Search Results

The IMMULITE® IMMULITE® 1000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE/IMMULITE 1000 Analyzer for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

IMMULITE® 2000 High Sensitivity CRP assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma as an aid in the detection and evaluation of infection, tissue injury and inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndrome may be useful as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

The IMMULITE/IMMULITE 1000 and IMMULITE 2000 High Sensitivity CRP is a solid-phase, chemiluminescent immunometric assay. The assay utilizes a 14-inch polystyrene bead coated with anti-ligand. The bead is co-incubated with sample, murine monoclonal anti-CRP, and alkaline phosphatase (bovine calf intestine)-conjugated to rabbit polyclonal anti-CRP in buffer for 30 minutes on each IMMULITE/IMMULITE 1000 and IMMULITE 2000 platform. Unbound enzyme conjugate is removed by a centrifugal wash procedure. Substrate is added and the resulting chemiluminescence is read in the luminometer.

The IMMULITE®/IMMULITE® 1000 and IMMULITE® 2000 High Sensitivity CRP assays are immunological test systems designed for the quantitative measurement of C-Reactive protein (CRP) in serum or plasma. These devices are intended to aid in the detection and evaluation of infection, tissue injury, inflammatory disorders, associated diseases, and in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP measurements, when used with traditional clinical evaluations of acute coronary syndrome, may also serve as an independent marker for recurrent events in patients with stable coronary disease or acute coronary syndrome.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The available document describes performance studies, clinical comparisons, and assay characteristics for both the IMMULITE/IMMULITE 1000 and the IMMULITE 2000 assays.

• Method Comparison (Test Set):

  • IMMULITE/IMMULITE 1000 vs. Dade Behring N HSCRP:
    • Full range (0.3 to 22.9 mg/L): N=175 samples
    • Range < 10 mg/L (0.3 to 9.4 mg/L): N=165 samples (a subset of the full range)
  • IMMULITE 2000 vs. Dade Behring N HSCRP:
    • Full range (0.2 to 22.9 mg/L): N=185 samples
    • Range < 10 mg/L (0.2 to 9.4 mg/L): N=175 samples (a subset of the full range)

• Data Provenance: The document does not explicitly state the country of origin for the samples used in the method comparison or whether the data was retrospective or prospective. Given the nature of a 510(k) submission and the context of comparing a new device to an existing predicate, it's highly probable that these were prospective studies conducted using patient samples in a clinical laboratory setting. However, this is not definitively stated.

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

This information is not applicable to the provided document. The "ground truth" for the method comparison studies was established by the measurement results from the legally marketed predicate device, the Dade Behring N High Sensitivity CRP assay. There were no human experts or diagnosticians establishing ground truth for these quantitative measurements.

4. Adjudication Method for the Test Set:

This information is not applicable to the provided document. Adjudication methods are typically used in clinical studies where subjective interpretations (e.g., image readings, clinical assessments) are made by multiple experts, and disagreements need to be resolved. In this context of quantitative laboratory assays, the comparison is directly between the numerical results of two different analytical methods, not subjective expert 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:

This information is not applicable to the provided document. The device is an in vitro diagnostic assay (a laboratory test) that provides a quantitative measurement. It is not an AI-assisted diagnostic tool that human readers would interpret or use to improve their performance. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.

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

This information is partially applicable to the provided document. The performance characteristics described (Working Range, Analytical Sensitivity, Functional Sensitivity, Precision, Linearity, Spiked Recovery, Interfering Substances, Cross-Reactivity, High Dose Hook Effect) represent the "standalone" performance of the IMMULITE/IMMULITE 1000 and IMMULITE 2000 assays. These are objective measurements of the device's analytical capabilities without human interpretation influencing the numerical result. The method comparison study also assesses the standalone numerical output against a predicate. While a human initiates the test and reviews the result, the core performance reported is the algorithm/assay's ability to accurately quantify CRP.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the performance studies and method comparison was primarily:

• Reference Standards: The assays are standardized to WHO IS 85/506 and CRM 470 reference standards.
• Predicate Device Measurements: For the method comparison, the measurements obtained from the legally marketed Dade Behring N High Sensitivity CRP assay served as the comparator or "ground truth" to demonstrate substantial equivalence.
• Established Analytical Methods: For other performance characteristics (e.g., precision, linearity), standard analytical methodologies and established quality control practices define the expected performance against internal standards or known concentrations.

8. The Sample Size for the Training Set:

The document describes a 510(k) submission for an in vitro diagnostic assay, which typically does not involve machine learning algorithms that require "training sets" in the conventional sense. The performance characteristics and comparison studies are analogous to "test sets" for verifying the analytical performance of the assay.

