BK241075 · Siemens Healthcare Diagnostics, Inc. Tarrytown, NY · MZF · Nov 7, 2024 · Microbiology
Device Facts
Record ID
BK241075
Device Name
Atellica® IM HIV Ag/Ab Combo (CHIV)
Applicant
Siemens Healthcare Diagnostics, Inc. Tarrytown, NY
Product Code
MZF · Microbiology
Decision Date
Nov 7, 2024
Decision
SESE
Regulation
21 CFR 866.3956
Device Class
Class 2
Attributes
Pediatric
Indications for Use
The Atellica® IM HIV Ag/Ab Combo (CHIV) assay is for in vitro diagnostic use in the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group "O") and type 2, in serum and plasma (potassium EDTA, lithium heparin, sodium heparin) using the Atellica® CI Analyzer. The Atellica IM CHIV assay is intended to be used as an aid in the diagnosis of HIV infection in pediatric and adult populations, including pregnant women. The Atellica IM CHIV assay is not intended for the screening of donors of blood and blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps). Although the effectiveness of the assay for screening blood or plasma donors has not been established, the assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable, or if their use is impractical. A reactive result using the Atellica IM CHIV assay does not distinguish HIV-1 p24 antigen, HIV-1 antibody, HIV-2 antibody, and HIV-1 group O antibody.
Device Story
Atellica IM HIV Ag/Ab Combo (CHIV) is a 2-step antigen/antibody sandwich immunoassay performed on the Atellica CI Analyzer. Input: 100 µL human serum or plasma. Principle: Chemiluminescence using paramagnetic microparticles coated with HIV antigens and monoclonal antibodies; acridinium ester-labeled tracer reagents. The analyzer automates sample pipetting, incubation at 37°C, and photon counting via PMT. Output: Qualitative result (reactive/non-reactive) based on a 1.0 Index cutoff. Used in clinical laboratories by trained personnel. Results aid clinicians in diagnosing HIV infection. Benefits include rapid, automated, high-throughput detection of HIV-1/2 and p24 antigen.
Clinical Evidence
Clinical performance evaluated using 993 confirmed HIV-positive and 2509 negative samples. Sensitivity: 99.78% (95% CI: 99.22%–99.97%). Specificity: 99.76% (95% CI: 99.48%–99.91%). Concordance study (n=3456) showed 99.96% negative agreement and 99.66% positive agreement with the predicate. Bench testing included precision, reproducibility, dilutional sensitivity, carry-over, and high-dose hook effect, all meeting acceptance criteria.
Technological Characteristics
Chemiluminescence immunoassay; paramagnetic microparticle solid phase; acridinium ester label. Reagents: recombinant HIV antigens, mouse monoclonal anti-HIV antibodies. Platform: Atellica CI Analyzer (automated, random access). Connectivity: Networked laboratory system. Software: Embedded firmware for assay control and data processing. Sterilization: N/A (reagents).
Indications for Use
Indicated for qualitative detection of HIV p24 antigen and HIV-1/2 antibodies in serum and plasma. Intended for use as an aid in HIV diagnosis in pediatric and adult populations, including pregnant women. Not for routine blood donor screening.
Regulatory Classification
Identification
Human immunodeficiency virus (HIV) serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues. The tests are intended for use as an aid in the diagnosis of infection with HIV and are for professional use only. The test results are intended to be interpreted in conjunction with other relevant clinical and laboratory findings. These tests are not intended to be used for monitoring patient status, or for screening donors of blood or blood products, or human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) For all HIV serological diagnostic and supplemental tests
(i) The labeling must include:
(A) An intended use that states that the device is not intended for use for screening donors of blood or blood products or HCT/Ps.
(B) A detailed explanation of the principles of operation and procedures used for performing the assay.
(C) A detailed explanation of the interpretation of results and recommended actions to take based on results.
(D) Limitations, which must be updated to reflect current clinical practice and disease presentation and management. The limitations must include, but are not limited to, statements that indicate:
(
*1* ) The matrices with which the device has been cleared, and that use of this test kit with specimen types other than those specifically cleared for this device may result in inaccurate test results.(
*2* ) The test is not intended to be used to monitor individuals who are undergoing treatment for HIV infection.(
*3* ) A specimen with a reactive result should be investigated further following current guidelines.(
*4* ) All test results should be interpreted in conjunction with the individual's clinical presentation, history, and other laboratory results.(
*5* ) A test result that is nonreactive does not exclude the possibility of exposure to or infection with HIV. Nonreactive results in this assay may be due to analyte levels that are below the limit of detection of this assay.(ii) Device verification and validation must include:
(A) Detailed device description, including the device components, ancillary reagents required but not provided, and an explanation of the methodology. Additional information appropriate to the technology must be included, such as the amino acid sequence of antigen(s) and design of capture antibodies.
(B) For devices with assay calibrators, the design of all primary, secondary, and subsequent quantitation standards used for calibration as well as their traceability to a reference material. In addition, analytical testing must be performed following the release of a new lot of the standard material that was used for device clearance, or when there is a transition to a new calibration standard.
(C) Detailed documentation of analytical performance studies conducted as appropriate to the technology, specimen types tested, and intended use of the device, including, but not limited to, limit of blank, limit of detection, cutoff determination, precision, endogenous and exogenous interferences, cross reactivity, carryover, quality control, matrix equivalency, and sample and reagent stability. Samples selected for use in analytical studies or used to prepare samples for use in analytical studies must be from subjects with clinically relevant circulating genotypes in the United States.
(D) Multisite reproducibility study that includes the testing of three independent production lots.
(E) Analytical sensitivity of the test must be the same as or better than that of other cleared or approved tests. Samples tested must include appropriate numbers and types of samples, including real clinical samples near the lower limit of detection. Analytical specificity of the test must be the same as or better than that of other cleared or approved tests. Samples must include appropriate numbers and types of samples from patients with different underlying illnesses or infections and from patients with potential endogenous interfering substances.
