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The AUTION CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.

The AUTION CHECK Plus, is a two level liquid control prepared from human urine source material with added stabilizers and preservatives. Level 1 is positive for bilirubin and urobilinogen and Level 2 is positive for glucose, protein, blood, ketone, nitrite and leukocytes.

Here's a breakdown of the acceptance criteria and study information for the AUTION CHECK Plus device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: For value assignment, the testing involves three operators and three analyzers, with each performing four tests on the control product. This means 3 operators * 3 analyzers * 4 tests = 36 individual tests per lot for value assignment.
• Data Provenance: The data is prospective, generated by Quantimetrix Corporation's Quality Control group in their laboratories. The document doesn't specify the country of origin, but given the FDA submission, it's presumably US-based.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three different operators were used for the value assignment process.
• Qualifications of Experts: The document does not explicitly state the qualifications of the operators beyond them being "operators" in the Quality Control group.

4. Adjudication Method for the Test Set

• Adjudication Method: The value assignment process uses a consensus approach where "The means from all three operators and analyzers must fall within the specification range for the lot to be released." This implies a form of consensus-based adjudication, where all operators/analyzers must agree within a specified range for the lot to be accepted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This device is a quality control material, not a diagnostic device intended for human interpretation or a device designed to assist human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This device is a quality control material; therefore, the concept of an "algorithm" or "human-in-the-loop" performance doesn't directly apply in the same way it would for an AI diagnostic tool. The performance evaluation is based on the chemical properties and stability of the control material, and its ability to produce expected results on Arkray analyzing equipment. The "standalone" performance here refers to the intrinsic characteristics of the control material.

7. Type of Ground Truth Used

• For the value assignment (which serves as the "ground truth" for the control material's expected performance), the ground truth is established by internal laboratory analysis, comparing the control material's results against a pre-defined "specification range for the lot." This effectively establishes a known, expected range for the control.
• For the stability studies, the "ground truth" is the performance of the device over time compared to its initial established values, under various storage conditions.

8. Sample Size for the Training Set

• This product is a quality control material, not an AI or machine learning model that requires a "training set." Therefore, this question is not applicable.

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

• Since there is no training set for this device, this question is not applicable.

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The Quantimetrix Complete D® 25-OH Vitamin D Control is intended for the quality control of laboratory procedures used to quantitate Total 25-OH Vitamin D.

This quality control product is intended to allow an objective measurement of a laboratories performance (procedures and personnel techniques) in comparison to known values. Two clinically relevant levels of controls are available to compare observations with expected ranges therefore assuring consistent performance.

The provided text is a 510(k) summary for the Quantimetrix Complete D® 25-OH Vitamin D Control. This document is a premarket notification for an in vitro diagnostic (IVD) quality control device, not a medical device that diagnoses or treats patients. Therefore, the typical acceptance criteria and study design elements requested in the prompt, which are usually applicable to diagnostic or therapeutic AI/ML devices, do not directly apply here.

The "device" in this context is a quality control product designed to ensure the accuracy of laboratory procedures for quantifying Total 25-OH Vitamin D. Its performance is assessed in terms of its ability to provide known values for comparison, rather than its diagnostic accuracy or impact on human readers.

However, I will extract and present the relevant information from the document in the spirit of the request, mapping the concepts as best as possible.

1. A table of acceptance criteria and the reported device performance

For a quality control product, "acceptance criteria" generally refer to its stability, formulation characteristics, and its intended use aligning with its predicate. "Reported device performance" would relate to its composition and ability to serve its quality control purpose, rather than diagnostic accuracy metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail specific "test set" sample sizes or data provenance in the context of clinical performance evaluation because this is a quality control device. The comparison provided is between the new product's characteristics and those of the predicate device. The information is descriptive of the product's formulation and specifications.

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 concept is not applicable to a quality control product. The "ground truth" for a quality control material is its precisely manufactured, known concentration of the analyte (25-OH Vitamin D). This "truth" is established during the manufacturing process, not by expert interpretation in a clinical setting.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in clinical studies to resolve discrepancies in expert readings for diagnostic outcomes. For a quality control material, the "truth" is inherent in its formulation.

