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To collect, transport, store and process blood for testing serum in the clinical laboratory. In addition, tubes are suitable for therapeutic drug monitoring.

The Greiner VACUETTE® blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator and an inert polymeric barrier material.

The provided text describes a 510(k) submission for a labeling change to the Greiner VACUETTE® blood collection tube. The change is to include therapeutic drug monitoring (TDM) as an indicated use. The submission aims to demonstrate substantial equivalence to both Greiner's previously cleared device (K960858) and Becton Dickinson VACUTAINER® Brand plain glass blood collection tubes.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for agreement, bias, or precision). However, the implicit acceptance criterion is "no significant clinical difference" between the modified Greiner VACUETTE® tubes and the predicate devices.

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

• Sample Size: Not explicitly stated. The document mentions "clinical tests" and "comparison studies" but does not provide details on the number of samples or subjects involved.
• Data Provenance: Not explicitly stated. The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.

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

Not applicable. This device is a blood collection tube, and the "ground truth" for its performance comparison would typically involve laboratory measurements and statistical analysis of collected blood samples, not expert interpretation of images or other subjective data.

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

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

Not applicable for this type of device. MRMC studies are typically used for evaluating diagnostic imaging or AI devices where human reader performance is a key outcome.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical medical device (blood collection tube), not an algorithm or AI.

7. Type of Ground Truth Used:

The "ground truth" in this context refers to the results obtained from analyses of blood samples collected in the predicate devices. The study compares the performance of the Greiner VACUETTE® tubes (with and without gel separator, and with the proposed TDM indication) against these established methods. The comparison likely involved measuring various analytes relevant to therapeutic drug monitoring and other clinical laboratory tests.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not a machine learning algorithm that requires a training set. The "studies" mentioned are performance comparison studies, not model training.

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

Not applicable. See point 8.

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The Greiner Vacuette® ESR blood collection tube with citrate solution is an evacuated blood collection device intended for use in evaluations of blood sedimentation rate.
Indication for Use: To evaluate blood-sedimentation-rates.

The Greiner Vacuette® ESR blood collection tube with citrate solution is an evacuated blood collection device intended for use in evaluations of blood sedimentation rate.

The Greiner Vacuette® ESR blood collection tube with citrate solution is an evacuated blood collection device intended for use in evaluations of blood sedimentation rate. The device's performance was evaluated by comparing it to a legally marketed predicate device, Becton Dickinson's Vacutainer® brand citrate ESR tube.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated in the provided text. The text only mentions "paired samples."
• Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective.

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 given text. The study focuses on comparing the assay results between two collection tubes, rather than subjective interpretation of results requiring expert consensus for ground truth.

4. Adjudication method for the test set:

• This information is not applicable and therefore not provided. The study compares quantitative assay results, not subjective interpretations that would require an adjudication 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:

• This information is not applicable and therefore not provided. This is a study for a blood collection tube, not an AI-assisted diagnostic device that would involve human readers.

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

• This information is not applicable and therefore not provided. This is a study for a blood collection tube, not an algorithm or AI.

7. The type of ground truth used:

• The ground truth used was the ESR measurement obtained using the legally marketed predicate device (Becton Dickinson Vacutainer® brand citrate ESR tube). The study's objective was to demonstrate equivalence to this established method.

8. The sample size for the training set:

• This information is not applicable and therefore not provided. This study is not for an AI/machine learning device that would require a training set.

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

• This information is not applicable and therefore not provided, as there is no training set for this type of device.

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The Greiner Vacuette® blood collection tube with EDTA K2 is an evacuated blood collection device containing EDTA K2 anticoagulant additive and intended for use in evaluations of whole blood specimens.

The Greiner Vacuette® blood collection tube with EDTA K2 is an evacuated blood collection device containing EDTA K2 anticoagulant additive. The tube material is clear plastic.

