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OPUS hLH Controls are quality control materials intended for use in the clinical laboratory to assess or verify the performance of the OPUS hLH assay, run on the OPUS analyzers.

OPUS hLH Controls are intended for use as quality control material to monitor the accuracy and precision of the OPUS hLH assay run on the OPUS analyzers.

The provided document is a 510(k) Notification for the OPUS hLH Controls, a quality control material, not an AI/ML powered device. As such, many of the requested categories in the prompt (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, how ground truth was established for training set) are not applicable to this type of medical device submission.

However, I can extract information related to the device performance characteristics, which serve as the acceptance criteria for this quality control material.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Intra-assay precision: 20 replicates for each of the three levels of control material (total of 60 measurements).
  • Inter-assay precision: Duplicate measurements over a five-day period, totaling 20 replicates for each of the three levels of control material (total of 60 measurements).
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is a submission for a quality control material, and such studies are typically performed in a controlled laboratory setting by the manufacturer (Dade-Behring Inc., located in Westwood, MA, USA).

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

Not applicable. This device is a quality control material. Its "ground truth" (i.e., expected LH levels) is established during its manufacturing and assay process, not by expert review of patient data. The study focuses on the precision of the control material when run on an analyzer.

4. Adjudication method for the test set

Not applicable. There is no expert adjudication for the performance of a quality control material. The performance is assessed purely based on statistical precision metrics.

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/ML-powered diagnostic tool requiring human reader studies.

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

Not applicable. This device is a quality control material for an immunoassay, not an algorithm.

7. The type of ground truth used

For quality control materials, the "ground truth" refers to the target or assigned values for the analytes within the control. These are established through:

• Manufacturer's internal assays: Batch testing during production to determine the concentration of hLH at each control level.
• Assigned values: The control material is "assayed," meaning it comes with lot-specific values, likely determined by the manufacturer against a reference method or standard.

The study then assesses how precisely the OPUS hLH assay measures these known levels within the control material.

8. The sample size for the training set

Not applicable. Quality control materials do not typically have a "training set" in the context of AI/ML or classification algorithms.

9. 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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N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine, used as an aid in the diagnosis of kidney and intestinal diseases.

The proposed product, N Antiserum to Human Albumin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of albumin in human serum, cerebrospinal fluid and urine.

In the proposed product, proteins contained in the human serum or urine samples, form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

The N Antiserum to Human Albumin underwent studies to demonstrate its performance, specifically focusing on its correlation with a legally marketed predicate device and its precision.

1. Acceptance Criteria and Reported Device Performance

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N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine, used as an aid in the diagnosis of latent and manifest iron deficiency and iron overload, and glomerular defects.

The proposed product, N Antiserum to Human Transferrin is an in vitro diagnostic reagent intended to be used together with the Behring Nephelometer Systems in the measurement of transferrin in human serum and urine.

In the proposed product, proteins contained in the human serum or urine samples, form immune complexes with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Here's an analysis of the provided text regarding the acceptance criteria and study for the N Antiserum to Human Transferrin device:

Acceptance Criteria and Device Performance Study for N Antiserum to Human Transferrin

The document describes the performance characteristics of the N Antiserum to Human Transferrin, primarily focusing on correlation and precision studies for urine samples.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" values. The values listed under "Acceptance Criteria (Implicit)" are inferred from general expectations for good performance in comparative and precision studies for diagnostic assays.

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

• Test Set Sample Size: 53 urine samples.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a German manufacturer, the samples could be from Germany or elsewhere, and the study design (retrospective vs. prospective) is not specified.

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

The concept of "experts" to establish ground truth in the context of this device (an immunoassay for transferrin) is not directly applicable in the same way as for image-based diagnostics. For this type of device, the "ground truth" or reference method is typically the comparator device, which itself is a validated assay. The study compares the new device's measurements against these reference measurements. There's no mention of a ground truth panel established by human experts in this document.

