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Dri-STAT® Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.

The Dri-STAT® Reagent ACP may be used on the family of Synchron Systems. The reagent kit contains 20 reagent bottles that needs to be manually transferred into a Beckman Coulter User-Define Cartridge. Also with 1 bottle of Acetate Buffer. The reagent kit contains a bottle of Acetate Buffer along with a sample treatment.

Here's a breakdown of the acceptance criteria and study information for the Dri-STAT® ACP Reagent, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in the typical sense of threshold values (e.g., "r-value > 0.95"). Instead, it presents performance data for method comparison and imprecision. The implicit acceptance criterion is that the performance of the candidate device (Dri-STAT® ACP Reagent on Synchron Systems) is substantially equivalent to the predicate device (Dri-STAT® ACP Reagent on Cobas Fara). Substantial equivalence is demonstrated through the presented performance data.

Study Details

The provided document describes a study that aims to demonstrate substantial equivalence between the Dri-STAT® ACP Reagent on Synchron Systems (candidate device) and the Dri-STAT® ACP Reagent on Cobas Fara (predicate device).

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

   • Method Comparison Test Set:
     • TACP (Total Acid Phosphatase): 94 serum samples.
     • NPAP (Non-Prostatic Acid Phosphatase): 47 serum samples.
   • Imprecision Test Set: 80 measurements for each control level and human pool for both TACP and NPAP.
   • Data Provenance: Not explicitly stated, but clinical laboratory samples are typically collected in the country where the studies are performed (presumably USA given the manufacturer's location and FDA submission). The studies are retrospective or concurrent analyses of specimens, as it involves method comparison and imprecision testing on collected samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For in vitro diagnostic (IVD) assays like this, the "ground truth" is typically established by the reference method (the predicate device in this case) or known assayed values of controls, rather than human expert consensus.

3. Adjudication method for the test set: Not applicable. As this is an IVD assay evaluation, there is no human adjudication process involved in establishing ground truth for the samples. The predicate device's results serve as the comparison point.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is an evaluation of an in vitro diagnostic reagent, not a medical imaging or interpretation device that would involve multiple human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the entire evaluation is for the standalone performance of the Dri-STAT® ACP Reagent on Synchron Systems as an automated assay. There is no human-in-the-loop component described for its operation or result generation.

6. The type of ground truth used:

   • Method Comparison: The "ground truth" or reference values are the results obtained from the predicate device (Dri-STAT® ACP Reagent on Cobas Fara).
   • Imprecision: "Ground truth" for controls are their known assayed values, and for human pools, the mean determined value from multiple measurements.

7. The sample size for the training set: Not applicable. For IVD reagents, there isn't a "training set" in the machine learning sense. The device's performance characteristics are established through analytical validation studies (method comparison, linearity, imprecision), not by training an algorithm on a dataset. The reagent formulation and instrument settings are designed and optimized by the manufacturer, rather than "trained."

8. How the ground truth for the training set was established: Not applicable, as there is no training set in this context.

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The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to measure total and non-prostatic acid phosphatase concentrations in human serum.
The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.

The ADVIA 1650 acid phosphatase method measures total and non-prostatic acid phosphatase in serum by a colorimetric procedure published by Hillmann. Tartrate inhibits prostatic acid phosphatase, allowing for measurement of non-prostatic acid phosphatase. The prostatic acid phosphatase concentration can be manually calculated by determining the difference between total acid phosphatase and non-prostatic acid phosphatase.

Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA® 1650™ Acid Phosphatase assay, based on the provided text:

Acceptance Criteria and Device Performance

Note regarding Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for most of these parameters. However, in the context of a 510(k) submission, the "acceptance criteria" are implicitly met if the reported performance is demonstrated to be "substantially equivalent" to predicate devices and acceptable for the intended use in a clinical laboratory setting. The FDA's issuance of the 510(k) implies that the provided data was deemed acceptable.

Study Details

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

   • Correlation (NpACP): N = 64 serum samples.
   • Correlation (Total ACP): N = 71 serum samples.
   • Imprecision: Not explicitly stated as a "test set" in the same way as correlation. Imprecision studies typically involve repeated measurements of control materials or pooled patient samples over several days. For MDC, 44 replicates over 11 days (22 runs) were used.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full study report, but is not present in this summary.

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

   • This device is an in vitro diagnostic assay for measuring biomarkers, not an image-based or diagnostic interpretation device requiring expert review for ground truth. The "ground truth" for method comparison and imprecision studies relies on the established reference method (the predicate device for correlation) and the inherent chemical properties of the analytes. Therefore, this question is not directly applicable in the same way as it would be for AI-powered diagnostic tools. There would be no "experts" establishing ground truth in this context.

