K Number

Device Name

ARCHITECT HAVAB-G

Manufacturer

ABBOTT LABORATORIES

Date Cleared

2012-06-28

(195 days)

Product Code

LOL JIS MJX MJY

Regulation Number

866.3310

Intended Use

The ARCHITECT HAVAB-G assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the immune status of individuals to hepatitis A virus infection. Warning: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. This assay cannot be used for the diagnosis of acute HAV infection. Assay performance characteristics have not been established when the ARCHITECT HAVAB-G assay is used in conjunction with other hepatitis assays.

Device Description

The ARCHITECT HAVAB-G assay determines the presence of IgG anti-HAV in human serum. After an acute HAV infection, IgG anti-HAV levels rise quickly and may persist for life. The presence of IgG anti-HAV implies past HAV infection (recent or distant) or vaccination against HAV. Detectable levels above the assay cut-off suggest immunity to HAV infection. The ARCHITECT HAVAB-G assay is a two-step immunoassay for the qualitative detection of IgG anti-HAV in human serum using CMIA technology with flexible assay protocols, referred to as Chemiflex. In the first step, sample, assay diluent, and hepatitis A virus (human) coated paramagnetic microparticles are combined. IgG anti-HAV present in the sample binds to the hepatitis A virus (human) coated microparticles. After washing, the anti-human IgG acridinium-labeled conjugate that is added in the second step binds to IgG anti-HAV. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). The presence or absence of IgG anti-HAV in the sample is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from an ARCHITECT HAVAB-G calibration. Specimens with signal to cutoff (S/CO) values > 1.00 are considered reactive for IgG anti-HAV. Specimens with S/CO values < 1.00 are considered nonreactive.

More Information

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Center

Panel

Date Received

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Device Name

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Class Advise Committee

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Third Party Reviewed

Expedited Review

Predicate Devices

ARCHITECT HAVAB-M (K063329)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunoassay using chemiluminescent technology to detect antibodies. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
This device is an immunoassay used for the qualitative detection of IgG antibodies to hepatitis A virus, which helps determine immune status. It is a diagnostic tool, not a therapeutic one that treats or prevents disease.

Diagnostic

Yes

The device detects IgG antibody to hepatitis A virus to determine the immune status of individuals, which is a form of diagnosis for immunity.

SaMD (Software as a Medical Device)

The device is a chemiluminescent microparticle immunoassay (CMIA) which is a laboratory-based test involving reagents and physical processes, not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the qualitative detection of IgG antibody to hepatitis A virus in human serum. This is a test performed in vitro (outside the body) on a biological sample to provide information about a person's health status.
Device Description: The description details a laboratory-based immunoassay process using human serum, reagents, and an instrument to measure a biological marker (IgG anti-HAV). This is characteristic of an IVD.
Sample Type: The assay uses human serum, which is a biological specimen.
Purpose: The purpose is to determine the immune status of individuals to hepatitis A virus infection, which is a diagnostic or health-related assessment.
Performance Studies: The document describes clinical and analytical performance studies conducted on human specimens, which are required for IVD devices to demonstrate their accuracy and reliability.
Predicate Device: The mention of a predicate device (ARCHITECT HAVAB-M) with a K number (K063329) indicates that this device is being compared to a previously cleared IVD.

All these factors align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Warning: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. This assay cannot be used for the diagnosis of acute HAV infection.

Assay performance characteristics have not been established when the ARCHITECT HAVAB-G assay is used in conjunction with other hepatitis assays.

ARCHITECT HAVAB-G Calibrator:
The ARCHITECT HAVAB-G Calibrator is for the calibration of the ARCHITECT i System, when used for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the immune status of individuals to hepatitis A virus infection, using the ARCHITECT HAVAB-G Reagent Kit. The performance of the ARCHITECT HAVAB-G Calibrator has not been established with any other IgG anti-HAV assays.

