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The Albumin BCP assay is used for the quantitation of albumin in human serum. Albumin BCP measurements are used in the diagnosis and treatment of kidney disease and liver disease.

Albumin BCP is an in vitro diagnostic assay for the quantitative determination of albumin in human serum. The Albumin BCP assay is a clinical chemistry assay in which the albumin in the sample binds to bromcresol purple. The absorbance of the complex is measured at 600 nm and is directly proportional to the albumin concentration in the sample.

Here's an analysis of the provided text regarding the Abbott Laboratories Albumin BCP assay, structured to address your specific questions about acceptance criteria and the supporting study:

The provided document is a 510(k) summary for the Abbott Laboratories Albumin BCP assay, indicating that it is an in vitro diagnostic assay for the quantitative determination of albumin in human serum. The core of this submission is to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implicitly defined by the sponsor's demonstration of substantial equivalence to a legally marketed predicate device (Boehringer Mannheim Albumin BCP Assay on the Hitachi 717 Analyzer). Therefore, the acceptance criteria are that the new device's performance characteristics are "similar" or "acceptable" in comparison to the predicate. The "reported device performance" refers to the results obtained for the Abbott Albumin BCP assay.

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

The document provides the following information:

• Sample Size: The exact number of samples (individual patient samples) in the "comparative performance studies" for method comparison is not explicitly stated. It mentions "two levels of control material" for precision studies, but this refers to quality control samples, not patient samples for method comparison.
• Data Provenance: The document does not specify the country of origin of the data. The study involved "human serum," but whether it was prospective or retrospective is not explicitly stated. Given that it's a 510(k) for an in vitro diagnostic, these studies are typically performed with collected patient samples, which could be retrospective (archived samples) or prospective (newly collected samples specifically for the study).

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

This type of information is not applicable to this 510(k) submission. For quantitative in vitro diagnostic assays like this, "ground truth" is typically established by:

• Reference Methods: Highly accurate and precise analytical methods.
• Predicate Device: In this case, the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer itself serves as the "standard" against which the new device is compared to establish substantial equivalence.

There were no human experts adjudicating images or clinical outcomes to establish ground truth for this type of device.

4. Adjudication Method for the Test Set

This is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 are used typically in studies involving subjective interpretation (e.g., radiology, pathology slides) to resolve discrepancies between multiple readers. For a quantitative clinical chemistry assay, the output is a numerical value, and comparison is statistical, not based on human expert consensus.

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

This information is not applicable. This submission is for an in vitro diagnostic assay, which is an automated or semi-automated laboratory test, not an AI-powered image analysis or clinical decision support tool designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.

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

Yes, implicitly. The performance characteristics reported (method comparison, precision, linearity, sensitivity) are all standalone performance data of the Abbott Albumin BCP assay. The device itself (the assay and its measurement on the ALCYON™ Analyzer) operates without continuous human intervention in the measurement process to produce the quantitative albumin value.

7. The Type of Ground Truth Used

For method comparison, the "ground truth" was effectively the measurements obtained from the legally marketed predicate device, the Boehringer Mannheim Albumin BCP assay on the Hitachi 717 Analyzer. The goal was to show that the new device's results are sufficiently similar to those of the predicate. For precision, linearity, and sensitivity, the "ground truth" or reference values are established through rigorous analytical testing using known concentrations or appropriate statistical methods.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" for the assay itself. For clinical chemistry assays like this, there isn't typically a "training set" in the machine learning sense. The assay method is developed and validated, and its performance characteristics are then evaluated. The term "training set" is more relevant for AI/ML-based devices. Development would involve extensive testing and optimization, but not usually in a "training set" / "test set" paradigm.

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

Since there is no explicit "training set" mentioned in the context of machine learning, this question is not applicable. The "ground truth" for the development and validation of the chemical assay would have been established through established analytical chemistry principles, reference materials, and comparison to other validated methods during the assay's development prior to the 510(k) submission.

