(108 days)
Not Found
No
The 510(k) summary describes a calibrator product for in vitro diagnostic use, which is a chemical reagent used to calibrate laboratory instruments. There is no mention of AI or ML in the intended use, device description, or any other section. The device's function is purely chemical calibration, not data analysis or interpretation using AI/ML.
No.
The device is an in vitro diagnostic calibrator used for laboratory testing, not for directly treating a disease or condition in a patient.
No
The device is a calibrator for in vitro diagnostic tests, not a diagnostic device itself. Its purpose is to ensure the accuracy of other diagnostic methods.
No
The device description clearly states it is a "liquid, human serum based product containing multiple analytes" and comes in "vials," indicating it is a physical, chemical calibrator, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use in the calibration of..." This is the primary indicator that the device is intended for use outside of a living organism to diagnose or monitor a condition.
- Device Description: The description mentions it's a "human serum based product containing multiple analytes." This further supports its use in laboratory testing of biological samples.
- Calibration: The purpose of the device is to calibrate methods used on ADVIA Chemistry Systems. Calibration is a crucial step in ensuring the accuracy of diagnostic tests performed on these systems.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Chemistry DRUG Calibrator I is for in vitro diagnostic use in the calibration of Phenobarbital (PHNB_2), Phenytoin (PHNY_2), and Theophylline (THEO 2) methods on the ADVIA Chemistry Systems.
Product codes (comma separated list FDA assigned to the subject device)
JIX
Device Description
ADVIA Chemistry DRUG Calibrator I is a multi-analyte, liquid, human serum based product containing multiple analytes. The kit consists of 2 vials each of 5 calibrator levels which are ready for use (no preparation is required). The volume per vial is 3.0 mL. Phenobarbital, Phenytoin, and Theophylline are value assigned for ADVIA Chemistry systems. In addition DRUG Calibrator I also contains Lithium and Digoxin with no specific value assignment on ADVIA Chemistry systems at this time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
510(k) Summary of Safety and Effectiveness for the
ADVIA® Chemistry DRUG Calibrator I
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. 510(k) Number: K093732
B. Date of Preparation: December 03, 2009
C. Proprietary and Established Names:
MAR 2 2 2010
ADVIA® Chemistry DRUG Calibrator I
D. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591
Kira Gordon, Sr. Regulatory Affairs Specialist
Office: (914) 524-2996 Fax: (914) 524-2500
E. Regulatory Information:
ADVIA Chemistry DRUG Calibrator I
-
- Regulation section: 21 CFR § 862.1150 Calibrator.
-
- Classification: Class II
-
- Product Code: JIX, calibrator, multi-analyte mixture
-
- Panel: Clinical Chemistry
F. Predicate Device:
ADVIA Chemistry DRUG Calibrator I is substantially equivalent to the (formerly) Dade Behring Dimension Drug Calibrator (DC22B) cleared under K011035.
G. Device Description:
ADVIA Chemistry DRUG Calibrator I is a multi-analyte, liquid, human serum based product containing multiple analytes. The kit consists of 2 vials each of 5 calibrator levels which are ready for use (no preparation is required). The volume per vial is 3.0 mL. Phenobarbital, Phenytoin, and Theophylline are value assigned for ADVIA
1
Chemistry systems. In addition DRUG Calibrator I also contains Lithium and Digoxin with no specific value assignment on ADVIA Chemistry systems at this time.
H. Intended Use:
The ADVIA Chemistry DRUG Calibrator I is for in vitro diagnostic use in the calibration of Phenobarbital (PHNB_2), Phenytoin (PHNY_2), and Theophylline (THEO 2) methods on the ADVIA Chemistry Systems
I. Substantial Equivalence Information:
The ADVIA Chemistry DRUG Calibrator I and Dimension Drug Calibrator I were compared in the following table.
| Item | New Device - The ADVIA
Chemistry DRUG Calibrator I | Predicate Device - (formerly) Dade
Behring Dimension Drug Calibrator
(DC22B) |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | for in vitro diagnostic use in the
calibration of Phenobarbital_2
(PHNB_2), Phenytoin_2 (PHNY_2),
and Theophylline_2 (THEO_2)
methods on the ADVIA Chemistry
Systems . | DRUG CAL is an in vitro diagnostic
product intended to be used to calibrate
digoxin, lithium, phenobarbital,
phenytoin and theophylline methods on
the Dimension System |
| Formulation /
analytes present | Digoxin
Phenobarbital
Phenytoin
Theophylline
Lithium | Digoxin
Phenobarbital
Phenytoin
Theophylline
Lithium |
| Measured
Analytes (value
assigned) | Phenobarbital
Phenytoin
Theophylline | Digoxin
Phenobarbital
Phenytoin
Theophylline
Lithium |
| Form | Liquid | Liquid |
| Traceability | USP | USP |
| Matrix | Human Serum | Human Serum |
| Number of
Levels | five | five |
| Packaging | Ten vials: two vials at five levels (3.0
mL each) | Ten vials: two vials at five levels (3.0
mL each) |
| Stability | 18 months - shelf-life
90 days open vial | 18 months - shelf-life
90 days open vial |
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J. Conclusion:
The multi-analyte, five level, human serum based ADVIA Chemistry DRUG Calibrator I is substantially equivalent to the Dimension DRUG Calibrator. They are identical in composition and both used in calibration of TDM methods on Chemistry systems.
・
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is stylized and simplified, with only a few lines used to create its form.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Siemens Healthcare Diagnostics c/o Kira Gordon 511 Benedict Ave Tarrytown, NY 10591
K093732 Re:
Trade Name: Advia Chemistry Drug Calibrator I Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Codes: JIX Dated: February 5, 2010 Received: February 12, 2010
MAR 2 2 2010
Dear Ms. Gordon:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K093732 510(k) Number (if known):
Device Name: ADVIA® Chemistry DRUG Calibrator I
Indications For Use:
For in vitro diagnostic use in the calibration of Phenobarbital 2 (PHNB 2), Phenytoin 2 (PHNY_2), and Theophylline_2 (THEO_2) methods on the ADVIA Chemistry Systems .
Prescription Use _ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K 093732
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