(F) Detailed documentation of performance from a multisite clinical study. Performance must be analyzed relative to an FDA-cleared or approved comparator. This study must be conducted using patient samples, with an appropriate number of HIV positive and HIV negative samples in applicable risk categories. Additional subgroups or types must be validated using appropriate numbers and types of samples. The samples may be a combination of fresh and repository samples, sourced from within and outside the United States, as appropriate. The study designs, including number of samples tested, must be sufficient to meet the following criteria:
(
*1* ) Clinical sensitivity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 99 percent.(
*2* ) Clinical specificity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 99 percent.(G) Strategies for detection of new strains, types, subtypes, genotypes, and genetic mutations as they emerge.
(H) Risk analysis and management strategies, such as Failure Modes Effects Analysis and/or Hazard Analysis and Critical Control Points summaries and their impact on test performance.
(I) Final release criteria to be used for manufactured test lots with appropriate evidence that lots released at the extremes of the specifications will meet the claimed analytical and clinical performance characteristics as well as the stability claims.
(J) All stability protocols, including acceptance criteria.
(K) Appropriate and acceptable procedure(s) for evaluating customer complaints and other device information that determines when to submit a medical device report.
(L) Premarket notification submissions must include the information contained in paragraph (b)(1)(ii)(A) through (K) of this section.
(iii) Manufacturers must submit a log of all complaints. The log must include the following information regarding each complaint if available: The type of event (
*e.g.,* false negative/false nonreactive or false positive/false reactive), lot, date, population, and whether or not the complaint was reported under part 803 of this chapter (Medical Device Reporting). The log must be submitted annually on the anniversary of clearance for 5 years following clearance of a traditional premarket notification.(2) If the test is intended for Point of Care (PoC) use, the following special controls, in addition to those listed in paragraph (b)(1) of this section apply:
(i) The PoC labeling must include a statement that the test is intended for PoC use.
(ii) The PoC labeling must include the following information near the statement of the intended use:
(A) That the test is for distribution to clinical laboratories that have an adequate quality assurance program, including planned systematic activities that provide adequate confidence that requirements for quality will be met and where there is assurance that operators will receive and use the instructional materials.
(B) That the test is for use only by an agent of a clinical laboratory.
(C) Instructions for individuals to receive the “Subject Information Notice” prior to specimen collection and appropriate information when test results are provided.
(iii) PoC labeling must include instructions to follow current guidelines for informing the individual of the test result and its interpretation.
(iv) The instructions in the labeling must state that reactive results are considered preliminary and should be confirmed following current guidelines.
(v) Device verification and validation for PoC use must include:
(A) Detailed documentation of performance from a multisite clinical study conducted at appropriate PoC sites. Performance must be analyzed relative to an FDA cleared or approved comparator. This study must be conducted using patient samples, with appropriate numbers of HIV positive and HIV negative samples in applicable risk categories. Additional subgroup or type claims must be validated using appropriate numbers and types of samples. The samples may be a combination of fresh and repository samples, sourced from within and outside the United States, as appropriate. If the test is intended solely for PoC use, the test must meet only the performance criteria in paragraphs (b)(2)(v)(A)(
*1* ) and (*2* ) of this section and not the criteria in paragraph (b)(1)(ii)(F) of this section:(
*1* ) Clinical sensitivity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 98 percent.(
*2* ) Clinical specificity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 98 percent.(B) Premarket notification submissions must include the information contained in paragraph (b)(2)(v)(A) of this section.
(3) If the test is intended for supplemental use in addition to use as an aid in initial diagnosis, the following special controls, in addition to those listed in paragraphs (b)(1) and (2) of this section, as appropriate, apply:
(i) The labeling must include a statement that the test is intended for use as an additional test to confirm the presence of HIV antibodies or antigens in specimens found to be repeatedly reactive by a diagnostic screening test.
(ii) Device validation and verification for supplemental use must include a clinical study, including samples that were initially reactive and repeatedly reactive on a diagnostic test but were negative or indeterminate on a different confirmatory test. Premarket notification submissions must include this information.
(4) If the test is intended solely as a supplemental test, the following special controls, in addition to those listed in paragraphs (b)(1) and (2) of this section, except those in paragraphs (b)(1)(ii)(F) and (b)(2)(v)(A) of this section, as appropriate, apply:
(i) The labeling must include a statement that the test is intended for use as an additional test to confirm the presence of HIV antibodies or antigens in specimens found to be repeatedly reactive by a diagnostic screening test.
(ii) The labeling must clearly state that the test is not for use for initial diagnosis or is not intended as a first-line test.
(iii) Device validation and verification must include a clinical study including samples that were initially reactive and repeatedly reactive on a diagnostic test but were negative or indeterminate on a confirmatory test. Premarket notification submissions must include this information.
(5) If the test is intended to differentiate different HIV types, the following special controls, in addition to those listed in paragraphs (b)(1) through (4) of this section, as appropriate, apply:
(i) The labeling must include the statement that the test is intended for the confirmation of initial results from a diagnostic test and differentiation of different HIV types.
(ii) The results interpretation in the labeling must include instructions for the user on how to interpret the results, including un-typeable and co-infection results.
(iii) Device validation and verification must include evaluation of analytical and clinical sensitivity and specificity for each of the HIV types, strains, and subtypes of HIV intended to be differentiated. Premarket notification submissions must include this information.
Predicate Devices
ADVIA Centaur® HIV Ag/Ab Combo (CHIV) assay (BP140103)
Submission Summary (Full Text)
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Siemens Healthcare Diagnostics
## 510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92 and the Safe Medical Device Act of 1990.
The assigned 510(k) Number is: BK241075
### 1. Date Prepared
November 6, 2024
### 2. Applicant Information
*Contact:* Asha Gartland
Regulatory Affairs Specialist
*Address:* Siemens Healthcare Diagnostics Inc.
