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AnemoCheck Home is intended for home use for the determination of hemoglobin level in whole blood from a finger stick by people over the age of 18. This device is intended for people with anemia caused by iron deficiency anemia, vitamin B12 deficiency anemia, folate deficiency anemia, or who have chronic anemia due to sickle cell disease or thalassemia. AnemoCheck Home tests are for in vitro diagnostic use only. Prescription Use Only.

AnemoCheck Home is a home use with prescription anemia test that is semiquantitative, color based, single use test for hemoglobin level determination. Simply, a user performs a finger stick, less than one drop of blood (5uL) is collected into a collection tube within the test cap, the test cap is mated with the test body and shaken. After 2 minutes of development time, the resulting color of the test solution correlates to a color on a color card. The color results correlate to total hemoglobin levels. As shown, the colors range from blue to red (blue and green indicating low hemoglobin levels, yellow indicating slightly decreased hemoglobin levels and orange and red indicating high levels of hemoglobin), with 1.0 g/dL color block resolution. Users may assign values in between two color blocks for a resolution of 0.5 g/dL. AnemoCheck Home is rapid (2 minutes), simple to use, disposable, and is a stand-alone system that does not require electrical power, additional equipment, or training. The device is semi-quantitative and designed to use a specific test body, test cap, blood collection tube and chemical reagent solution. The blood collection tube serves as a pipette and measuring instrument. No dilution is required or measuring is required by the lay user. AnemoCheck Home leverages the same chemistry and technology used in AnemoCheck (K163215). When blood is mixed with the pre-filled solution, an oxidation-reduction (redox) 3.3.5.5.5 tetramethylbenzidine (TMB) and hydrogen peroxide, leading to stable oxidized TMB products. The products exhibit different colors based on the amount of total hemoglobin present in the sample. After 2 minutes, the resulting color of the solution then allows for visual interpretation with the naked eye using a color card for determination of hemoglobin (g/dL).

The provided document is a 510(k) summary for the AnemoCheck Home device. It details a semi-quantitative, color-based test for hemoglobin levels from a finger stick, intended for home use by individuals over 18 with certain types of anemia.

Based on the provided text, here's an attempt to extract the requested information, acknowledging that some specific details (like exact sample sizes for training or specific expert qualifications for ground truth) might not be explicitly stated in this high-level summary.

Acceptance Criteria and Device Performance:

The document broadly states that "Analytical testing of AnemoCheck Home versus the predicate device and comparator methods demonstrate substantial equivalence based on accuracy and precision." However, specific numerical acceptance criteria (e.g., a defined range for accuracy or precision) are not detailed in this summary. Similarly, the "reported device performance" in terms of specific quantitative results for accuracy and precision are also not explicitly provided in a table format. The text only offers a general conclusion that the test results are "comparable to other test methods."

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

Here's the rest of the information based on the provided document:

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

• Test Set Sample Size: Not explicitly stated in the summary document. It mentions "analytical testing" and "test results in the hands of the intended user," implying a test set was used, but the size is not given.
• Data Provenance: Not specified in the summary document. There is no mention of country of origin of the data, nor 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 510(k) summary. The document does not describe the process of establishing ground truth for the test set in detail. It refers to "clinical laboratory and point-of-care settings" as comparator methods, implying these settings generated the reference values, but not how experts specifically established "ground truth" labels for individual samples.

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

• This information is not provided in the 510(k) summary. The document does not describe any specific adjudication method for the test set results or ground truth establishment.

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 device is a semi-quantitative, color-based test for hemoglobin levels. It is interpreted visually by the user based on a color card. There is no mention of an AI component or "human readers" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study with AI assistance would not be applicable here, and no effect size would be reported.

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

• This is not an algorithm-only device. It is a physical, color-based test that requires user interpretation. Therefore, a "standalone algorithm-only" performance assessment is not applicable. The device's performance is inherently "human-in-the-loop" as the user matches the color to a card. The summary states, "Test results in the hands of the intended user, an untrained lay user, are comparable to other test methods."

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

• The ground truth appears to have been established by "other test methods in clinical laboratory and point-of-care settings." This implies reference laboratory methods (e.g., automated hematology analyzers, or other established POCT devices with known accuracy) were used to determine the true hemoglobin levels for comparison. The specific type of "ground truth" (e.g., expert consensus on visual assessment, or a gold-standard lab test) is not explicitly detailed beyond "comparator methods."

8. The sample size for the training set:

• The 510(k) summary for a medical device (especially one without a complex AI model) typically describes validation studies rather than "training sets" in the machine learning sense. This document describes "analytical testing" and "assessment of performance." The concept of a "training set" for the device's development (e.g., for calibrating the color card) is not explicitly detailed in terms of sample size within this summary.