This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request as it pertains to a blood collection tube rather than a device with diagnostic performance metrics. However, based on the provided text, I can infer and answer the relevant points to the best of my ability.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: For a blood collection tube, "acceptance criteria" would primarily revolve around demonstrating that the tube does not negatively impact the clinical assay results and that its performance is equivalent to a predicate device. The summary implicitly states this by evaluating "equivalency of assay results."

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 subjects or samples used in the "paired samples" study. It only mentions "paired samples for 15 hematology parameters."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This question is not applicable to this submission. The "ground truth" for a blood collection tube's performance isn't established by expert consensus on diagnoses, but rather by the analytical performance of the assays run on the collected blood. The "experts" involved would likely be clinical laboratory professionals determining if the analytical results are comparable. The document does not specify who performed the analyses or interpreted the "good correlation."

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in medical imaging or diagnostic studies where human readers interpret data that may have ambiguous findings. For comparing analytical assay results from blood tubes, statistical methods for correlation and equivalence would be used, not human adjudication in that sense.

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

No. An MRMC study is relevant for diagnostic devices where multiple human readers interpret results (e.g., radiologists reading images) and the impact of an AI algorithm on their performance is being assessed. This submission is for a blood collection tube; therefore, an MRMC study is not relevant.

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

Yes, in a way that's applicable to this type of device. The study described is fundamentally a "standalone" analytical performance comparison of the tube itself. The performance being measured is the tube's ability to facilitate equivalent assay results, without any human diagnostic interpretation "in the loop" impacting the primary measurement of tube equivalence.

7. The Type of Ground Truth Used

The "ground truth" here is the analytical results obtained from the predicate device (Becton Dickinson Vacutainer® brand EDTA K additive tube). The Greiner Vacuette® tube's performance is judged against whether it can provide comparable analytical results to the established predicate.

8. The Sample Size for the Training Set

Not applicable. Blood collection tubes do not typically have a "training set" in the context of machine learning. Their performance is inherent to their material and additive, and assessed through analytical studies.

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

Not applicable for the reasons mentioned in point 8.

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evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.

Greiner Vacuette® blood collection tube with EDTA and sodium fluoride; and (2) its Greiner Vacuette® blood collection tube with potassium oxalate and sodium fluoride. Both Greiner Vacuette® blood collection tubes are evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as requested.

The provided document is a 510(k) summary for a medical device (blood collection tubes) and, as such, does not typically contain the detailed "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the format one might expect for an AI algorithm or a diagnostic imaging device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

However, based on the information provided, we can infer some "acceptance criteria" related to the performance of the new device compared to the predicate, and describe the study conducted to support this claim.

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

Note: The document only states "good correlation was observed." It does not provide specific metrics or thresholds (e.g., Pearson correlation coefficient > 0.95, or bias within a certain range). This level of detail is usually found in the full 510(k) submission, not the summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided summary. The text mentions "paired samples," indicating that for each comparison (Greiner EDTA/NaF vs. BD EDTA/NaF, and Greiner K.Oxalate/NaF vs. BD K.Oxalate/NaF), a set of blood samples was collected from an unspecified number of subjects.
• Data Provenance: Not specified. It's likely a controlled laboratory study, but the country of origin, and whether it was retrospective or prospective, are not mentioned. Given the nature of a 510(k) submission for a new device, it would most likely be a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable to this type of device and study. The "ground truth" here is the actual glucose and lactate levels in the blood, measured by standard laboratory methods. There is no expert interpretation of images or other subjective data involved. The "truth" is established by the assay itself.

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

• Not applicable. See point #3. The study compares quantitative measurements, not subjective interpretations requiring 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 study is not evaluating an AI algorithm or human reader performance. It's comparing the performance of a blood collection tube.

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

• Not applicable. This study is not evaluating an AI algorithm.