4. Adjudication Method for the Test Set

Not applicable. The study is a quantitative comparison between two laboratory assays, not requiring human adjudication.

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 is typically for image-based diagnostic devices where multiple human readers interpret cases. The N Antiserum to Human Transferrin is a laboratory reagent for an immunoassay.

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

Yes, the studies presented are standalone performance evaluations of the N Antiserum to Human Transferrin Reagent when used with Behring Nephelometer Systems. The performance (correlation and precision) is inherent to the reagent and instrument system, operating without direct human interpretation of individual results beyond running the assay and reading the quantitative output.

7. Type of Ground Truth Used

The "ground truth" for the comparative studies was established by measurements from the legally marketed predicate device, Beckman Transferrin (TRF) Reagent. For the precision studies, the ground truth is essentially the inherent variability of the assay itself under controlled conditions.

8. Sample Size for the Training Set

The document does not provide information about a separate "training set" or its sample size. For an immunoassay, the development often involves method optimization and validation, but not typically a distinct "training set" in the machine learning sense. The provided data relates to performance testing.

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

Not applicable, as a distinct training set (with associated ground truth establishment) is not described or implicitly suggested in the provided submission for this type of device.

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OPUS Ferritin is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of ferritin in human serum, as an aid in the diagnosis of hemochromatosis (iron overload) and iron deficiency anemia. OPUS Serum Ferritin is intended for use with the OPUS analyzers.

OPUS Ferritin is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ferritin in human serum.

Here's a breakdown of the acceptance criteria and the study details for the Behring Diagnostics Inc. OPUS® Serum Ferritin 510(k) Notification, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria. Instead, it reports the performance characteristics, implying that these values met internal or regulatory expectations for substantial equivalence to the predicate device (Abbott IMX Ferritin).

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

• Sample Size for Test Set:
  • Precision (Intra-assay): 3 levels of control material, 20 replicates each.
  • Precision (Inter-assay): 3 levels of control material, duplicate assays over 5 days (total 20 replicates).
  • Accuracy by Recovery: Not explicitly stated, but “different levels of ferritin” in pooled human serum, assayed in triplicate.
  • Accuracy by Correlation: 70 serum samples.
• Data Provenance: Not explicitly stated. Likely retrospective clinical samples or laboratory-prepared samples (e.g., spiked samples for recovery). The country of origin is not mentioned, but given the manufacturer's location (Westwood, MA, USA), it's highly probable the data is from the USA.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Not Applicable. This device is an in vitro diagnostic (IVD) for quantitative measurement of a biomarker. The "ground truth" for such devices is typically established through reference methods, certified standards, or comparison to a legally marketed predicate device, rather than expert consensus on interpretation. The document describes comparison to a commercially available Ferritin assay (the Abbott IMX Ferritin) as the reference for accuracy.

4. Adjudication Method (Test Set):

• Not Applicable. As noted above, adjudication by experts for interpretation is not relevant for this type of quantitative IVD device.

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

• No. This is an automated in vitro diagnostic (IVD) device. MRMC studies are typically for image-based diagnostic systems where human readers interpret results, and the AI's effect on their performance is being evaluated. This device provides a quantitative measurement, not an interpretation that human readers would perform.

6. Standalone (Algorithm Only) Performance:

• Yes. The reported performance characteristics (Precision, Accuracy by Recovery, Accuracy by Correlation) are all measures of the OPUS Ferritin assay's performance by itself or in direct comparison to another assay, without human intervention in the result determination. The device's output is a quantitative ferritin value.

7. Type of Ground Truth Used:

• (For Accuracy by Correlation): Results from a commercially available, legally marketed Ferritin assay (Abbott IMX Ferritin). This serves as the comparative "ground truth" for evaluating substantial equivalence.
• For Precision: Based on the inherent variability within the assay when measuring control materials.
• For Accuracy by Recovery: Based on the known amount of ferritin spiked into samples.