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

• As above, the concept of a "training set" as it relates to machine learning is not directly applicable or discussed in detail for this type of device in the provided summary. The process of how the color card was developed and correlated to specific hemoglobin values during the device's development (which could be considered analogous to "training") is not described in detail, but it would presumably involve comparing the device's color output to measured hemoglobin values from reference methods in a laboratory setting.

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The AnemoCheck is an in vitro diagnostic semi-quantitative assay for use in point-of-care, clinical and doctor office laboratories for the determination of hemoglobin level and estimation of hematocrit percentage (within normal hemoglobin range) in anticoagulated (K2EDTA, heparin or citrate) whole blood (capillary or venous). AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).

The AnemoCheck™ is a semi-quantitative colorimetric assay for determination of total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood. Capillary or venous blood may be used. The assay is rapid (development time is 2 minutes) and is a manual test that does not require electrical power or additional equipment.

The Sanguina AnemoCheck device is a semi-quantitative colorimetric assay for determining total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood.

Here's an analysis of its acceptance criteria and supporting study information:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates "substantial equivalence based on accuracy and precision" relative to the predicate device. For a semi-quantitative device measuring hemoglobin, typical acceptance criteria would involve a certain level of agreement or correlation with a reference method, often expressed as a percentage of agreement within a clinically acceptable range or a specific mean difference and standard deviation.

The document states:

• "Bench testing of AnemoCheck versus the predicate device demonstrate substantial equivalence based on accuracy and precision."
• "Test results are comparable to other test methods in clinical laboratory and point-of-care practices."

Without specific numerical targets for accuracy (e.g., within X% of a reference method) or precision (e.g., coefficient of variation below Y%), the exact "acceptance criteria" are not fully detailed. The conclusion of "substantial equivalence" implies that the performance met the FDA's criteria for a device of this type, likely benchmarked against predicate devices like the Hemocue® Hemoglobin Hb 201+ Analyzing System and Siemens® Advia 2120i.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not explicitly state the sample size used for the test set in the "Summary of Non-clinical Testing" or "Assessment of Performance" sections.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and their Qualifications for Ground Truth

• The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications. Given that it's an in vitro diagnostic device for hemoglobin measurement, the "ground truth" would typically be established by a laboratory reference method (e.g., a hematology analyzer) rather than expert consensus, though interpretation of results might involve medical professionals.

4. Adjudication Method

• The document does not describe any adjudication method. This is expected given that the ground truth for an IVD device like this would likely be an objective measurement from a reference instrument, not subjective assessment requiring adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed. This type of study is typically relevant for interpretative devices where human readers assess medical images or data. The AnemoCheck is a direct measurement device, not an interpretative one in the context of MRMC studies.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was performed. The "Summary of Non-clinical Testing" states: "Bench testing of AnemoCheck versus the predicate device demonstrate substantial equivalence based on accuracy and precision." This implies the device's performance was evaluated inherently, as a semi-quantitative colorimetric assay, without human interpretation as part of the core measurement. The output of the device (color change) is interpreted manually to determine the hemoglobin level, making it a "manual test that does not require electrical power or additional equipment."

7. Type of Ground Truth Used

• The type of ground truth used would be objective laboratory measurements from predicate or reference devices. The text states: "Bench testing of AnemoCheck versus the predicate device..." and "Test results are comparable to other test methods in clinical laboratory and point-of-care practices." This strongly indicates the AnemoCheck's measurements were compared against established, quantitative hemoglobin assays (like the Hemocue Hb 201+ or Siemens Advia 2120i) which serve as the ground truth.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for any training set. As a manual, semi-quantitative colorimetric assay, the development process might involve calibration and optimization rather than a "training set" in the machine learning sense. The information provided focuses on the validation of the final device.

9. How Ground Truth for the Training Set Was Established

• The document does not provide information on how ground truth was established for any training set. If a training phase existed (e.g., for optimizing the color scale), it would logically also rely on objective laboratory measurements from reference methods for hemoglobin.

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The AnemiaPro™ Self-Screener is intended for over-the-counter distribution, for the determination of hemoglobin concentration in a self-collected capillary whole blood sample. The device is not intended for use in neonates.