3. Adjudication method for the test set:

   • Not applicable. As this is a quantitative chemical assay, the "adjudication" (if one could use that term) is based on the result from the predicate device and standard analytical chemistry principles, not expert consensus or review.

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 is a standalone in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, this entire submission describes the standalone performance of the ADVIA 1650 Acid Phosphatase assay as a laboratory instrument. The performance metrics (imprecision, correlation, interference, analytical range, MDC) are all measures of the device's inherent analytical capabilities.

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

   • For the correlation study, the "ground truth" was established by the predicate device (Roche Acid Phosphatase method on the Hitachi system). The ADVIA 1650's results were compared against this established method.
   • For imprecision, analytical range, and MDC, the "ground truth" is derived from standard analytical chemistry and metrology principles, using reference materials, control solutions, and repeated measurements.

7. The sample size for the training set:

   • Not applicable. As an in vitro diagnostic assay using established chemical reactions (Hillmann colorimetric procedure), there is no 'training set' in the machine learning sense. The method's parameters are based on scientific principles and validated through the studies presented.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this type of IVD device.

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An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in serum.

Acid Phosphatase is an in vitro diagnostic assay for the quantitative determination of total and prostatic acid phosphatase in human scrum. The Acid Phosphatase assay is a clinical chemistry assay in which the acid phospliatase in the sample catalyzes the hydrolysis of alpha-naphthylphosphate liberating the alpha-naphthol and phosphate. The alpha-naphthol is then coupled with diazotized 2-amino-5-chlorotoluene (Fast Red TR) to form a diazo dye. The absorbances measured at 412 and 660 nm are directly proportional to the amount of acid phosphatase present in the sample. The addition of I .- Tartrate inhibits prostatic acid phosphatase, but does not inhibit other isocnzymes. The difference between the two protocols (Total Acid Phosphatasc and Non-Prostatic Acid Phosphatase) is the level of prostatic acid phosphatase in the sample.

Acceptance Criteria and Device Performance for ACP (Acid Phosphatase) Assay

Study Proving Acceptance Criteria:

The study conducted to prove the device meets the acceptance criteria is a comparative performance study demonstrating substantial equivalence to a legally marketed predicate device.

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

   • Test Set Sample Size: Not explicitly stated. The document refers to "comparative performance studies" and "precision studies conducted using two levels of control material," but the precise number of patient samples or runs for method comparison is not provided.
   • Data Provenance: Not explicitly stated. However, given the context of a 510(k) submission for a clinical chemistry assay in the US, the data would likely be from prospective studies conducted in a laboratory setting for regulatory submission in the United States.

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

   • Not applicable in this context. The "ground truth" for this type of in vitro diagnostic assay typically refers to the results obtained from the predicate device (Trace® Acid Phosphatase Assay on Hitachi® 717 Analyzer), which itself is a validated and legally marketed device. Expert human interpretation, as found in imaging or pathology studies, is not the primary method for establishing ground truth in clinical chemistry assays measuring analyte concentrations.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where there might be disagreement among experts. In this case, the comparison is made between quantitative measurements of two assays.

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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study focuses on human reader performance, often with and without AI assistance, which is irrelevant for a quantitative clinical chemistry assay where results are generated by an instrument.

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

   • Yes, this was a standalone performance study in the sense that it evaluates the instrument and reagent system (the ACP assay) itself. There isn't a "human-in-the-loop" component in the direct measurement process of a clinical chemistry assay in the same way there might be for an AI-assisted diagnostic tool for image interpretation. The performance characteristics (correlation, precision, linearity, sensitivity) are intrinsic to the assay system.

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

   • The "ground truth" for comparative studies in clinical chemistry is typically established by the legally marketed predicate device's performance results. In this case, the Trace® Acid Phosphatase Assay on the Hitachi® 717 Analyzer served as the comparator or "gold standard" against which the new ACP assay's performance was measured for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This device is an in vitro diagnostic assay, not an AI/ML algorithm that requires a "training set" to learn from data. The performance characteristics are determined by the chemical reagents and instrument design.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" for this type of device.

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Photometric clinical chemistry analyzer for clinical laboratory use. Applications include colorimtric, turbidimetric, latex agglutination and homogenous enzyme immunoassay.

