Search Results

1. VITROS Chemistry Products CI- Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products Cl-Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

2. VITROS Chemistry Products ECO2 Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Bicarbonate/ carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.

3. VITROS Chemistry Products GLU Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products Cl- Slides, VITROS Chemistry Products ECO2 Slides, and VITROS Chemistry Products GLU Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CI-, ECO2, and GLU assays.

The provided text describes the performance evaluation of VITROS Chemistry Products Cl- Slides, ECO2 Slides, and GLU Slides on the VITROS XT 7600 Integrated System, demonstrating their substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the successful outcomes of the various performance studies (method comparison, precision, linearity, detection limits, specificity). Explicit numerical acceptance criteria are not always stated for each test result in the summary, but rather the conclusion that performance was "acceptable" or "supported the claimed measuring ranges."

Summary of VITROS XT 7600 Method Comparison Regression Analysis Data

Precision (Representative samples shown for Cl- Serum and ECO2)

The precision tables present the mean, N, SD, and %CV for Repeatability (Within Run), Within Day, Between Day, Between Calibration, and Within Lab (Total) for various fluids. The acceptance criteria are implicitly that the reported %CV and SD values are within acceptable clinical laboratory standards for these analytes, though specific numeric targets are not explicitly stated in this summary.

Detection Limits

The acceptance criterion for LoQ is explicitly mentioned: "Ortho defines LoQ as the lowest concentration with an imprecision of ≤20% and percent total allowable error < 8% for chloride (serum); imprecision of ≤5 % and percent total allowable error < 10% for chloride (urine), imprecision of ≤20% and percent total allowable error < 30% for carbon dioxide, and imprecision of _20% and total allowable error < 30% for glucose in serum, urine, and CSF." The table shows the reported LoQ values are either equal to or lower than the claimed LoQ, indicating compliance.

Specificity (Interference Testing)

• Known Interferents: Observed bias compared to predetermined Maximum Allowable Interference (MAI) or Claimed Bias. If observed bias was within MAI and/or less than Claimed Bias, performance was acceptable. If greater than Claimed Bias, compared to 95% Confidence Limit (one-sided); acceptable if Claimed Bias fell within 95% CL.
• Potential Interferents and Non-Interfering Substances: Observed bias compared to MAI. Acceptable if within MAI. If greater than MAI, compared to 95% Confidence Limit (two-sided); acceptable if Claimed Bias fell within 95% CL.
• Performance: Results demonstrated "acceptable bias" for existing claimed interferents and led to updates in the Instructions For Use (IFU) for newly identified interferents (110 mmol/L Cl- with 4 mg/dL 4-Aminosalicylate on Cl- MicroSlides, and Triglyceride on Cl- MicroSlides).

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

• Method Comparison:
  • Test Set Size: Minimum of 125 human serum samples for chloride, carbon dioxide, and glucose. 125 human urine samples for chloride. 125 human urine samples and 125 human CSF samples for glucose.
  • Data Provenance: "human serum samples," "human urine samples," "human CSF samples" - indicating human origin, but specific countries are not mentioned. The studies appear to be prospective for the purpose of device validation.
• Precision:
  • Test Set Size: Minimum of two Quality Control fluids and three human-based precision fluids for chloride, carbon dioxide, and glucose assays. Each specimen was tested for 80 runs (20 days, 2 runs/day, 2 replicates/specimen).
  • Data Provenance: "human based precision fluids."
• Linearity:
  • Test Set Size: A series of eleven proportionally related admixtures of low and high test fluids. Each sample tested in triplicate (with a minimum of two replicates acceptable for analysis).
  • Data Provenance: Test fluids (specific origin not detailed).
• Detection Limits (LoB, LoD, LoQ):
  • LoB: 4 blank samples tested in replicates of 6 over 3 days, using 3 lots of reagents (4 samples per day). Total of 216 observations (72 results per reagent lot).
  • LoD: 4 pools of human samples tested in replicates of 6 over 3 days, using 3 lots of reagents (4 human sample pools per day). Total of 216 observations (72 results per reagent lot).
  • LoQ: 4 pools of low-level samples tested in replicates of 4 over 3 days, using 3 lots of reagents (4 samples per day). Total of 144 observations (48 results per reagent lot).
  • Data Provenance: "blank samples" and "human samples."
• Specificity (Interference Testing):
  • Test Set Size: Not explicitly stated as a single number, but involved testing with known chemical interferents, common chemical substances, and "paireddifference" assessment at a minimum of two analyte levels.
  • Data Provenance: Not explicitly stated, but implies laboratory-prepared samples with interferents.

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

This document describes in-vitro diagnostic devices for quantitative measurements. The "ground truth" here is typically established by reference methods or predicate devices and certified reference materials, not by human expert consensus or pathology review in the same way an AI imaging device would.

The studies compared the new device (VITROS XT 7600 Integrated System) against a predicate device (VITROS 5600 Integrated System), which is considered the "ground truth" or reference for establishing substantial equivalence in this context. The qualifications of personnel operating these systems or interpreting the raw data are not specified in this summary.

4. Adjudication Method for the Test Set

Not applicable in the context of quantitative IVD assays where results are numerical and compared against reference methods or predicate devices, rather than human expert interpretations. The comparisons described are statistical (e.g., Passing Bablok, Deming regression).

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 document is for in-vitro diagnostic devices (chemistry analyzers) that produce quantitative readings, not interpretative imaging or diagnostic aids that involve human "readers" or "AI assistance" in the sense of a decision support system.

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

Yes, the studies described are standalone performance evaluations of the VITROS XT 7600 Integrated System with the new VITROS Chemistry Products Slides. The system generates quantitative results without human interpretative input beyond operating the device and reviewing the numerical output. The "algorithm" here refers to the underlying chemical reactions and detection methods of the device itself.

7. The Type of Ground Truth Used

The ground truth for these studies was primarily established by:

• Predicate Device Comparison: The VITROS 5600 Integrated System served as the reference for method comparison studies.
• Reference Materials/Controls: Precision studies used quality control fluids and human-based precision fluids. Linearity used low and high test fluids. Detection limits used blank samples, human samples, and low-level samples. These are assumed to have known or established values.
• Statistical Guidelines: Adherence to CLSI guidelines (e.g., EP05-A3, EP06-A, EP17-A2, EP07-A2) implies the use of accepted methodologies for establishing performance characteristics.

8. The Sample Size for the Training Set

Not explicitly mentioned in terms of a "training set" as this is a traditional IVD device, not an AI/machine learning algorithm requiring a separate training phase. The analytical validation studies described (method comparison, precision, linearity, detection limits, specificity) serve to characterize the device's performance across its operational range, similar to a "test set" for validating generalizability.

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

Not applicable, as a discrete "training set" for an AI algorithm is not described. The ground truth for the validation studies was established by comparison to the predicate device and the use of characterized control materials and human samples as detailed in point 7.

Ask a specific question about this device