8. Sample Size for the Training Set:

• Not explicitly stated/Not Applicable in the traditional sense. For an immunoassay like this, the "training" isn't typically based on a large dataset in the way a machine learning algorithm is trained. Instead, the assay's development involves:
  • Assay Optimization: Iterative laboratory experiments to determine optimal reagent concentrations, incubation times, etc. This doesn't involve a distinct "training set" of patient samples in the same way an AI model would.
  • Calibrator Definition: The six-level calibrator system is established with known concentrations to define the assay's standard curve for quantitative measurement.

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

• Not applicable in the traditional sense of a "training set" for an AI algorithm.
  • The "ground truth" for the calibrators would be established by preparing solutions with precisely known concentrations of ferritin, using highly purified ferritin standards. These standards would be traceable to recognized reference materials if available.
  • The overall functionality of the immunoassay system (reagents, instrument) is developed and optimized as described in point 8, through biochemical and analytical testing, rather than "ground truth" labels on a dataset.

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OPUS D-Dimer is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of cross-linked fibrin degradation products (XL-FDP) containing D-Dimer in human plasma, used in the diagnosis of thromboembolic events. OPUS D-Dimer is intended for use with the OPUS analyzers.

OPUS D-Dimer is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of cross-linked fibrin degradation products containing D-Dimer in human plasma.

Here's a breakdown of the acceptance criteria and study information for the Behring Diagnostics Inc. OPUS® D-Dimer device, based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in the format of pass/fail thresholds for the device's performance. Instead, it presents performance characteristics determined through several studies. The underlying acceptance is implied by the FDA's "substantial equivalence" determination, meaning the performance is considered comparable and safe/effective relative to the predicate device.

However, we can infer the reported device performance from the "Device Performance Characteristics" section.

Table of Performance Characteristics:

The document doesn't provide a typical "acceptance criteria" table with specific targets. Instead, it reports the resulting performance metrics from the studies conducted.

Study Details

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

• Accuracy by Correlation: 321 human plasma samples.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the samples were collected retrospectively or prospectively. It refers to "human plasma samples."

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

• This information is not provided in the document. For in vitro diagnostic devices like D-Dimer assays, "ground truth" is typically established by comparing the device's results to a recognized reference method or a legally marketed predicate device. The document uses the "ASSERACHROM® D-Di" as the comparator for accuracy by correlation, implying its results served as the reference. There's no mention of human experts establishing ground truth for the D-Dimer levels in the plasma samples.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The evaluation methods described (precision studies, recovery studies, and correlation with a predicate device) do not involve adjudication by multiple human readers in the way typically seen for medical imaging or clinical decision support AI devices. The comparison is between the new device and a reference method.

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

• No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic aids that assist human interpretation (e.g., radiologists reading images). The OPUS D-Dimer is a standalone in vitro diagnostic assay that quantitatively measures a biomarker, not a device that assists human readers in interpreting clinical cases.

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

• Yes, the OPUS D-Dimer is an in vitro diagnostic standalone device. Its performance characteristics (precision, recovery, and correlation with another assay) are reported for the device itself, without human-in-the-loop interpretation being part of the primary performance evaluation. It's an automated fluorometric immunoassay system.

7. The Type of Ground Truth Used

• For the "Accuracy by Correlation" study, the ground truth was effectively the results obtained from the legally marketed predicate device, ASSERACHROM® D-Di, which is a "commercially available D-Dimer assay." For precision and recovery studies, the ground truth was based on pre-defined control materials or spiked samples with known concentrations.

8. The Sample Size for the Training Set

• This document does not mention a "training set" in the context of machine learning or AI models. The OPUS D-Dimer is an immunoassay system. While the system would have undergone internal development, calibration, and validation, the concept of a separate "training set" and "test set" for an AI algorithm is not applicable here. The reported studies describe analytical performance evaluation, not AI model deployment.

