Multichem ID-HIVp24 is intended for use as a qualitative quality control serum to monitor the precision of laboratory testing procedures for the HIV-1 p24 antigen detected by the heterogeneous immunoassay systems listed in the Instructions for Use. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Device Story
Multichem ID-HIVp24 is a liquid, ready-to-use, third-party quality control serum; composed of disease state human serum diluted with negative human serum, preservatives, and stabilizers. Designed for use in clinical laboratories to monitor the precision of HIV-1 p24 antigen immunoassay testing procedures. Supplied in barcoded vials for automated platform application. Laboratory personnel use the control to verify system performance; it does not replace manufacturer-provided controls. The device provides a stable reference to detect systematic deviations in assay performance, supporting good laboratory practices.
Clinical Evidence
Bench testing only. Precision study (20 days, 240 replicates) and reproducibility study (5 days, 225 replicates) conducted on the cobas e801 instrument. Precision results showed low variability (within-run %CV 1.74%, between-run %CV 1.99%). Reproducibility study across three sites showed low %CV across all sources of variability (within-run 1.41%, between-day 1.51%, between-site 9.68%, between-QC lots 9.55%).
Technological Characteristics
Liquid, serum-based quality control; contains HIV-1 p24 antigen, preservatives, and stabilizers. Ready-to-use, barcoded vials. Storage at 2–8°C. Shelf life 13 months. No energy source or software algorithm; manual/automated laboratory assay control.
Regulatory Classification
Identification
An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.
Special Controls
An assayed quality control material for clinical microbiology assays must comply with the following special controls: (1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate: (i) Analyte concentration; Expected values: (ii) Analyte source: (iii) (iv) Base matrix; (v) Added components; (vi) Safety and handling information; and, (vii) Detailed instructions for use. (2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including: (i) Description of the process for value assignment and validation. (ii) Description of the protocol(s) used to establish stability. (iii) Line data establishing precision/reproducibility. (iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance. (v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method. (vi) Where applicable, detailed documentation related to studies for surrogate controls. (3) Premarket notification submissions must include an adequate mitigation (e.g., realtime stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling. (4) Your 21 CFR 809.10 compliant labeling must include the following: (i) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following: (A) Assayed control material analyte(s); (B) Whether the material is intended for quantitative or qualitative assays: (C) Stating if the material is a surrogate control; (D)The system(s), instrument(s), or test(s) for which the quality control material is intended. (ii) The intended use in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(b)(2) compliant labeling must include the following statement: "This product is not intended to replace manufacturer controls provided with the device." (iii)A limiting statement that reads "Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements."
*Classification.* Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”
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**CLINICAL
DIAGNOSTICS**
**Science for a Safer World**
## 510(k) SUMMARY
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21CFR 807.92.
| **Applicant Name** | Techno-path Manufacturing Ltd. |
| --- | --- |
| **Applicant Address** | Fort Henry Business Park, Ballina Co. Tipperary V94 FF1P Ireland |
### Device Identification
| **Trade Name** | Multichem ID-HIVp24 |
| --- | --- |
| **Common Name** | N/A |
| **Classification Name** | Assayed quality control material for clinical microbiology assays |
| **Regulation Number** | 21 CFR 866.3920 |
| **Product code** | QCH |
### Device Substantial Equivalence
| **Predicate Device** | |
| --- | --- |
| Predicate Trade Name | BioRad VIROTROL® HIV-1 Ag |
| Predicate Common Name | N/A |
| Predicate Classification Name | Kit, quality control for blood banking reagents |
| Regulation Number | 21 CFR 864.9650 |
| Product code | KSF |
| Predicate 510(k) Number | BK930033 |
### 1. Device Description
Multichem ID-HIV p24 is supplied as a single level, liquid control that is ready-to-use with barcodes that are designed for application on to the targeted platform. It consists of disease state human serum diluted with negative human serum.
Multichem ID-HIV p24 is a liquid stable, third-party quality control used to monitor the precision of laboratory testing procedures and is an integral part of good laboratory practices. A control is provided to allow performance monitoring of the test system. The Multichem ID-HIV p24 Quality Control has been prepared from human plasma to which preservatives and stabilizers have been added. Multichem ID-HIV p24 is intended for use as a qualitative quality control serum to monitor the precision of laboratory testing procedures for the HIV-1 p24 antigen detected by the heterogeneous immunoassay systems listed in the package insert. These products are not intended to replace manufacturer’s recommended controls provided in their package insert.
Techno-path Manufacturing Limited. Registered in Ireland No. 419288. Registered Office: Fort Henry Business Park, Ballina, Co. Tipperary, Ireland.