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The Calcium assay is used for the quantitation of calcium in human serum, plasma, or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms).

Calcium is an in vitro diagnostic assay for the quantitative determination of calcium in serum, plasma, or urine. The Calcium assay is a clinical chemistry assay in which arsenazo-III dye reacts with calcium in an acid solution to form a blue-purple complex. The color developed is measured at 600 nm and is proportional to the calcium concentration in the sample.

Here's an analysis of the provided information regarding the Calcium assay, focusing on acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't explicitly state "acceptance criteria" in a quantified manner beyond "acceptable correlation." Instead, it uses the performance of a predicate device as the benchmark for substantial equivalence.

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

• Sample Size for Test Set: The document does not explicitly state the number of individual patient samples (test set) used for the comparative performance studies. It mentions "two levels of control material" for precision studies. For the method comparison, it implies a patient sample set was used to generate correlation, slope, and intercept, but the size is not quantified.
• Data Provenance: Not specified. It's an in vitro diagnostic assay, so it's likely laboratory-based data. The country of origin and whether it's retrospective or prospective data are not mentioned.

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

This type of information is generally not applicable to a clinical chemistry assay like a calcium assay. The "ground truth" for a quantitative analyte is typically established by the reference method (in this case, the Boehringer Mannheim Calcium assay on the Hitachi 717 Analyzer) or by a highly accurate laboratory method. There are no human experts involved in visually interpreting or diagnosing based on the raw calcium measurement for ground truth establishment in this context.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative assay comparison against a predicate device, not a diagnostic interpretation that requires expert adjudication.

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-assisted diagnostic device, nor does it involve human readers interpreting images or data. It's a quantitative in vitro diagnostic assay.

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

Yes, this study is inherently "standalone" in the sense that it evaluates the performance of the Calcium assay itself (the "algorithm" being the chemical reaction and measurement process) against a reference standard. There is no human interpretation or intervention in the measurement process itself that alters the output of the device.

7. The Type of Ground Truth Used

The ground truth or reference standard used for comparison is the Boehringer Mannheim® Calcium assay on the Hitachi® 717 Analyzer. This is a well-established, legally marketed predicate device, serving as the benchmark for acceptable performance. The study aims to demonstrate that the new Calcium assay yields "similar clinical results" and highly correlated quantitative measurements to this predicate.

8. The Sample Size for the Training Set

Not applicable in the context of this device. This is a traditional chemical assay, not a machine learning or AI-driven device that requires a "training set" in the computational sense. The assay's parameters (reagents, reaction conditions, measurement wavelength) are intrinsically defined by its chemical methodology, not by being "trained" on a dataset.

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

Not applicable (as per point 8).

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The Carbon Dioxide (CO2) assay is used for the quantitation of carbon dioxide in human serum or plasma. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

Carbon Dioxide (CO2) is an in vitro diagnostic assay for the quantitative determination of carbon dioxide in human serum or plasma. The Carbon Dioxide assay is a clinical chemistry assay in which carbon dioxide, as bicarbonate (HCO3 ), and phospho(enol)pyruvate (PEP) are converted to oxalacetate and phosphate in the reaction, catalyzed by phospho(enol)pyruvate carboxylase (PEPC). Malate dehydorgenase (MDH) catalyzes the reduction of oxalacetate to malate with the concomitant oxidation of reduced nicotinamide adenine dinucleotide (NADH). The resulting decrease in absorbance at 380 nm is proportional to the CO2 content of the sample.

The provided text describes a 510(k) submission for the Abbott Laboratories Carbon Dioxide (CO2) assay. The study presented is a comparative performance study against a predicate device, not a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study. The data is about an in-vitro diagnostic method, which does not involve human readers or AI in the traditional sense. Therefore, many of the requested sections about human performance, AI, and ground truth establishment from expert consensus are not applicable.