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

• As mentioned above, the concept of a "training set" for an AI model is not applicable to this device. For the development and calibration of the immunoassay, ground truth would have been established through highly characterized reference materials and established laboratory methods. The document does not provide details on the specific methods used for establishing these intrinsic reference values during product development.

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The Von Willebrand Reagent is intended for the determination of the ristocetin cofactor activity in human plasma.

Von Willebrand Reagent is used for the determination of ristocetin cofactor activity in human plasma. The determination of ristocetin cofactor activity is important in:

• The diagnosis of Von Willebrand's disease.
• The diagnosis of diseases characterized by changes in the ristocetin cofactor.
• Pre-operative screening of haemorrhagic diatheses.

The Von Willebrand Reagent consists of lyophilized platelets and ristocetin.

The provided text describes a 510(k) premarket notification for a medical device called "Von Willebrand Reagent" by Behring Diagnostics. The key information for determining acceptance criteria and the study that proves the device meets them is in the "510(k) SUMMARY OF SAFETY AND EFFECTIVENESS" section (page 2).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with pass/fail thresholds in a formal table format. However, it reports performance characteristics and compares them to a predicate device, implying these are the metrics used for demonstrating substantial equivalence. Acceptance is based on the substantial equivalence to the predicate device, Helena Laboratories Ristocetin Cofactor Assay.

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: A total of 70 patients (normal and pathological samples).
• Data Provenance: Not explicitly stated, but given the manufacturer (Behring Diagnostics GmbH, Marburg, Germany) and contact information (San Jose, CA, USA), it's likely a prospective study conducted for regulatory submission. The country of origin of the data is not specified.

3. Number of Experts and their Qualifications for Ground Truth

• This information is not provided in the document. The determination of "normal and pathological samples" for Von Willebrand disease is usually based on clinical diagnosis and often confirmed by laboratory tests, but the specific process for establishing ground truth for these specific samples (e.g., number of clinicians, their specialties, and experience) is not detailed.

4. Adjudication Method for the Test Set

• This information is not provided in the document. For laboratory assays like this, ground truth is typically assessed by established diagnostic criteria and reference methods rather than expert adjudication in the same way as, for example, image interpretation.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic reagent, not an imaging device or AI-assisted diagnostic tool that would typically involve multiple human readers interpreting results. The comparison is between the new reagent and a predicate reagent.

6. Standalone Performance Study

• Yes, a standalone performance study was done for the Von Willebrand Reagent. The "Comparative Analysis" and "Precision" sections describe the device's performance characteristics in determining ristocetin cofactor activity, independent of human interpretation or assistance beyond standard laboratory procedures.

7. Type of Ground Truth Used

• The ground truth was based on clinical classification of "normal and pathological samples" combined with the results from the predicate device (Helena Laboratories Ristocetin Cofactor Assay), against which the new device's performance was compared using regression analysis.

8. Sample Size for the Training Set

• The document does not mention a separate training set. For in-vitro diagnostic reagents of this type, the development often involves optimization and verification using various samples, but a formally defined "training set" in the context of machine learning is not applicable here. The 70 patients mentioned are for the comparative analysis and likely serve as the primary validation dataset.

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

• As no separate training set is mentioned, this information is not applicable.

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OPUS Ethanol is an in vitro diagnostic thin film-based, fluorescence inhibition test for the quantitative measurement of ethanol in human serum or plasma as an aid in the diagnosis and treatment of alcohol intoxication and poisoning. OPUS Ethanol is intended for use with the OPUS analyzers.

OPUS Ethanol is a set of in vitro diagnostic reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ethanol in human serum or plasma. Assay range is 10-300 mg/dl.

Kanzoll Behring Diagnostics Inc. OPUS® Ethanol 510(k) Notification

Here's an analysis of the provided Kanzoll document, focusing on acceptance criteria and the study proving the device meets them:

Missing Information Disclaimer:

It's important to note that the provided document is a 510(k) summary, which often provides a high-level overview. Consequently, some details typically found in a full study report (like acceptance criteria for precision and accuracy, detailed ground truth establishment for training, or explicit statements about standalone performance and MRMC studies) may not be explicitly stated or fully detailed. In such cases, I will infer based on common medical device submission practices or mark as "Not explicitly stated."

