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The Audit™ MicroCV™ Procalcitonin Linearity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte.

The Audit™ MicroCV™ Procalcitonin Linearity Set is a bovine serum albumin, freeze dried, five level set of QC material, with each level containing one analyte: Procalcitonin. It is used to confirm the proper calibration, linear operating range, and reportable range of Procalcitonin. Level A has concentration near the lower limit level and Level E has concentrations near the upper limit level of instruments. Levels B – D are related by linear dilution of Level A and Level E.

The provided document describes a 510(k) summary for the Audit™ MicroCV™ Procalcitonin Linearity Set, a quality control material. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a new clinical diagnostic device. Therefore, much of the requested information regarding clinical studies, sample sizes, expert ground truth, and comparative effectiveness is not applicable or available in this specific document.

However, based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) like a diagnostic device would. Instead, the "performance" here relates to the stability of the QC material, and the acceptance is based on demonstrating substantial equivalence to a predicate device for its intended use.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of clinical performance evaluation using patient samples. The device is a quality control material. The stability studies carried out would involve batches of the QC material.

• Sample Size: Not specified in terms of clinical samples. Stability studies would have used multiple units/batches of the QC material.
• Data Provenance: Not explicitly stated as "country of origin" for clinical data. The studies were performed internally by Aalto Scientific, Ltd. (Carlsbad, CA, USA). The studies are "real-time studies," which indicates a prospective data collection for stability.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. As this is a quality control material, the "ground truth" for its performance relates to its chemical stability and linearity, which are evaluated through laboratory-based analytical methods rather than expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a quality control material, not a diagnostic device requiring MRMC studies for human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a laboratory reagent, not an algorithm.

7. The Type of Ground Truth Used

For the stability and linearity claims:

• Ground Truth: Laboratory analytical measurements (e.g., spectrophotometry, immunoassay to quantify Procalcitonin concentrations) performed on the QC material over time and across different dilutions. These measurements are typically compared against established analytical standards and internal specifications to confirm stability and linearity.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control material and does not involve machine learning or a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

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For use in monitoring the performance of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (EDTA, citrate and heparin). The performance of the Vitros Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assays. For in vitro diagnostic use.

The Vitros Immunodiagnostic System uses luminescence as the signal in the qualitative detection of HBsAg in human plasma and serum. Coated microwells are used as the solid phase separation system. The system is compromised of three main elements: The Vitros Immunodiagnostic Products range of products, in this case Vitros Immunodiagnostic Products HBsAg Reagent Pack and Vitros Immunodiagnostic Products Calibrator; The Vitros Immunodiagnostic System- instrumentation; Common reagents used by the Vitros System in each assay, the Vitros Immunodiagnostic Products Signal Reagent and the Vitros Immunodiagnostic Products Universal Wash Reagent. The Vitros System and common reagents are dedicated specifically only for use with the Vitros Immunodiagnostic Products range of immunoassay products.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vitros Immunodiagnostic Products HBsAg Controls:

This 510(k) summary (K030067) is for a quality control material (HBsAg Controls), not a diagnostic device that performs detection. Therefore, the typical "acceptance criteria" and "device performance" metrics for diagnostic accuracy (like sensitivity, specificity, AUC) are not directly applicable in the same way. Instead, the "performance" here refers to the ability of the control material to reliably monitor the performance of the associated diagnostic system (Vitros ECi Immunodiagnostic System).

The primary focus of this submission is an expansion of the intended use for the controls, specifically to include the monitoring of HBsAg detection in human plasma (EDTA, citrate, and heparin) in addition to serum. The original predicate device's controls were already approved for serum.

Given this context, the "acceptance criteria" relate to demonstrating that the controls perform equivalently across different sample matrices (serum vs. various plasma types).

1. Table of Acceptance Criteria and Reported Device Performance

Note: Specific quantitative acceptance criteria (e.g., "± X% variation") are not explicitly stated in the provided document for the control material's performance across different matrices. Instead, the document describes the demonstration that "all samples (serum, EDTA, citrate or heparin) behave similarly in the assay." This implies an acceptance criterion of comparable performance, but without specific numerical thresholds.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document states "multiple samples collected as either whole serum or in the presence of EDTA citrate or heparin." A specific number for the test set sample size is not provided in this summary.
• Data Provenance: Not explicitly stated, but clinical laboratory in vitro diagnostic studies typically use banked or prospectively collected samples from a relevant patient population. No country of origin is mentioned. The study is described as an "assessment," suggesting it was likely a prospective or retrospective analysis of samples tested with the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This submission concerns the performance of quality control material for an HBsAg assay. The concept of "ground truth" established by experts (e.g., radiologists interpreting images) is not directly applicable here. The "truth" for the samples used in the study was determined by:

• Unspiked (negative) samples: Inherently negative for HBsAg.
• Spiked (positive) samples: Spiked with known positive HBsAg plasma, close to the weak positive detection level of the assay. This establishes their 'true positive' status for the purpose of the control's evaluation.

Therefore, no panel of independent experts was used to establish ground truth in the traditional sense for these control samples. The ground truth was defined by the sample preparation (negative or spiked positive).

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" was established by the design of the samples (unspiked negative or spiked positive), not by an expert adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance (e.g., radiology AI). The Vitros HBsAg Controls are quality control materials for an automated immunoassay system, not a device requiring human interpretation in this context.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question also doesn't directly apply. The "device" in question is a control material, not an algorithm, and the Vitros ECi Immunodiagnostic System itself is an automated system (algorithm-only in terms of result generation). The study described evaluated the control material's robustness across different sample matrices within the context of the automated system. It's an evaluation of the control's standalone performance in that respect, but not in the "algorithm-only vs. human-in-the-loop" sense.

7. The Type of Ground Truth Used

The ground truth used for the samples in the study was defined by the sample preparation:

• Known Negative: Unspiked samples were presumed negative.
• Known Positive (weak): Samples spiked with known HBsAg positive plasma to a level near the assay's weak positive detection threshold.

8. The Sample Size for the Training Set

• Not applicable directly. This submission is for a quality control material where performance is assessed through consistency and stability, not by training a machine learning algorithm. The "training set" concept is typically for AI/ML models.
• The quoted mean values and standard deviations for the controls are derived from "a minimum of 10 assays" in "a number of different laboratories using different reagent lots." This process, while not a "training set" in the AI sense, contributes to establishing the expected performance range of the controls.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As explained above, there is no "training set" in the context of an AI/ML model for this quality control material. The "ground truth" for the controls' expected values is established through repeated measurements (minimum of 10 assays) across various labs and reagent lots.

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SYSCON IDC-G is a human serum based unassayed control used to monitor analytical procedures and reagents for detecting agents of infectious diseases in patient serum or plasma specimens. These controls are to be used with in vitro immunoassay procedures for the qualitative determination of Chlamydia, Epstein-Barr related antigen, Borrelia burgdorferi, Herpes Complex, Hepatitis, and TORCH. These controls are not to be used as replacements for the kit controls and are not FDA cleared in use for testing blood or plasma donors.

SYSCON IDC-G, NEGATIVE AND POSITIVE is a human serum based unassayed control.

The provided text is a scanned FDA 510(k) clearance letter and an Indications for Use statement for the "SYSCON IDC-G, NEGATIVE AND POSITIVE" device. This type of document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device performance study.

The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The Indications for Use describe what the device is for (monitoring analytical procedures and reagents for detecting infectious disease agents in patient serum or plasma) but does not include any performance metrics or study data.

Therefore, I cannot provide the requested table and information based on the given text.

To answer the user's request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed product manual that includes performance data.

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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.

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