← Product Code [MZF](/productcode/MZF) · BK230804

# Elecsys HIV Duo (BK230804)

_Roche Diagnostics Indianapolis, IN · MZF · Apr 4, 2023 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/BK230804

## Device Facts

- **Applicant:** Roche Diagnostics Indianapolis, IN
- **Product Code:** [MZF](/productcode/MZF.md)
- **Decision Date:** Apr 4, 2023
- **Decision:** SESE
- **Regulation:** 21 CFR 866.3956
- **Device Class:** Class 2
- **Review Panel:** Microbiology
- **Attributes:** Pediatric

## Indications for Use

Elecsys HIV Duo is an immunoassay intended for the in vitro simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV, HIV-1 (groups M and O) and HIV-2 in human serum and plasma. Elecsys HIV Duo assay is intended to be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in subjects greater than 2 years of age and in pregnant women. Elecsys HIV Duo is not intended for the screening of donors of blood and blood components or human cells, tissues, and cellular and tissue-based products (HCT/Ps). Elecsys HIV Duo is an electrochemiluminescence immunoassay “ECLIA” intended for use on the cobas e 402 and cobas e 801 immunoassay analyzers.

## Device Story

Elecsys HIV Duo is a qualitative sandwich immunoassay for detection of HIV-1 p24 antigen and HIV-1/HIV-2 antibodies in human serum/plasma. Operates on cobas e 402 analyzer using electrochemiluminescence immunoassay (ECLIA) principle. Sample (30 μL) reacts with biotinylated and ruthenylated monoclonal antibodies (for Ag) or recombinant antigens (for Ab) to form sandwich complexes. Complexes bind to streptavidin-coated microparticles; magnetically captured on electrode surface. Voltage application induces electrochemiluminescent emission measured by photomultiplier. Software automatically calculates results based on signal-to-cutoff ratios (COI). Used in clinical laboratory settings by trained technicians. Output aids healthcare providers in diagnosing HIV infection. Benefits include rapid, automated, simultaneous detection/differentiation of HIV-1 p24 antigen and HIV antibodies.

## Clinical Evidence

Bench testing only. Method comparison study evaluated 101 negative and 291 positive samples across three sites. Combined negative percent agreement was 100.00%; combined positive percent agreement was 99.39% (95% CI: 96.63% lower limit). Precision, limit of blank, limit of detection, and seroconversion sensitivity studies confirmed performance equivalence to the predicate analyzer.

## Technological Characteristics

Electrochemiluminescence immunoassay (ECLIA). Materials: biotinylated/ruthenylated monoclonal antibodies, recombinant antigens, streptavidin-coated microparticles. Analyzers: cobas e 402 (120 tests/hour) and cobas e 801 (300 tests/hour). Detection via photomultiplier. Software-based automated signal-to-cutoff ratio calculation. Traceability and calibration identical to predicate.

## Regulatory 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

- Elecsys HIV Duo (BP190403)

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# Elecsys HIV Duo  
510(k) Summary  
BK230804

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

The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the Elecsys HIV Duo immunoassay on the **cobas e** 402 analyzer.

|  **Submitter Name** | Roche Diagnostics  |
| --- | --- |
|  **Address** | 9115 Hague Road Indianapolis, IN 46256 United States  |
|  **Contact** | Tammy Dean Phone: (317) 450-5193 Email: (b) (6) @roche.com  |
|  **Date Prepared** | March 15, 2023  |
|  **Proprietary Name** | Elecsys HIV Duo  |
|  **Common Name** | Human immunodeficiency virus (HIV) serological diagnostic and/or supplemental test  |
|  **Classification Name** | Test, HIV Detection  |
|  **Product Code, Regulation Number** | MZF, Regulation Number 866.3956  |
|  **Predicate Device Number, Trade Name, Product Code** | BP190403, Elecsys HIV Duo, MZF  |

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# 1. DEVICE DESCRIPTION SUMMARY

The Elecsys HIV Duo is a qualitative serologic sandwich immunoassay intended for the detection and differentiation of HIV-1 p24 antigen and antibodies to HIV, HIV-1(group M, and group O) and HIV-2, in human serum and plasma. This assay design consists of two modules, one for detection of HIV-1 p24 antigen using monoclonal antibodies to (HIV-1) p24 and the second for detection of HIV-1 and HIV-2 antibodies using recombinant antigens derived from the Env and Pol-region of HIV-1 (including group O) and HIV-2. The immunoassay is based on the electrochemiluminescence immunoassay (ECLIA) principle.

