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For in vitro diagnostic use only.

For the quantitative measurement of CK-MB in human serum and plasma (EDTA or heparin) using the VITROS 3600 Immunodiagnostic System.

Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The VITROS Immunodiagnostic Products CK-MB assay is performed using the VITROS CK-MB Reagent Pack and the VITROS CK-MB Calibrators on the VITROS Systems.

The current VITROS Immunodiagnostic Products CK-MB assay is susceptible to interference from biotin. Ortho has made a modification to the manufacturing process to allow the biotinylated antibody capture conjugate to be pre-bound to the well, thus mitigating the risk of biotin interference.
The modified product utilizes all the same antibodies and raw materials with the exception of the addition of 0.7% Tween 20 and an increase in EDTA concentration from 0.001M to 0.030M, both of these modifications are to improve serum/plasma agreement which required a conversion factor in the previously cleared product.

An immunometric immunoassay technique is used, which involves the reaction of CK-MB present in the sample with a microwell coated with biotinylated Antibody (Mouse monoclonal anti-CK-BB bound to Streptavidin), and a Horseradish Peroxidase (HRP)-labeled antibody conjugate (Mouse monoclonal anti-CK-MB). Unbound (HRP)-labeled anti-CK-MB antibody conjugate is removed by washing.

The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of CK-MB conjugate bound is directly proportional to the concentration of CK-MB present in the sample.

The provided document describes the 510(k) premarket notification for the VITROS Immunodiagnostic Products CK-MB Reagent Pack. This is an in vitro diagnostic device, not an AI/ML-based medical device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., number of experts for ground truth, adjudication methods, MRMC studies, sample sizes for training sets) are not applicable to this document.

The document focuses on demonstrating the substantial equivalence of a modified CK-MB assay to a legally marketed predicate device, primarily through non-clinical performance studies.

Here's an analysis based on the provided text, addressing the applicable criteria for an in vitro diagnostic device:

1. Table of Acceptance Criteria and Reported Device Performance

For an in vitro diagnostic device like this, acceptance criteria typically revolve around analytical performance characteristics such as precision, linearity, detection limits, and method comparison to a predicate. The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold, but rather presents the results of various validation studies.

• Cefoxitin (at 521 mg/dL): -27.7% bias at 3.00 ng/mL CK-MB
• Dextran 40 (at 2400 mg/dL): -15.0% bias at 3.00 ng/mL CK-MB; -44.9% bias at 50.0 ng/mL CK-MB |
  | Cross-Reactivity | Minimal or no cross-reactivity with structurally similar substances. | CK-BB (50 µg/dL): Not Detectable
  CK-MM (4 mg/dL): Not Detectable |
  | Method Comparison to Predicate Device (Accuracy) | Strong correlation and minimal bias compared to the predicate device, with slope close to 1 and intercept close to 0. | System (3600 vs. Comparative Method):
• n: 149 patient samples
• Slope: 0.99 (95% CI: 0.9812 to 0.9950)
• Correlation Coefficient: 0.999
• Intercept: 0.112 ng/mL (95% CI: 0.05080 to 0.1723) |
  | High Dose Hook Effect | No significant hook effect within relevant supraphysiological concentrations. | No high dose hook effect up to 44,200 ng/mL (µg/L). |

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

• Precision:
  • Sample Size: 80 observations (likely meaning replicates across runs and days, as per CLSI EP05 methodology) for each of 4 patient pools.
  • Data Provenance: Not explicitly stated, but typically from internal lab testing.
• Limit of Detection/Quantitation: Not explicitly stated, but derived from experiments consistent with CLSI document EP17.
• Analytical Specificity (Interference) & Cross-Reactivity: Not explicitly stated, but involves testing at specific concentrations of CK-MB and interferents.
• Method Comparison to Predicate Device:
  • Sample Size: 149 patient (serum) samples.
  • Data Provenance: Not explicitly stated regarding country of origin, but described as "patient (serum) samples," implying collected clinical samples. The study is an analytical/non-clinical study, not a clinical trial, so it's prospective in the sense of testing the new device on these samples.

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

• Not Applicable. This is an in vitro diagnostic device measuring a biomarker concentration. The "ground truth" for method comparison is the measurement obtained by the predicate device and the analytical properties of the reference materials. Expertise is in laboratory medicine and analytical chemistry, not interpretation of images for diagnosis by human experts.