Here's the information that can be extracted and presented based on the provided text:

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the provided text for the comparative performance study.
   • Data Provenance: Not explicitly stated, however, the study was conducted using the ALCYON™ Analyzer and compared against the Roche Cobas Mira Plus Automated Chemistry System. The nature of in vitro diagnostic assays implies laboratory samples, typically from human serum or plasma. It is a prospective study as it was conducted to demonstrate performance for the 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For an in vitro diagnostic assay, the "ground truth" is typically established by reference methods or validated predicate devices rather than expert consensus on images or similar data.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to expert review of ambiguous cases, which is not relevant for this type of analytical performance study.

4. 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 study is for an in vitro diagnostic assay, not a device involving human readers or AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The provided study describes the performance of the Carbon Dioxide assay method itself, which operates as a standalone diagnostic test without human-in-the-loop performance in the AI context. The study is a standalone performance assessment of the device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this study was established by comparison to a legally marketed predicate device, the Roche® Cobas Mira® Plus Automated Chemistry System Carbon Dioxide assay (K844987). This means the predicate device's results served as the reference for determining the substantial equivalence of the new device's performance.

7. The sample size for the training set: Not applicable. This is an analytical performance study for an in vitro diagnostic assay, not a machine learning model requiring a training set.

8. How the ground truth for the training set was established: Not applicable. (See #7).

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The subject device is intended for intravenous fluid, blood and blood products, and for delivery of short-term epidural administration not exceeding 96 hours, in the hospital and home care environment.

Not Found

This looks like a 510(k) premarket notification letter from 1997 for an infusion pump, which is a medical device. This type of document typically approves a device for market based on substantial equivalence to a predicate device, rather than presenting a detailed study proving acceptance criteria.

The information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training set details, and ground truth establishment) is characteristic of a performance study report, often found in premarket approval (PMA) submissions or detailed clinical trial reports. These are generally much more extensive documents than a 510(k) approval letter.

Therefore, the provided text does not contain the specific information needed to answer your questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what we can infer:

• 510(k) Process: A 510(k) submission primarily demonstrates "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as a device already on the market. It often relies on a comparison of design, materials, performance specifications, and intended use, rather than a full-blown clinical trial with detailed efficacy and safety endpoints like those requested in your prompt.
• Lack of Performance Data: The letter mentions the "Abbott Lifecare Standard Tubing Infusion Pump" and its intended use for intravenous fluid, blood, blood products, and short-term epidural administration. However, it does not provide any specific performance metrics (e.g., flow rate accuracy, alarm sensitivity, failure rates) or the results of a study designed to test these against pre-defined acceptance criteria.
• No Study Details: There's no mention of a particular study, sample sizes, experts, adjudication methods, or multi-reader multi-case studies. These are all elements of a robust clinical or performance evaluation study.
• Ground Truth: For an infusion pump, "ground truth" would typically relate to the accuracy of fluid delivery, the reliability of safety mechanisms (e.g., occlusion detection, air-in-line detection), and the pump's ability to maintain a set flow rate. This document doesn't delve into how these were established or tested in a study.

In summary, based solely on the provided text, I cannot complete the table or answer the questions because the document is an FDA approval letter for substantial equivalence, not a performance study report.

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The Primary I.V. Set with Backcheck Valve is used for the delivery of I.V. fluids through the primary line or through the attachment of a secondary line into the backcheck valve. A backcheck valve prevents the intermixing of fluids while the secondary line is running. Then, when the secondary line is emptied, the valve automatically restores flow from the primary container.

Primary I.V. Set with Backcheck Valve

This document is a 510(k) clearance letter from the FDA for a medical device called "Primary I.V. Set with Backcheck Valve." It does not contain information on acceptance criteria, device performance, an associated study, or any of the other specific details requested in the prompt (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).

The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is substantially equivalent to legally marketed predicate devices. It then outlines the regulatory framework and responsibilities for the manufacturer.

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