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Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for Hemoglobin A1c and methods listed in this package insert.

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This regulatory document is a 510(k) clearance letter from the FDA for a quality control material used in diabetes testing. It does not contain information about acceptance criteria or a study proving a device meets them in the way typically found for an AI/ML medical device.

The document pertains to a "Quality control material (assayed and unassayed)" and states that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976." This is a Class I device, which generally means it poses the lowest risk and is subject to general controls, not typically requiring extensive clinical studies to demonstrate performance against specific acceptance criteria like an AI diagnostic algorithm would.

Therefore, I cannot provide the requested information for the following reasons:

• No specific acceptance criteria or performance metrics are listed: The document is a clearance letter, not a detailed technical report or study summary. It doesn't define quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy) because it's a quality control material rather than a diagnostic device that directly interprets patient data.
• No study details provided: The letter states "we have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent." This determination is based on a comparison to existing predicate devices, implying that detailed performance studies as understood for AI/ML devices were not necessary for this type of product and regulatory pathway.
• No AI/ML component: The device is a "Liquid Assayed Diabetes Control," a chemical reagent used for quality control, not an AI/ML algorithm or software. Therefore, concepts like "test set," "training set," "ground truth experts," "adjudication," or "human-in-the-loop performance" are not applicable.

In summary, the provided text is an FDA clearance letter for a quality control material. It does not provide the kind of performance data or study details required to answer your specific questions regarding acceptance criteria and study methodologies, particularly in the context of AI/ML device evaluation.

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The ARCHITECT® Troponin-I Controls are for verification of the accuracy and precision of the ARCULLECT i2000gg System when used for the quantitative determination of cardiac Troponin-1 in human serum and plasma. Refer to the ARCHITECT STAT Troponin-1 reagent package insert for additional information.

ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control Level L, M and H

1. Acceptance Criteria and Reported Device Performance:

This document is a 510(k) clearance letter for a quality control material, not a diagnostic device with performance metrics like sensitivity and specificity. Therefore, the concept of "acceptance criteria" for a diagnostic accuracy study and "reported device performance" are not directly applicable in the same way they would be for a screening or diagnostic tool.

For this specific device (ARCHITECT STAT Troponin I Liquid Assayed Cardiac Marker Control), the primary acceptance criterion for its 510(k) clearance is substantial equivalence to a legally marketed predicate device. This means the FDA has determined that the new device is as safe and effective as a similar device already on the market.

While not explicitly stated in the provided text as "acceptance criteria" and "reported performance" in a quantitative table for a diagnostic study, the core function of a quality control material is to verify the accuracy and precision of an assay. The premarket notification would have included data demonstrating that this control material performs as expected in validating the ARCHITECT i2000sr System for Troponin-I measurements. This would typically involve:

• Stability data: Showing the control material maintains its specified concentration levels over its shelf life and under various storage conditions.
• Lot-to-lot consistency: Demonstrating that different manufacturing lots of the control material produce consistent results.
• Assigned values and expected ranges: The control material would have known target values for Troponin I that it should register within a specified range when run on the ARCHITECT i2000sr System.

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

This document is a regulatory clearance letter and does not contain details about specific test set sample sizes or data provenance. For a quality control material, the "test set" would be the internal validation studies conducted by the manufacturer to demonstrate the material's properties (stability, lot consistency, assigned values). Details like sample size, country of origin, and retrospective/prospective nature of these internal studies are not part of the 510(k) clearance letter's publicly available information.

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

Not applicable. As a quality control material, the "ground truth" is established by the manufacturer through rigorous analytical testing and assignment of target values for the constituents within the control. This is not a human-interpreted diagnostic task requiring expert consensus on images or clinical cases.

4. Adjudication Method for the Test Set:

Not applicable. There is no human interpretation or diagnostic decision-making involved requiring an adjudication method.

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

Not applicable. MRMC studies are used to evaluate the impact of a diagnostic device (often image-based AI) on human reader performance. This device is a quality control material, not a diagnostic tool that directly aids human readers in interpretation.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This device is a quality control material, not an algorithm, so the concept of standalone algorithm performance does not apply.

7. Type of Ground Truth Used:

The ground truth for a quality control material is established through analytical testing and assigned values by the manufacturer. This involves precise laboratory measurements using validated reference methods to determine the concentration of the analyte (Troponin I in this case) within the control material. There is often an expected range of values the control should fall within when run on the target instrument.

