(235 days)
Amplichek I is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the quantitative detection of Human Immunodeficiency Virus Type 1 (HIV-1), Hepatiis B Virus (HBV) and Hepatitis C Virus (HCV) for molecular diagnostic platforms listed in the package insert. This product is not intended to replace manufacturer controls provided with the device. This product is not intended for use with blood donor screening assays in U.S. or Canada.
Amplichek I is a set of quality controls consisting of four levels filled in individual vials with 1.2 mL of material. Each level is packaged separately in configuration of 10 tubes per box and four tubes per box in a MiniPak (trial size). This product is prepared from normal human plasma based material non-reactive to HIV-1 Ribonucleic Acid (RNA), HBV Deoxyribonucleic Acid (DNA) and HCV Ribonucleic Acid (RNA) with added proteins from human sources, antimicrobial agents as preservatives, and stabilizers. The positive levels are prepared using purified preparations of HIV, HBV and HCV isolated from human plasma or grown in cell cultures and are reactive for HIV-1 RNA, HBV DNA and HCV RNA. Amplichek I contains human plasma and purified retroviral and viral hepatitis materials derived from human plasma and/or cultured human cell line sources. Each human unit used in the preparation of this product is tested using licensed reagents and must be found to be non-reactive to HBsAg, antibodies to HIV-1 and HIV-2 and antibodies to HCV. Retroviral and viral hepatitis materials derived from human plasma and/or cultured human cell line sources are treated to inactivate infectious agents. However, no known test method can assure that products derived from human sources will not transmit infection. The labeling recommends that this product and all human specimens be handled in accordance with Biosafety Level 2 practices as described in the United States Department of Health and Human Services Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), Biosafety in Microbiological and Biomedical Laboratories, or other equivalent guidelines. The package insert will provide lot specific mean and ranges for each analyte on various platforms. The assigned values listed in the proposed package insert were generated in the same manner as used for unknown specimens using FDA approved commercial test kits. The negative control reports qualitative results. The means for the positive controls were calculated from the total laboratory data generated for each analyte on the specific platform and the 3SD range was then assigned. The Amplichek I labeling recommends that each laboratory establish its own acceptable range for each analyte. Procedures for implementing a quality assurance program and monitoring test performance on a routine basis must be established by each individual laboratory. Amplichek I product should not be used as a standard. It is recommended that each laboratory establish its own means and acceptable ranges and use those provided only as quides.
The provided text describes the Bio-Rad Amplichek I, an assayed quality control material, and its substantial equivalence to a predicate device (Amplichek II). It does not contain information about a medical device that requires a study to prove it meets acceptance criteria in the typical sense of a diagnostic or AI-powered device.
Therefore, many of the requested categories for a study on device performance, such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable to this document. This document primarily focuses on the regulatory submission and comparison of a quality control material.
However, I can extract the acceptance criteria related to product stability based on the provided text.
Here's a summary of the stability acceptance criteria and the device's reported performance:
Acceptance Criteria and Reported Device Performance for Bio-Rad Amplichek I
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Shelf Life (unopened vial) | |
| Duration | 16 months |
| Storage Condition | -20 to -70 °C |
| Analyte Stability | All analytes remain stable |
| Open Vial Stability | |
| Duration (time) | 7 days |
| Number of entries | 3 vial entries |
| Storage Condition | 2 to 8 °C (tightly capped) |
| Analyte Stability | All analytes remain stable |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text states "Stability studies have been performed..." but does not detail the methodology, sample sizes, or data provenance for these studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as the device is an assayed quality control material, not a diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for this type of product refers to the pre-assigned values and ranges determined by the manufacturer for the analytes. The document mentions: "The assigned values listed in the proposed package insert were generated in the same manner as used for unknown specimens using FDA approved commercial test kits. The negative control reports qualitative results. The means for the positive controls were calculated from the total laboratory data generated for each analyte on the specific platform and the 3SD range was then assigned." This describes a laboratory-based method using commercial test kits, not a panel of human experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for a quality control material as there is no human interpretation or adjudication process described for the stability studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human readers, which is not the nature of the Amplichek I device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation in the context of an algorithm or AI system was not done. The stability studies evaluate the physical and chemical stability of the quality control material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of this quality control material is established through laboratory testing using FDA approved commercial test kits, whereby lot-specific mean and ranges are determined for each analyte on various platforms. For the stability studies, the acceptance criteria are based on whether the material retains its expected performance (e.g., within established ranges) after storage under specified conditions.
8. The sample size for the training set
This information is not applicable. The Amplichek I is a quality control material, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this device.
§ 866.3920 Assayed quality control material for clinical microbiology assays.
(a)
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.(b)
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.”