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

• The "ground truth" for the comparison is the glucose assay results obtained from the predicate device's tubes (Becton Dickinson Vacutainer®), assumed to represent the established standard. The study seeks to show that the new Greiner tubes yield results that are "good correlation" with these established standards. Essentially, the predicate device's performance acts as the reference or implicitly "ground truth" for what constitutes acceptable glucose and lactate levels.

8. The sample size for the training set

• Not applicable. This study does not involve machine learning or a training set.

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

• Not applicable. This study does not involve machine learning or a training set.

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The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.

The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive. The tube material for the Greiner product is clear plastic.

This document is a 510(k) summary for a blood collection tube, not a medical device involving AI or complex algorithms. Therefore, much of the requested information (e.g., AI performance, expert consensus, training sets, MRMC studies) is not applicable.

Here's the relevant information based on the provided text:

I. Acceptance Criteria and Study Details for Greiner Vacuette® Blood Collection Tube with Sodium Citrate

This submission describes a direct comparison study to establish substantial equivalence for a new medical device (blood collection tube) with an existing predicate device. The acceptance criteria and performance are based on the correlation of results from these two devices for specific laboratory tests.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria (e.g., correlation coefficient thresholds). Instead, it uses the qualitative term "good correlation."

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

• Sample Size: Not explicitly stated. The study involved "paired samples."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, given the nature of a 510(k) submission for a physical device, it's highly likely to be prospective clinical laboratory testing conducted in a controlled environment.

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

• Not Applicable: For a blood collection tube, "ground truth" is established by the analytical results of standardized laboratory tests. There are no human experts interpreting images or making diagnoses in this context to establish a conventional "ground truth." The "ground truth" is effectively the result obtained from the predicate device which is considered the standard.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods are typically used for subjective diagnostic tasks (e.g., image interpretation). This study involves objective laboratory measurements. The comparison is direct, not interpretive.

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

• No: An MRMC comparative effectiveness study is not applicable as this device is a blood collection tube, not an AI-powered diagnostic tool requiring human interpretation.

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

• Not Applicable: This is a physical blood collection device, not an algorithm, so "standalone performance" in the AI sense is not relevant. The performance is the analytical result generated by the laboratory instrument after blood collection in the tube.

7. The Type of Ground Truth Used

• Comparator Device Results: The "ground truth" or reference standard for comparison was the results obtained from the Becton Dickinson Vacutainer® sodium citrate tube (predicate device). The equivalency was evaluated by comparing test results from the new device against the established predicate.

8. The Sample Size for the Training Set

• Not Applicable: This is a physical medical device, not an AI model. Therefore, there is no "training set."

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

• Not Applicable: As there is no training set for this type of device, this question is irrelevant.

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The Greiner Vacuette™ blood collection tube with EDTA K, is an evacuated blood collection device containing EDTA K, anticoagulant additive and intended for use in evaluations of whole blood specimens.

The Greiner Vacuette™ blood collection tube with EDTA K, is an evacuated blood collection device containing EDTA K, anticoagulant additive. The tube material for the Greiner product is clear plastic.

Here's an analysis of the provided 510(k) summary for the Greiner Vacuette™ blood collection tube with EDTA K3, addressing your requested information points.

Important Note: This document describes a medical device (blood collection tube), not a software-based AI device. Therefore, many of your requested criteria, which are standard for AI/ML medical devices, are not applicable in this context. I will address each point, clarifying why certain information is missing or not relevant for this type of device.

Acceptance Criteria and Device Performance (Greiner Vacuette™ blood collection tube with EDTA K3)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the number of patients or samples used in the equivalency study. It only mentions "paired samples."
• Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.

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

• Not Applicable. This is a physical medical device (blood collection tube) for which "ground truth" is established by laboratory analytical methods, not by expert interpretation of images or clinical data. The accuracy of the hematology parameters is the "ground truth" in this context, measured by standard laboratory assays.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is not a device requiring human experts to establish ground truth or adjudicate results in the way an AI/ML device would. The "adjudication" is essentially the comparison of quantitative laboratory results between the two tube types.

