Name

Common Name: IgM Antibody to Hepatitis A Virus (Anti-HAV IgM Assay) ADVIA Centaur® HAV IgM ReadyPack Reagents Trade Name: ADVIA Centaur® HAV IgM ReadyPack Calibrators FDA Classification: Class II (special controls)

Device Classification Name: Hepatitis A Test IgM Antibody 4.

5. Intended Use:

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6. Device Description

The modified ADVIA Centaur® HAV IgM Assay is comprised of the following:

ADVIA Centaur HAV IgM ReadyPack primary reagent pack is composed of three components:

Solid Phase Streptavidin coated paramagnetic microparticles with bovine serum albumin and . preservatives
Ancillary Well Reagent Inactivated purified hepatitis A virus (<0.1 ug/ml) in buffer with bovine . serum albumin and preservatives

ADVIA Centaur HAV IgM Readypack ancillary reagent pack containing ADVIA Centaur HAV IgM Ancillary Reagent which is composed of biotinylated mouse monoclonal to anti-human IgM in buffer with bovine serum albumin and preservatives.
ADVIA Centaur HAV IgM Calibrators

7. Substantial Equivalence

The modified ADVIA Centaur HAV IgM assay has the same operating principles, design, method of manufacture, assay performance characteristics and intended use as the predicate device. The modified ADVIA Centaur HAV IgM assay is substantially equivalent to the predicate ADVIA Centaur HAV IgM assay.

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services (USA). The seal features a stylized eagle with its wings spread, facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 7 2008

Siemens Healthcare Diagnostics Inc. C/O Mary Seeger, Ph.D. Manager, Regulatory Affairs 511 Benedict Avenue Tarrytown, New York 10592

Re: K081716

Trade/Device Name: ADVIA Centaur HAVM Assay Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A IgM Regulatory Class: Class II Product Code: LOL Dated: June 16, 2008 Received: June 18, 2008

Dear Dr. Seeger:

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. Insting 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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sally attaym

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K081716

Device Name: ADVIA Centaur® HAV IgM ReadyPack Reagents ADVIA Centaur® HAV IgM Quality Control Materials

Indications for Use:

The ADVIA Centaur HAV IgM assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus.

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, infants, or children.

WARNING: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. United States federal law restricts this device to sale by or on the order of a physician.

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 Device Eyaluation (ODE)

Uve Schuf

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

208 1716 510(k)-

Regulation Number and Section

§ 866.3310 Hepatitis A virus (HAV) serological assays.

(a)
Identification. HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.(b)
Classification. Class II (special controls). The special control is “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.” See § 866.1(e) for the availability of this guidance document.