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Urine Chemistry Control, Level 1, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.

Urine Chemistry Control, Level 1, is designed to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites. Human and porcine components are added to a human urine based matrix to provide a control that closely mimics human urine. The product contains no preservatives. Urine Chemistry Control, Level 1 will be offered in 10.0 mL and 25.0 mL fill vials.

1. Table of Acceptance Criteria and Reported Device Performance

This submission does not explicitly state "acceptance criteria" in the traditional sense of performance metrics for an AI/CADe device. Instead, it focuses on demonstrating "substantial equivalency" to a predicate device for a control material (Urine Chemistry Control, Level 1). The performance is evaluated by comparing its characteristics to those of the predicate device.

Acceptance Criteria (Implied for Substantial Equivalency): The implied acceptance criteria for substantial equivalency is that the technological characteristics of the new device are "as safe and effective as" the predicate device and do not raise new questions of safety or effectiveness. This is shown through direct comparison of features.

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

This document does not describe a "test set" in the context of evaluating an AI/CADe device. The submission is for a control material. The evaluation relies on a comparative analysis of product characteristics rather than performance data derived from a distinct test set. Therefore, information on sample size and data provenance for a test set is not applicable or provided.

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

Not applicable. This is not an AI/CADe device submission that requires expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a control material, not an AI/CADe device designed to assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This device is a control material, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of typical AI/CADe device evaluation using "ground truth" labels. For this control material, the "ground truth" equivalent would be the established specifications and performance of the predicate device against which the new device's characteristics are compared for substantial equivalency.

8. The Sample Size for the Training Set

Not applicable. This is a control material, not an AI/CADe device that requires a training set.

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

Not applicable.

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Urine Chemistry Control, Level 2, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.

Urine Chemistry Control. Level 2, is designed to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites. Human and porcine components are added to a human urine based matrix to provide a control that closely mimics human urine. The product contains no preservatives. Urine Chemistry Control, Level 2 will be offered in 10.0 mL and 25.0 mL fill vials.

The provided text describes a Urine Chemistry Control, Level 2 device, which is a quality control material, not an AI or imaging device. Therefore, many of the requested fields regarding acceptance criteria, study design, expert involvement, and reader studies are not applicable.

Here's the relevant information that can be extracted from the provided document:

1. Acceptance Criteria and Reported Device Performance

For this quality control device, the "acceptance criteria" are primarily related to its design and intended use being substantially equivalent to a predicate device. The "performance" in this context refers to its ability to serve as a quality control material, which is implied by its composition and intended use.

Conclusion from document: The device is concluded to be "substantially equivalent" to the predicate device due to the comparison of intended uses and physical properties.

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

Not applicable. This is a quality control material evaluation, not a diagnostic device with a test set of patient data. The "comparison" was made against a predicate device's characteristics.

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

Not applicable. Ground truth for a test set is not relevant for this type of device submission.

4. Adjudication method for the test set

Not applicable.

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 is not an AI or imaging diagnostic device.

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

Not applicable. This is not an algorithm.

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

Not applicable in the conventional sense of diagnostic device evaluation. The "ground truth" for this product, if one could apply the term, would be the established performance and characteristics of the predicate device (LYPHOCHEK® QUANTITATIVE URINE CONTROL BIO-RAD Laboratories K-880495) and the standard analytical methods used to verify the composition and stability of the control material itself.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device that requires a training set.

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

Not applicable.

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Reference Material for Delta-9-THC-COOH in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte in human urine.

Reference Material for Delta-9-THC-COOH in Human Urine

The provided text is a 510(k) clearance letter from the FDA for a Reference Material for Delta-9-THC-COOH in Human Urine. This type of device is a calibration or control material used to verify the accuracy of laboratory tests (specifically GC/MS methods) for detecting a marijuana metabolite.

The information you are asking for, such as acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment, is not typically found in a 510(k) clearance letter.

A 510(k) clearance letter primarily states that the FDA has reviewed the device and determined it to be "substantially equivalent" to a legally marketed predicate device. This equivalence is based on the data and information provided by the manufacturer in their 510(k) submission, which would contain the study details. However, the clearance letter itself only summarizes the FDA's decision, not the full details of the supporting studies.

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

To answer your questions, I would need access to the actual 510(k) submission which would include the performance data and study reports.

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QUICKCHECK CONFORMANCE® Chemistry Control C3 are materials intended for use in monitoring the accuracy and precision of clinical chemistry procedures.

QUICKCHECK Lyophilized Chemistry Control Also Distributed as: CONFORMANCE® Chemistry Control C3

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them, as requested in your prompt. The document is an FDA 510(k) clearance letter for a device called "QUICKCHECK Lyophilized Chemistry Control" (also distributed as "CONFORMANCE® Chemistry Control C3").

This letter primarily states that the device is substantially equivalent to a predicate device and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance with manufacturing practices. It also includes an "Indication for Use" section.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test or training sets.
• Details on data provenance or ground truth establishment.
• The number or qualifications of experts used.
• Adjudication methods.
• Information about multi-reader multi-case (MRMC) studies or standalone performance.

The document is a regulatory approval, not a scientific study report or a detailed performance and validation document. Therefore, I cannot extract the specific information you are looking for from this text.

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Reference Material for Amphetamine/Methamphetamine in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte and imetabolite in human urine.

Reference Material for Amphetamine/Methamphetamine in Human Urine

The provided text is a 510(k) clearance letter from the FDA for a diagnostic reference material, not an AI device. As such, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving an AI device meets these criteria.

The document discusses:

• The FDA's determination of substantial equivalence for a "Reference Material for Amphetamine/Methamphetamine in Human Urine."
• Regulatory classifications and general controls for medical devices.
• Requirements under CLIA-88 (Clinical Laboratory Improvement Amendments of 1988).
• Contact information for various FDA departments.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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Clinical laboratories performing chemistry assays may use huve mentioned controls routinely as a means of estimating precision and monitoring test system performance, provided: (a) the above mentioned controls (Levels 1 and 2) are used as an adjunct to primary control procedure recommended by the manufacturer of reagents and instrument used for the measurement; (b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory quality control goals; (c ) above mentioned controls are validated for use with the specific clinical chemistry test system used by the laboratory.

QUIKCHECK Unassayed Chemistry Control Levels 1 and 2

This document is a 510(k) premarket notification response from the FDA for a chemistry control device. It does not contain information about studies proving the device meets acceptance criteria as this is typically found in a Premarket Approval (PMA) application or a more detailed 510(k) submission document. The provided text is a notification that the device has been found substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details.

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Qualitrol Unassayed H. Pylori Control Set, consisting of positive and negative human serum based controls, may be used by laboratories, performing immunoassays for qualitative determination of Helicobacter pylori IgG antibody in human serum, routinely as a means of estimating precision and systematic shift in accuracy, provided: (a.) above mentioned controls are used as an adjunct to reagents provided by kit manufacturers and according to the recommended procedure provided specifically for the test system being used by the laboratory; (b.) above mentioned controls are validated for use with the test system being used: (c.) above mentioned controls are used in accordance with the quality control requirement of regulatory and/or accrediting organizations and laboratory quality control goals.

Qualitrol Unassayed H. Pylori Control Set (Positive and Negative Serum Controls)

This document is a 510(k) clearance letter from the FDA for a medical device called "Qualitrol Unassayed H. Pylori Control Set (Positive and Negative Serum Controls)". This type of document does not contain the detailed study information generally associated with device acceptance criteria and performance data.

Here's why and what's typically missing:

• 510(k) Clearance: This is for demonstrating substantial equivalence to a predicate device, not necessarily for proving novel clinical effectiveness or meeting specific performance criteria through a rigorous clinical trial. The focus is on showing the new device is as safe and effective as something already on the market.
• "Control Set" Device: The device itself is a "control set" for Helicobacter pylori IgG antibody immunoassays. This means it's used to verify the performance of other diagnostic tests, not to diagnose patients directly. Therefore, the "acceptance criteria" and "device performance" would relate to its ability to reliably provide positive and negative control results, not to clinical metrics like sensitivity or specificity for H. pylori infection in humans.
• Information Not Included: The letter does not detail any specific studies (e.g., sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets) because that level of detail is typically found in the 510(k) submission itself, not the clearance letter. The letter just confirms the FDA's decision based on that submission.

Therefore, based on the provided text, I cannot fill out the requested table or answer the specific questions about acceptance criteria and study details. The document's purpose is to grant market clearance, not to publish an abstract of the underlying performance studies.

If you had access to the full 510(k) submission (which is usually a much larger document than this clearance letter), you might find some of this information.

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Clinical laboratories, performing immunoassays for drugs, hormones and proteins on automated immunoassay systems may use Qualitrol Immunoassay DHP Control or CONFORMANCE MCC-Ligand Control routinely as a means of estimating precision and monitoring test system performance, provided:

(a) the above mentioned controls, provided as a set (Levels 1, 2 3) are used as an adjunct to primary control procedure and recommended by the manufacturer of immunoassay systems.

(b) above mentioned controls are used in accordance with the quality control requirements of regulatory and/or accrediting organizations and laboratory's quality control goals;

(c ) above mentioned controls are validated for use with the specific immunoassay test system being used by the clinical laboratory.

These controls have been assayed with AxSYM, IMx and TDX systems manufactured by Abbott Laboratories (Abbott Park, USA). The expected values, for these systems, are included in the package insert. The controls may be used as assayed controls for the stated indication for use when measurements are made with above-mentioned immunoassay systems.

Not Found

This is an FDA Premarket Notification (510k) letter for a device called "Qualitrol DHP Immunoassay Control Levels 1, 2, and 3". As such, the purpose of this document is to establish substantial equivalence to a predicate device, not to present a study proving the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. There is no information provided in this document that would allow for the completion of the requested table and study details.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act)."

The "Indication for Use" section describes how the control solution should be used (e.g., as an adjunct to primary control procedures, in accordance with quality control requirements, and validated for the specific immunoassay system). It also mentions that the controls have been assayed with specific immunoassay systems (AxSYM, IMx, and TDX systems manufactured by Abbott Laboratories) and that expected values are included in the package insert. However, this does not constitute a study with acceptance criteria and performance metrics for the control device itself in the way typically expected for a diagnostic or AI-enabled device.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets those criteria, as this information is not present in the provided document.

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