The device is a kit containing the materials necessary to self-collect and test a capillary blood sample using a single-use, disposable unit. The test unit is a self-contained plastic housing for a nitrocellulose-based test strip, which employs the principals of blood cell separation. The plasma that is obtained during blood separation migrates through the test strip, and the migration front is made visible by staining with an impregnated dye. The plasma migration distance is linearly and inversely proportional to hemoglobin concentration. The kit is comprised of a blood testing unit packaged in a foil pouch, alcohol prep pad, disposable lancets, gauze pad, bandage strip, and collection instructions containing information about anemia.

Here's a breakdown of the acceptance criteria and study information for the AnemiaPro™ Self-Screener, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it does describe the performance studies conducted and what they aimed to evaluate. The results indicate that the device met the implicit criteria for substantial equivalence to the predicate devices.

Study Information

The document provides a summary of the performance studies.

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

   • Sample Size for Test Set: Not explicitly stated as a single number. The studies were conducted on "self-collected capillary blood samples from volunteer study subjects." The phrase "three different geographical trial sites" suggests a decent number of participants, but the exact number isn't provided in this summary.
   • Data Provenance: Prospective. The studies involved "volunteer study subjects" from whom samples were "collected." Samples were collected from "three different geographical trial sites."

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

   • "A corresponding venous blood sample and a professionally collected capillary blood sample were collected by the health care professional in order to compare venous hemoglobin results to those obtained from both capillary blood samples tested on the Anemia Test Devices."
   • The "health care professional" served as the primary expert for professional capillary blood sample collection.
   • "Venous samples were express shipped to BIOSAFE Laboratories for hemoglobin analysis using the predicate methods." This implies that the predicate devices' results, performed by qualified laboratory personnel at BIOSAFE Laboratories, served as the ground truth. The specific number and qualifications of these laboratory personnel are not provided.

3. Adjudication Method for the Test Set:

   • The document does not explicitly describe an adjudication method for conflicting results. The comparison was made between the AnemiaPro™ device, professionally collected capillary samples, and venous blood samples tested on predicate devices. It seems the predicate device results served as the reference standard.

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

   • No, an MRMC comparative effectiveness study involving human readers assisting with the device's output and measuring their improvement was not conducted or described. This device is an in vitro diagnostic (IVD) for determining hemoglobin concentration, not an imaging or diagnostic aid for human interpretation.

5. Standalone (Algorithm Only) Performance:

   • Yes, the performance study effectively evaluates the standalone performance of the AnemiaPro™ Self-Screener. The device provides "determination of hemoglobin concentration," which is a direct output. Its performance was compared against predicate devices, indicating its standalone accuracy.

6. Type of Ground Truth Used:

   • The primary ground truth appears to be comparison with predicate devices (Cell Dyn 3700 Analyzer and HemoCue B-Hemoglobin Instrument) using venous blood samples, which are generally considered a gold standard for hemoglobin measurement in a clinical setting. Professionally collected capillary blood samples also served as a comparative reference.

7. Sample Size for the Training Set:

   • The document does not mention a separate training set or its sample size. The description focuses on "performance studies" and "clinical trials" which are typically used for validation. For a device like this, the 'training' often refers to assay development and optimization, rather than a machine learning training set as in AI.

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

   • Since a separate "training set" in the context of machine learning or complex algorithms is not described, the method for establishing ground truth for such a set is not applicable or provided in this summary. The fundamental accuracy and comparison were based on the predicate devices during the performance studies.

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The Stat-Site® M Hgb System is for in-vitro diagnostic use only. The Stat-Site® M Hgb Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® M Hgb meter.

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The provided text is a 510(k) cleared document for the Stat-Site® M *** System Whole Blood Hemoglobin Assay. It does not contain the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

The document is a clearance letter and an "Indications for Use Statement". It confirms that the device is substantially equivalent to a legally marketed predicate device and outlines its intended use. It does not include the technical study results or performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test set and data provenance.
3. Number and qualifications of experts.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter in a point-of-care setting such as a physician's office or hospital.

The HemoSite® Test System is a whole blood hemoglobin measurement device which consists of the Stat-Site® Meter (K911801), HemoSite® Test Card and {lot-specific} HemoSite® Test Module. The test employs dry reagent technology based on the azidemethemoglobin method. The blood sample is applied to one side of the HemoSite® Test Card and the color develops on the opposite side. The color produced is directly proportional to the concentration of hemoglobin in the sample and is read using light reflectance at a specific wavelength; the reflectance reading is performed and reported by the Stat-Site® meter.

The provided text describes the HemoSite® Test System, a whole blood hemoglobin measurement device. Here's an analysis of the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only provides these three statistical parameters from a regression analysis. It does not explicitly state pre-defined thresholds for "acceptance" for each of these metrics. The conclusion states that the results "compare acceptably with the reference methods," implying that these values were within acceptable limits for FDA clearance.

