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510(k) Data Aggregation
(29 days)
LOCI Cardiac Troponin-I Control (low), LCTNI CON L LCTNI CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical blas in the quantitative determination of cardiac troponin-l (CTNVTNI) on the Dimension Vista® System and Dimension® EXL ™ integrated chemistry system with LOCI® module.
LOCI Cardiac Troponin-I Control (medium), LCTNI CON M LCTNI CON M is an assayed, mid level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-l (CTNI/TNI) on the Dimension Vista@ System and Dimension® EXL ™ integrated chemistry system with LOCI® module.
LOCI Cardiac Troponin-I Control (high), LCTNI CON H LCTNI CON H is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias in the quantitative determination of cardiac troponin-l (CTNI/TNI) on the Dimension Vista® System and Dimension® EXL ™ integrated chemistry system with LOCI® module.
LOCI Cardlac Troponin-I Control (low), LCTNI: CON L LCTNI CON L is a liquid, frozen, low level, human serum based product containing native human cardiac troponin complex. LCTNI CON L is packaged as 12 vials containing 2.2 mL quality control material per vial.
LOCI Cardiac Troponin-I Control (medium), LCTNI CON M LCTNI CON M is a liquid, frozen, mid level, human serum based product containing native human cardlac troponin complex. LCTNI CON M is packaged as 12 vials containing 2.2 mL quality control material per vial.
LOCI Cardiac Troponin-I Control (high), LCTNI CON H LCTNI CON H is a liguid, frozen, high level, human serum based product containing native human cardlac troponin complex. LCTNI CON H is packaged as 12 vials containing 2.2 mL quality control material per vial.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LOCI Cardiac Troponin-I Control (Low, Medium, and High) devices:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a medical device, specifically a quality control material. For such devices, "acceptance criteria" and "device performance" are typically related to the validation of their features rather than diagnostic accuracy metrics like sensitivity or specificity.
| Feature Assessed | Acceptance Criteria (Implicit from validation) | Reported Device Performance (as stated) |
|---|---|---|
| Traceability | (Implied: Demonstrated adherence to established reference materials/methods) | "The traceability... of the LOCI Cardiac Troponin-I Control L, M and H have been validated following procedures of Siemens Healthcare Diagnostics, Inc." |
| Value Assignment | (Implied: Accurate determination of target values for each control level) | "The... value assignment... of the LOCI Cardiac Troponin-I Control L, M and H have been validated following procedures of Siemens Healthcare Diagnostics, Inc." |
| Stability | (Implied: Maintenance of control integrity over time and under specific conditions) | "The... stability... of the LOCI Cardiac Troponin-I Control L, M and H have been validated following procedures of Siemens Healthcare Diagnostics, Inc." |
| Matrix Effects | (Implied: Minimal interference from the control material's composition with the assay) | "The... matrix effects of the LOCI Cardiac Troponin-I Control L, M and H have been validated following procedures of Siemens Healthcare Diagnostics, Inc." |
| Substantial Equivalence | (Implied: Similar intended use and fundamental scientific technology to predicate device) | "LOCI Cardiac Troponin-I Control (low), LOCI Cardiac Troponin-I Control (medium) and LOCI Cardiac Troponin-I Control (high) are substantially equivalent in design and intended use to the previously cleared Abbott ARCHITECT STAT Troponin-I Controls (K041194)." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the traditional sense of a dataset used for evaluating a predictive algorithm. This device is a quality control material, not a diagnostic algorithm. Therefore, there's no mention of a separate test set, data provenance, or country of origin in this context. The "validation" mentioned likely refers to internal testing of the control material's characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As a quality control material, "ground truth" here refers to the assigned values and validated characteristics of the control itself, established through internal company procedures, not through expert consensus on a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no test set or adjudication process described for this type of device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. An MRMC comparative effectiveness study is designed to evaluate the performance of human readers, sometimes with AI assistance, on diagnostic tasks. This device is a quality control material and does not involve human readers for diagnostic interpretation.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a quality control material and not a standalone algorithm. Its purpose is to assess the precision and analytical bias of an existing diagnostic system (Dimension Vista® System and Dimension® EXL™ integrated chemistry system with LOCI® module).
7. The Type of Ground Truth Used
The "ground truth" for this quality control material would be its reference values and validated characteristics (traceability, value assignment, stability, matrix effects). These are established through scientific and analytical procedures by the manufacturer, Siemens Healthcare Diagnostics, Inc., not necessarily through pathology, outcomes data, or expert consensus in the diagnostic sense.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device. The characteristics of the control material are established through internal validation procedures as referenced in the document.
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