1. Table of Acceptance Criteria and Reported Device Performance

Note: Acceptance criteria for precision and accuracy are not explicitly stated in the provided summary. The reported performance is presented as the study result.

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

• Sample Size for Precision:
  • Intra-assay: 3 levels of control material, 20 replicates each. (Total 60 measurements)
  • Inter-assay: 3 levels of control material, duplicate measurements over 5 days. (Total 30 measurements)
• Sample Size for Accuracy (Recovery): 4 dilutions of an elevated patient sample, assayed in duplicate. (Total 8 measurements)
• Sample Size for Accuracy (Correlation): 50 serum samples.
• Data Provenance: Not explicitly stated (e.g., specific country, demographic details). "Normal human serum poor" and "elevated Bone AP patient sample" are mentioned, suggesting human biological samples. The study appears to be retrospective as it's testing pre-existing samples or control materials.

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

• Not Applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of ethanol. The "ground truth" for such devices is typically established through analytical methods with known concentrations (e.g., spiked samples, reference materials, or a legally marketed predicate device). It does not involve expert readers establishing ground truth as in imaging or diagnostic pathology AI.
• The "ground truth" for the correlation study was established by comparing to a "commercially available immunoassay" (the Abbott TDx/TDxFLx REA Ethanol assay, as implied by the substantial equivalence claim).

4. Adjudication Method for the Test Set

• Not Applicable. As an IVD device measuring a chemical analyte, expert adjudication methods (like 2+1 or 3+1) are not relevant here. The comparison is against established analytical methods/predicate devices.

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

• Not Applicable.
  • The OPUS Ethanol device is a laboratory instrument/reagent system for quantitative measurement. It does not involve human "readers" interpreting images or clinical data in the same way an AI-powered diagnostic imaging tool would. Therefore, an MRMC study is not relevant to its evaluation.
  • The study focuses on the analytical performance characteristics of the device itself (precision, accuracy) when processing samples.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, this is a standalone study.
  • The performance characteristics (precision, recovery, correlation) reported are for the OPUS Ethanol system operating independently. There is no mention of human-in-the-loop assistance influencing the reported measurements. The device provides a quantitative measurement directly.

7. The Type of Ground Truth Used

• For Precision: Based on control materials with established (or internally validated) target ethanol concentrations.
• For Accuracy (Recovery): Created by dilutions of an elevated patient sample into a normal human serum pool. This implies a known expected concentration after dilution.
• For Accuracy (Correlation): Measurements from a legally marketed predicate device, the Abbott TDx/TDxFLx REA Ethanol assay. This is a common method for IVD studies to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

• Not applicable / Not explicitly stated for 'training'.
  • The OPUS Ethanol device is an immunoassay system, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. It relies on chemical reactions and optical detection, not a learned model from a dataset.
  • Therefore, the concept of a training set as understood in AI/ML is not relevant here. The manufacturing and calibration process of the reagents and instrument would be analogous to "training" in a broad sense, but not with a separate data set as described for AI.

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

• Not Applicable. (See explanation in point 8).
  • The "ground truth" for the calibration of the instrument would be established through a six-level calibrator system (as mentioned in point 6, comparing it to the predicate). These calibrators are solutions with precisely known concentrations of ethanol, used to create a standard curve.

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The Emit® Calibrator B Level 1 and Calibrator B Level 2 are used in the calibration of the Emite d.a.u.™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/ml cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphen. A caws. The Emit Calibrator B Level 1 and Calibrator B Level 2 are also used in the calibration of the Emite II Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaquelone, Opiates 300/2000, and Propoxyphene Assays.