511 Benedict Avenue
Tarrytown, NY 10591-5097
*Phone:* 845-327-8296
*Email* asha.gartland@siemens-healthineers.com
### 3. Regulatory Information
| **Trade Name** | Atellica® IM HIV Ag/Ab Combo (CHIV) |
| --- | --- |
| **Common Name** | Test, HIV Detection |
| **Classification Name** | Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test |
| **FDA Classification** | Class II |
| **Review Panel** | Microbiology |
| **Product Code** | MZF |
| **Regulation Number** | 21 CFR 866.3956 |
### 4. Predicate Device Information
Predicate Device Name: ADVIA Centaur® HIV Ag/Ab Combo (CHIV) assay
PMA Number: BP140103
### 5. Intended Use / Indications for Use
The Atellica® IM HIV Ag/Ab Combo (CHIV) assay is for *in vitro* diagnostic use in the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group "O") and type 2, in
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## 510(k) Summary
serum and plasma (potassium EDTA, lithium heparin, sodium heparin) using the Atellica® CI Analyzer. The Atellica IM CHIV assay is intended to be used as an aid in the diagnosis of HIV infection in pediatric and adult populations, including pregnant women.
The Atellica IM CHIV assay is not intended for the screening of donors of blood and blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps). Although the effectiveness of the assay for screening blood or plasma donors has not been established, the assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable, or if their use is impractical.
A reactive result using the Atellica IM CHIV assay does not distinguish HIV-1 p24 antigen, HIV-1 antibody, HIV-2 antibody, and HIV-1 group O antibody.
## 6. Special Conditions for Use Statement
For Prescription Use
## 7. Device Description
| Component | Volume | Ingredients |
| --- | --- | --- |
| ***Atellica IM CHIV ReadyPack primary reagent pack (included in assay kit)*** | | |
| Lite Reagent | 5.0 mL/pack | Recombinant HIV antigens (~0.12 µg/mL) and mouse monoclonal anti-HIV antibody (~0.004 µg/mL) labeled with acridinium ester in buffer; bovine serum albumin; mouse IgG; goat serum; surfactant; preservatives |
| Solid Phase | 10.0 mL/pack | Streptavidin-coated paramagnetic microparticles preformed with biotinylated HIV antigens (~1.5 µg/mL) and biotinylated mouse monoclonal anti-HIV antibodies (~4.5 µg/mL) in buffer; bovine serum albumin; mouse IgG; surfactant; preservatives |
| Ancillary Lite Reagent | 5.0 mL/pack | Recombinant HIV antigens (~0.23 µg/mL) and mouse monoclonal anti-HIV antibody (~1.5 µg/mL) labeled with acridinium ester in buffer; bovine serum albumin; mouse IgG; goat serum; surfactant; preservatives |
| ***Atellica IM CHIV CAL (included in assay kit)*** | | |
| CHIV CAL L | 2.0 mL/vial | Heat-inactivated goat serum; sodium azide (< 0.1%); preservatives |
| CHIV CAL H | 2.0 mL/vial | Processed* human plasma negative for antibodies to HIV and spiked with antibodies to HIV-1; sodium azide (< 0.1%); preservatives **Processed plasma is defibrinated and filtered plasma.* |
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510(k) Summary
## 8. Comparison of Technological Characteristics with the Predicate Device
The following tables describe the comparison between the Atellica IM HIV Ag/Ab Combo (CHIV) assay (Candidate Device), and the ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay (BP140103 - Predicate Device) and similarities and differences between Atellica CI Analyzer and ADVIA Centaur XP system.
| Item | Candidate Device Atellica® IM HIV Ag/Ab Combo (CHIV) assay (on Atellica CI Analyzer) | Predicate Device ADVIA Centaur® HIV Ag/Ab Combo (CHIV) assay (on ADVIA Centaur XP system; BP140103) |
| --- | --- | --- |
| Intended Use | The Atellica® IM HIV Ag/Ab Combo (CHIV) assay is for *in vitro* diagnostic use in the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group 'O') and type 2, in serum and plasma (potassium EDTA, lithium heparin, sodium heparin) using the Atellica® CI Analyzer. The Atellica IM CHIV assay is intended to be used as an aid in the diagnosis of HIV infection in pediatric and adult populations, including pregnant women. The Atellica IM CHIV assay is not intended for the screening of donors of blood and blood products or human cells, tissues, and cellular and tissue-based products (HCT/Ps). Although the effectiveness of the assay for screening blood or plasma donors has not been established, the assay can be used as a blood donor screening assay in urgent situations where traditional licensed blood donor screening tests are unavailable, or if their use is impractical. A reactive result using the Atellica IM CHIV assay does not distinguish HIV-1 p24 antigen, HIV-1 antibody, HIV-2 antibody, and HIV-1 group O antibody. | Same |
| Indications For Use | Same | Same |
| Measurement | Qualitative | Same |
| Operating Principle | 2-step antigen/antibody sandwich immunoassay | Same |
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510(k) Summary
| Item | Candidate Device Atellica® IM HIV Ag/Ab Combo (CHIV) assay (on Atellica CI Analyzer) | Predicate Device ADVIA Centaur® HIV Ag/Ab Combo (CHIV) assay (on ADVIA Centaur XP system; BP140103) |
| --- | --- | --- |
| Detection Antibody | Lite Reagent: Recombinant HIV antigens (~0.12 μg/mL) and mouse monoclonal anti-HIV antibody (~0.004 μg/mL) labeled with acridinium ester in buffer; bovine serum albumin; mouse IgG; goat serum; surfactant; preservatives Ancillary Lite Reagent: Recombinant HIV antigens (~0.23 μg/mL) and mouse monoclonal anti-HIV antibody (~1.5 μg/mL) labeled with acridinium ester in buffer; bovine serum albumin; mouse IgG; goat serum; surfactant; preservatives | Same |
| Capture Antibody | Solid Phase: Streptavidin-coated paramagnetic microparticles preformed with biotinylated HIV antigens (~1.5 μg/mL) and biotinylated mouse monoclonal anti-HIV antibodies (~4.5 μg/mL) in buffer; bovine serum albumin; mouse IgG; surfactant; preservatives | Same |
| Sample Type | Human serum and plasma (potassium EDTA, lithium heparin, sodium heparin) | Same |
| Sample Volume | 100μL | Same |
| Reagent on Board Stability | 35 Days | 42 Days |
| Calibration | 2 Levels | Same |
| Calibrators | Liquid, ready to use | Same |
| Calibrator On Board Stability | 8 hours | Same |
| Intended Use Population | Pediatric and adult populations, including pregnant women | Same |
| Cut off Index Value | 1.0 | Same |
| Interpretation | Non-reactive, reactive | Same |
Similarities and Differences Table for Comparison of ADVIA Centaur XP and Atellica CI Analyzer platforms.