Photometric clinical chemistry analyzer

This document is a 510(k) clearance letter from the FDA for the Olympus AU400 Clinical Chemistry Analyzer in 1998. It does not contain the acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. The FDA determines substantial equivalence based on information provided by the manufacturer, but the 510(k) process typically doesn't involve the FDA conducting or requiring detailed studies with specific acceptance criteria in the same way a Premarket Approval (PMA) would.

Therefore, I cannot extract the requested information about acceptance criteria and a study to prove device performance from this document. The document's purpose is to grant clearance for the device to be marketed, not to provide a detailed performance study report.

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The cassette COBAS INTEGRA Acid / Prostatic Phosphatase contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of total and prostatic acid phosphatase in serum.

The cassette Roche COBAS INTEGRA Benzodiazepines contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA for the semi-quantitative detection of benzodiazepines in human urine using the enzyme ß-glucuronidase.

The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.

The provided text describes two in vitro diagnostic reagent systems: COBAS INTEGRA Acid/Prostatic Phosphatase (ACPP) and COBAS INTEGRA Benzodiazepines with β-glucuronidase (BNZGL). The 510(k) summary focuses on demonstrating their substantial equivalence to previously marketed devices rather than establishing novel acceptance criteria or performing a comparative effectiveness study in the typical sense of AI/human reader studies.

Here's an analysis of the provided information against your requested categories, acknowledging that some categories may not be directly applicable to this type of device and submission:

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

The document presents performance characteristics for the new devices and compares them to their predicate devices, implying these are the "acceptance criteria" for demonstrating substantial equivalence. Exact numerical acceptance criteria (e.g., "CV must be < X%") are not explicitly stated, but rather the performance is shown to be comparable.

COBAS INTEGRA Acid/Prostatic Phosphatase (ACPP)

COBAS INTEGRA Benzodiazepines with β-glucuronidase (BNZGL)

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

• ACPP Accuracy Test Set:
  • Total Acid Phosphatase: n = 260 samples.
  • Prostatic Acid Phosphatase: n = 264 samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective comparisons to predicate devices' performance claims.
• BNZGL Accuracy Test Set:
  • Positive Samples: n = 50 samples for INTEGRABNZGL vs GC/MS comparison.
  • The table indicates accuracy for positive samples where both INTEGRA with and without β-glucuronidase, and GC/MS all show 50 positive samples and 0 negative samples. This implies 50 positive samples were tested, and perhaps an additional number of negative samples that are not detailed in this specific comparison row, but rather in "overall agreement" data that is not fully presented.
  • Data Provenance: Not explicitly stated (e.g., country of origin). Appears to be retrospective.

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

This information is not provided in the document. For in vitro diagnostic devices, ground truth for quantitative measurements (like acid phosphatase levels) typically comes from reference methods or established laboratory procedures, not from human experts adjudicating images or other subjective interpretations. For benzodiazepine detection, GC/MS is treated as the reference ground truth, which is an analytical method.

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

Not Applicable for these types of in vitro diagnostic tests, which rely on quantitative measurements compared to reference methods (e.g., GC/MS) or predicate biochemical assays. There is no human adjudication process described.

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 document describes in vitro diagnostic assays, not AI-powered medical image analysis tools or other devices that involve human readers/interpreters. Therefore, no MRMC study or AI assistance effect size is discussed.

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

This refers to the performance of the device without human intervention. In the context of these IVD devices, the stated performance characteristics (e.g., precision, accuracy, sensitivity, assay range) are the standalone performance of the reagent system on the COBAS INTEGRA Analyzer. There is no human-in-the-loop component for the analytical part of these tests.

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

• COBAS INTEGRA Acid/Prostatic Phosphatase:
  • Ground truth for accuracy was established by comparison to the predicate device, "Roche Reagent for Acid Phosphatase" (K831834). This is a method comparison study where the predicate acts as the reference or "ground truth."
• COBAS INTEGRA Benzodiazepines with β-glucuronidase:
  • Ground truth for accuracy was established by comparison to Gas Chromatography/Mass Spectrometry (GC/MS) (as indicated in the "Accuracy Positive Samples" table for the predicate device, which is then compared for the new device). GC/MS is a widely accepted confirmatory method for drug detection and serves as the gold standard ground truth in this context.

8. The sample size for the training set

The document does not explicitly identify or specify a "training set" in the context of machine learning. For these diagnostic assays, the development and optimization of the reagent formulation and instrument parameters are analogous to "training" in a broader sense, but there's no data given for this phase. The presented performance data are from validation/verification studies, which would be considered test sets.

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

As there is no explicitly defined "training set" in the machine learning sense, this question is not applicable. The ground truth for the performance evaluations (test sets) is described in point 7.

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