(112 days)
The i-STAT Cardiac Markers Controls are an assayed liquid serum used to verify the integrity of newly received i-STAT cTnl cartridges.
The i-STAT Cardiac Markers Calibration Verification Controls are an assayed liquid serum used to verify the calibration of i-STAT cTnl cartridges throughout the reportable range.
The i-STAT Cardiac Markers Controls are supplied in three levels packaged as six vials of one level per box, with each vial containing 1 mL of control material. The three levels are each comprised of a different level of cardiac Troponin I, human creatinine kinase -- MB isoform CK-MB, and myoqlobin (all native forms) derived from human cardiac material, prepared in human serum, and preserved with sodium azide to inhibit microbial growth. The CK-MB and myoglobin are unassayed components in these materials. Only the cardiac troponin I (cTnl) values will be provided in the value assignment sheets for these products.
The Cardiac Markers Calibration Control Set is packaged as a tri-level set, comprised of two vials of each of three levels per box.
The acceptance criteria and study details for the i-STAT Cardiac Markers Control devices are described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Within-level vial imprecision for all three levels of cardiac markers controls | Ranged from 1.9% to 5.7% |
| Stability after thawing (4 hours at 2 to 8°C) | All three levels meet the claim of 4 hours' stability |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document specifies "testing three lots of each control level" for the within-level vial imprecision study. The exact number of individual samples (vials) per lot is not provided.
- Data Provenance: Not explicitly stated, but given the context of a 510(k) submission, the data would typically be generated in-house by i-STAT Corporation (the manufacturer) in the United States, and would be prospective in nature, as it's a validation study for a new device.
3. Number of Experts and Qualifications
Not applicable. This device is a quality control material, not a diagnostic device requiring expert interpretation of images or patient data.
4. Adjudication Method
Not applicable for this type of device and study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a quality control material, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was performed. The data presented ("within-level vial imprecision" and "stability after thawing") represents the intrinsic performance of the control material itself, without human interpretation in the workflow.
7. Type of Ground Truth Used
The ground truth for this device is based on the inherent biochemical properties of the control material (cardiac Troponin I, CK-MB, and myoglobin), prepared in human serum, and preserved. The "assayed" components (cTnI) would have their values established through validated reference methods.
8. Sample Size for the Training Set
Not applicable. This device is a quality control material, not an AI algorithm that requires a training set. The performance studies are validation studies for the control material itself.
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 "ground truth" for the control material's values (specifically for the assayed cTnI) would be established through a rigorous value assignment protocol using reference methods and multiple measurements, typically by the manufacturer.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.