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. MRMC studies are used to evaluate the impact of a diagnostic tool on human reader performance, typically for image-based diagnostics. This device is a quality control standard for laboratory assays, not a diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This refers to the performance of an algorithm without human intervention, again typically for diagnostic AI. The Quantimetrix Complete D® 25-OH Vitamin D Control is a physical quality control material, not an algorithm. Its "standalone" performance refers to its inherent properties and stability. The document focuses on characterizing these properties and comparing them to a predicate device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device is the known, precisely manufactured concentration of 25-OH Vitamin D within the control material. This is established through analytical chemistry and manufacturing processes, not clinical outcomes or expert consensus. It acts as a reference point for other laboratory assays.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set is involved for this type of device.

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The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.

Dropper A1c Controls are supplied in two levels, 4 bottles total, 2 x 2 mL each level per box. The controls are supplied as a ready-to-use frozen liquid, requiring no reconstitution or dilution. They are prepared in a whole blood matrix fortified to target levels with reagent grade chemicals added to achieve the two levels. Preservatives have been added to inhibit microbial growth.

This document is a 510(k) premarket notification for a medical device called "Dropper A1c Diabetes Control" by Quantimetrix Corporation. This device is a quality control material intended for laboratory procedures to quantify HbA1c (Hemoglobin A1c).

The document is a regulatory submission, not a study report demonstrating the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable to this type of document.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance metrics against established acceptance criteria.

Here's how the provided information relates to your request:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. This document does not present acceptance criteria for device performance nor does it report specific numerical performance data against such criteria. The submission aims to demonstrate substantial equivalence, not to quantify performance against pre-defined thresholds.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This document does not describe a "test set" in the context of device performance evaluation. The "assayed values are determined from in-house data," but no details on sample size, provenance, or study design are provided for this internal data generation.

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)

• Not Applicable. Ground truth, in the context of device performance evaluation by experts, is not relevant to this submission. The "assayed values" for the control are internally determined, likely through a validated process using reference methods, but not by a panel of external experts establishing a "ground truth" for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. There is no "test set" and no expert adjudication described in this regulatory submission.

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 quality control material, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. This device is a physical control material, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for the assayed values of the control material (i.e., what the HbA1c levels should be) would be established by in-house data using validated methods, likely traceable to a recognized reference measurement procedure for HbA1c. The document states "Assayed values are determined from in-house data."

8. The sample size for the training set

• Not Applicable. This device is a quality control material, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set for an algorithm, this question is not applicable.

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The Quantimetrix Corp. NiCosure Cotinine Urine Control is intended as a means of monitoring the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine levels in unknown urine specimens. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

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This document is a 510(k) clearance letter from the FDA for a medical device called "Quantimetrix NiCosure Cotinine Urine Control." It does not contain information about acceptance criteria or a study proving device performance as requested in the prompt. This letter signifies that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, which is a regulatory decision and not a performance study report.

Therefore, I cannot provide the requested information from the given text.

To answer your specific questions, I would need a document that describes the performance characteristics and validation study of the "Quantimetrix NiCosure Cotinine Urine Control," not just its regulatory clearance.

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The Quantimetrix Corp. Cardiasure Cardiac Markers Control is intended as a means of monitoring serum cardiac analyte monitoring methods to validate measurement of patient serum samples. Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves a device meets these criteria. The document is a 510(k) clearance letter from the FDA for a device called "Quantimetrix Cardiac Markers Control," which is a quality control material.

The text describes:

• The FDA's decision that the device is substantially equivalent to legally marketed predicate devices.
• The regulatory classification of the device (Class I quality control material).
• General controls and potential additional controls if classified differently.
• The purpose of the device as stated in the "Indications for Use Statement," which is for monitoring serum cardiac analyte monitoring methods.

It does not contain any of the following requested information:

• A table of acceptance criteria or reported device performance.
• Sample sizes, data provenance, number or qualifications of experts for ground truth, or adjudication methods for test sets.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on the type of ground truth used or sample sizes/ground truth establishment for training sets.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided text.

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The Quantimetrix Corp. Drug of Abuse Urine Screen Control is intended to be used as a means of monitoring the performance of Abuscreen ONLINE, AxSYM, Triage and other drugs of abuse screening methods used for detecting drugs in unknown urine specimens.

