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

Intended 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)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

SIEMENS HEALTHCARE DIAGNOSTICS SUSAN FERRIN REGULATORY AFFAIRS CLINICAL SPECIALIST 333 CONEY STREET E. WALPOLE, MA 02032

November 17, 2016

Re: K162538

Trade/Device Name: ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) ADVIA Centaur (IRI) Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT, JJX Dated: October 17th, 2016 Received: October 18th, 2016

Dear Ms. Ferrin:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Katherine Serrano -S

For:

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) k162538

Device Name

ADVIA Centaur® Insulin (IRI) M aster Curve Material (MCM ) ADVIA Centaur® Insulin (IRI) Calibrator

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.3333 2H2.66667C2.29848 2 2 2.29848 2 2.66667V13.3333C2 13.7015 2.29848 14 2.66667 14H13.3333C13.7015 14 14 13.7015 14 13.3333V2.66667C14 2.29848 13.7015 2 13.3333 2ZM12.6667 12.6667H3.33333V3.33333H12.6667V12.6667ZM11.3333 4H4.66667V5.33333H11.3333V4ZM11.3333 6.66667H4.66667V8H11.3333V6.66667ZM8 9.33333H4.66667V10.6667H8V9.33333Z" fill="black"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="12" stroke="black" stroke-width="2" width="12" x="2" y="2"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# SIEMENS

## 510(k) Summary

A summary of information in accordance with 21 CFR 807.92 is provided below.

| The assigned 510(k) Number | K162538 |
|----------------------------|---------|
|----------------------------|---------|

| Applicant Information<br>Mailing Address: | Siemens Healthcare Diagnostics Inc.<br>333 Coney Street<br>East Walpole, MA 02032 |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Contact Person: | Susan Ferrin |
| Phone Number:<br>Fax Number:<br>E-mail Address:<br>Date Prepared: | 508-660-4487<br>508-660-4591<br>[e-mail]<br>November 16, 2016 |

| Device Information<br>Trade/Proprietary Name | ADVIA Centaur® Insulin (IRI)<br>Master Curve Material (MCM) | ADVIA Centaur® Insulin<br>(IRI) Calibrator |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name | Assay verification material | Calibrator/normalizer |
| Regulation Section | 21 CFR 862.1660 | 21 CFR 862.1150 |
| Classification | Class I Reserved | Class II |
| Products Code | JJX – Single (Specified) Analyte<br>Controls (Assayed and Unassayed) | JIT - Calibrator, Secondary |
| Panel | Clinical Chemistry (75) | Clinical Chemistry (75) |
| Predicate | ADVIA Centaur® Insulin (IRI)<br>Master Curve Material (MCM) | ADVIA Centaur® Insulin (IRI)<br>Calibrator |
| 510(k) No. | K142864 | K021535 |
| Device Description: | ADVIA Centaur® Insulin (IRI)<br>Master Curve Material is a set of<br>ten vials of material containing<br>various levels of insulin in<br>buffered saline with casein,<br>potassium thiocyanate (3.89%),<br>sodium azide (<0.1%), and<br>preservatives. Each set contains<br>ten levels (MCM1-10); ready-to-<br>use 1.0 mL per level. MCM1<br>contains no analyte. The IRI<br>MCMs assigned values are lot-<br>specific of target values: 0.0, 2.5,<br>4.5, 10.0, 20.0, 39.0, 79.0, 158,<br>225, and 330 mU/L. | ADVIA Centaur® Insulin (IRI)<br>Calibrator is a set of four vials<br>(two vials of low calibrator<br>and two vials of high<br>calibrator) comprised of<br>buffered saline, with casein,<br>potassium thiocyanate, sodium<br>azide and preservative. Only<br>the high calibrator contains<br>insulin. |
| Intended Use and Indications<br>for Use | The ADVIA Centaur® Insulin<br>(IRI) Master Curve Material is for<br>in vitro diagnostic use in the<br>verification of calibration and<br>reportable range of the ADVIA<br>Centaur® Insulin assay. | The ADVIA Centaur® Insulin<br>(IRI) Calibrator is for in vitro<br>diagnostic use in calibrating<br>the ADVIA Centaur® systems<br>Insulin assays. |
| Special Conditions for Use<br>Statement(s) | For prescription use only | None |
| Instrument Requirements: | ADVIA Centaur® Systems<br>A description of the ADVIA<br>Centaur® system is documented in<br>K971418. Subsequent<br>modifications to the instrument<br>have been reviewed and cleared<br>in K032525 and K041133. | ADVIA Centaur® Systems<br>A description of the ADVIA<br>Centaur® system is<br>documented in K971418.<br>Subsequent modifications to<br>the instrument have been<br>reviewed and cleared in<br>K032525 and K041133. |
| Comparison of Technological<br>Characteristics: | Summarized in Table 1 below. | Summarized in Table 2 below. |