8. Sample Size for the Training Set:

Not applicable. This device is a quality control material, not a machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. See point 8.

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The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control scrum suitable for monitoring assay conditions in specific cardiac marker determinations. Include this product with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

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The provided text is a 510(k) clearance letter from the FDA for a cardiac marker control device. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets performance criteria in the way a diagnostic or AI-driven device would. The device, "MAS® CardioImmune® TL Liquid Assayed Cardiac Marker Control Level 1, 2 and 3," is a quality control material intended for use in clinical laboratories to monitor assay conditions for cardiac marker determinations.

Therefore, I cannot provide the requested information for acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. This type of information is not typically part of a 510(k) clearance letter for a quality control material.

The letter primarily focuses on:

• Substantial equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
• Device classification: Class I.
• Intended Use: "intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations."

The clearance process for a quality control material like this primarily involves demonstrating that it performs as intended for quality control without significant safety or effectiveness concerns, often through comparisons to existing, similar products rather than extensive clinical efficacy trials as you would see for a diagnostic test.

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The MAS® PAR TDM is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include PAR TDM with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove acceptance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. The document is an FDA 510(k) clearance letter for a device named MAS® PAR TDM, Level 1, 2 and 3, which is a clinical toxicology control material. The letter confirms substantial equivalence to a predicate device and states its intended use for monitoring assay conditions in clinical laboratory determinations.

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The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include CardioImmune® TL with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

The MAS® CardioImmune® proBNP is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include CardioImmune® proBNP with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

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This is a 510(k) premarket notification for a Class I quality control material. Typically, for this type of device, substantial equivalence is established by demonstrating that the device has the same intended use and similar technological characteristics as a predicate device, and does not raise different questions of safety and effectiveness.

The provided document (K032335) does not contain the information requested regarding acceptance criteria studies, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. These types of detailed performance studies are generally not required for Class I quality control materials where the regulatory path focuses on substantial equivalence to existing devices.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This confirms the basis of the clearance.

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

Summary of what can be inferred or is missing:

1. Table of acceptance criteria and reported device performance: Not provided. The document is a clearance letter, not a study report.
2. Sample size used for the test set and data provenance: No test set information is provided as this is not a study report.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable/Not provided.
4. Adjudication method for the test set: Not applicable/Not provided.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted/Not reported for this type of device.
6. Standalone performance study: Not reported. The clearance is based on substantial equivalence, not a detailed performance study like what would be seen for a diagnostic algorithm.
7. Type of ground truth used: Not applicable/Not provided. For quality control materials, "ground truth" often refers to assigned values established by reference methods or validated consensus processes, but details are not in this document.
8. Sample size for the training set: Not applicable/Not provided. There is no mention of a training set as this is not an AI/ML algorithm device.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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MAS® Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

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The provided text is a 510(k) clearance letter from the FDA for a device named "MAS® Bilirubin – Liquid Assayed Bilirubin Control." This device is a quality control material and not a diagnostic or AI-powered device that would typically undergo the types of studies you are asking about (test sets, training sets, expert ground truth, MRMC studies, etc.).

Therefore, the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and comparative effectiveness studies cannot be extracted from this document.

The document primarily focuses on:

• Device Name: MAS® Bilirubin – Liquid Assayed Bilirubin Control
• Regulation Number: 21 CFR 862.1660 (Quality control material)
• Regulatory Class: Class I
• Product Code: JJX
• Indications for Use: "MAS® Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument."

This is a quality control material, meaning its purpose is to verify the performance of other analytical instruments and reagents in a laboratory setting. Its "performance" is about its stability, consistency, and having accurately assigned values, not about diagnostic accuracy or the performance of an algorithm.

In summary, none of the requested information regarding acceptance criteria derived from a diagnostic study, test sets, training sets, or expert ground truth is present in this FDA clearance letter because the device is a quality control material, not a diagnostic device or AI model.

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MAS® UrichemTRAK Tri-Level control is intended for use in the clinical laboratory as consistent test samples of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK control with patient urine specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a quality control material (MAS® UrichemTRAK, Tri-Level Liquid Assayed Urine Control). This document does not contain information about studies proving a device meets acceptance criteria related to its performance in diagnosing or making clinical decisions. Instead, it's about the substantial equivalence determination for a quality control product, which itself is used to monitor the performance of other diagnostic assays.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies from this document.