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

• Not Applicable. This type of study is designed for diagnostic imaging devices where human readers provide interpretations (e.g., radiologists reading images). This is a blood collection tube; there are no "readers" in the context of its primary function.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable. This is a physical device, not an algorithm or software. There is no "algorithm only" performance to evaluate. The device's performance is its ability to collect and preserve blood for accurate analysis.

7. Type of Ground Truth Used

• Laboratory Assay Results: The "ground truth" is established by the results of standard hematology assays performed on the collected blood samples. The comparison is between the assay results obtained from samples collected in the predicate device vs. the new device.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a training set. The "study" here is a comparative bench/clinical equivalency study, not a machine learning model's development.

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

• Not Applicable. (See point 8).

Summary of the Study:

The study conducted was a direct comparative equivalency study. Paired blood samples were collected from an unspecified number of subjects. One sample from each pair was collected in the predicate device (Becton Dickinson Vacutainer® EDTA K3 tube, K940905) and the other in the new Greiner Vacuette™ EDTA K3 tube. These samples were then analyzed for 15 hematology parameters using standard laboratory methods. The "good correlation" observed between the results from the two tube types demonstrated that the Greiner tube performed equivalently to the predicate device, despite the difference in tube material (plastic vs. glass). This equivalency supports the claim of substantial equivalence for regulatory purposes.

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The Greiner Vacuette™ blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.

The Greiner Vacuette™ blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material.

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study.

It's important to note that this 510(k) predates many of the more rigorous statistical and AI-specific reporting standards now common, so some of the requested information may not be explicitly present or detailed.

Acceptance Criteria and Study Details for Greiner Vacuette™ Blood Collection Tube

Given the nature of the device (blood collection tube) and the era of the submission (1996), the "acceptance criteria" here refer to demonstrating substantial equivalence to a predicate device, primarily through performance in clinical assays. The criteria are implicitly tied to "Good correlation" of assay results.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical thresholds for "good correlation" (e.g., minimum r-value) are not explicitly stated in this summary, but the reported range implies the criteria were met.

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

• Sample Size: The summary mentions "paired samples." While the number of analytes tested is 23 (plus 3 hormones), the number of patient samples or specimens used for this testing is not explicitly stated. It's common in such studies for a certain number of patient blood draws to be split between the two tube types. Without this detail, we cannot confirm the exact sample size for the test set.
• Data Provenance: This information is not specified in the summary. We do not know the country of origin of the data, nor whether the study was retrospective or prospective. Given it's a 510(k) from 1996, it's highly likely to have been a prospective comparison study.

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

• Not applicable / Not specified. For a device like a blood collection tube, "ground truth" for assay results is typically established by the analytical method itself (e.g., a chemistry analyzer, immunoassay platform) run in a clinical laboratory setting, not by human expert consensus or adjudication on diagnostic interpretation. The "truth" is the measured value from the predicate device tube. There is no indication of human experts establishing a "ground truth" in the way it's done for imaging or diagnostic algorithms.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, the study compared quantitative assay results. There was no need for human adjudication of qualitative interpretations.

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 study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks, especially with AI assistance. The Greiner device is a blood collection tube; therefore, an MRMC study is not applicable to its evaluation.

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

• Not applicable. This device is a physical medical device (blood collection tube), not an algorithm or AI system. Therefore, standalone algorithm performance is not a concept that applies here.

7. The Type of Ground Truth Used

• The "ground truth" was established by the assay results obtained from the predicate device (Becton Dickinson Vacutainer® tubes). The objective was to demonstrate that the Greiner tube yielded comparable results. In essence, the predicate device's performance served as the reference standard.

8. The Sample Size for the Training Set

• Not applicable. This study is a direct comparison study for a physical medical device, not an AI/ML development. There is no concept of a "training set" for this type of submission.

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

• Not applicable. See point 8.

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