| Feature | ADVIA Centaur XP® (cleared under K041133) | Atellica® CI (cleared under K222116) |
| --- | --- | --- |
| **SIMILARITIES** | | |
| Optical System | PMT used in photon counting mode | Same |
| Intended Use | Automated, immunoassay analyzer designed to perform in vitro diagnostic tests | Same |
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# **510(k) Summary**
| Feature | ADVIA Centaur XP® (cleared under K041133) | Atellica® CI (cleared under K222116) |
| --- | --- | --- |
| Operating Assay Principle | Chemiluminescence using magnetic-particle solid phase and chemiluminescent label | Same |
| Type of System | Random access and batch | Same |
| Test Processing | Sample scheduling optimized for throughput; continuous operation | |
| | Reactions are controlled at 37°C | |
| **Sample Handling** | | |
| Sample Container | Sample cups or primary tubes | Same |
| Sample Type | Serum, plasma, urine, whole blood hemolysate, amniotic fluid | Same |
| Sample Pipette | Disposable sample pipette tips | Same |
| Dispense System | Automated pipetting of samples using precision syringe | Same |
| Sample Probe | Air pressure fluid sensing and disposable tip sensing; clog detection mechanism to alert operator to clogged sample probe | Same |
| Dilutions | Allowed on a per-assay basis; capability of dilution of samples requiring pretreatment | Same |
| **Reagent Handling** | | |
| Dispense system | Automated pipetting using precision syringes | Same |
| Mixing | Reagents mixed via rocking platform | Same |
| Reagents | Primary Reagent Pack has separate wells for Solid Phase, Lite Reagent and Ancillary reagents | Same (identical reagent formulation) |
| | Ancillary Reagent Pack – contains components of the active reagent and/or sample diluents | Same (identical reagent formulation). Modification in container shape (Uses the Atellica IM ancillary reagent packs) |
| **Calibration** | | |
| Reagent | 6 to 10-point stored calibration for each reagent | Same |
| | 2-point user run calibration | |
| Calibrators | Calibrators checked with barcode | Same |
| | Calibrator lot numbers stored and displayed | |
| Controls | Capability to run controls and track results | Same |
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510(k) Summary
| Feature | ADVIA Centaur XP® (cleared under K041133) | Atellica® CI (cleared under K222116) |
| --- | --- | --- |
| **DIFFERENCES** | | |
| Throughput Rate | 120 to 240 tests/hr | 75 to 150 tests/hr |
| Time to First Result | 18 min. to 56 min. depending upon assay protocol | 10 min. to 55 min. depending upon the assay protocol |
| Ambient Temperature and Humidity Range | 18 - 30°C, 20 - 80% RH | 18 - 30°C, 20 - 80% RH. |
| | | Fluids and air under the system cover are temperature controlled. |
| Test Processing | 7.5-minute incubation, single step | "Fast 1-pass" assays: 8-minute incubation |
| | 20-minute incubation, single step | "Routine 1-pass" assays: 12-minute incubation |
| | 7.5 minute - 20-minute incubation, two step | Not Applicable |
| | 20-minute - 20-minute incubation, two step | "2-pass" assay: 12 minute - 12-minute incubations or 12 minute - 20-minute incubations |
| **Sample Handling** | | |
| Sample Volume | 10 to 200 μL | 10 to 100 μL |
| Sample Rack | 5 tube racks hold sample tubes | 6 tube racks hold sample tubes |
| | The Sample Input, In-Process and Output Queue holds up to 180 samples | The sample Input, In-Process and Output Queue holds up to 132 samples |
| | Tube size selected on sample tube rack using an encoded barcode with the additional capability of multiple size tubes on the same rack | Tube size identified by Atellica Direct Load 2.0 |
| **Reagent Handling** | | |
| Assay Reagent Tray | Refrigerated with 30 positions | Refrigerated with 20 positions |
| | Reagent Pack contains both Solid Phase and Tracer Reagent in separate wells | Reagent Pack contains both Solid Phase and Tracer Reagent in separate wells |
| Ancillary Reagent Tray | Mobile refrigerated tray with 25 positions | Stationary refrigerated tray with 20 positions |
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510(k) Summary
| Feature | ADVIA Centaur XP® (cleared under K041133) | Atellica® CI (cleared under K222116) |
| --- | --- | --- |
| Reagent Storage | 4°C to 8°C | 4°C to 10°C |
| System Bulk Fluids | Wash 1, Acid, Base and Cleaner | Same (identical reagent formulation). Wash, |
| | | Modifications in container size and shape (same AIM Bulk Fluid containers) |
| Reagent Probes | Three probes | One probe |
| | Reagent preheating | No reagent preheating |
| | No level sense | No Level sense |
| | Probe sent to bottom of container | Probe sent to bottom of container |
| | Fluid monitoring during aspiration | Fluid monitoring on aspiration and dispense using liquid pressure sensing |
### 9. Non-Clinical and Clinical Test Summary & Conclusions
The reagent formulations of the Atellica IM HIV Ag/Ab Combo (CHIV) assay used on the Atellica CI Analyzer are the same as those of the ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay used on the ADVIA Centaur XP system. Some performance characteristics were established using the ADVIA Centaur XP system (PMA BP140103 and BP140103/8).