Technopath Clinical Diagnostics is a registered business name of Techno-path Manufacturing Limited. LGC Clinical Diagnostics, Maine Standards,
SeraCare, Technopath Clinical Diagnostics, and The Native Antigen Company are trading names of LGC Limited.
lgcclinicaldiagnostics.com
Page 1 of 4
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LGC
CLINICAL DIAGNOSTICS
Science for a Safer World
# Intended Use/Indications for Use
Multichem ID-HIVp24 is intended for use as a qualitative quality control serum to monitor the precision of laboratory testing procedures for the HIV-1 p24 antigen detected by the heterogeneous immunoassay systems listed in the Instructions for Use. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
# 2. Comparison with Predicate Device
Table 2. General Device Characteristic Similarities
| | Subject Device: | Predicate Device: BK930033 |
| --- | --- | --- |
| | Multichem ID-HIVp24 | VIROTROL HIV-1 Ag |
| Intended Use | Multichem ID-HIVp24 is intended for use as a qualitative quality control to monitor the precision of laboratory testing procedures for the HIV-1 p24 antigen detected by heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements. | VIROTROL HIV-1 Ag is intended for use as an unassayed reactive quality control with in vitro assay procedures for determination of antigens to Human Immunodeficiency Virus Type 1 (HIV-1). This product is intended to provide a means of estimating precision and has the potential for detecting systematic deviations from specific laboratory testing procedures. |
| Form | Liquid | Same |
| Storage | 2 - 8°C Single use only; discard after use. | Same |
| Matrix | Serum | Same |
| Assay Target Analyte | HIV-1 p24 Antigen | HIV-1 p24 antigen |
TECHNOPATH CLINICAL DIAGNOSTICS
lgcclinicaldiagnostics.com
Techno-path Manufacturing Limited. Registered in Ireland No. 419288. Registered Office: Fort Henry Business Park, Ballina, Co. Tipperary, Ireland. Technopath Clinical Diagnostics is a registered business name of Techno-path Manufacturing Limited. LGC Clinical Diagnostics, Maine Standards, SeraCare, Technopath Clinical Diagnostics, and The Native Antigen Company are trading names of LGC Limited.
Page 2 of 4
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LGC
CLINICAL DIAGNOSTICS
Science for a Safer World
Table 3. General Device Characteristic Differences
| | Subject Device: Multichem ID-HIVp24 | Predicate Device: BK930033 VIROTROL HIV-1 Ag |
| --- | --- | --- |
| Open Vial Stability | 30 days at 2 – 8°C | 60 days at 2 – 8°C |
| Shelf Life | 13 months at 2 – 8°C | 18 months at 2 – 8°C |
### 3. Non-Clinical Performance Evaluation
A summary of nonclinical performance testing associated with the Multichem ID-HIVp24 Quality Control is as follows:
#### 4.1 Precision
A 20-day precision study with two runs per day and two replicates per run using three lots of the Multichem ID-HIVp24 quality control was performed on the cobas e801 instrument by a single operator which resulted in 240 replicates (80 replicates per each QC lot). The data obtained were analyzed for the components of Cut-off Index (COI) variation within-run (repeatability), and between-runs. As demonstrated in Table 4a the variability between-run, and within-run was low.
Table 4a. Precision of Multichem ID-HIVp24 on the cobas e801 instrument
| Sample | N | Mean COI | Within-Run (Repeatability) | | Between-Run | |
| --- | --- | --- | --- | --- | --- | --- |
| | | | SD | % CV | SD | % CV |
| HIV p24 | 240 | 5.65 | 0.09 | 1.74 | 0.11 | 1.99 |
N= number of replicates tested, COI = Cut-off Index, SD = Standard Deviation, %CV = percent Coefficient of Variation.
#### 4.2 Reproducibility
A five-day reproducibility study was performed using three lots of the Multichem ID-HIVp24 quality control, with five replicates per lot on the cobas e801 instrument at three different sites, which resulted in a total of 225 replicates (75 replicates per each QC lot). The data obtained were analyzed for the components of Cut-off Index (COI) variation within-run, between-days, between-sites, and between the three QC lots. As demonstrated in Table 4b the percent coefficient of variation (%CV) was low between the various sources of variability.
Table 4b. Reproducibility of Multichem ID-HIV p24 on the cobas e801 instrument
| Sample | N | Mean COI | Within-Run | | Between-Day | | Between-Site | | Between-QC Lots | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | | SD | % CV | SD | % CV | SD | % CV | SD | % CV |
| HIV p24 | 225 | 6.08 | 0.87 | 1.41 | 0.87 | 1.51 | 0.58 | 9.68 | 0.58 | 9.55 |
N= number of replicates tested, COI = Cut-off Index, SD = Standard Deviation, %CV = percent Coefficient of Variation.
TECHNOPATH
CLINICAL DIAGNOSTICS
lgcclinicaldiagnostics.com
Techno-path Manufacturing Limited. Registered in Ireland No. 419288. Registered Office: Fort Henry Business Park, Ballina, Co. Tipperary, Ireland. Technopath Clinical Diagnostics is a registered business name of Techno-path Manufacturing Limited. LGC Clinical Diagnostics, Maine Standards, SaraCare, Technopath Clinical Diagnostics, and The Native Antigen Company are trading names of LGC Limited.
Page 3 of 4
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LGC CLINICAL DIAGNOSTICS
Science for a Safer World
#### 4. Conclusions
The Multichem ID-HIVp24 is a serum-based quality control reagent used for monitoring the performance of immunoassay procedures for the qualitative detection of HIV-1 p24 antigen. It is comprised of ready-to-use, barcoded vials that have an expiration of 13 months when stored at 2 – 8°C. The Multichem ID-HIVp24 has the same technology, similar intended use and the data presented demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
lgcclinicaldiagnostics.com
Techno-path Manufacturing Limited. Registered in Ireland No. 419288. Registered Office: Fort Henry Business Park, Ballina, Co. Tipperary, Ireland.
Technopath Clinical Diagnostics is a registered business name of Techno-path Manufacturing Limited. LGC Clinical Diagnostics, Maine Standards, SeraCare, Technopath Clinical Diagnostics, and The Native Antigen Company are trading names of LGC Limited.
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