However, the "Expected Values" section mentions: "A study performed on 100 apparently healthy volunteers yielded a median of 1.4 mg/L and an upper 97.5th percentile of 11 mg/L." This could be considered a reference range study, but it's not a "training set" for an algorithm.

The document states that assay reagents, components, and performance characteristics "remain as previously established in 510(k) K003372." This implies that the current submission builds upon previous extensive validation data, which would have involved numerous samples (calibrators, controls, patient samples) used in the development and initial validation of the original IMMULITE hsCRP assays. The sample sizes for those earlier studies are not detailed in this specific document.

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

As there is no "training set" for a machine learning algorithm described, this question is not directly applicable. If considering the development and validation of the original assays (from K003372), the "ground truth" for calibrators and controls would be established through highly characterized reference materials (like WHO IS 85/506 and CRM 470) and rigorous analytical chemistry methods. For patient samples used in method development, the "ground truth" would be the measurements obtained from an established, clinically accepted reference method or comparison to other well-validated commercial assays.

Ask a specific question about this device

The IMMULITE 2500 Vitamin B12 assay is for in vitro diagnostic use with the IMMULITE 2500 Analyzer — for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.

The IMMULITE 2500 Folic Acid is for in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

IMMULITE 2500 Vitamin B12 is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

IMMULITE 2500 Folic Acid is a solid-phase, two-site chemiluminescent enzyme immunoassay for use with the IMMULITE 2500 Automated Analyzer.

The provided text is a 510(k) summary for the IMMULITE 2500 Vitamin B12 and IMMULITE 2500 Folic Acid assay. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical study data with specific acceptance criteria and detailed performance statistics as might be found in a PMA submission or a full clinical study report.

Therefore, the document does not contain the detailed information required to fill out all sections of your request. Specifically, it lacks:

• Explicit acceptance criteria: While the claim of "substantial equivalence" implies that performance is comparable to the predicate, specific quantitative acceptance criteria for each analytical performance parameter are not listed.
• Detailed study results (test set sample size, provenance, ground truth establishment, expert details, adjudication methods, MRMC studies, standalone performance): The summary states the conclusion of substantial equivalence based on information presented in the Special 510(k), but it doesn't provide the raw data, study design, or methodology for how that equivalence was demonstrated in terms of clinical performance or specific analytical studies for new aspects of the device. Special 510(k)s often refer to changes that do not affect the intended use or fundamental scientific technology, relying on previous data and analytical verification.
• Training set details: Information on a separate training set is not present as this is typically required for AI/ML device submissions, which this is not.

Based on the information available:

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

This information is not explicitly provided in the given 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (IMMULITE 2000 Vitamin B12 and IMMULITE 2000 Folic Acid), implying that its performance is critically comparable to that predicate. Specific numerical acceptance criteria and detailed performance results of verification and validation studies are not included in this summary document. Performance data would typically be found in the manufacturer's internal validation reports, which are not publicly available in this summary.

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

This information is not provided in the given 510(k) summary.

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 information is not applicable as this device is an in-vitro diagnostic test for quantitative measurement of biomarkers, not an imaging device requiring expert interpretation for ground truth establishment.

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

This information is not applicable as this device is an in-vitro diagnostic test.

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. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable in the context of an "algorithm only" performance for an IVD test in the same way it would be for an AI/ML device. The device's performance is intrinsically standalone as it quantitatively measures a biomarker. The summary implies the device's analytical performance (accuracy, precision, linearity, etc.) was assessed, but details are not provided here.

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

For an in-vitro diagnostic device like IMMULITE 2500 Vitamin B12, the "ground truth" would typically refer to the true concentration of Vitamin B12 in a sample. This "ground truth" is usually established through:

• Reference Methods: Comparison against established, highly accurate reference methods, often involving mass spectrometry or validated laboratory methods.
• Certified Reference Materials: Using materials with known, accurately assigned concentrations of the analyte.
• Spiked Samples: Samples artificially augmented with known amounts of the analyte.

The specific methods used to establish this "ground truth" for the performance studies are not detailed in this 510(k) summary.

8. The sample size for the training set:

This information is not provided/not applicable for this type of IVD device in the context of AI/ML training data.

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

This information is not provided/not applicable for this type of IVD device in the context of AI/ML training data.

Ask a specific question about this device

For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended as an aid in the differential diagnosis of hypercalcemia and hypocalcemia and can be used intraoperatively.