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

Behring Diagnostics Inc. is submitting this Premarket Notification, 510(k) to convey our intention to manufacture for commercial distribution a modified Emit® Calibrator B Level 1 (cutoff) and a modified Emit® Calibrator B Level 2 (high) used in the calibration of the Emit® d.a.u. ™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphene Assays. Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) are also used in the calibration of the Emit® II Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaqualone, Opiates 300/2000, and Propoxyphene Assays.

The modified Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) are substantially equivalent to the currently marketed Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) (K912729) with regard to intended use and overall performance characteristics. The most significant difference between the modified Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high) is the addition of morphine at 2000 ng/mL in the Calibrator B Level 1 (cutoff) and morphine at 4000 ng/mL in the Calibrator B Level 2 (high).

The modified Calibrators B contain the following drug concentrations:

| | Level 1
(ng/mL) | Level 2
(ng/mL) |
|-----------------|--------------------|--------------------|
| Benzoylecgonine | 150 | 3000 |
| d-Amphetamine | 300 | 2000 |
| Methadone | 300 | 1000 |
| Methaqualone | 300 | 1500 |
| Morphine | 2000 | 4000 |
| Oxazepam | 300 | 1000 |
| Propoxyphene | 300 | 1000 |
| Secobarbital | 300 | 1000 |

This document describes the equivalence of a modified calibrator device (Emit® Calibrator B Level 1 (cutoff) and Emit® Calibrator B Level 2 (high)) to a previously marketed device (K912729). It does not describe a study proving a device meets acceptance criteria related to a general medical device or AI system. Instead, it demonstrates the substantial equivalence of a modified calibrator in the context of drug assays.

Therefore, many of the requested fields are not applicable to this type of submission. However, I can extract the relevant information and explain why other fields are not present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of accuracy, precision, or other performance metrics usually seen for diagnostic devices. Instead, the "acceptance criteria" for this submission appear to be the demonstration of substantial equivalence to the predicate device in terms of intended use and overall performance characteristics. The key performance characteristic mentioned is the composition of the calibrator.

The key modification and reported performance are the new drug concentrations for the modified calibrators. The performance is that these new calibrators will function equivalently for their intended use in the listed assays.

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

• Sample Size: Not applicable. This document describes the composition change of a calibrator, not a study involving a test set of patient samples.
• Data Provenance: Not applicable. The "study" here is a submission demonstrating equivalence. No specific patient data or retrospective/prospective studies are detailed.

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

• Number of Experts: Not applicable. The "ground truth" for calibrators is their manufactured concentration, not an expert-derived diagnosis.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

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

• MRMC Study: No. This is not a diagnostic device involving human readers or interpretation.

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

• Standalone Performance: Not applicable. This product is a chemical calibrator; it does not involve algorithms or human-in-the-loop performance in the sense of AI. Its performance is related to its chemical composition and stability.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for a calibrator is its known, manufactured chemical concentrations of the listed substances. This is established through analytical chemistry and quality control during the manufacturing process.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not an AI or machine learning device requiring a training set.

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

• Ground Truth Establishment: Not applicable.

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The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analysis of opiates in human urine.

The Emit® II Opiates 300/2000 Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff, The Emit® II Opiates 300/2000 Assay has been found to be substantially equivalent to the predicate device: Emit® II Opiate Assay (K902577) with regard to intended use, assay sample, and overall performance characteristics.

Here's an analysis of the provided text regarding the Emit® II Opiates 300/2000 Assay, broken down into the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes qualitative and semi-quantitative performance, with different metrics for each.

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

The document does not explicitly state the sample size for the test set. It mentions "spiked samples" and comparison to a "predicate method" and "GC/MS confirmation," but no specific numbers of samples or origins (e.g., retrospective/prospective, country of origin) are provided for these test sets.

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

Not applicable. This device is an in-vitro diagnostic assay for opiate detection in urine. The ground truth is established through analytical methods (GC/MS confirmation, predicate device comparison) rather than expert human interpretation of images or other subjective data. No experts for ground truth establishment are mentioned.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the ground truth is established through objective analytical methods. There is no mention of human adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging or interpretation-based diagnostic devices where human readers are involved. The Emit® II Opiates 300/2000 Assay is an automated in-vitro diagnostic test.