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This document is a 510(k) clearance letter from the FDA for a medical device called "Quantimetrix Drug of Abuse Urine Screen Control." It is a control material used for monitoring the performance of drug of abuse screening methods.

Unfortunately, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study results.

The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It focuses on regulatory compliance and administrative details, not on a detailed scientific efficacy study report.

Therefore, I cannot provide the requested information based on the input text.

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The Quantimetrix GlycoHemosure is intended for the quality control of laboratory procedures for the quantitation of HbA1c.

The Quantimetrix GlycoHemosure is supplied liquid in glass bottles. It consists of humansource blood that was treated to give a stable liquid formulation of two distinct levels of HbA1c.

The provided text describes a 510(k) summary for the Quantimetrix GlycoHemosure, a quality control material for HbA1c quantitation. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for a medical device that makes diagnostic claims (e.g., sensitivity, specificity, accuracy).

Instead, the documentation focuses on the stability of the control material, which is a key performance characteristic for a quality control device.

Here's an analysis based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The text explicitly mentions "stability studies" were performed to "validate the shelf life claim and the opened vial claim." This implies that the acceptance criteria for these claims would be met if the control material remained within acceptable analytical ranges over these timeframes. However, the specific numerical acceptance limits (e.g., ±X% variation from initial value) are not provided in this summary.

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

The text states "Accelerated stability studies (25°C and 37°C) and real time studies (2-8°C) were performed."

• Sample Size: Not specified. This typically refers to the number of vials or batches tested.
• Data Provenance: Not specified, but implies internal testing by Quantimetrix Corporation. It is prospective testing for stability.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This device is a control material, not a diagnostic device that requires expert interpretation for its "ground truth." Its performance relates to its internal stability and consistency over time, measured against a reference method.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for the performance of a quality control material in this context. The "truth" for its stability is determined by analytical measurements against a defined reference.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is not relevant for a quality control material. MRMC studies are designed for diagnostic devices where human readers interpret results, and the study assesses how the device aids human performance.

6. Standalone Performance

Yes, implicitly. The stability studies evaluate the performance of the GlycoHemosure control material itself, without human interpretation or intervention beyond conducting the analytical measurements. The device's "performance" here is its inherent stability over time when measured using a standard HbA1c immunoassay.

7. Type of Ground Truth Used

The ground truth for the GlycoHemosure's stability is established by analytical measurement against a reference method or baseline value. The initial HbA1c concentration of the control material was determined using an immunoassay method (e.g., Dade HbA1c assay), and stability is assessed by comparing subsequent measurements to this initial value (or a derived reference) over time under different conditions.

8. Sample Size for the Training Set

Not applicable. Quality control materials fundamentally operate differently from AI/ML algorithms which require training sets. The GlycoHemosure is a prepared biological material with known concentrations, not an algorithm that learns from data.

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

Not applicable, as there is no training set for this type of device. The quality control material itself serves as a "known" for laboratories to check the performance of their own HbA1c assays. Its own characteristics (concentration, stability) are established through analytical testing and manufacturing specifications.

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The Preciset DAT Amphetamine calibrators are designed for the calibration of the Roche Abuscreen® OnLine assays for Amphetamines and the cassette COBAS INTEGRA® Amphetamines (AMPS) for the determination of amphetamines in human urine on automated clinical chemistry analyzers.

The Quantimetrix Preciset® DAT Amphetamine drug of abuse calibrator and controls are supplied liquid in a glass bottle. They consist of drug-free human urine to which preservative, stabilizer and drug analyte have been added to achieve distinctive levels. The drug added is: d-amphetamine. Drug concentration is determined using GC/MS.

The provided document is a 510(k) summary for a drug of abuse calibrator/control device (Preciset® DAT Amphetamine). It's important to note that this device is a calibrator/control for an assay, not the assay itself or a diagnostic device that directly determines patient outcomes. Therefore, the "acceptance criteria" and "device performance" are related to the stability and functionality of the calibrator/control with respect to the assays it's intended to calibrate. The document does not describe a clinical study comparing human readers with and without AI assistance, nor does it detail a standalone algorithm performance for diagnostic purposes.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a table format but describes performance in terms of stability and functionality with the target assays.

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

The document does not specify a "test set" in the context of patient data or clinical samples that would require a sample size. It refers to stability studies and testing with immunoassays.