For HIV Ag detection (HIVAG), 30 μL of sample react with biotinylated monoclonal anti-p24 antibodies and ruthenylated monoclonal anti-p24 antibodies, to form a sandwich complex. For anti-HIV detection (AHIV), 30 μL of sample react with biotinylated HIV-specific recombinant antigens/peptides and ruthenylated HIV-specific recombinant antigens/peptides, to form a sandwich complex. The incubations are performed in parallel in two separate vessels.

In the second incubation step, after addition of streptavidin-coated microparticles and the complex becomes bound to the solid phase via interaction of biotin and streptavidin.

The reaction mixture is aspirated into the measuring cell of the analyzer where the micro particles are magnetically captured onto the surface of an electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode induces electrochemiluminescent emission which is measured by a photomultiplier.

The Elecsys HIV Duo immunoassay requires the use of quality control reagents, the Elecsys PreciControl HIV Gen II and the Elecsys PreciControl HIV; HIV-2+ Grp O. Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the sample with the cutoff value obtained by HIV Ag embedded and Anti-HIV embedded calibrations. The Elecsys HIV Duo result is calculated automatically based on signal to cutoff ratios (cutoff index, COI) from HIV Ag and anti-HIV.

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## 2. INTENDED USE/INDICATIONS FOR USE

Elecsys HIV Duo is an immunoassay intended for the in vitro simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and antibodies to HIV, HIV-1 (groups M and O) and HIV-2 in human serum and plasma. Elecsys HIV Duo assay is intended to be used as an aid in the diagnosis of HIV-1 and/or HIV-2 infection, including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2 infection in subjects greater than 2 years of age and in pregnant women. Elecsys HIV Duo is not intended for the screening of donors of blood and blood components or human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Elecsys HIV Duo is an electrochemiluminescence immunoassay “ECLIA” intended for use on the **cobas e 402** and **cobas e 801** immunoassay analyzers.

## 3. INDICATIONS FOR USE COMPARISON

The intended use is the same as the predicate, with the exception that the **cobas e 402** analyzer is being added to the intended use statement. The intended use population and assay targets are identical to the predicate. The reagent formulation has not changed. The **cobas e 402** analyzer is being added to the method sheet is a member of the Elecsys instrument family and analytical performance data were produced to show equivalence.

## 4. TECHNOLOGICAL COMPARISON

The Elecsys HIV Duo immunoassay approved in conjunction with the **cobas e 801** analyzer has the same technological characteristics when used on the **cobas e 402** analyzer. The test principle, working solutions, traceability, calibration, quality control, and results calculation are identical. The differences between the instruments are to account for throughput differences (i.e. 300 tests/hour on the **cobas e 801** analyzer and 120 tests/hour on the **cobas e 402** analyzer). A summary of the technological differences between **cobas e 801** and **cobas e 402** is provided below in the table.

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|  General Instrument Characteristic Differences | Device Elecsys HIV Duo **cobas e 402** analyzer | Predicate Elecsys HIV Duo **cobas e 801** analyzer  |
| --- | --- | --- |
|  Throughput: | 120 test/hour/module | 300 test/hour/module  |
|  Sample capacity on-board: | 50 | 300  |
|  On-board Reagent Capacity | Reagent compartment (rotor) for 28 reagent containers | Reagent compartment (rotor) for 48 reagent containers  |
|  System Cycle Time-Measuring Cell | 30 seconds | 24 seconds  |
|  Reagent Probes | 1 polished steel probe | 2 polished steel probes  |
|  Measuring Units/Channels | 1 | 2  |

## 5. NON-CLINICAL AND/OR CLINICAL TEST SUMMARY & CONCLUSIONS

A summary of nonclinical performance testing associated with the Elecsys HIV Duo on **cobas e 402** analyzer is as follows:

### 5.1. Precision

Precision measurements were conducted for five days to evaluate repeatability (within-run precision) and the intermediate precision (within-laboratory precision) were calculated following the guidelines of the CLSI EP05-A3. Samples tested included human specimens and controls measured on three lots of Elecsys HIV Duo reagent on one **cobas e 402** analyzer. Measurements spanned multiple calibration events. Precision measurements were also conducted for five days to evaluate reproducibility. Testing occurred at three sites and with three lots (2 lots per site) of Elecsys HIV Duo reagent on one **cobas e 402** analyzer per site. Repeatability, intermediate precision and reproducibility were calculated according to a modified version of CLSI EP05-A3.

For comparison, repeatability and intermediate precision data were collected on the predicate (Elecsys HIV Duo on the **cobas e 801** analyzer).

All **cobas e 402** results for repeatability and intermediate precision fulfill the acceptance criteria and show equivalent performance to the **cobas e 801** analyzer.