#### Precision
The Precision study was performed in accordance with the guidelines in CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition. Samples were assayed on two Atellica CI Analyzers in duplicate in two runs per day for 20 days at one site with one reagent lot, producing a total of 80 measurements. The study assessed a ten-member sample panel for HIV antibody, a two-member panel for HIV-1 antigen and two negative samples. Repeatability and within-laboratory precision were determined using a nested, two factor (days and runs nested within days) ANOVA model. Each system was analyzed separately. The following results were obtained:
| Sample Type | Mean of 80 reps (Index) | Repeatability | | Within-Laboratory precision | |
| --- | --- | --- | --- | --- | --- |
| | | SD (Index) | % CV | SD (Index) | % CV |
| Serum A | 0.16 | 0.012 | 7.5 | 0.014 | 8.8 |
| Serum B | 2.93 | 0.068 | 2.3 | 0.123 | 4.2 |
| Serum C | 4.92 | 0.079 | 1.6 | 0.180 | 3.7 |
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# **510(k) Summary**
| Serum D | 2.76 | 0.060 | 2.2 | 0.157 | 5.7 |
| --- | --- | --- | --- | --- | --- |
| Serum E | 1.48 | 0.023 | 1.6 | 0.045 | 3.0 |
| Serum F | 3.38 | 0.069 | 2.0 | 0.107 | 3.2 |
| Serum G | 0.72 | 0.026 | 3.6 | 0.030 | 4.2 |
| Serum H | 1.17 | 0.038 | 3.2 | 0.042 | 3.6 |
| Serum I | 4.92 | 0.077 | 1.6 | 0.152 | 3.1 |
| Control 1 | 0.26 | 0.015 | 5.8 | 0.016 | 6.2 |
| Control 2 | 4.99 | 0.097 | 1.9 | 0.120 | 2.4 |
| Control 3 | 2.94 | 0.046 | 1.6 | 0.083 | 2.8 |
| Control 4 | 3.07 | 0.052 | 1.7 | 0.140 | 4.6 |
| Control 5 | 2.41 | 0.038 | 1.6 | 0.089 | 3.7 |
The repeatability and within-laboratory precision study results using the Atellica CI analyzer (candidate) were within the acceptance criteria for all samples tested and demonstrated equivalent performance to the ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay (predicate) on ADVIA Centaur XP system.
# **Reproducibility**
The reproducibility study design consisted of three sites, five days, two runs per day, and three replicates per run using one reagent lot. A panel of 14 samples, consisting of two negative and 12 positive samples for either HIV antibody or HIV-1 antigen . Results were analyzed by individual site as well as all three sites combined.
The following are the reproducibility results of the Atellica IM CHIV assay on Atellica CI Analyzers at three sites:
| System: Atellica CI Analyzer | | | Repeatability | | Between-Run | | Between-Day | | Between-Site | | Reproducibility | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Sample | n | Mean (Index) | SD (Index) | %CV | SD (Index) | %CV | SD (Index) | %CV | SD (Index) | %CV | SD (Index) | %CV |
| Negative Control | 85* | 0.14 | 0.033 | 23.6 | 0.022 | 15.7 | 0.010 | 7.1 | 0.031 | 22.1 | 0.052 | 37.1 |
| HIV-1 Control | 90 | 5.15 | 0.158 | 3.1 | 0.000 | 0.0 | 0.055 | 1.1 | 0.069 | 1.3 | 0.181 | 3.5 |
| HIV-2 Control | 90 | 3.19 | 0.090 | 2.8 | 0.064 | 2.0 | 0.046 | 1.4 | 0.126 | 3.9 | 0.174 | 5.5 |
| Group O Control | 90 | 6.32 | 0.344 | 5.4 | 0.000 | 0.0 | 0.000 | 0.0 | 0.426 | 6.7 | 0.547 | 8.7 |
| P24 Antigen Control | 90 | 3.52 | 0.109 | 3.1 | 0.045 | 1.3 | 0.050 | 1.4 | 0.082 | 2.3 | 0.153 | 4.3 |
| Negative Serum Pool 9 | 89* | 0.18 | 0.030 | 16.7 | 0.003 | 1.7 | 0.028 | 15.6 | 0.014 | 7.8 | 0.043 | 23.9 |
| P24 Antigen Serum Pool 7 | 90 | 3.94 | 0.120 | 3.0 | 0.052 | 1.3 | 0.072 | 1.8 | 0.155 | 3.9 | 0.215 | 5.5 |
| P24 Antigen Serum Pool 8 | 90 | 7.13 | 0.179 | 2.5 | 0.096 | 1.3 | 0.078 | 1.1 | 0.287 | 4.0 | 0.360 | 5.0 |
| Group O Serum Pool 6 | 90 | 5.84 | 0.245 | 4.2 | 0.198 | 3.4 | 0.000 | 0.0 | 0.333 | 5.7 | 0.458 | 7.8 |
| HIV-2 Serum Pool 4 | 90 | 1.47 | 0.053 | 3.6 | 0.007 | 0.5 | 0.046 | 3.1 | 0.064 | 4.4 | 0.095 | 6.5 |
| HIV-2 Serum Pool 5 | 90 | 3.79 | 0.110 | 2.9 | 0.044 | 1.2 | 0.066 | 1.7 | 0.120 | 3.2 | 0.181 | 4.8 |
| HIV-1 Serum Pool 1 | 90 | 0.55 | 0.034 | 6.2 | 0.000 | 0.0 | 0.023 | 4.2 | 0.044 | 8.0 | 0.060 | 10.9 |
| HIV-1 Serum Pool 2 | 90 | 1.02 | 0.047 | 4.6 | 0.017 | 1.7 | 0.018 | 1.8 | 0.024 | 2.4 | 0.059 | 5.8 |
| HIV-1 Serum Pool 3 | 90 | 5.89 | 0.142 | 2.4 | 0.000 | 0.0 | 0.059 | 1.0 | 0.122 | 2.1 | 0.196 | 3.3 |
\* At least 1 result was out of the measuring interval.
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## 510(k) Summary
The reproducibility results for the Atellica IM CHIV assay on the Atellica CI Analyzer (candidate) were within the acceptance criteria for all samples tested and demonstrated equivalent performance to the ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay on ADVIA Centaur XP system (predicate).