• Sample Size for Test Set: Not applicable in the context of typical diagnostic device studies. The "test set" here refers to the calibrator/control vials themselves that were subjected to stability testing and functional evaluation with the specified assays. The number of such vials is not provided.
• Data Provenance: Not applicable in the context of patient data. The studies were laboratory-based (accelerated and real-time stability studies) performed by the manufacturer, Quantimetrix Corporation. There is no mention of country of origin of data in terms of patient samples, as this is a calibrator/control device. The studies were prospective in nature (designed to validate claims).

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

This section is not applicable for this type of device. Ground truth in the context of diagnostic devices usually refers to a definitive diagnosis or condition established by clinical experts or gold standard methods (e.g., pathology, follow-up). For a calibrator/control, the "ground truth" for the drug concentration is established through analytical methods like GC/MS.

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

4. Adjudication Method for the Test Set

This section is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among expert readers in diagnostic image or clinical data interpretation. For a calibrator, the "truth" of its concentration is chemically determined.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study involves human readers interpreting diagnostic cases, often with and without AI assistance, to measure the impact of AI on reader performance. This device is a calibrator/control, not an AI diagnostic tool.

• Effect size of human readers improving with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) performance study as typically understood for AI diagnostic devices was not done. This device is a chemical calibrator/control, not an algorithm. The performance described relates to its stability and its ability to function correctly with specific immunoassay systems.

7. Type of Ground Truth Used:

For assessing the concentration of the drug (d-amphetamine) in the calibrator/control, the ground truth was established using an analytical reference method.

• Ground Truth Type: Drug concentration determined using GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and precise analytical chemistry technique used for quantifying substances.

8. Sample Size for the Training Set

This section is not applicable. This device is a calibrator/control, not a machine learning or AI model that requires a "training set" of data.

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

This section is not applicable as there is no training set for this type of device.

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The Preciset DAT Plus calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Quantimetrix Preciset® DAT Plus drug of abuse calibrator is supplied liquid in a glass bottle. It consists of drug-free human urine to which preservative, stabilizer and drugs of abuse have been added to achieve six distinct levels. The drugs added are: metamphetamine, nordiazepam, barbiturates, cocaine metabolites, methadone, morphine, phencyclidine, propoxyphene, cannabinoids. Drug concentrations are determined using GC/MS.

This document describes the Preciset® DAT Plus, a drug of abuse calibrator. It does not contain information about a device that uses AI or machine learning, nor does it detail a study with acceptance criteria and device performance in the context of such technology. Therefore, I cannot generate the requested table and study information.

The document primarily focuses on the 510(k) submission for the Preciset® DAT Plus calibrators, detailing its classification, intended use, and substantial equivalence to a predicate device. It briefly mentions "Performance Characteristics" related to stability studies but does not provide specific acceptance criteria or quantitative performance data.

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The Quantimetrix Lipoprint™ System LDL Subfractions is a device intended to measure lipoprotein cholesterol (for lipoprotein fractions and subfractions) in fasting serum or plasma with a Total Cholesterol concentration of ≥ 100 mg/dl. Lipoprotein cholesterol measurements are used as an aid in evaluating lipid metabolism disorders when used in conjunction with other lipid tests, patient risk assessment and clinical evaluation.

Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions. The software application is used in conjunction with commercially available hardware (computer, scanner and color printer) to analyze scanned tube images and generate characterizations of lipoprotein fractions and subfractions resolved by Lipoprint (VLDL, IDL, LDL, HDL).

The provided text is a 510(k) summary for the LipoPrint™ System LDL Subfractions, detailing its intended use and classification. However, it does not contain the specific information required to answer the question about acceptance criteria and the study proving the device meets those criteria.

The document states that Quantimetrix is implementing an analysis software capability to the LipoPrint™ System LDL Subfractions, and the modification was determined to be "moderate," concerning only the software. It also indicates that the intended use of the modified device remains the same as the unmodified device.

Therefore, crucial information such as acceptance criteria, reported performance, sample sizes, data provenance, expert qualifications, ground truth establishment, adjudication methods, multi-reader multi-case study details, or standalone algorithm performance are not present in the provided text.

Without this information, it is impossible to create the requested table and provide descriptions of the studies.

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