The document discusses:

• Device Name: MAS® UrichemTRAK, Tri-Level Liquid Assayed Urine Control
• Regulation Number: 21 CFR 862.1660
• Regulation Name: Quality control material (assayed and unassayed)
• Regulatory Class: Class I
• Product Code: JJW
• Indications for Use: "MAS® UrichemTRAK Tri-Level control is intended for use in the clinical laboratory as consistent test samples of known concentration for monitoring assay conditions in many urine determinations. Include UrichemTRAK control with patient urine specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment." It also mentions "For in vitro diagnostic use to monitor the precision and the accuracy of chemistry systems, including the ADVIA IMS®".

This type of device is not "tested" in the same way a diagnostic algorithm or a new medical treatment device would be. Its "performance" is based on its stability and consistency in providing known concentrations, rather than diagnostic accuracy metrics like sensitivity or specificity. While the manufacturer would have internal data to ensure the quality control material itself meets manufacturing specifications, this document does not describe such studies or acceptance criteria for a diagnostic performance context.

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MAS® Tox · Ammonia Control is intended for use in the clinical laboratory as quantitative controls for monitoring test procedures used to assay human serum and/or plasma specimens for alcohol, ammonia, acetaminophen and salicylate. Include Tox · Ammonia Control with patient serum or plasma specimens when assaying for any of the listed constituents. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

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This document is a 510(k) clearance letter from the FDA for a device called "MAS® Tox - Ammonia Control Liquid Assayed Toxicology Control." This type of device is a control material used in clinical laboratories to monitor the performance of diagnostic tests.

The information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is typically found in the 510(k) submission itself or a summary of its contents, not in the FDA's clearance letter. The clearance letter only states that the FDA has reviewed the submission and found the device to be "substantially equivalent" to a legally marketed predicate device. This means the FDA believes the new device is as safe and effective as a similar device already on the market.

Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications. The letter primarily focuses on regulatory approval.

Here's what I can extract from the provided text, and why the other information is missing:

• Device Name: MAS® Tox - Ammonia Control Liquid Assayed Toxicology Control
• Predicate Device Mentioned: Bayer ToxAmmonia Control (in the Indications for Use form)
• Regulation Number: 21 CFR 862.3280 (Clinical toxicology control material)
• Regulatory Class: Class I
• Product Code: DKC
• Indications for Use: "MAS® Tox · Ammonia Control is intended for use in the clinical laboratory as quantitative controls for monitoring test procedures used to assay human serum and/or plasma specimens for alcohol, ammonia, acetaminophen and salicylate. Include Tox · Ammonia Control with patient serum or plasma specimens when assaying for any of the listed constituents. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument."
• Predicate Device Indications for Use (from the form): "For in vitro diagnostic use to monitor the precision and the accuracy of chemistry systems, including the ADVIA IMS®"

Why the specific questions cannot be answered from this document:

1. Table of acceptance criteria and reported device performance: This letter does not contain performance data or acceptance criteria for the new device. It only refers to a "substantial equivalence" determination based on information provided in the 510(k) submission.
2. Sample sizes, data provenance: The document doesn't detail any specific study data or sample sizes used to demonstrate performance.
3. Number of experts, qualifications: Not applicable for this type of regulatory letter; this relates to the specific studies performed, not the FDA's decision letter.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as this is a control material, not typically an AI-assisted diagnostic device. Its performance is about its stability and accurate concentration, not reader interpretation.
6. Standalone performance: While the device has "standalone performance" in the sense that it performs as a control, the document does not describe a study proving this performance.
7. Type of ground truth used: Not applicable in the context you're asking (e.g., expert consensus for images). For a control material, the "ground truth" would be the assayed values of the analytes within the control, which are established through analytical methods by the manufacturer.
8. Sample size for training set: Not applicable, as this is a control material, not an algorithm trained on data.
9. How ground truth for training set was established: Not applicable.

To obtain the detailed information you are seeking regarding a device's performance, acceptance criteria, and study methodology, you would need to access the actual 510(k) submission summary (often available on the FDA's website) or the manufacturer's technical documentation for the device.