### WHO p24 Detection
Analytical sensitivity of the Atellica IM CHIV assay when used on the Atellica CI analyzer for HIV-1 p24 antigen was determined using the WHO International Standard, NIBSC code: 90/636 at the CHIV cutoff of 1.00 Index. The standard was reconstituted in 1.0 mL of distilled water to a concentration of 1000 IU/mL and then diluted 40-fold using a p24 antigen-negative human serum pool and subsequently serially diluted 2-fold using the same negative serum pool.
Each sample was assayed in four replicates on one test day. Concentrations were determined using a single 2-point calibration for each lot and analyzer. The study was performed with two reagent lots, one on Atellica CI Analyzer and one on ADVIA Centaur XP system. The p24 antigen concentration at the CHIV cutoff of 1.00 Index was calculated from the linear regression equation for each analyzer and lot. The results using the Atellica CI Analyzer were compared to those of the ADVIA Centaur XP system. Table below summarizes the p24 antigen concentration at the CHIV cutoff of 1.00 Index calculated from the regression equations for each lot and analyzer.
| Platform | Reagent Lot | Slope | Intercept | R^{2} | p24 Concentration at 1.00 Index (IU/mL) |
| --- | --- | --- | --- | --- | --- |
| Atellica CI | 1 | 1.9155 | -0.5645 | 0.998 | 1.35 |
| ADVIA Centaur XP | 1 | 1.8272 | -0.5913 | .0998 | 1.24 |
| Atellica CI | 2 | 1.5320 | -0.3437 | 0.999 | 1.19 |
| ADVIA Centaur XP | 2 | 1.5053 | -0.3573 | 0.998 | 1.15 |
The HIV-1 p24 Antigen sensitivity, 1st International Reference Reagent concentration at the Atellica IM CHIV assay cut-off value is 1.35 IU/mL on the Atellica CI Analyzer and 1.24 IU/mL for the ADVIA Centaur XP system. The performance of the Atellica CI Analyzer (candidate) demonstrated equivalent performance to the ADVIA Centaur XP system (predicate).
### Dilutional Sensitivity
Eight serial dilution panels for HIV-1 Group O, 9 panels for HIV-2, and 10 panels each for HIV (unspecified type) and HIV-1 were tested in singlicate on both the Atellica CI Analyzer and ADVIA Centaur XP system platforms over five days. The dilution panels were prepared by serially diluting sample to a final dilution factor of 64 in HIV negative human serum. Concentrations were determined using a single 2-point calibration for each analyzer. The study was performed with one reagent lot of Atellica IM CHIV assay on one Atellica CI Analyzer and one ADVIA Centaur XP system platform. Data were evaluated by comparison of the Atellica CI Analyzer results to those of the ADVIA Centaur XP system. The first dilution
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## 510(k) Summary
where the sample result was nonreactive marked the dilutional sensitivity point, which was compared with that of the ADVIA Centaur XP system.
For HIV-1 HIV (unspecified type) and HIV Group O samples, the Atellica IM CHIV assay and the ADVIA Centaur CHIV assay dilutional sensitivity ranged from 1/16 to 1/32. For the HIV-2 samples, dilutional sensitivity ranged from 1/2 to 1/64 for both assays. There was no difference in sensitivity between the systems.
The Atellica IM CHIV assay on the Atellica CI Analyzer (candidate) had the same dilutional sensitivity point as the ADVIA Centaur CHIV assay on the ADVIA Centaur XP system (predicate) for all samples tested. The performance of the Atellica CI Analyzer at low analyte levels demonstrated equivalent performance to the ADVIA Centaur XP system.
### Carry-Over
Three reagent pairs were used with Atellica IM CHIV assay on the Atellica CI Analyzer to evaluate carry-over. Negative and positive human serum pool controls were assayed in 10 replicates each to establish baseline values for the testing. Ten replicate each controls were run, followed by alternating high and low controls, followed by five replicates of each control. Sample concentrations were determined using a single 2-point calibration. The study was performed using one reagent lot on one Atellica CI Analyzer. The average of the first 10 replicates, the 10 alternated replicates and the five final replicates were calculated for each control.
The verification data collected met the acceptance criteria and demonstrated that the reagent carryover mitigations for the Atellica IM CHIV assay were effective on the Atellica CI analyzer.
### Clinical Performance
Clinical Sensitivity and Specificity data is available in PMA approval for ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay on the ADVIA Centaur XP system (PMA Number BP140103).
### Detection of HIV-1 and HIV-2 Antigen Subtypes
Data on detection of HIV-1 and HIV-2 antigen subtypes is available in PMA approval for ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay (PMA Number BP140103).
### Genotype Study
Data on genotype is available in PMA approval for ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay (PMA Number BP140103).
### Interference
The analytical specificity/interference for the Atellica IM CHIV assay on the Atellica CI analyzer was evaluated on the ADVIA Centaur XP system under PMA BP140103. This Atellica IM CHIV assay run on the Atellica CI Analyzer is the identical Atellica IM CHIV assay under PMA Supplement BP140103/8 for Atellica IM CHIV assay on Atellica IM Analyzer.
This data is available in PMA approval for ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay (PMA Number BP140103).
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# **510(k) Summary**
# **Cross-Reactivity**
Data on cross-reactivity is available in PMA approval for ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay (PMA Number BP140103).
# **Specimen Equivalency**
Data on specimen equivalency is available in PMA approval for ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay (PMA Number BP140103).