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# SIEMENS

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### Table 1: ADVIA Centaur® Insulin (IRI) Master Curve Material

| Characteristic | Candidate Device -<br>ADVIA Centaur® Insulin<br>Master Curve Material (MCM) | Cleared Device -<br>ADVIA Centaur® Insulin Master<br>Curve Material (MCM) |
|--------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same | The ADVIA Centaur® Insulin (IRI) Master Curve Material is for <i>in vitro</i> diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur Insulin assay. |
| Instrument | Same | ADVIA Centaur Systems |
| Form | Same | Liquid |
| Matrix | Same | Buffered saline with casein, postassium thiocyanate, sodium azide and preservatives |
| Ingredient | Human Insulin (porcine sourced) | Human Insulin (human sourced) |
| Number of Levels | Same | 10 |
| Target<br>Concentrations | Same | 0.0, 2.5, 4.5, 10.0, 20.0, 39.0, 79.0, 158, 225, 330 mU/L |
| Fill Volume | Same | 1.0 mL |
| Shelf Life/Stability | Same | 12 months at 2-8 degrees C |
| On board Stability | Same | 8 hours on board |

### Table 2: ADVIA Centaur® Insulin (IRI) Calibrator

| Characteristic | Candidate Device<br>ADVIA Centaur® Insulin<br>Calibrator | Predicate Device<br>ADVIA Centaur® Insulin Calibrator |
|--------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same | The ADVIA Centaur® Insulin (IRI)<br>Calibrator is for <i>in vitro</i> diagnostic use<br>in calibrating the ADVIA Centaur®<br>systems Insulin assays. |
| Instrument | Same | ADVIA Centaur Systems |
| Form | Same | Liquid |
| Matrix | Same | Buffered saline with casein, potassium<br>thiocyanate, sodium azide and<br>preservatives |
| Ingredient | Human Insulin (porcine sourced) | Human Insulin (human sourced) |
| Number of Levels | Same | 2 |
| Target<br>Concentrations | Same | Low: <0.5 mU/L<br>135 – 165 mU/L |
| Fill Volume | Same | 1.0 mL |
| Shelf Life/Stability | Same | 18 months at 2-8 degrees C |
| On board Stability | Same | 8 hours |

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# SIEMENS

### Summary of Design Control Activities

The procedure for risk management activities is based on ISO 14971 (2007), Medical Devices -Application of Risk Management to Medical Devices and the risk analysis method used to assess the impact of the device modification was a Failure Modes and Effects Analysis. The following performance characteristics of the devices were considered for potential hazards: Shelf Life (closed vial) and Shelf Life (onboard). Verification testing was conducted and results show that the modified devices meet pre-determined acceptance criteria. Additionally, a method comparison study demonstrates that human clinical sample results are equivalent with both calibrators (modified and unmodified) using different antigen sources (human and porcine). The modification does not negatively impact the performance of the devices or the safety and effectiveness of the devices.

### Conclusion

The modified ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM) and ADVIA Centaur® Insulin (IRI) Calibrator devices are substantially equivalent to the currently marketed ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM) and ADVIA Centaur® Insulin (IRI) Calibrator. Based on the testing completed and the comparisons with predicate device, the ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM) and ADVIA Centaur® Insulin (IRI) Calibrator devices do not raise any new questions on safety and effectiveness and the results support a determination of substantial equivalence.