Search Results

The STA® - Hybrid Hep Calibrator is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity using the chromogenic method, STA® - Rotachrom® Heparin.

The STA® Hybrid Hep Calibrator is a set of lyophilized human plasmas used to create the calibration curve on the STA® line of IVD instruments performing the chromogenic method for heparin (UFH and LMWH) assays. Each STA® Hybrid Hep Calibrator available contains: 4 x 1-ml vials of Reagent 1: STA® Hybrid Hep Calibrator O lyophilized human plasma free of heparin. 4 x 1-ml vials of Reagent 2: STA® Hybrid Hep Calibrator 3 lyophilized human plasma containing a well-defined quantity of UFH. 4 x 1-ml vials of Reagent 3: STA® Hybrid Hep Calibrator 6 lyophilized human plasma containing a well-defined quantity of UFH that is greater than that of Reagent 2. 4 x 1-ml vials of Reagent 4: STA® - Hybrid Hep Calibrator 9 lyophilized human plasma containing a well-defined quantity of LMWH. 4 x 1-ml vials of Reagent 5: STA® Hybrid Hep Calibrator 18 lyophilized human plasma containing a well-defined quantity of LMWH that is greater than that of Reagent 4.

The provided text describes a 510(k) summary for the STA® - Hybrid Hep Calibrator, a medical device. This submission seeks to bundle two previously cleared devices (STA® - Hepanorm® H and STA® - Calibrator HBPM/LMWH Kit) into a single kit. The document focuses on demonstrating substantial equivalence to these predicate devices for regulatory purposes.

Therefore, the document does not contain information about:

• Specific acceptance criteria for device performance (e.g., accuracy, precision) as typically defined in a clinical study.
• A formal study that proves the device meets specific acceptance criteria in terms of measured performance metrics.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone performance, or grand truth types.
• Training set sample sizes or how their ground truth was established, as this is a calibrator device and not an AI/ML diagnostic system.

The document states that the STA® - Hybrid Hep Calibrator and its predicate devices are "identical products regarding indication/intended use, formulation or materials of construction and design, technology, and safety." The primary difference is the bundling of two existing calibrators into one kit. The substantial equivalence argument relies on the fact that no new questions of safety, effectiveness, or technology are raised due to this bundling.

Essentially, the "study" proving the device meets acceptance criteria is implied by its substantial equivalence to previously cleared devices. The acceptance criteria, in this regulatory context, are primarily that the bundled calibrator performs equivalently to the two separate predicate calibrators, which have already been deemed safe and effective.

Summary of available information related to device performance and regulatory acceptance:

Information not available in the provided text:

• Sample sized used for the test set and the data provenance: Not applicable in this context as this is a calibrator, not a diagnostic algorithm. Performance is assessed through equivalence to existing calibrators.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a calibrator device, not an algorithm.
• The type of ground truth used: For calibrators, ground truth typically refers to the accurately assigned values of the analytes (UFH and LMWH in this case) within the calibrator plasmas. The text states the plasmas contain "well-defined quantity of UFH" and "well-defined quantity of LMWH", implying these values are established and verified during manufacturing of the calibrator materials.
• The sample size for the training set: Not applicable as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device