# **Seroconversion Panels**
Twenty commercially available seroconversion panels were tested using the ADVIA Centaur CHIV assay on the ADVIA Centaur XP system and the Atellica IM CHIV assay on an Atellica CI Analyzer. Seroconversion panel performance was tested according to the guidelines of the CLSI EP09C-ED3: *Measurement Procedure Comparison and Bias Estimation Using Patient Samples* and CLSI EP12-A2: *User Protocol for Evaluation of Qualitative Test Performance*. Samples were assayed in one replicate on the Atellica CI Analyzer and ADVIA Centaur system. Testing was completed over four days using a single 2-point calibration per analyzer/system. Each panel was tested with one of two reagent lots on one of three Atellica CI Analyzers and one ADVIA Centaur XP system. The performance of the Atellica IM CHIV assay on the seroconversion panels matched the performance of the ADVIA Centaur CHIV assay. The following results were obtained:
| Panel ID | CHIV Reactive Results From Initial Draw Date | | ADVIA Centaur XP system vs Atellica CI Analyzer |
| --- | --- | --- | --- |
| | ADVIA Centaur Assay (Days) | Atellica CI Assay (Days) | Difference in Bleed Number (Bleeds) |
| 62216 | 22 | 22 | 0 |
| 63215 | 24 | 24 | 0 |
| 63753 | 66 | 66 | 0 |
| 64578 | 25 | 25 | 0 |
| 65376 | 16 | 16 | 0 |
| 65389 | 16 | 16 | 0 |
| 65522 | 12 | 12 | 0 |
| 65685 | 38 | 38 | 0 |
| 66048 | 146 | 146 | 0 |
| 66575 | 28 | 28 | 0 |
| 66632 | 50 | 50 | 0 |
| 68106 | 38 | 38 | 0 |
| 68205 | 44 | 44 | 0 |
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# **510(k) Summary**
| Panel ID | CHIV Reactive Results From Initial Draw Date | | ADVIA Centaur XP system vs Atellica CI Analyzer |
| --- | --- | --- | --- |
| | ADVIA Centaur Assay (Days) | Atellica CI Assay (Days) | Difference in Bleed Number (Bleeds) |
| 68582 | 47 | 47 | 0 |
| 73695 | 119 | 119 | 0 |
| 73698 | 28 | 28 | 0 |
| 75062 | 40 | 40 | 0 |
| 77600 | 49 | 49 | 0 |
| 77840 | 13 | 13 | 0 |
| 1043487 | 7 | 7 | 0 |
The Atellica CI Analyzer seroconversion results are equivalent to the seroconversion results generated using the ADVIA Centaur XP system. Therefore, Atellica CI Analyzer (candidate) has comparable seroconversion sensitivity as the ADVIA Centaur CHIV assay on the ADVIA Centaur XP system (predicate).
# **High Dose Hook**
High anti-HIV antibody concentrations can cause a paradoxical decrease in the RLUs (high-dose hook effect) from a sample. Anti-HIV-1 and anti-HIV-2 positive samples with a value > 1000 Index were tested using the Atellica IM CHIV assay on the Atellica CI Analyzer and the samples reported an Index > 12.00. No hook effect was observed for patient samples with a value > 1000 Index.
Recombinant p24 antigen spiked into a negative sample was tested using the Atellica IM CHIV assay on the Atellica CI Analyzer and the sample reported a value > 12.00 Index. At 1 µg/mL of p24 antigen, no hook effect was observed.
# **Stability**
The Atellica IM HIV Ag/Ab Combo (CHIV) reagents and calibrators are stable through the expiration date on the product when stored at 2-8 °C. Calibrators are stable for 8 hours at room temperature per the original PMA (BP140103).
On-Board Stability (OBS) and Pack Calibration Interval (In-Use) stability was evaluated for the Atellica IM CHIV assay when used with the Atellica CI analyzer according to the guidelines of the CLSI EP25-A: *Evaluation of Stability of In Vitro Diagnostic Reagents*.
The results demonstrate that the Atellica IM CHIV assay is stable onboard the Atellica CI Analyzer for 35 days with a pack calibration interval of 35 days.
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# **510(k) Summary**
# **Clinical Performance**
# **Clinical Sensitivity:**
A total of 993 confirmed HIV positive samples were tested in the Atellica CHIV assay on the Atellica CI Analyzer, out of which 99.80% (991/993) were initially reactive. A total of 926 had sufficient volume for further testing and this resulted in a repeat reactive rate of 99.78% (924/926).
Of the 965 samples tested with the ADVIA Centaur CHIV assay on the ADVIA Centaur XP system, 99.79% (963/965) were initially reactive. Of these samples, 933 had sufficient volume for further testing and this resulted in a repeat reactive rate of 99.79% (931/933).
| Category | Atellica CI Analyzer | | | | | ADVIA Centaur XP System | | | | | Repeatedly Reactive Specimens (Number Reactive Positive by Method) | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Initial | | | Final Algorithm | | Initial | | | Final Algorithm | | HIV-1 HIV-2 Ab Diff | HIV-1 Qual RNA |
| | N Samples | Non-Reactive | Reactive | N Samples | Repeatedly Reactive | N Samples | Non-Reactive | Reactive | N Samples | Repeatedly Reactive | | |
| Group O Contrived | 6 | 0 | 6 | 6 | 6 | 5 | 0 | 5 | 4 | 4 | 0 | 0 |
| Group O Native | 50 | 0 | 50 | 48 | 48 | 48 | 0 | 48 | 34 | 34 | 0 | 0 |
| HIV Positive Pediatric | 50 | 0 | 50 | 50 | 50 | 50 | 0 | 50 | 45 | 45 | 0 | 0 |
| HIV Positive Pregnant | 37 | 0 | 37 | 37 | 37 | 37 | 0 | 37 | 37 | 37 | 0 | 0 |
| HIV-1 Pos | 601 | 0 | 601 | 536 | 536 | 576 | 0 | 576 | 568 | 568 | 0 | 0 |
| HIV-2 Positive | 197 | 0 | 197 | 197 | 197 | 197 | 0 | 197 | 193 | 193 | 0 | 0 |
| p24 Contrived | 37 | 0 | 37 | 37 | 37 | 37 | 0 | 37 | 37 | 37 | 0 | 0 |
| p24 Native | 15 | 2 | 13 | 15 | 13 | 15 | 2 | 13 | 15 | 13 | 0 | 0 |
| Total | 993 | 2 | 991 | 926 | 924 | 965 | 2 | 963 | 933 | 931 | 0 | 0 |
| Total (%) | | 0.20% | 99.80% | | 99.78% | | 0.21% | 99.79% | | 99.79% | | |
The overall clinical sensitivity of the Atellica CHIV assay on the Atellica CI Analyzer CHIV assay was 99.78% (924/926, 95% CI of 99.22% - 99.97%) upon repeat testing.
