Search Results

The Microgel Alkaline Hemoglobin Electrophoresis test kit is intended for qualitative and semiquantitative determination of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using agarose gel. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglish hemoglobin electrophoresis is necessary. The electrophoretic test is performed at allialine pH and provides a valuable screening method for hemoglobin patterns. Densitometry of the pattern allows the relative quantification of hemogram patism belief allows the pattern allows the relative automated Microod instrument automated Microgel instrument.

The Microgel Acid Hemoglobin Electrophoresis kit is a qualitative test for the identification of both normal and abnomal or variant hemoglobins, and to confirm the identify of clinication of hemoglobins such as A. E. Gand O. Th hemoglobins such as A, F, S and C. The Acid Hemoglobin test kit employs agarose gel at acidic pH and is for in vitro diagnes and of The Rold Hemoglouin test Kit Employs agarose gel at acidid Microgel instrument Microgel instrument.

Not Found

The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. It is a 510(k) clearance letter for the "Microgel Hemoglobin Test Systems by Electrophoresis."

This document primarily states:

• The device name and its regulatory classification.
• That the device has been found substantially equivalent to legally marketed predicate devices.
• The intended use of the device, which includes qualitative and semi-quantitative determination of various hemoglobins using electrophoresis.
• General regulatory requirements.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
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.

This type of detailed performance data is typically found in the full 510(k) submission, not summarized in the clearance letter itself.

Ask a specific question about this device

The Interlab Acid Hemoglobin Electrophoresis is a qualitative test system intended for the electrophoretic separation of hemoglobins to confirm the identity of clinically relevant hemoglobins such as A, F, S and C. It is to be used in conjunction with the Interlab Alkaline Hemoglobin Electrophoresis test kit. The Acid Hemoglobin test kit employs cellulose acetate supported on Mylar® as the medium and is for in vitro diagnostic use. The test can be automated on the Microtech 672 PC and Microtech 648 ISO instruments.

The InterLab Acid Hemoglobin test kits for the electrophoretic separation of hemoglobin in whole blood and are intended for In-Vitro diagnostic use only. The InterLab Acid Hemoglobin Electrophoresis Test Devices provide qualitative identification of abnormal hemoglobin bands visualized by staining of the fractions. The principle of hemoglobin electrophoresis is based upon the visualization of specific hemoglobin bands following separation by electrophoresis. Dilutions of a patient's specimen are placed on separate tracks (fingers) on a cellulose acetate slide six fingers shaped, and the major hemoglobin groups are separated by electrophoresis. The migration rate depends on the temperature, pH, ionic force of the solution and proportions of the reactants. After electrophoresis, the slide is processed to remove excess soluble materials through a washing step. Fractionated hemoglobins are stained. The excess of stain is removed by a destaining step. The slides visually read to identify the bands present.

Here's a breakdown of the acceptance criteria and study information for the InterLab Acid Hemoglobin Electrophoresis device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Comparative Study (Primary Equivalence Study): 71 samples (combined normal and pathological).
• Data Provenance: Samples were obtained from "normal and suspected pathological patients submitted for routine testing to the clinical or hospital laboratory." The studies were run at two clinical facilities. The raw geographical origin of the samples (e.g., country) is not specified. The data is retrospective as it involved samples "submitted for routine testing."
• Sample Size for Analytical Sensitivity: Not explicitly stated as a single number. Samples were "serially diluted" to determine detection limits.
• Sample Size for Precision (Within Slide): 3 different serum samples, each run in replicate (12 or 8 replicates per sample, depending on the kit).
• Sample Size for Precision (Slide to Slide): 3 different serum samples, each run in triplicate on multiple separate slides (30, 33, or 36 replicates per sample, depending on the kit).

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

• Number of Experts: Not explicitly stated. The determination of ground truth relied on "the laboratory's routine commercially available test system following the laboratory's procedure." This implies trained laboratory personnel interpreted the results of these reference methods, but specific numbers or qualifications of individual experts are not provided.
• Qualifications of Experts: Not specified beyond the implication that they are trained laboratory personnel operating "routine commercially available test system" in clinical or hospital laboratories.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly described. The text states "Comparison was accomplished exclusively by visual inspection of the electrophoretic patterns" against reference methods. For the primary equivalence study, there was a "100% agreement to the reference methods for the observed bands at both sites," suggesting a direct comparison or concordance rather than a separate adjudication process beyond the visual comparison.

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 MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers. The assessment focused on the device's performance against established laboratory methods.

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

• This device is not an algorithm, but a laboratory test system. The "InterLab Acid Hemoglobin Electrophoresis" system involves a physical process of electrophoresis, followed by visual inspection of stained bands. Therefore, a standalone algorithm performance study is not applicable. The device itself, when operated, performs the separation and produces the bands that are then visually interpreted. The performance reported (e.g., 100% agreement) is of the combined system's output.

7. The Type of Ground Truth Used

• Ground Truth Type: For the primary equivalence study, the ground truth was established by comparison to existing "commercially available test system[s]" (reference methods) in the clinical laboratory setting.
  • Site one's reference: "HPLC analysis of blood samples displays values of hemoglobin fractions that are outside the reference ranges...electrophoresis is required as an additional confirmatory test."
  • Site two's reference: "commercially available Alkaline Hemoglobin Electrophoresis system to screen the patient samples. Fractions identified as potentially abnormal are run on the Acid Hemoglobin test for confirmation."

