(66 days)
No
The device description and performance studies focus on chemical composition and analytical performance of calibrators and control materials for an immunoassay, with no mention of AI/ML algorithms for data analysis or interpretation.
No
The device is described as being for "in vitro diagnostic use" for the verification of calibration and reportable range of an insulin assay, and for calibrating insulin assays. It does not treat or diagnose disease, rather it helps ensure the accuracy of other diagnostic devices.
No
The device is a calibrator/master curve material used for verifying and calibrating in vitro diagnostic assays, not for diagnosing patients directly.
No
The device description clearly indicates that the device is a set of physical vials containing materials for in vitro diagnostic use, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "The ADVIA Centaur® Insulin (IRI) Master Curve Material (MCM) is for in vitro diagnostic use..."
- "The ADVIA Centaur® Insulin (IRI) Calibrator is for in vitro diagnostic use..."
This clearly indicates that the device is intended to be used outside of the body to examine specimens for diagnostic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JIT, JJX
Device Description
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 (
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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
1
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
Mailing Address: | Siemens Healthcare Diagnostics Inc.
333 Coney Street
East Walpole, MA 02032 |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Contact Person: | Susan Ferrin |
| Phone Number:
Fax Number:
E-mail Address:
Date Prepared: | 508-660-4487
508-660-4591
susan.ferrin@siemens.com
November 16, 2016 |
| Device Information
Trade/Proprietary Name | ADVIA Centaur® Insulin (IRI)
Master Curve Material (MCM) | ADVIA Centaur® Insulin
(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
Controls (Assayed and Unassayed) | JIT - Calibrator, Secondary |
| Panel | Clinical Chemistry (75) | Clinical Chemistry (75) |
| Predicate | ADVIA Centaur® Insulin (IRI)
Master Curve Material (MCM) | ADVIA Centaur® Insulin (IRI)
Calibrator |
| 510(k) No. | K142864 | K021535 |
| Device Description: | 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 (in vitro 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
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
ADVIA Centaur® Insulin
Calibrator | Predicate Device
ADVIA Centaur® Insulin Calibrator |
|--------------------------|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same | The ADVIA Centaur® Insulin (IRI)
Calibrator is for in vitro diagnostic use
in calibrating the ADVIA Centaur®
systems Insulin assays. |
| Instrument | Same | ADVIA Centaur Systems |
| Form | Same | Liquid |
| Matrix | Same | Buffered saline with casein, potassium
thiocyanate, sodium azide and
preservatives |
| Ingredient | Human Insulin (porcine sourced) | Human Insulin (human sourced) |
| Number of Levels | Same | 2 |
| Target
Concentrations | Same | Low: