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For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.

Here's a breakdown of the acceptance criteria and study details for the Acetaminophen L3K® Assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" because the document states "Testing results demonstrate that the Acetaminophen L3K® Assay is equivalent to the predicate device" and focuses on the high correlation coefficients and favorable regression results as proof of this equivalence, rather than explicitly listing numerical thresholds for acceptance. The core of the acceptance criteria for a 510(k) often revolves around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.

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

• Serum Test Set Sample Size: 100 samples
• Plasma Test Set Sample Size: 25 samples
• Data Provenance: Not explicitly stated regarding the country of origin. The submission is from Genzyme Diagnostics P.E.I. Inc. in Canada, so it's likely the data originated there or in a region where they conducted their studies. The data is retrospective as it involves comparing the new device's measurements against an existing "reference method" (presumably the predicate device or a clinical laboratory's established method).

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 given document. For an in vitro diagnostic (IVD) like this, "ground truth" would typically be established by comparing the device's results to a recognized reference method or a method already validated for clinical use, rather than expert consensus on individual cases. The "reference method" is the de facto "ground truth" here.

4. Adjudication Method for the Test Set

• This information is not applicable for this type of IVD performance study. Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or clinical trials where human interpretation or endpoint determination requires consensus among multiple experts. For a quantitative assay, the comparison is directly numerical 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

• No, this was not done. The Acetaminophen L3K® Assay is an in vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.

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

• Yes, this was a standalone performance study. The Acetaminophen L3K® Assay is a laboratory assay that produces quantitative results directly. Its performance was evaluated purely on its analytical capabilities (accuracy, correlation) when measuring acetaminophen in samples, without any human-in-the-loop interpretation beyond standard laboratory procedures and result reporting.

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

• The ground truth was established by a "similar acetaminophen method" referred to as the "reference method" in the serum comparison and the "This method (serum)" in the plasma comparison. This implies an existing, validated laboratory method. For IVDs, this is often a widely accepted and validated analytical method or the predicate device itself.

8. The sample size for the training set

• This information is not provided as this is not an AI/ML device that requires a distinct "training set" in the conventional sense. The studies described are validation (test) studies to demonstrate performance. The "training" for such an assay would be its initial development and optimization, which isn't typically detailed in a 510(k) summary for a chemical assay.

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

• This information is not applicable as there is no mention of a "training set" in the context of an AI/ML device. For the development of the assay, standard analytical chemistry principles, method development, and optimization techniques would have been employed to ensure accuracy, but this is distinct from establishing ground truth for machine learning.

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For the IN VITRO quantitative measurement of Total Bilirubin in serum and plasma.

Measurement of Total Bilirubin is used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases and disorders involving the metabolism of bilirubin.

Not Found

This is a 510(k) clearance letter for a device called "Total Bilirubin L3K, Model 295-10 and 295-30," which is an in vitro diagnostic (IVD) test system. The document states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document primarily focuses on:

• Device Name: Total Bilirubin L3K, Model 295-10 and 295-30
• Regulation Number/Name: 21 CFR Sec. 862.1110, Bilirubin (total or direct) test system
• Regulatory Class: Class II
• Product Code: CIG
• Submission Date: December 5, 2008 (Received December 8, 2008)
• Clearance Date: December 16, 2008
• Manufacturer: Genzyme Diagnostics P.E.I. Inc.
• Intended Use: For the in vitro quantitative measurement of Total Bilirubin in serum and plasma, used in the diagnosis and management of liver disease, biliary tract obstruction, various hemolytic diseases, and disorders involving the metabolism of bilirubin.

To answer your specific questions, I would need access to the actual 510(k) submission document (K082210) itself, which would detail the performance data, acceptance criteria, and study methodologies used to demonstrate substantial equivalence. This clearance letter is merely the FDA's decision based on that submission.

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The OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.

The OSOM hCG Combo device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume Pipette provided. The sample migrates through reaction pads where hCG, if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled hCG complex is captured at a test line region containing immobilized rabbit anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it). The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.

Here's a breakdown of the acceptance criteria and the study details for the OSOM hCG Combo test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Details

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

• Urine Test Set: 634 samples
• Serum Test Set: 691 samples
• Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin.

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

• Not explicitly stated. The comparison was made against a "currently marketed qualitative hCG assay," implying the predicate device's results were accepted as the reference.

3. Adjudication method for the test set:

• Not applicable/Not explicitly stated. The comparison was a direct agreement with a predicate device. There is no mention of independent expert adjudication.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done. This device is a rapid immunoassay for qualitative detection, not an AI-assisted diagnostic tool.

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

• Yes, this was a standalone performance study. The device itself performs the detection and provides a visual result (bands). The study assesses the device's accuracy in producing these results compared to a reference standard.

6. The type of ground truth used:

• The ground truth was established by comparison to the results obtained with a currently marketed qualitative hCG assay (presumably the predicate device, Quidel QuickVue®+ One-Step hCG Combo Test). This implies a comparative agreement study where the predicate device serves as the reference standard.

7. The sample size for the training set:

• Not applicable/Not explicitly stated. This device is a traditional immunoassay, not a machine learning or AI-based system that typically requires a discrete training set. The "development" and "validation" would rely on analytical studies and clinical performance rather than a separate "training set" in the AI sense.

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

• Not applicable (as per point 7).

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This is an immunochromatographic assay for the simultaneous qualitative detection and distinguishing of Giardia and Cryptosporidium specific antigens in aqueous extracts of fecal specimens.

It is intended for professional laboratory use.

For In Vitro Diagnostic Use.

Immunoassay for Giardia and Cryptosporidium Antigens

Here's a breakdown of the acceptance criteria and study details for the Genzyme Contrast® Giardia/Cryptosporidium Combo Rapid Assay:

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria thresholds like "Sensitivity > 95%". Instead, the performance is presented as the outcome of the study, implying that the observed high sensitivity and specificity values were considered acceptable for demonstrating substantial equivalence. The precision studies explicitly state 100% agreement as the specification.

Study Details

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

   • Retrospective Analysis vs Microscopic Examination:
     • Giardia: 33 positive, 109 negative (total 142)
     • Cryptosporidium: 37 positive, 105 negative (total 142)
   • Prospective Analysis vs Microscopic Examination:
     • Giardia: 50 positive, 452 negative (total 502)
     • Cryptosporidium: 73 positive, 429 negative (total 502)
   • Retrospective Analysis vs Rapid EIA (Predicate):
     • Giardia: 142 samples (agreement reported for 138/142)
     • Cryptosporidium: 142 samples (agreement reported for 142/142)
   • Provenance: The document does not explicitly state the country of origin. Both "Retrospective Analysis" and "Prospective Analysis" are mentioned, indicating a mix of historical and newly collected samples for the microscopic comparison. The comparison against the predicate EIA is stated as "Retrospective Analysis."

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

   • The document does not specify the number or qualifications of experts. Ground truth was established by "microscopic examination," which is typically performed by trained laboratory personnel (e.g., medical technologists or microbiologists) but no specific expert details are provided.

3. Adjudication method for the test set:

   • The document does not specify any adjudication method (e.g., 2+1, 3+1). It simply states "microscopic examination" as the reference method, implying a single definitive read or a standard laboratory process.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This study is for an in vitro diagnostic (IVD) assay, not an AI-assisted device for human readers. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.

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

   • Yes, effectively. The "Genzyme Giardia/Cryptosporidium Assay" performance (sensitivity and specificity) is reported as a standalone device performance when compared against the reference method (microscopic examination) and the predicate method (Alexon ProSpecT). As an IVD, it is essentially an "algorithm only" in the sense that the assay itself produces the result, without direct human cognitive input to interpret an image or signal beyond reading the immunoassay result.

6. The type of ground truth used:

   • Expert Consensus / Reference Method: "Microscopic examination" is stated as the "Reference method." This implies that microscopic identification of Giardia and Cryptosporidium organisms in fecal samples serves as the gold standard for establishing the ground truth.

7. The sample size for the training set:

   • The document does not provide any information regarding a training set sample size. This is typical for traditional IVD assays, where method development and optimization (analogous to training) involve internal studies and reagent formulation, which are distinct from the formal clinical performance studies presented here.

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

   • As no training set is explicitly mentioned or detailed, there is no information provided on how its ground truth was established.

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The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician's office laboratory and the clinical laboratory.

Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen using mouse monoclonal anti-IgM antibodies and heterophile antigen from bovine red blood cells.

Here's an analysis of the provided text regarding the Genzyme Diagnostics Contrast® Mono test, structured according to your request:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: 480 specimens (serum, plasma, and whole blood)
• Data Provenance: Retrospective (specimens submitted for infectious mononucleosis testing) and prospective (students presenting with symptoms) from a multicenter clinical study. The study was conducted in three physician's office laboratories (POLs), including two university student health centers and one clinical 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 text states that the Genzyme device was compared to the "reference method" and the legally marketed "Quidel Concise® Plus™ Mono Test." The predicate device likely served as the de facto "ground truth" or a strong proxy for it. There is no information provided about the number of experts or their qualifications used to establish this reference method or to adjudicate the results of the Quidel test itself for the purpose of this study.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "reference method" or the predicate device's results were used for comparison. It's implied that the results of these reference methods were taken as authoritative.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. The study focused on the agreement of the novel device with a predicate device, not on how human readers' performance improved with or without AI assistance.

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

Yes, this was a standalone performance study. The Genzyme Diagnostics Contrast® Mono Test is a rapid immunoassay kit. Its performance was evaluated by comparing its direct results to those of a reference method/predicate device. There is no "human-in-the-loop" aspect to the device's output itself.

7. The Type of Ground Truth Used

The ground truth was established by comparing the test device's results to a legally marketed predicate device (Quidel Concise® Plus™ Mono Test) and a "reference method." While the nature of the "reference method" isn't explicitly detailed, in the context of IVD devices like this, it typically refers to a well-established and accepted diagnostic procedure for the disease.

8. The Sample Size for the Training Set

This information is not provided. The document describes a clinical study to evaluate the device's performance, but it does not detail any separate training set or process for developing the immunoassay itself.

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

This information is not provided, as details about a specific "training set" for the device's development are absent from the document. The immunoassay itself would have been developed based on scientific principles and internal validation, but the documentation focuses on the external clinical validation study.

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The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy for use in the physician's office and clinical laboratories.

Rapid membrane based immunoassay for the qualitative detection of hCG using mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies.

The provided text describes a 510(k) summary for the Genzyme Diagnostics Contrast® Rapid™ hCG test, a qualitative assay for human chorionic gonadotropin (hCG) in urine or serum.

Here's an analysis based on your requested information:

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

The document implies that detecting 10 mIU/mL hCG in serum within 7 minutes is a key performance metric for early pregnancy determination. The study confirms the device meets this level of sensitivity.

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 explicitly stated as a single number. The study used "Coded serum specimens, spiked with hCG at different levels." These specimens were tested in triplicate on three different days. This implies a set of specimens, each tested 9 times in total (3 triplicates * 3 days). The exact number of unique "spiked specimens" at "different levels" is not provided.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but given the manufacturer (Genzyme Diagnostics) is in San Carlos, CA, it's highly probable the study was conducted in the USA.
  • Retrospective or Prospective: Prospective, as "Coded serum specimens, spiked with hCG at different levels, were provided to all sites." This indicates a controlled, pre-planned study with specific samples.

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)

• The document does not mention the use of experts to establish ground truth in the traditional sense of clinical interpretation.
• The "ground truth" for this diagnostic test is based on the known, spiked concentrations of hCG in the serum specimens. The device's performance is measured against these pre-defined concentrations, not against expert interpretation of biological samples.
• The study was conducted in "three physician's offices/clinics (POL)," implying testing was performed by laboratory personnel or healthcare professionals in those settings, but their role was to perform the test, not to establish the ground truth of the hCG levels.

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

• None in the context of expert adjudication. The ground truth was based on the known spiked hCG concentrations.
• The study design involved testing in "triplicate on each of three different days," which provides internal replication and can be used for reproducibility assessment, but not for adjudicating expert disagreement.

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.
• This device is a standalone diagnostic assay, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• Yes, a standalone performance study was done. The described activity is a "multicenter sensitivity and reproducibility study" of the device itself (the "Genzyme Diagnostics Rapid hCG™ Urine/Serum Test"). The performance metric ("can detect 10 mIU/mL hCG in serum at 7 minutes") is a measure of the device's inherent capability. While performed by humans, the device's output (positive/negative line on the test) is the primary outcome, reflecting the "algorithm only" in the context of a rapid immunoassay.

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

• The ground truth used was spiked concentrations of human chorionic gonadotropin (hCG) in serum specimens. This is a form of analytical gold standard where the true concentration of the analyte is known and controlled.

8. The sample size for the training set

• Not applicable / not mentioned. This document describes the performance evaluation of a rapid diagnostic test, not a machine learning algorithm that requires a training set. The device is based on immunoassay principles, not AI.

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

• Not applicable. As a non-AI diagnostic device, there is no "training set" in the context of machine learning. The device's components (antibodies, reagents) are developed and optimized through R&D processes, but this isn't the same as training an algorithm.

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The qualitative detection of human chorionic gonadotropin (hCG) in urine or serum for the early determination of pregnancy in physician's office and clinical laboratories.
The intended use of the Genzyme Diagnostics Contrast® Strip hCG is the early determination of pregnancy by the qualitative detection of human chorionic gonadotropin (hCG) in human serum or urine. Our intent is to market this product for laboratory and professional use.

Rapid membrane based immunoassay for the qualitative detection of hCG using mouse monoclonal anti-hCG and sheep anti-alpha hCG polyclonal antibodies.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Genzyme Diagnostics Contrast® Strip hCG:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in numerical terms (e.g., "sensitivity must be >95%"). Instead, the study's primary objective was to demonstrate 100% agreement with an existing legally marketed device (the Rapid hCG™ Urine/Serum Test). The device also aimed to reproducibly detect hCG at specific concentration levels.

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

• Test Set Sample Size:
  • Urine: 209 samples
  • Serum: 177 samples
  • Reproducibility/Sensitivity Panel: Not explicitly stated, but handled by eight individuals and included urine and serum samples with defined hCG levels.
• Data Provenance:
  • Country of Origin: Not specified, but the study was conducted in "four physician's offices/clinics (POL)" and "three POLs," implying a local (likely US, given the 510(k) context) setting.
  • Retrospective or Prospective: The study appears prospective, as specimens were tested in participating physician's offices from "female patients seeking confirmation of pregnancy, those who were confirmed pregnant, post-menopausal women and assumed negatives" and for "confirmation of pregnancy or non-pregnancy status prior to treatment."

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

The ground truth was established by comparing the Contrast® Strip hCG to the legally marketed and cleared Rapid hCG™ Urine/Serum Test. Therefore, the "experts" in this context are the original studies and validations performed for the Rapid hCG™ Urine/Serum Test, which is considered the reference standard here. The document does not specify the number or qualifications of experts involved in the original establishment of the Rapid hCG™ Urine/Serum Test's accuracy.

For the reproducibility and sensitivity panel, eight individuals with various levels of training tested the blind panel. Their specific qualifications (e.g., clinical laboratory scientists, nurses, physicians) are not detailed beyond "various levels of training."

4. Adjudication Method for the Test Set

There was no explicit "adjudication method" in the sense of multiple human readers independently assessing the results and then resolving discrepancies. The study's design was a direct comparison of the new device's results against those of the predicate device for each sample. The predicate device's result served as the "truth" for comparison. For the reproducibility panel, the expected hCG levels (known concentration) served as the ground truth.

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

No, a traditional MRMC comparative effectiveness study was not explicitly described. The study focused on agreement with a predicate device and reproducible detection of known concentrations, not on measuring human reader improvement with or without AI assistance, as AI was not involved in this device.

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

This question is not applicable. The device is a diagnostic test kit (an immunoassay strip), not an algorithm or AI. Its performance is inherent to the chemical reactions and visual interpretation, which is then performed by a human user without an AI component. The "standalone" performance is essentially what was evaluated through its agreement with the predicate device and its ability to detect known hCG concentrations.

7. The Type of Ground Truth Used

The primary ground truth for the clinical comparison was the results obtained from a legally marketed and predicate device (Rapid hCG™ Urine/Serum Test).

For the reproducibility and sensitivity claims, the ground truth was based on known concentrations of hCG in prepared panels.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as this is a traditional diagnostic assay, not a machine learning model. There was no algorithm trained on data. The device's performance is determined by its inherent chemical and biological design.

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

As there was no training set for a machine learning model, this question is not applicable. The ground truth for the study (test set) was established as described in section 7.

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