8. The Sample Size for the Training Set

• The document implies that this is a 510(k) submission for a device, and the studies described are validation studies for device performance, not training for a machine learning algorithm. Therefore, there is no explicit "training set" mentioned in the context of the device's development or evaluation as described here.

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

• Since there is no explicit "training set" for an algorithm, this question is not applicable in the context of the provided document. The device operates based on the physical-chemical principles of electrophoresis, not on a machine learning model trained on data.

Ask a specific question about this device

The Interlab Alkaline Hemoglobin Electrophoresis test system is intended for the separation of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using cellulose acetate supported on Mylar®. The test is a screening method for in vitro diagnostic use on the Microtech 672 PC and the Microtech 648 ISO fully automated analyzers. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglobin electrophoresis is necessary.

The InterLab Hemoglobin devices test kits for the electrophoretic separation of hemoglobin in whole blood and are intended for In-Vitro diagnostic use only. The InterLab Alkaline Hemoglobin Electrophoresis Test Devices provide semi-quantitative identification of hemoglobin bands visualized by staining of the fractions. The principle of hemoglobin electrophoresis is based upon the visualization of specific hemoglobin bands following separation by electrophoresis. Dilutions of a patient's specimen are placed on separate tracks (fingers) on a cellulose acetate slide six fingers shaped, and the major hemoglobin groups are separated by electrophoresis. The migration rate depends on the temperature, pH, ionic force of the solution and proportions of the reactants. After electrophoresis, the slide is processed to remove excess soluble materials through a washing step. Fractionated hemoglobins are stained. The excess of stain is removed by a destaining step.

Here's an analysis of the provided text, outlining the acceptance criteria and the study that demonstrates the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the comparison to a commercially available reference method and the statistical results (correlation coefficients, precision metrics) achieved.

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

• Sample Size: 93 samples (from both normal and suspected pathological patients).
• Data Provenance: Retrospective, as samples were "submitted for routine testing to the hospital laboratory." The country of origin is not explicitly stated.

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

The document does not explicitly state the number of experts or their qualifications. It mentions that comparative studies were done against "the laboratory's routine commercially available agarose gel test system following the manufacturers' procedure." This implies that the results from the reference method, presumably interpreted by qualified laboratory personnel, served as the ground truth.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The "ground truth" seems to be established by the results of the reference agarose gel test, which implies a single reference result per sample rather than a consensus among multiple readers for the test set itself.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not indicated. This device is an in-vitro diagnostic test system for semi-quantitative identification of hemoglobin bands, not an AI-assisted diagnostic tool that aids human readers. The comparison is between two laboratory testing methods.

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

The device is described as an "electrophoretic hemoglobin analysis system" that performs semi-quantitative identification of bands after processing. While it runs on "fully automated analyzers" (Microtech 672 PC and Microtech 648 ISO), the identification of bands and their comparison to a reference method (agarose gel test) implies that the system outputs results, and these results (band patterns) are then visually inspected and compared. The study data focuses on the performance of the test system itself, suggesting standalone performance in generating the patterns. However, the qualitative assessment ("visually inspected") suggests human interpretation is still involved in confirming results against the reference.

7. The Type of Ground Truth Used

The ground truth for the method comparison and agreement studies was established by a reference method, specifically "the laboratory's routine commercially available agarose gel test system."

8. The Sample Size for the Training Set

The document does not mention the use of a separate training set. The study described uses 93 samples for performance evaluation, compared against a reference method. This appears to be a validation/verification study, not a development study involving a distinct training phase for an algorithm.

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

As no training set is mentioned for an algorithm, this question is not applicable to the provided information.

Ask a specific question about this device

Interlab Immunofixation Electrophoresis Test is for the qualitative in vitro diagnostic separation and identification of abnormal immunoglobulins (IgG, IgM, IgA) and kappa and lambda light chains in human serum and concentrated urine using cellulose acetate supported on Mylar® for the Microtech 672 PC and IFX 600 instruments. This test is useful as an aid in identifying suspected monoclonal gammopathies.

Not Found

I am sorry, but based on the provided text, I cannot extract any information regarding acceptance criteria or a study that proves the device meets those criteria.

The document is an FDA 510(k) clearance letter for the "InterLab Immunofixation Electrophoresis Test System." It primarily confirms that the device is substantially equivalent to a legally marketed predicate device and outlines the regulatory requirements for marketing the device.

Here's why I cannot fulfill your request:

• No Acceptance Criteria or Study Details: The letter does not contain a table of acceptance criteria, reported device performance metrics, sample sizes, data provenance, information about ground truth establishment, expert qualifications, adjudication methods, or details on comparative effectiveness studies (MRMC) or standalone performance studies.
• Focus on Substantial Equivalence: The FDA 510(k) process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on new studies proving specific acceptance criteria beyond what has been established for the predicate. While performance data would have been submitted to the FDA as part of the 510(k) application (K033187), those details are not included in this official clearance letter.
• Limited Scope of the Document: The document is primarily an administrative letter from the FDA, confirming clearance for marketing. It is not a scientific report or a summary of the performance study results.

To get the information you are looking for, you would need to access the full 510(k) submission document (K033187) or any associated performance study reports that InterLab Scientific Instruments SRL would have submitted to the FDA.

Ask a specific question about this device