HAVAB-G Controls:
The ARCHITECT HAVAB-G Controls are used for monitoring the performance of the ARCHITECT i System, when used for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the immune status of individuals to hepatitis A virus infection, using the ARCHITECT HAVAB-G Reagent Kit. The performance of the ARCHITECT HAVAB-G Controls have not been established with any other IgG anti-HAV assays

Product codes

LOL, MJY, MJX, JIS

Device Description

The ARCHITECT HAVAB-G assay determines.the presence of IgG anti-HAV in human serum. After an acute HAV infection, IgG anti-HAV levels rise quickly and may persist for life. The presence of IgG anti-HAV implies past HAV infection (recent or distant) or vaccination against HAV. Detectable levels above the assay cut-off suggest immunity to HAV infection. 1.2

The ARCHITECT HAVAB-G assay is a two-step immunoassay for the qualitative detection of IgG anti-HAV in human serum using CMIA technology with flexible assay protocols, referred to as Chemiflex.
In the first step, sample, assay diluent, and hepatitis A virus (human) coated paramagnetic microparticles are combined. IgG anti-HAV present in the sample binds to the hepatitis A virus (human) coated microparticles. After washing, the anti-human IgG acridinium-labeled conjugate that is added in the second step binds to IgG anti-HAV. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). The presence or absence of IgG anti-HAV in the sample is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from an ARCHITECT HAVAB-G calibration. Specimens with signal to cutoff (S/CO) values > 1.00 are considered reactive for IgG anti-HAV. Specimens with S/CO values

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.

Summary

K//13704

JUN 2 8 2012

510(k) Summary

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant Name:

Abbott Laboratories Diagnostics Division Dept. 9V6. AP5N-2 100 Abbott Park Road Abbott Park, IL 60064

Contact person for all communications:

Judith Wallach, ADD, Regulatory Affairs Project Manager . Phone (847) 937-1132 Fax (847) 937-4836 E-Mail judith.r.wallach@abbott.com
or
Grace LeMieux, ADD, Regulatory Affairs Director . Phone (847) 935-0409 Fax (847) 937-4836 E-mail grace.lemieux@abbott.com

Device Name:

Reagent Kit

Classification Name: Hepatitis A virus (HAV) serological assays Trade Name: ARCHITECT HAVAB-G (List No. 6L27) Common Name: Hepatitis A Test (IgG Antibody) Governing Regulation: 866.3310 Device Classification: II Classification Panel: Microbiology Code: LOL

Calibrator Kit Classification Name: Calibrator Trade Name: ARCHITECT HAVAB-G Calibrator Kit (List No. 6L27-01) Common Name: Calibrator Governing Regulation: 862.1150 Device Classification: II Classification Panel: Clinical Chemistry Code: JIS

Control Kit

Classification Name: Quality control material (assayed and unassayed) Trade Name: ARCHITECT HAVAB-G Control Kit (List No. 6L27-10) Common Name: Control Governing Regulation: 862.1660 Device Classification: I Classification Panel: Microbiology Code: MJY/MJX

Legally marketed device to which equivalency is claimed:

ARCHITECT HAVAB-M (K063329)

FDA Document Numbers of all prior related submissions (regardless of outcome): ARCHITECT HAVAB-G Pre-IDE I00394

Intended Use of Device:

Warning: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. This assay cannot be used for the diagnosis of acute HAV infection.

Device Description:

The ARCHITECT HAVAB-G assay is a two-step immunoassay for the qualitative detection of IgG anti-HAV in human serum using CMIA technology with flexible assay protocols, referred to as Chemiflex.

In the first step, sample, assay diluent, and hepatitis A virus (human) coated paramagnetic microparticles are combined. IgG anti-HAV present in the sample binds to the hepatitis A virus (human) coated microparticles. After washing, the anti-human IgG acridinium-labeled conjugate that is added in the second step binds to IgG anti-HAV. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). The presence or absence of IgG anti-HAV in the sample is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from an ARCHITECT HAVAB-G calibration. Specimens with signal to cutoff (S/CO) values

1.00 are considered reactive for IgG anti-HAV. Specimens with S/CO values