(58 days)
ACCURUN™ 140 Rubella IgG Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Rubella virus. This control is not intended as a substitute for controls provided with test kits.
ACCURUN™ 140 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.
This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Rubella virus in human serum and plasma.
ACCURUN™ 140 Rubella IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to Rubella, but is nonreactive for antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ as preservative. The manufacturer recommends that the user observe the Centers for Disease Control (CDC) recommended Universal Precautions for handling ACCURUN™ 140 and all human blood.
This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgG antibodies to Rubella virus in human serum and plasma.
This control is supplied as 1 x 1 ml vial or 1 x 5 ml vial. ACCURUN™ 140 should be stored at 2-8°C. Once opened, ACCURUN™ 140 should be discarded after 60 days.
The provided document describes the ACCURUN™ 140 Rubella IgG Positive Control and its substantial equivalence determination, but it does not contain specific acceptance criteria or a study directly comparing reported device performance against numerical acceptance criteria in a table format.
The document focuses on:
- Device description: Ingredients, storage, intended use.
- Existing products and practices: States it's substantially equivalent to other commercial controls.
- Summary of studies: Mentions stability studies (real-time, ambient temperature, heat stress, freeze-thaw, open vial) and clinical laboratory evaluations at BBI and two external labs.
- Conclusions drawn from studies: Indicates the product is stable under various conditions and that "The clinical trial data demonstrate that ACCURUN™ 140 is safe and effective in three different laboratories with three manufactured ACCURUN™ 140 lots, and under various conditions of stress."
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance using the provided text. The document describes the types of studies conducted and their general conclusions but does not quantify performance metrics against pre-defined thresholds.
Here's a breakdown of what can be extracted or inferred from the document regarding the other points, along with what cannot be provided:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document states general conclusions about stability and effectiveness but does not present specific numerical acceptance criteria (e.g., "stability must be maintained within X% for Y days") or quantitative device performance data against such criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not explicitly stated. The document mentions "clinical laboratory evaluations were performed at BBI and at two clinical laboratories" and that "three manufactured ACCURUN™ 140 lots" were used. It refers to "clinical trial data" but doesn't quantify the number of tests, specimens, or specific patient samples in these evaluations.
- Data provenance: While the sponsor, Boston Biomedica, Inc., is based in West Bridgewater, MA, USA, the specific country of origin for the clinical evaluation data is not mentioned, other than being conducted at BBI and "two clinical laboratories" (location unspecified). The studies appear to be prospective for the purpose of demonstrating stability and performance for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not available. This device is a positive control, not a diagnostic device that interprets clinical findings. Its "ground truth" is its known positive status for Rubella IgG antibodies. Ground truth in the context of expert review for diagnostic interpretation isn't relevant here. The clinical evaluations would have assessed its consistency and performance in detecting Rubella IgG in test systems, not its ability to diagnose a patient.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available. As a control, adjudication of results in the traditional sense of resolving discrepancies in diagnoses is not relevant. The performance was likely assessed through consistency and expected reactivity in various Rubella IgG assays.
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
- Not applicable. This device is a control, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improve with AI" are not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a human-blood-based laboratory control, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this positive control is its inherent positivity for Rubella IgG antibodies, manufactured from human serum or plasma containing these antibodies. This is established during its manufacturing and characterization rather than through expert consensus, pathology, or outcomes data in the context of patient diagnosis. Its performance is then evaluated by testing its reactivity in Rubella IgG assays.
8. The sample size for the training set
- Not applicable. This is a biological control, not a machine learning or AI device that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.