(61 days)
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No
The document describes a chemical calibrator for laboratory tests, with no mention of AI or ML technology.
No
This device is an in vitro diagnostic (IVD) calibrator, used to calibrate methods for measuring drug levels in patient samples. It does not directly treat or diagnose a disease or condition in a living organism.
No
This device is a calibrator, used to calibrate methods on diagnostic systems. It is not an imaging device that directly diagnoses disease.
No
The device description clearly states it is a "liquid, bovine serum based product containing multiple analytes" and comes in "vials," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "The ADVIA Chemistry TDM DRUG Calibrator II is for in vitro diagnostic use..." This is the most direct indicator.
- Function: The device is a calibrator used to calibrate methods for measuring specific drugs (Carbamazepine, Gentamicin, Tobramycin, Valproic Acid, and Vancomycin) on a chemistry system. These measurements are performed on biological samples (like serum, as indicated by the "bovine serum based product" in the description) outside of the body, which is the definition of in vitro.
- Context: The device is used in conjunction with methods on "ADVIA Chemistry Systems," which are laboratory instruments used for diagnostic testing.
Therefore, based on the provided information, the ADVIA Chemistry TDM DRUG Calibrator II is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA Chemistry TDM DRUG Calibrator II is for in vitro diagnostic use in the calibration of Carbamazepine 2 (CARB_2), Gentamicin_2 (GENT_2), Tobramycin_2 (TOBR_2), Valproic Acid_2 (VPA_2), and Vancomycin_2 (VANC_2) methods on the ADVIA Chemistry Systems.
Product codes
DKB
Device Description
ADVIA Chemistry TDM DRUG Calibrator II is a multi-analyte, liquid, bovine serum based product containing multiple analytes. The kit consists of 2 vials of each of 5 calibrator levels which are ready for use (no preparation is required). The volume per vial is 5.0 mL. Tobramycin, Carbamazepine, Valproic Acic, Vancomycin and Gentamicin analytes are value assigned for ADVIA Chemsitry systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology 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. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (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.
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510(k) Summary of Safety and Effectiveness for the
ADVIA® Chemistry DRUG Calibrator II
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: K090900
B. Date of Preparation: December 22, 2008
C. Proprietary and Established Names:
ADVIA® Chemistry DRUG Calibrator II
D. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591
Kira Gordon. Sr. Regulatory Affairs Specialist
Fax: (914) 524-2500 Office: (914) 524-2996
E. Regulatory Information:
ADVIA Chemistry DRUG Calibrator II
-
Regulation section: 21 CFR § 862.3200 Clinical Toxicology Calibrator.
-
Classification: Class II
-
Product Code: DKB, calibrators, drug mixture
-
Panel: Toxicology
F. Predicate Device:
ADVIA Chemistry TDM DRUG Calibrator II is substantially equivalent to the (formerly) Dade Behring Dimension Drug Calibrator II (DRUG CAL II - DC49D) cleared under K033809.
G. Device Description:
ADVIA Chemistry TDM DRUG Calibrator II is a multi-analyte, liquid, bovine serum based product containing multiple analytes. The kit consists of 2 vials of each of 5 calibrator levels which are ready for use (no preparation is required). The volume per
1
vial is 5.0 mL. Tobramycin, Carbamazepine, Valproic Acic, Vancomycin and Gentamicin analytes are value assigned for ADVIA Chemsitry systems.
H. Intended Use:
The ADVIA Chemistry TDM DRUG Calibrator II is for in vitro diagnostic use in the calibration of Carbamazepine 2 (CARB 2), Gentamicin 2 (GENT 2), Tobramycin_2 (TOBR_2), Valproic Acid_2 (VPA_2), and Vancomycin_2 (VANC_2) methods on the ADVIA Chemistry Systems
I. Substantial Equivalence Information:
The ADVIA Chemistry TDM Drug Calibrator II and Dimension Drug Calibrator II were compared in the following table.
| Item | New Device - The ADVIA
Chemistry TDM Drug II Calibrator | Predicate Device - (formerly) Dade
Behring Dimension Drug Calibrator II
(DC49D) |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For in vitro diagnostic use in the
calibration of Carbamazapine_2
(CARB_2), Gentamicin_2
(GENT_2), Tobramycin_2 (TOB_2),
Valproic Acid_2 (VPA_2), and
Vancomycin_2 (VANC_2) methods
on the ADVIA Chemistry
systems. | DRUG CAL II is an in vitro diagnostic
product for the calibration of the
following methods packaged in the
Flex reagent cartridges: acetaminophen
(ACTM), carbamazepine (CRBM),
digitoxin (DGTX), gentamicin
(GENT), lidocaine (LIDO), N-
acetylprocainamide (NAPA),
procainamide (PROC), tobramycin
(TOBR), valproic acid (VALP), and
vancomycin (VANC). |
| Formulation /
analytes present | carbamazepine, gentamicin,
tobramycin, valproic acid,
vancomycin | acetaminophen, carbamazepine,
digitoxin, gentamicin, lidocaine, N-
acetylprocainamide, procainamide,
tobramycin, valproic acid, and
vancomycin |
| Measured
Analytes (value
assigned) | Carbamazepine (CARB_2),
Gentamicin (GENT_2), Tobramycin
(TOBR_2), Valproic Acid_2
(VPA_2), Vancomycin (VANC_2) | acetaminophen (ACTM),
carbamazepine (CRBM), digitoxin
(DGTX), gentamicin (GENT),
lidocaine (LIDO), N-
acetylprocainamide (NAPA),
procainamide (PROC), tobramycin
(TOBR), valproic acid (VALP), and
vancomycin (VANC). |
| Form | Liquid | Liquid |
| Traceability | USP | USP |
| Matrix | Bovine | Bovine |
| Number of
Levels | five | five |
| Packaging | Ten vials: two vials at five levels (5.0
mL each) | Ten vials: two vials at five levels (5.0
mL each) |
2
| Stability | 12 months - shelf-life
30 days open vial | 12 months - shelf-life
30 days open vial |
| ----------- | --------------------------------------------- | --------------------------------------------- |
|---|
J. Conclusion:
The multianalyte, five level, bovine serum base ADVIA Chemistry TDM DRUG Calibrator II is substantially equivalent to the Dimension DRUG Calibrator II. They are identical in composition and both used in calibration of TDM on Chemistry systems.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" around the perimeter. Inside the circle is an eagle with a caduceus, a symbol of medicine, entwined around its wing.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics, Inc. c/o Dr. Kira Gordon 511 Benedict Ave Tarrytown, NY 10591
JUN - 1 2009
Re: K090900
Trade Name: ADVIA Chemistry DRUG Calibrator II Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Codes: DKB Dated: March 31, 2009 Received: April 1, 2009
Dear Dr. 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).
4
Paqe - 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/,
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
$\mathcal{A}$ C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K090900
. इन्द्
ADVIA Chemistry DRUG Calibrator II Device Name:
Indication For Use:
The ADVIA Chemistry TDM DRUG Calibrator II is for in vitro diagnostic use in the calibration of Carbamazepine 2 (CARB_2), Gentamicin_2 (GENT_2), Tobramycin_2 (TOBR 2), Valproic Acid 2 (VPA 2), and Vancomycin 2 (VANC 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 (OIVD)
Keeley Erff
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090900