IMMULITE/IMMULITE 1000 Turbo Intact PTH is a solid-phase, chemiluminescent immunometric assay employing a goat polyclonal anti-PTH (44-84) antibody as the capture antibody and a goat polyclonal anti-PTH (1-34) antibody conjugated to alkaline phosphatase as the detection antibody.

Here's an analysis of the IMMULITE®/IMMULITE® 1000 Turbo Intact PTH device's acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Mayo Clinic Study: 47 parathyroid gland surgery patients.
• Washington University/Barnes Jewish Hospital Study:
  • Study Group (with intraoperative PTH): 49 patients.
  • Control Group (without intraoperative PTH): 55 patients.
• Data Provenance: Retrospective, as the device was previously cleared (K992105) and these studies compared the already available device's performance to clinical data. The studies were conducted in the US (Mayo Clinic, Rochester, Minnesota and Washington University School of Medicine/Barnes Jewish Hospital, St. Louis, Missouri).

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

The document does not explicitly state the number or specific qualifications of experts establishing the ground truth for the test set in terms of individual review of each case.

However, the "ground truth" for the device's efficacy in the clinical studies was implicitly established through:

• Clinical outcomes: "clinically cured," "achieved normocalcemia postoperatively." This implies assessment by treating physicians/surgeons, likely qualified in endocrinology and/or surgery, whose consensus on patient's post-operative status served as a form of ground truth.
• "Generally accepted guideline": The 50% decrease in PTH from baseline is a widely accepted clinical guideline in parathyroid surgery, implying a collective expert consensus within the medical community.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for establishing ground truth from multiple experts for each patient's outcome. Instead, it relies on:

• Clinical outcomes: The patients' actual post-operative clinical status (e.g., cure, normocalcemia) determined by their treating medical teams.
• Established clinical guidelines: The 50% PTH decrease rule, which is a pre-defined and widely accepted criterion.

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 involves an in vitro diagnostic (IVD) assay, not an AI-powered image analysis device or a system requiring human "readers" in the context of interpreting AI output. Therefore, an MRMC study is not applicable, and no effect size for human improvement with "AI assistance" is provided or relevant. The "assistance" here is a rapid laboratory test providing objective numbers to the surgeon.

The Washington University study did compare a group of patients receiving intraoperative PTH determinations (the device's output) to a control group that did not. This isn't an "AI assistance" scenario, but rather a direct comparison of a surgical workflow with and without the device. The "effect size" in this context could be viewed as:

• Identical physiological outcomes: 90% vs 89% normocalcemia (indicating no negative impact and equivalent success).
• Reduced frozen section use: Statistically significantly less (p<0.0001) in the study group, demonstrating a positive impact on surgical efficiency/practice.

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

Yes, the device is a standalone in vitro diagnostic assay. It measures PTH levels and provides a quantitative result. There is no "human-in-the-loop" performance in terms of interpreting algorithmic output for diagnosis in the way one would for an AI imaging device. The device itself performs the measurement, and the quantitative result is then used by the surgeon in conjunction with clinical guidelines.

7. The Type of Ground Truth Used

The ground truth used in these studies was primarily:

• Clinical outcomes/follow-up Data: Post-operative clinical cure, achievement of normocalcemia, and the efficacy of the surgery.
• Expert Consensus/Established Guidelines: The "generally accepted guideline that a 50% or greater decrease from the baseline PTH value suggests complete tumor removal."

8. The Sample Size for the Training Set

The document states that the IMMULITE/IMMULITE 1000 Turbo Intact PTH assay kit has not changed from its original FDA clearance on July 6, 1999 (K992105). This 510(k) is for demonstrating performance equivalence for a specific intraoperative use of an already cleared device.

Therefore, there isn't a "training set" in the context of developing a new algorithm or model for this 510(k) submission. The initial development and validation of the assay (which would involve a "training set" to establish its analytical characteristics like precision, linearity, etc.) would have occurred prior to its original 1999 clearance. The studies presented here are validation studies for a specific use case of an already established and cleared device.

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

Since this 510(k) pertains to a specific use of an already cleared device, the concept of a "training set" for this submission is not directly applicable.

For the original development of the IMMULITE/IMMULITE 1000 Turbo Intact PTH assay (prior to K992105), the ground truth for establishing its analytical performance (e.g., accuracy, precision, linearity) would have been established through:

• Reference Methods: Comparison to established standard methods or reference assays for measuring PTH.
• Known Concentrations: Testing samples with known, spiked concentrations of PTH.
• Clinical Correlation: Initial studies correlating assay results with clinical diagnoses and outcomes to validate its diagnostic utility.

However, these details are not provided in the given document, as it focuses on demonstrating equivalence for a new indication of use for an existing device.

Ask a specific question about this device