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

• Sample Size: 151 whole blood clinical samples.
• Data Provenance: The samples were obtained at 3 independent physician's office sites. This indicates prospective data collection. The country of origin is not explicitly stated, but given the FDA submission, it is highly likely to be the United States.

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

The ground truth was established using a "certified reference standard." The document does not mention the number of experts, their qualifications, or their role in establishing this reference standard. It is implied that the reference standard itself is considered the expert "ground truth."

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by comparison to a "certified reference standard," not through expert adjudication of results.

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 done. The HemoSite® Test System is a device for quantitative determination of hemoglobin, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

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

Yes, this was a standalone performance study. The HemoSite® Test System, which includes the Stat-Site® Meter, HemoSite® Test Card, and Test Module, directly provides the hemoglobin measurement. The study evaluated the performance of this system against a reference standard. There is no mention of human-in-the-loop performance being a variable in the study design.

7. The Type of Ground Truth Used

The ground truth used was a "certified reference standard" for whole blood hemoglobin determination.

8. The Sample Size for the Training Set

The document does not mention a training set. The study described is a clinical validation against a reference standard for the purpose of demonstrating substantial equivalence, not the development or training of a machine learning model.

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

Not applicable, as no training set is mentioned in the document.

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The GDS® HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter.

The HemoSite® Test Cards are dry-chemistry Test Cards that contain chemicals which react and produce color when hemoglobin is present. The Stat-Site® Meter is a reflectance colorimeter that reads color intensity. A Test Module is provided with each box of Test Cards. The Test-Module contains all current calibration information for the specific lot of reagent. The Test Module and Test Cards are coded to each other, and the Stat-Site® Meter will only operate if they are properly matched. HemoSite® Test Cards are dry reagent cards based on the azidemethemoglobin method. When a drop of whole blood is applied to the top of the Test Card, hemolysis occurs, with the release of hemoglobin. Sodium nitrite converts the hemoglobin to methemoglobin. Sodium azide converts methemoglobin to azidemethemoglobin to produce a brown color that is measured at 580 nm using the Stat-Site® Meter. The Stat-Site® Meter measures the color intensity and calculates the hemoglobin concentration.

Here's an analysis of the provided text regarding the HemoSite® Test System, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for the regression analysis or precision. Instead, it presents the results of a comparison study against a predicate device and concludes that the results "compare well." Based on the provided data, we can infer the performance metrics reported.

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

• Sample Size for the Test Set: A total of 212 venous and capillary blood samples were used.
• Data Provenance: The samples were obtained internally and at three different physician's office sites. This suggests a blend of controlled laboratory and real-world point-of-care settings. The document does not specify the country of origin, but given the submission is to the FDA, it is highly probable the data is from the United States. The study appears to be prospective in nature, as it describes obtaining samples to compare the new device against a reference method.

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 submission. The ground truth for this device (hemoglobin concentration) is established by a quantitative measurement from a predicate laboratory instrument, not by expert interpretation.

4. Adjudication Method for the Test Set

This type of information is not applicable to this submission. Adjudication methods are typically used when subjective interpretations (e.g., image readings) require consensus among experts. Here, the comparison is direct quantitative measurement against 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

This type of study is not applicable to the HemoSite® Test System. This device is a standalone diagnostic test for hemoglobin, not an AI-assisted interpretation system for human readers.

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

Yes, a standalone performance evaluation was done. The HemoSite® Test System itself is the "algorithm only" in this context. Its quantitative measurements were compared against the established reference method (Coulter® JT) without human interpretation as part of the measurement process. The device's performance (regression statistics and precision) represents its standalone capability.

7. The Type of Ground Truth Used

The ground truth used was measurements from a predicate laboratory instrument: the Coulter® JT hematology analyzer. This is a form of reference standard/comparative method rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This is a 1998 510(k) submission for a diagnostic device that performs a chemical reaction and colorimetry. While the device likely has internal calibration and validation processes (which could be considered analogous to "training" in a very broad sense), the submission focuses on the performance of the final device against a predicate, not on the development of a complex algorithm that requires a distinct, external training set in the modern AI sense. The "Test Module" provided with each box of Test Cards contains "all current calibration information for the specific lot of reagent," implying internal calibration data, but the size or nature of this data is not detailed as a "training set."

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

Since a "training set" in the modern sense of AI/machine learning isn't explicitly described or applicable, the method for establishing its ground truth is also not applicable. The device's function relies on established chemical principles and colorimetric measurement, with calibration data likely derived from known hemoglobin standards.

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