(66 days)
The ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur® Insuin assay.
The ADVIA Centaur® Insulin (IRI) Calibrator is for in vitro diagnostic use in calibrating the ADVIA Centaur® systems Insulin assays.
ADVIA Centaur® Insulin (IRI) Master Curve Material is a set of ten vials of material containing various levels of insulin in buffered saline with casein, potassium thiocyanate (3.89%), sodium azide (
The provided text describes modifications to the "ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM)" and "ADVIA Centaur® Insulin (IRI) Calibrator" and outlines the studies conducted to demonstrate their substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and the study information, extracting what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria in a table format with corresponding performance metrics for the modified devices. Instead, it states that "Verification testing was conducted and results show that the modified devices meet pre-determined acceptance criteria." and that a "method comparison study demonstrates that human clinical sample results are equivalent with both calibrators (modified and unmodified)."
However, based on the context, the implicit acceptance criteria and reported performance would be:
| Acceptance Criteria Category | Implicit Acceptance Criteria (based on "same" characteristics and equivalence claims) | Reported Device Performance (based on "same" characteristics and equivalence claims) |
|---|---|---|
| ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM) | ||
| Intended Use | Same as predicate | Same as predicate |
| Instrument | Same as predicate (ADVIA Centaur Systems) | Same as predicate (ADVIA Centaur Systems) |
| Form | Same as predicate (Liquid) | Same as predicate (Liquid) |
| Matrix | Same as predicate (Buffered saline with casein, potassium thiocyanate, sodium azide and preservatives) | Same as predicate (Buffered saline with casein, potassium thiocyanate, sodium azide and preservatives) |
| Number of Levels | Same as predicate (10) | Same as predicate (10) |
| Target Concentrations | Same as predicate (0.0, 2.5, 4.5, 10.0, 20.0, 39.0, 79.0, 158, 225, 330 mU/L) | Same as predicate (0.0, 2.5, 4.5, 10.0, 20.0, 39.0, 79.0, 158, 225, 330 mU/L) |
| Fill Volume | Same as predicate (1.0 mL) | Same as predicate (1.0 mL) |
| Shelf Life/Stability | Same as predicate (12 months at 2-8 degrees C) | Same as predicate (12 months at 2-8 degrees C) |
| On board Stability | Same as predicate (8 hours on board) | Same as predicate (8 hours on board) |
| ADVIA Centaur® Insulin (IRI) Calibrator | ||
| Intended Use | Same as predicate | Same as predicate |
| Instrument | Same as predicate (ADVIA Centaur Systems) | Same as predicate (ADVIA Centaur Systems) |
| Form | Same as predicate (Liquid) | Same as predicate (Liquid) |
| Matrix | Same as predicate (Buffered saline with casein, potassium thiocyanate, sodium azide and preservatives) | Same as predicate (Buffered saline with casein, potassium thiocyanate, sodium azide and preservatives) |
| Number of Levels | Same as predicate (2) | Same as predicate (2) |
| Target Concentrations | Same as predicate (Low: |
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.