ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator

K162538 · Siemens Healthcare Diagnostics · JIT · Nov 17, 2016 · Clinical Chemistry

Device Facts

• Record ID: K162538
• Device Name: ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Nov 17, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

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.

Device Story

ADVIA Centaur Insulin (IRI) Master Curve Material and Calibrator; used for calibration and master curve generation in insulin assays; modification involves switching insulin source from human-sourced to porcine-sourced; used in clinical laboratory settings; provides reference values for assay standardization; ensures accurate insulin measurement; supports clinical decision-making regarding insulin levels.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by design control activities and verification testing confirming performance consistency following the change in insulin source material.

Technological Characteristics

Liquid-form reagents; buffered saline matrix with casein, potassium thiocyanate, and sodium azide. MCM: 10 levels (0.0 to 330 mU/L). Calibrator: 2 levels. Antigen source: porcine-sourced human insulin. Shelf life: 12-18 months at 2-8°C; 8-hour onboard stability. Used on ADVIA Centaur systems.

Indications for Use

Indicated for use as a Master Curve Material and Calibrator for the ADVIA Centaur Insulin (IRI) assay.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• ADVIA Centaur® Insulin (IRI) Master Curve Material (k142864)
• ADVIA Centaur® Insulin (IRI) Calibrator (k021535)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER k162538

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device:
- ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM), k142864
- ADVIA Centaur® Insulin (IRI) Calibrator, k021535

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:
Modifying the source of the insulin used in ADVIA Centaur® Insulin (IRI) Master Curve Material and Insulin (IRI) Calibrator from human-sourced to porcine-sourced insulin. The corresponding labeling was also revised to include the animal source material caution statement.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and ingredients.

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.