4. Adjudication Method for the Test Set

• Not Applicable. As above, no human expert adjudication is involved in establishing the "ground truth" for quantitative assay validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI/ML device, nor does it involve human readers interpreting images.

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

• Not Applicable. While the device operates standalone (human performs the test, the system provides a result), the concept of an "algorithm only" performance study typically refers to AI/ML models. For an IVD, the "standalone performance" is exactly what is described in the precision, linearity, and detection limit sections.

7. The Type of Ground Truth Used

• For precision, linearity, and detection limits: Analyte concentrations of reference materials or patient pools. The "truth" is established by highly controlled laboratory methods.
• For method comparison: Results obtained from the legally marketed predicate device (VITROS Immunodiagnostic CK-MB Reagent Pack, K993068). The predicate serves as the "true" or gold standard against which the modified device is compared. This is a common "ground truth" for demonstrating substantial equivalence for IVDs. While not explicitly stated, these predicate measurements would have been established through a similar robust validation process.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set" in the sense of machine learning. The device's performance characteristics are inherent to its chemical and biological components and manufacturing process, validated through the non-clinical studies detailed.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The device development involved standard IVD R&D and manufacturing, not machine learning training.

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VITROS CK-MB Reagent Pack - Creatine phosphokinase/creatine kinase or isoenzymes test systems is a device intended to measure the enzyme creatine phosphokinase or its isoenzymes in serum and plasma in the diagnosis and treatment of myocardial infarction.
VITROS CK-MB Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CK-MB in human serum and plasma.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:

1. The VITROS Immunodiagnostic Products range of immunoassay products (in this case VITROS Immunodiagnostic Products CK-MB Reagent Pack, VITROS Immunodiagnostic Products CK-MB Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS CK-MB assay, and VITROS Immunodiagnostic Products High Sample Diluent B).
2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits.
3. Common reagents used by the VITROS System in each assay.
   The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided text describes a 510(k) summary for the VITROS CK-MB assay but it does not contain the specific details about acceptance criteria, detailed performance metrics, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, or MRMC studies that would allow for a complete response to all aspects of your request. It mainly focuses on demonstrating substantial equivalence to a predicate device.

However, I can extract the information that is present:

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

The document does not explicitly present a table of "acceptance criteria" with quantitative targets and a "reported device performance" against those targets in the format requested. Instead, it describes characteristics of the new device and compares them to the predicate device to demonstrate substantial equivalence. The overall conclusion is that the performance is "substantially equivalent."

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

The document states: "Equivalence was demonstrated using currently commercially available reagents along with patient samples covering a variety of clinical categories." However, it does not specify the sample size used for the test set, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the 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)

This is an in-vitro diagnostic (IVD) device, specifically an immunoassay for measuring CK-MB. The "ground truth" for such devices is typically established through reference methods or quantitative chemical analysis, not by human expert interpretation of images or clinical data in the same way as, for example, a radiology AI device. Therefore, the concept of "experts used to establish ground truth" with their qualifications is not applicable in this context.

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

Not applicable for an in-vitro diagnostic immunoassay. The evaluation relies on quantitative measurements against reference standards, not on human adjudication of ambiguous cases.

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

Not applicable. This is an immunoassay, not an AI or imaging device that assists human readers.

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

This refers to the performance of the immunoassay itself in producing quantitative measurements of CK-MB. The entire submission describes the standalone performance of this diagnostic assay. The device is intended for in vitro quantitative measurement and operates without a human-in-the-loop directly influencing the measurement result once the sample is processed.

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

For an immunoassay like the VITROS CK-MB assay, the "ground truth" is typically established by:

• Reference methods: Highly accurate and precise analytical methods.
• Known concentrations: Samples with precisely known concentrations of the analyte (CK-MB) through gravimetric preparation or using certified reference materials.
• Clinical correlation: While not technically "ground truth" for the measurement itself, the clinical utility of the measurement (i.e., its correlation with myocardial infarction) is a broader context.

The document states that equivalence was demonstrated using "patient samples covering a variety of clinical categories," implying that the measurements from the new device were compared to those from the predicate device on these samples, with the predicate device's results serving as the de facto reference for demonstrating equivalence in clinical performance.

8. The sample size for the training set

This document describes a 510(k) submission for an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable here.

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

As explained above, the concept of a "training set" is not applicable for this type of device.

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