The overall clinical sensitivity of the ADVIA Centaur CHIV assay on the ADVIA Centaur XP system was 99.79% (931/933, 95% CI of 99.23% - 99.97%) upon repeat testing.
The clinical sensitivity of the Atellica IM CHIV assay on the Atellica CI Analyzer met the acceptance criteria. The study results demonstrate that the clinical sensitivity is comparable between the Atellica CI Analyzer and the ADVIA Centaur XP system.
# **Clinical Specificity:**
A total of 2509 samples from apparently healthy, low-risk and high-risk population were tested on the Atellica CHIV assay on the Atellica CI Analyzer for this study. Seven out of 2509
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# **510(k) Summary**
samples were initially reactive, and six were repeat reactive. These six samples were confirmed negative by confirmatory test. Two samples were negative on the Atellica CI Analyzer and positive on the ADVIA Centaur XP system. Following the algorithm, both samples were repeat reactive on the ADVIA Centaur XP system and further confirmatory testing confirmed these samples are HIV-positive. The samples were removed from the specificity calculation.
Of the 2492 samples tested on the ADVIA Centaur CHIV assay on the ADVIA Centaur XP system, 99.56% (2481/2492) of the overall pooled population including apparently healthy, low-risk and high-risk population were non-reactive. Eleven samples out of 2492 were initially reactive, and nine out of 2492 samples were repeatedly reactive. Of nine repeatedly reactive samples, two were found positive by confirmatory testing. The results from these two specimens were excluded from the specificity calculation.
| Category | Atellica CI Analyzer | | | | | ADVIA Centaur XP System | | | | | Repeatedly Reactive Specimens (Number Reactive Positive by Method) | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | Initial | | | Final Algorithm | | Initial | | | Final Algorithm | | HIV-1 HIV-2 Ab Diff | HIV-1 Qual RNA |
| | N Samples | Non-Reactive | Reactive | N Samples | Repeatedly Reactive | N Samples | Non-Reactive | Reactive | N Samples | Repeatedly Reactive | | |
| Apparently Healthy | 734 | 734 | 0 | 734 | 0 | 730 | 729 | 1 | 730 | 1 | 1 | 0 |
| Apparently Healthy Pregnant | 249 | 249 | 0 | 249 | 0 | 246 | 246 | 0 | 246 | 0 | 0 | 0 |
| Hospital Specimen | 50 | 50 | 0 | 50 | 0 | 50 | 49 | 1 | 50 | 1 | 1 | 0 |
| Low HIV Risk Pediatric | 75 | 75 | 0 | 75 | 0 | 74 | 74 | 0 | 74 | 0 | 0 | 0 |
| High-Risk | 1401 | 1394 | 7 | 1400 | 6 | 1392 | 1383 | 9 | 1392 | 7 | 0 | 0 |
| Total | 2509 | 2502 | 7 | 2508 | 6 | 2492 | 2481 | 11 | 2492 | 9 | 2 | 0 |
| Total (%) | | 99.72% | 0.28% | | 0.24% | | 99.56% | 0.44% | | 0.36% | | |
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# **510(k) Summary**
The Atellica CHIV assay on the Atellica CI Analyzer clinical specificity for the overall pooled population was 99.76% (2500/2506) with a 95% confidence interval of 99.48% - 99.91% upon repeat testing.
The ADVIA Centaur CHIV assay on the ADVIA Centaur XP clinical specificity for the overall pooled population was 99.72% (2483/2490) with a 95% confidence interval of 99.42% - 99.89% upon repeat testing.
The Atellica CI Analyzer clinical specificity for the overall pooled populations met the acceptance criteria. The study results demonstrate that the clinical specificity is comparable between the Atellica CI Analyzer and the ADVIA Centaur XP system.
Other clinical supportive data:
The percent agreement between the Atellica CHIV assay on the Atellica CI Analyzer and the ADVIA Centaur CHIV assay on the ADVIA Centaur XP system was evaluated by testing a total of 3456 samples in singlicate across three clinical testing sites on an Atellica CI Analyzer and an ADVIA Centaur XP system. One lot of ADVIA Centaur CHIV reagents, calibrators, and controls and one lot of Atellica IM CHIV reagents, calibrators, and controls were used for the testing. The concordance analysis, based on the final test results for the Atellica CI Analyzer and the ADVIA Centaur XP system, is summarized in the tables below.
| Atellica CI Analyzer | ADVIA Centaur XP system | | |
| --- | --- | --- | --- |
| | Nonreactive | Reactive | Total |
| Nonreactive | 2483 | 3 | 2486 |
| Reactive | 1 | 887 | 888 |
| Total | 2484 | 890 | 3374 |
| | Atellica CI Analyzer/ ADVIA Centaur XP system | Agreement (%) | 95% Confidence Interval |
| --- | --- | --- | --- |
| Nonreactive (Negative) | 2483/2484 | 99.96% | 99.78%-100.00% |
| Reactive (Positive) | 887/890 | 99.66% | 99.02%-99.93% |
The results for the positive and negative percent agreements between the Atellica CHIV assay on the Atellica CI Analyzer (candidate) and the ADVIA Centaur CHIV assay on the ADVIA Centaur XP system (predicate) met the acceptance criteria. The assay performance between the Atellica CI Analyzer and the ADVIA Centaur XP system is therefore comparable.
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**510(k) Summary**---
## 10. Conclusions
Clinical and non-clinical, instrument-specific analytical studies were performed to demonstrate the performance of the Atellica IM HIV Ag/Ab Combo (CHIV) assay on the Atellica CI Analyzer. The data from analytical and clinical performance testing support a conclusion of substantial equivalence between the Atellica IM HIV Ag/Ab Combo (CHIV) assay on the Atellica CI Analyzer (candidate) and ADVIA Centaur HIV Ag/Ab Combo (CHIV) assay on the ADVIA Centaur XP system (predicate).
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