(49 days)
ACCURUN™ 150 HSV 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 herpes simplex virus (HSV). This control is not intended as a substitute for controls provided with test kits.
ACCURUN™ 150 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.
This product is not FDA cleared for use in testing blood or plasma donors.
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 HSV in human serum.
ACCURUN™ 150 HSV IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to herpes simplex virus, 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™ 150 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 HSV in human serum.
This control is supplied as 1 x 1 ml vial and 1 x 5 ml vial. ACCURUN™ 150 should be stored at 2-8°C. Once opened, ACCURUN™ 150 should be discarded after 60 days.
Here's an analysis of the provided text regarding the ACCURUN™ 150 HSV IgG Positive Control, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a control product, not a diagnostic device that measures a specific outcome. Therefore, the "acceptance criteria" and "device performance" are focused on the control's stability and its ability to consistently perform in laboratory settings using existing IgG antibody detection tests.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Stability at 2-8°C | "ACCURUN™ 150 can be stored at 2-8°C in its vialed form..." |
| Stability to Multiple Freeze-Thaw Cycles | "...is not affected by multiple freeze-thaw cycles." |
| Stability at Ambient Temperatures | "ACCURUN™ 150 is stable at ambient temperatures... for a short period of time with no adverse effects." |
| Stability under Heat Stress | "ACCURUN™ 150... under heat stress for a short period of time with no adverse effects." |
| Open Vial Stability (at 2-8°C) | "ACCURUN™ 150 remains stable even after the vials have been repeatedly opened and stored at 2-8°C for at least 60 days." |
| Consistency and Performance as an Independent Run Control | "The clinical trial data demonstrate that ACCURUN™ 150 is safe and effective in three different laboratories with three manufactured ACCURUN™ 150 lots, and under various conditions of stress." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of individual samples. The study involved "three different laboratories with three manufactured ACCURUN™ 150 lots." The data was collected through "clinical laboratory evaluations" performed at BBI (Boston Biomedica, Inc.) and at "two clinical laboratories."
- Data Provenance: Retrospective, as the study was completed to support the 510(k) submission. The country of origin is not explicitly stated, but given that Boston Biomedica, Inc. is a U.S.-based company and the FDA approval is for marketing in the U.S., it can be inferred the data largely originated from the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for a control material like this isn't typically established by expert consensus in the same way a diagnostic test is. Instead, it relies on the intrinsic properties of the control material (presence of IgG antibodies to HSV) and its consistent behavior when tested by standard HSV IgG assays.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a control material study, a formal adjudication method for ground truth in the sense of a diagnostic outcome is unlikely to have been applied. The "evaluation" would likely involve assessing the consistency of results obtained when the control was run through various HSV IgG tests.
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
No, an MRMC comparative effectiveness study was not done. This product is a positive control for detecting HSV IgG antibodies, not an AI-powered diagnostic device, and therefore does not involve human readers or AI assistance in its function.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. Again, this product is a biological control material, not an algorithm. Its performance is evaluated by its consistency when used with existing diagnostic tests.
7. The Type of Ground Truth Used
The "ground truth" for this control is its known composition: it is "manufactured from human serum or plasma containing IgG antibodies to herpes simplex virus." The performance evaluation confirms that this known positive status is consistently detected by various HSV IgG tests and that the control remains stable under different conditions. It's essentially a known positive sample used to verify the proper functioning of other diagnostic tests.
8. The Sample Size for the Training Set
This product is not an AI algorithm and therefore does not have a "training set" in the conventional sense. Its development involved sourcing human serum/plasma with specific antibodies and then formulating it with stabilizers and preservatives. The stability studies and clinical laboratory evaluations served as validation, not training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of product. The "ground truth" (the presence of HSV IgG antibodies) in the source material would have been established using validated, commercially available HSV IgG detection assays at the time of sourcing.
§ 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.