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

Yes, the performance presented is standalone. The Emit® II Opiates 300/2000 Assay is an automated homogeneous enzyme immunoassay. Its performance is measured directly by analyzing urine samples, not through human interpretation or a human-in-the-loop process.

7. The Type of Ground Truth Used

The types of ground truth used are:

• Predicate device comparison: The results were compared to a previously cleared device (Emit® II Opiate Assay, K902577).
• GC/MS confirmation: Gas Chromatography/Mass Spectrometry (GC/MS) is considered the gold standard for drug confirmation in toxicology and thus serves as an objective ground truth for both qualitative and quantitative analysis.
• Spiked samples: Samples with known concentrations of opiates were prepared and tested to assess the assay's ability to correctly identify and quantify them.

8. The Sample Size for the Training Set

The document describes performance studies, but it does not specify a separate "training set" sample size. This type of in-vitro diagnostic device development typically involves analytical validation (precision, accuracy, comparison studies) rather than a machine learning "training set" in the conventional sense. The "performance studies" are essentially the validation data.

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

As there isn't a "training set" in the machine learning context, this question is not fully applicable. However, the methods used to establish the "ground truth" for evaluating the device's performance (which would inform its development and validation) are the same as those listed in point 7: comparison to a predicate device, GC/MS confirmation, and known concentrations in spiked samples. These methods provide the reference standard against which the assay's accuracy is measured.

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OPUS PSA is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in serum. OPUS PSA is an adjunctive test used as an aid in the monitoring of prostate cancer patients. OPUS PSA is intended for use with the OPUS analyzers.

OPUS PSA is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of prostate specific antigen (PSA) in human serum.

Behring Diagnostics Inc. OPUS® PSA 510(k) Notification (K964595)

The Behring Diagnostics Inc. OPUS® PSA is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of prostate specific antigen (PSA) in human serum. It is intended as an adjunctive test to aid in the monitoring of prostate cancer patients.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: 145 serum samples were used for the accuracy by correlation study.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number and Qualifications of Experts for Ground Truth

• The document does not mention the use of experts to establish ground truth for the test set. The accuracy by correlation was performed against a legally marketed predicate device (Hybritech Tandem-E PSA), implying its results served as a comparative reference.

4. Adjudication Method for Test Set

• Not applicable, as the evaluation was based on quantitative measurements against a comparative device, not on subjective expert interpretation.

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

• No, an MRMC comparative effectiveness study was not done. The device is a quantitative immunoassay, not an imaging or diagnostic interpretation tool involving human readers.

6. Standalone Performance Study

• Yes, standalone performance was evaluated through precision, recovery, and correlation studies, demonstrating the algorithm's (immunoassay's) performance characteristics independently. The correlation study compared the OPUS PSA's quantitative results directly against those of the predicate device.

7. Type of Ground Truth Used

• For the accuracy by correlation study, the "ground truth" was established by the results obtained from a legally marketed device, the Hybritech Tandem-E PSA. This effectively uses a comparative reference method as the standard for evaluating the new device's performance. For precision and recovery, the ground truth was inherent to the control materials and spiked samples used.

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" or its size. As this is a 510(k) for an immunoassay, the development process would likely involve calibration and validation using control materials and patient samples, but the specific term "training set" in the context of machine learning is not used.

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

• Given the nature of an immunoassay, the "ground truth" for what might be considered calibration or development would typically involve:
  • Known concentrations: For calibrators, the PSA concentrations are precisely prepared and known.
  • Reference materials: Control materials would have established target ranges.
  • Clinical samples with expert-verified PSA levels: Patient samples used during development would likely have their PSA values determined by a reference method or established clinical assays.
    The document does not provide specifics on how these "ground truths" were established during the development phase.

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