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The MAS® Cardiolmmune® proBNP is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include Cardiolmmune® proBNP with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

MAS® CardioImmune® proBNP Liquid Assayed Cardiac Marker Control Level 1, 2 and 3

The provided document is a 510(k) premarket notification letter from the FDA regarding the MAS® CardioImmune® proBNP. This letter does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Regulatory classification: Class I product, regulation number 21 CFR 862.1660 (Quality Control Material, Assayed and Unassayed).
• Substantial equivalence: The device is deemed substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• General controls: Listing the requirements of the Federal Food, Drug, and Cosmetic Act (Act) that the manufacturer must comply with (e.g., registration, listing, labeling, good manufacturing practices).
• Indications for Use: The device is an assayed control serum for monitoring assay conditions in cardiac marker determinations in clinical laboratories.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them, as this information is not present in the provided text. The document is a regulatory clearance letter, not a performance study report.

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The MAS® chemTRAK® · H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include MAS® chemTRAK .. II with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges us a means of assuring consistent performance of reagent and instrument.

The DADE® Moni-Trol® • H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include DADE® Moni-Trolf · H with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

The OLYMPUS Chemistry Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Chemistry Control with patient serum specimens when assaying for any of the listed consititients. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

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The provided document is a 510(k) clearance letter from the FDA for several chemistry control materials (MAS® chemTRAK® H, DADE® Moni-Trol® H, and OLYMPUS Chemistry Control). This type of device is a "Quality control material (assayed and unassayed)" and is classified as Class I.

The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy or diagnostic performance in the way a medical diagnostic AI might. Therefore, the questions related to acceptance criteria for diagnostic performance, study design with test sets, ground truth establishment, expert adjudication, or MRMC studies are largely not applicable in the context of this specific regulatory document.

Here's how to address the questions based on the provided FDA letter:

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

• Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission of a Class I quality control material is demonstrating substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as the predicate. For quality control materials, this would involve comparing their physical and chemical properties, stability, and control ranges to that of established controls. The specific quantitative acceptance criteria (e.g., within certain percentage of known values, specific coefficient of variation) are not detailed in this FDA letter but would have been part of the 510(k) submission.
• Reported Device Performance: The FDA letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This is the reported "performance" in the context of regulatory clearance – the device met the criteria for substantial equivalence to a predicate. The specific performance data (e.g., assay values, stability data, precision data) for these specific controls are not detailed in the public FDA letter but would be in the confidential 510(k) submission. The "Indications for Use" section mentions that "Assay values are provided for the specific systems listed" and that users can "compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument." This implies that the controls provide known, consistent values.

2. Sample size used for the test set and the data provenance

• Not applicable in this document. A "test set" in the context of diagnostic AI algorithms is for evaluating performance on unseen data. For a Class I quality control material seeking 510(k) clearance for substantial equivalence, the "testing" involves demonstrating the product's consistency, stability, and ability to provide known control values. The document does not specify sample sizes for such internal validation studies for these control materials. Data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable in this document. "Ground truth" in the context of a diagnostic algorithm refers to a definitive diagnosis or finding. For a quality control material, the "ground truth" or "known concentration" is established through analytical methods and manufacturing processes, not typically by expert interpretation of patient data.

4. Adjudication method for the test set

• Not applicable in this document. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies for establishing ground truth for diagnostic devices, especially those involving image interpretation. This is not relevant for the clearance of liquid chemistry control materials.

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 (like AI) on human reader performance. This device is a quality control material, not a diagnostic tool that assists human readers.

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

• Not applicable. This device is a chemical control; it's not an algorithm, so "standalone performance" of an algorithm is not relevant.

7. The type of ground truth used

• For quality control materials, the "ground truth" refers to the assigned values or expected ranges for various analytes (e.g., glucose, cholesterol) within the control material. These values are established through rigorous analytical testing and calibration processes during the manufacturing and initial validation of the control material, often against reference methods or certified reference materials. It's not "expert consensus," "pathology," or "outcomes data" in the diagnostic sense.

8. The sample size for the training set

• Not applicable. "Training set" is a concept for machine learning models. This device is a manufactured chemical product, not an AI algorithm.

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

• Not applicable. As explained in point 8, there is no "training set" in the context of these quality control materials. The establishing of "known concentrations" for the control materials themselves is through analytical validation, as described in point 7.

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