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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a calibrator device, not a diagnostic device that performs human-in-the-loop analysis or has complex acceptance criteria based on diagnostic performance metrics like sensitivity, specificity, or AUC. Therefore, many of the typical questions for diagnostic devices, especially those involving AI or human readers, are not applicable.

This document describes a submission for demonstrating substantial equivalence of a new calibrator (ADVIA Chemistry DRUG Calibrator II) to a previously cleared predicate calibrator (Dade Behring Dimension Drug Calibrator II). The core of the study is a comparison of characteristics between the new and predicate devices to show they are fundamentally the same for their intended use.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a diagnostic performance study. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device. The comparison table below highlights the key characteristics that were evaluated to demonstrate this equivalence. The "performance" is that these characteristics are largely identical or comparable.

Characteristic	Acceptance/Equivalence Criteria (Implicit)	Reported Device Performance (ADVIA Chemistry TDM Drug II Calibrator)
Intended Use	For in vitro diagnostic use in the calibration of specific therapeutic drug monitoring (TDM) methods on chemistry systems. (Slight variations in specific analytes calibrated are noted but overall purpose is equivalent).	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 ADVIA Chemistry systems.
Formulation/Analytes Present	Similar set of analytes for TDM, often with overlapping crucial components.	Carbamazepine, gentamicin, tobramycin, valproic acid, vancomycin.
Measured Analytes (value assigned)	Similar TDM analytes for which values are assigned.	Carbamazepine (CARB_2), Gentamicin (GENT_2), Tobramycin (TOBR_2), Valproic Acid_2 (VPA_2), Vancomycin (VANC_2).
Form	Liquid.	Liquid.
Traceability	USP standards.	USP.
Matrix	Bovine serum-based.	Bovine.
Number of Levels	Five calibrator levels.	Five.
Packaging	Ten vials: two vials at five levels (5.0 mL each).	Ten vials: two vials at five levels (5.0 mL each).
Stability	Similar shelf-life and open-vial stability.	12 months shelf-life, 30 days open vial.

2. Sample Size Used for the Test Set and the Data Provenance

This document does not describe a "test set" in the context of clinical samples or patient data being analyzed by the device. The "study" here is a comparison of the characteristics of the new calibrator against a predicate calibrator. The "data provenance" refers to the characteristics and specifications of the calibrator products themselves.

The comparison is based on the inherent properties of the calibrators (e.g., active ingredients, matrix, form, stability specifications) rather than a performance study on a specific dataset.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. There is no "test set" of clinical cases or images to establish ground truth from experts. The "ground truth" for a calibrator relates to the accuracy of the assigned values of the analytes within the calibrator, which would be established through a rigorous manufacturing and quality control process using recognized reference methods and standards (like USP Traceability mentioned).

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a submission for a calibrator device, not a diagnostic device that would involve human readers or AI assistance in interpreting results for patient cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This device is a calibrator, a component used to ensure the accuracy of other diagnostic methods (ADVIA Chemistry Systems). It does not involve algorithms or standalone performance analysis in the sense of a diagnostic test. Its performance is tied to its stability and the accuracy of its assigned values, which are verified through manufacturing and quality control.

7. The Type of Ground Truth Used

The "ground truth" for a calibrator typically refers to the certified or assigned values of the analytes within the calibrator itself. This is established through:

Reference standards: The document states "USP Traceability," indicating that the analyte concentrations are traceable to United States Pharmacopeia reference standards.
Validated analytical methods: High-precision and accurate analytical methods are used during manufacturing to determine the precise concentration of each analyte in the calibrator levels.
Quality control processes: Extensive quality control ensures that each batch of calibrators meets the specified concentration ranges.

8. The Sample Size for the Training Set

Not applicable. "Training set" is a concept for machine learning algorithms or AI, which is not relevant to a chemical calibrator device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

Summary

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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:

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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 ADVIAChemistry TDM Drug II Calibrator	Predicate Device - (formerly) DadeBehring Dimension Drug Calibrator II(DC49D)
Intended Use	For in vitro diagnostic use in thecalibration of Carbamazapine_2(CARB_2), Gentamicin_2(GENT_2), Tobramycin_2 (TOB_2),Valproic Acid_2 (VPA_2), andVancomycin_2 (VANC_2) methodson the ADVIA Chemistrysystems.	DRUG CAL II is an in vitro diagnosticproduct for the calibration of thefollowing methods packaged in theFlex reagent cartridges: acetaminophen(ACTM), carbamazepine (CRBM),digitoxin (DGTX), gentamicin(GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA),procainamide (PROC), tobramycin(TOBR), valproic acid (VALP), andvancomycin (VANC).
Formulation /analytes present	carbamazepine, gentamicin,tobramycin, valproic acid,vancomycin	acetaminophen, carbamazepine,digitoxin, gentamicin, lidocaine, N-acetylprocainamide, procainamide,tobramycin, valproic acid, andvancomycin
MeasuredAnalytes (valueassigned)	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), andvancomycin (VANC).
Form	Liquid	Liquid
Traceability	USP	USP
Matrix	Bovine	Bovine
Number ofLevels	five	five
Packaging	Ten vials: two vials at five levels (5.0mL each)	Ten vials: two vials at five levels (5.0mL each)

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Stability	12 months - shelf-life30 days open vial	12 months - shelf-life30 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).

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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

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Indication for Use

510(k) Number (if known): K090900

. इन्द्

ADVIA Chemistry DRUG Calibrator II Device Name:

Indication For Use:

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

Regulation Number and Section

§ 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.