The ARCHITECT HAVAB-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HA V) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. A test for IgM anti-HAV is indicated for testing of specimens from individuals who have signs and symptoms consistent with acute hepatitis. Test results are used in conjunction with other laboratory results and clinical information as an aid in the diagnosis of acute or recent hepatitis A viral infection.

Warning: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT HAVAB-M for use in screening blood, plasma, or tissue donors has not been established.

Assay performance characteristics have not been established when the ARCHITECT HAVAB-M assay is used in conjunction with other manufacturers' assays for specific hepatitis markers. Users are responsible for establishing their own performance characteristics.

Device Description

The ARCHITECT HAVAB-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma and neonatal serum. The ARCHITECT HAVAB-M assay is calibrated with ARCHITECT HAVAB-M Calibrator. ARCHITECT HAVAB-M Controls are used for monitoring the performance of the Abbott ARCHITECT i System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Abbott ARCHITECT® HAVAB®-M device, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the ARCHITECT HAVAB-M assay are based on its agreement with a comparator assay (the predicate device, Abbott AxSYM® HAVAB®-M 2.0 assay). The study established various percent agreements for different populations.

Acceptance Criteria Category	Reported Device Performance (Percent Agreement)	95% Confidence Interval
Instrument Negative Percent Agreement	100.0%	96.38% to 100.00%
Instrument Positive Percent Agreement	100.0%	94.64% to 100.00%
Prospective Population Positive Agreement	98.10%	93.29% to 99.77%
Prospective Population Negative Agreement	100.00%	99.34% to 100.00%
Acute HAV Population Positive Agreement	98.10%	93.29% to 99.77%
Pediatric Low Risk Negative Agreement	100.00%	96.38% to 100.00%
Prospective Pediatric Positive Agreement	98.88%	93.90% to 99.97%
Prospective Pediatric Negative Agreement	100.00%	75.29% to 100.00%

Study Details

This submission describes a comparison study between the ARCHITECT HAVAB-M assay and its predicate device, the Abbott AxSYM® HAVAB®-M 2.0 assay, to demonstrate substantial equivalence.

1. Sample sizes used for the test set and data provenance:

Instrument Comparison Study:
- 100 IgM anti-HAV negative specimens
- 67 IgM anti-HAV positive specimens
Comparison of Results and Percent Agreement (General Population): The specific numbers for the "prospectively collected population" are not explicitly stated, but the percentages are based on a comparison to the comparator assay.
Acute HAV Population: Not specified, but the positive percent agreement is reported.
Pediatric Low-Risk Population: Not specified, but the negative percent agreement is reported.
Prospective Pediatric Population: Not specified, but positive and negative percent agreements are reported.
Data Provenance: The text states "prospectively collected population" for some of the comparisons, indicating prospective data collection. The geographic origin of the data is not specified.

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

This device is an in vitro diagnostic (IVD) assay for detecting IgM antibodies, not an imaging device or one that typically involves human expert interpretation of raw data for ground truth establishment in the same way as, for example, a radiology AI.
The ground truth for the test set is established by the results from the comparator assay (Abbott AxSYM® HAVAB®-M 2.0 assay), which is itself a legally marketed and presumably validated device. There is no mention of independent human experts establishing ground truth for individual samples beyond what the predicate assay determines.

3. Adjudication method for the test set:

Not applicable in the conventional sense. The "adjudication" is essentially the result provided by the predicate device. The study design is a comparison of the new device's results against those of the predicate. Discordant results are not explicitly mentioned as undergoing a separate adjudication process by additional experts.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

No, this is an in vitro diagnostic (IVD) assay, not an AI-powered image analysis tool or a device designed to assist human readers in interpretation. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not applicable and was not conducted.

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

Yes, the performance presented for the ARCHITECT HAVAB-M assay is its standalone performance (referred to as "algorithm only" in the context of an IVD) compared to the predicate assay. There isn't a human-in-the-loop component for the interpretation of the ARCHITECT HAVAB-M assay's results; it provides a qualitative "positive" or "negative" result.

6. The type of ground truth used:

The ground truth is established by the results of the predicate device, the Abbott AxSYM® HAVAB®-M 2.0 assay. This is a common approach for demonstrating substantial equivalence for new IVD assays. While not explicitly stated, the predicate assay itself would have been validated against clinical diagnosis or other accepted methods to determine acute Hepatitis A infection.

7. The sample size for the training set:

The document does not specify a separate "training set" for the ARCHITECT HAVAB-M assay. For IVDs, the development process typically involves internal validation and optimization using various sample panels during development, but these are rarely presented as distinct "training sets" in 510(k) summaries in the same way an AI/ML device would. The data presented here is for the test set used to demonstrate performance against the predicate.

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

Since a distinct training set and its ground truth establishment are not described, this information is not available from the provided text. For IVD development, samples used for optimization (analogous to a training set) would typically have their status (positive/negative for the analyte) determined by reference methods or clinical diagnosis.

Summary

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K063329

510(k) Summary

APR 16 2007

Abbott ARCHITECT® HAVAB®-M

Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

According to the requirements of 21 CFR §807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.