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## 5.2. Assay Limits

Limit of Blank was confirmed in accordance with CLSI Guideline EP17-A2. Five serum and five plasma analyte-free samples were tested in duplicate with two lots of Elecsys HIV Duo reagent, over six runs.

Limit of Detection was confirmed in accordance with CLSI Guideline EP17-A2. Five serum and five plasma low-level analyte samples were tested in duplicate with two lots of Elecsys HIV Duo reagent, over six runs.

The **cobas e 402** results for assay limits fulfill the acceptance criteria and show equivalent performance to the **cobas e 801** analyzer.

## 5.3. Cut-off (Antigen) Sensitivity

Cut-off (Antigen) Sensitivity was tested with three lots of Elecsys HIV Duo reagent on one **cobas e 801** analyzer and one **cobas e 402** analyzer. Samples tested in duplicate included dilutions of standards and an HIV Antigen Panel.

The acceptance criteria for antigen sensitivity is fulfilled for the Elecsys HIV Duo main results and the HIVAG module sub-results on the **cobas e 402** and **cobas e 801** analyzers.

## 5.4. Recovery of Controls

Recovery of Controls was tested with one lot of Elecsys HIV Duo reagents, five controls, over two runs on two analyzers.

The data demonstrated that the recovery of the values for PreciControl HIV Gen II and PreciControl HIV; HIV-2+GrpO generated on the **cobas e 402** analyzers are within the assigned target ranges.

## 5.5. Seroconversion Sensitivity

Seroconversion sensitivity was tested with 20 panels, including early seroconversion samples. Testing include one reagent lot of Elecsys HIV Duo reagent on both the **cobas e 402** (candidate) analyzer and the **cobas e 801** analyzer (predicate). The resulting data was assessed to confirm that the switch from negative to positive bleeds in a panel occurred on the same day and/or same bleed.

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The seroconversion sensitivity study showed no discrepant results for the Elecsys HIV Duo assay on the **cobas e 402** analyzer (candidate) versus the **cobas e 801** analyzer (predicate).

### 5.6. Method Comparison (MC)

Method Comparison was performed to evaluate the equivalency of performance of the Elecsys HIV Duo immunoassay, main result, on the **cobas e 402** (one analyzer at each of three sites) and **cobas e 801** analyzers (2 analyzers). Testing was performed using one lot of reagents with 101 negative and 291 positive samples. 73 anti-HIV-1 group M, 41 anti-HIV group O, 60 anti-HIV-2, 117 HIV Antigen, and 101 negative samples were included. Analysis for each site was conducted separately and a combined analysis for all system configurations was provided. The final status of samples tested on the **cobas e 402** was determined, in the case of discordant results among the three sites, as the result produced by two out of the three sites. The combined negative percent agreement was 100.00%, while the combined positive percent agreement was 99.39%. with one discordant result.

A summary of individual sites and combined method comparisons can be found in the table below:

|   | Samples | MC 1 | MC 2 | MC 3 | MC 4 (combined) | Acceptance criteria  |
| --- | --- | --- | --- | --- | --- | --- |
|  Negative % Agreement | negative | 100.00% | 100.00% | 100.00% | 100.00% | -  |
|  Positive % Agreement | positive | 98.78% | 99.39% | 100.00% | 99.39% | -  |
|  Lower limit of two-sided 95% CI of agreement rates | negative | 98.34% | 98.34% | 98.34% | 98.34% | ≥ 90%  |
|   |  positive | 95.66% | 96.63% | 97.71% | 96.63% | ≥ 90%  |

In addition, the data was analyzed for the subresults (i.e., HIV Antigen and Anti-HIV). Overall agreement ≥ 95 % of results with reference reported result “neg.” or “pos.” were found to be within the respective range. One discordant sample was generated in the anti-HIV subset.

### 6. CONCLUSIONS

Predefined acceptance criteria were met. Data supports the equivalence of the Elecsys HIV Duo immunoassay on both the **cobas e 801** and the **cobas e 402** immunoassay analyzers.

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As the Elecsys HIV Duo immunoassay reagents and intended use populations have not changed, additional clinical studies were not completed. Non-clinical studies were used to show performance of the additional analyzer (i.e, the **cobas e** 402 analyzer).

The nonclinical performance testing and method comparison study support a conclusion of substantial equivalence between the Elecsys HIV Duo immunoassay on the candidate (**cobas e** 402) and predicate (**cobas e** 801) analyzers.

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**Source:** [https://fda.innolitics.com/device/BK230804](https://fda.innolitics.com/device/BK230804)

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