Submitter's Name & Address: Abbott Laboratories

Diagnostic Division Department 09V6, Building AP6C-2 100 Abbott Park Road Abbott Park. Il 60064-6187 Telephone: (847) 938-6141 Fax: (847) 937-9616 Contact: Joseph C. Orlowski

Date Prepared:
Date Revised:
Device Proprietary Name:
Device Common Name:
Classification Number:

Predicate Device:

November 2, 2006 April 13, 2007 ABBOTT ARCHITECT® HAVAB®-M IgM antibody to hepatitis A virus (IgM anti-HAV) 21 CFR §866.3310

ABBOTT AxSYM® HAVAB®-M 2.0 assay. PMA Number: P790012/S011 Decision Date: February 2, 2004 Device reclassified from class III to class II (Guidance Document February 9, 2006)

Device Description:

The ARCHITECT HAVAB-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma and neonatal serum. The ARCHITECT HAVAB-M assay is calibrated with ARCHITECT HAVAB-M Calibrator. ARCHITECT HAVAB-M Controls are used for monitoring the performance of the Abbott ARCHITECT i System.

Device Intended Use:

ARCHITECT HAVAB-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. A test for IgM anti-HAV is indicated for testing of specimens from individuals who have signs and symptoms consistent with acute hepatitis. Test results are used in conjunction with other laboratory results and clinical information as an aid in the diagnosis of acute or recent hepatitis A viral infection.

Warning: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT HAVAB-M for use in screening blood, plasma, or tissue donors has not been established. Assay performance characteristics have not been established when the ARCHITECT HAVAB-M assay is used in conjunction with other manufacturers' assays for specific hepatitis markers. Users are responsible for establishing their own performance characteristics.

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The Intended Use of Predicate Device:

AxSYM HAVAB-M 2.0 is a microparticle enzyme immunoassay (MEIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human serum or plasma (potassium EDTA, sodium heparin, sodium citrate, or lithium heparin). A test for IgM anti-HAV is indicated as an aid in the laboratory diagnosis of acute or recent hepatitis A viral infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis A infection. WARNING: Assay performance characteristics have not been established for testing a pediatric population less than 10 years of age.

Instrument Percent Agreement:

A study was conducted to confirm that the ARCHITECT HAVAB-M assay can be used on the ARCHITECT i 2000 and ARCHITECT i 2000SR systems. One hundred IgM anti-HAV negative specimens and 67 IgM anti-HAV positive specimens were tested on two instruments (one i 2000 and one i 2000SR) using two lots of reagents and one lot of calibrators and controls. One replicate of each specimen was tested with the same reagent lot on both instruments. The negative percent agreement was 100.0% with a 95% confidence interval of 96.38% to 100.00%, and the positive percent agreement was 100.0% with a 95% confidence interval of 94.64 to 100.00%.

Comparison of Results and Percent Agreement:

The positive percent agreement of the ARCHITECT HAVAB-M assay with the comparator assay for the prospectively collected population was 98.10%, with a 95% confidence interval of 93.29% to 99.77%. The negative percent agreement of the ARCHITECT HAVAB-M assay with the comparator assay for the prospectively collected population was 100.00%, with a 95% confidence interval of 99.34% to 100.00%.

The positive percent agreement of the ARCHITECT HAVAB-M assay with the comparator assay for the acute HAV population is 98.10%, with a 95% confidence interval of 93.29% to 99.77%.

The negative percent agreement of the ARCHITECT HAVAB-M assay with the comparator assay for a pediatric population at low risk for hepatitis is 100.00%, with a 95% confidence interval of 96.38% to 100.00%.

The positive percent agreement for a prospectively collected pediatric population is 98.88%, with a 95% confidence interval of 93.90% to 99.97% and the negative percent agreement is 100.00%, with a 95% confidence interval of 75.29% to 100.00%.

In conclusion, these data demonstrate that the ARCHITECT HAVAB-M assay is as safe and effective as, and is substantially equivalent to, the Abbott AxSYM HAVAB-M 2.0 assay.

Prepared by and Submitted by: Joseph C. Orlowski, RAC Senior Regulatory Affairs Administrator ADD Regulatory Affairs

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wing-like shapes.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Joseph C. Orlowski, RAC Sr. Regulatory Affairs Administrator Abbott Laboratories Diagnostic Division 100 Abbott Park Road Department 09V6, Building AP6C-2 100 Abbott Park, IL 60064-6187

APR 16 2007

Re: K063329

Trade/Device Name: ARCHITECT® HAVAB®-M ARCHITECT® HAVAB®-M Calibrator ARCHITECT® HAVAB®-M Controls

Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A virus (HAV) serological assays Regulatory Class: Class II Product Code: LOL Dated: March 22, 2007 Received: March 23, 2007

Dear Mr. Orlowski:

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.

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 (QS) regulation (21 CFR Part 820).

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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 Iogal] marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally attorn

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): K063329

Device Name:

ARCHITECT® HAVAB®-M ARCHITECT® HAVAB®-M Calibrator ARCHITECT® HAVAB®-M Controls

Indications for Use:

Warning: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT HAVAB-M for use in screening blood, plasma, or tissue donors has not been established.

ARCHITECT HAVAB-M Calibrator:

The ARCHITECT HAVAB-M Calibrator is used to calibrate the ARCHITECT i System when the system is used for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) using the ARCHITECT HAVAB-M Reagent Kit. The performance of the ARCHITECT HAVAB-M Calibrator has not been established with any other IgM anti-HAV assays.

ARCHITECT HAVAB-M Controls:

The ARCHITECT HAVAB-M Controls are used for monitoring the performance of the ARCHITECT i System when used for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) using the ARCHITECT HAVAB-M Reagent Kit. The performance of the ARCHITECT HAVAB-M Controls has not been established with any other IgM anti-HAV assays.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Uve Schef
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

ko63329 510(k)________________________________________________________________________________________________________________________________________________________________________

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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.