The Dade Behring Dimension® Drug Calibrator II is a device intended for medical purposes for use on the Dade Behring Dimension® clinical chemistry system to establish points of reference that are used in determination of values in the measurement of substances in human specimens. The product is intended for the calibration of the following methods packaged in Dimension® Flex® reagent cartridges: Acetaminophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) N-acetylprocainamide (NAPA) Procainamide (PROC) Tobramycin (TOBR) Valproic acid (VALP) Vancomycin (VANC)

Device Description

The Dimension® Drug Calibrator II is a liquid, bovine serum base product. It is packaged as ten vials, two vials at each of five levels. Each vial contains 5.0 mL.

AI/ML Overview

The provided document is a 510(k) summary for the Dade Behring Dimension® Drug Calibrator II (DC49C). It focuses on establishing substantial equivalence to a predicate device (DC49B) rather than a study proving the device meets specific acceptance criteria in the traditional sense of a diagnostic test for disease.

Here's an analysis based on the information provided, explaining why some of your requested information is not applicable to this type of submission:

This submission is for a calibrator, which is a reference material used to set the scale of a measurement. It is not a diagnostic device that directly measures a patient's condition or provides a diagnosis. Therefore, the concepts of sensitivity, specificity, accuracy, and clinical performance studies (like MRMC) are not directly relevant in the way they would be for a device like an AI algorithm for image analysis.

The "acceptance criteria" here relate to the ability of the calibrator to accurately assign values to its constituents and ensure the continued accurate performance of the assays it calibrates. The "study" mentioned is the comparison to the predicate device, demonstrating that the new calibrator is functionally equivalent and performs its intended role adequately.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for a Calibrator)	Reported Device Performance
Matrix Type: Bovine serum base	Bovine serum base (Matches predicate, ensuring appropriate matrix for analytical methods).
Form: Liquid	Liquid (Matches predicate, ensuring ease of use and consistency).
Package: Ten vials - five levels, two vials/level, 5.0 mL/vial	Ten vials - five levels, two vials/level, 5.0 mL/vial (Matches predicate, ensuring consistent packaging and sufficient material for calibration).
Value Assignment Traceability: USP standards or highest-order purity material available	USP standards or highest-order purity material available (Matches predicate, indicating a robust and traceable method for assigning values to the calibrator, which is critical for its function).
Intended Use: Calibration of specified Dimension® Flex® methods on clinical chemistry systems	Intended for calibration of the following nine (9) Dimension® Flex® methods: Acetaminophen (ACTM), Carbamazepine (CRBM), Digitoxin (DGTX), Gentamicin (GENT), N-acetylprocainamide (NAPA), Procainamide (PROC), Tobramycin (TOBR), Valproic acid (VALP), Vancomycin (VANC). (Expands upon predicate by including NAPA and PROC calibration, demonstrating its ability to perform this extended function.)
Substantial Equivalence: Maintain same design, manufacture, and intended use as the predicate device (DC49B), with the only difference being value assignments for additional analytes.	Conclusion: "Based on the same design, manufacture and intended use as described above, the multianalyte, five level, bovine serum base Dimension® Drug Calibrator II products (DC49C and DC49B) are substantially equivalent. The only difference is the assigned values for the two additional analytes (procainamide and n-acetylprocainamide)." (Confirms it meets the criteria for substantial equivalence, implying it performs its calibrator function equivalently for the common analytes and adequately for the new ones.)

Additional Information (as applicable to a calibrator submission):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not applicable and not provided in the document. This submission is for a calibrator, which is a reference material itself, not a device being tested against patient samples for diagnostic accuracy. The "test set" in this context would likely refer to internal analytical validation data to establish the values of the calibrator and ensure its stability and consistency, which is not detailed in a 510(k) summary for a calibrator. The summary focuses on its composition and how it relates to a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable to a calibrator. The "ground truth" for a calibrator is established through highly precise analytical methods using primary reference materials (like USP standards) and robust metrological practices, not clinical expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies, particularly for subjective assessments like image interpretation.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. MRMC studies are for evaluating the performance of diagnostic systems (often AI-powered) where human interpretation is involved. This is a calibrator.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a calibrator, "ground truth" refers to the assigned concentration values of the analytes within the calibrator. This is established using pharmacopoeial standards (USP standards) or other highest-order purity materials available, meaning it's based on highly characterized chemical reference materials and analytical methodologies, not clinical outcomes or expert consensus.
The sample size for the training set:
- Not applicable. Calibrators do not have "training sets" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not applicable for the reasons mentioned above. For this device, the "ground truth" (assigned values) is established through analytical processes traceable to certified reference materials.

Summary

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K032574

Summary of Safety and Effectiveness Information

Dade Behring Dimension® Drug Calibrator II (DC49C)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR§807.92.

Submitter's Name:	Richard M. VaughtDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	August 19, 2003
Name of Product:	Dimension® Drug Calibrator II (DC49C)
FDA Classification Name:	Calibrator, drug mixture (91DKB)
Predicate Device:	Dimension® Drug Calibrator II (DC49B) [K990255].
Device Description:	The predicate Drug Calibrator II product labeling is being modified toinclude the assigned values for the additional N-acetylprocainamide(NAPA) and procainamide (PROC) constituents.The Dimension® Drug Calibrator II is a liquid, bovine serum baseproduct. It is packaged as ten vials, two vials at each of five levels.Each vial contains 5.0 mL.
Intended Use:	The Dimension® Drug Calibrator II is an in vitro diagnosticproduct intended for the calibration of the following methodspackaged in Dimension® Flex® reagent cartridges:Acetaminophen (ACTM)Carbamazepine (CRBM)Digitoxin (DGTX)Gentamicin (GENT)N-acetylprocainamide (NAPA)Procainamide (PROC)Tobramycin (TOBR)Valproic acid (VALP)

Comparison to Predicate Device:

A summary of the features of the proposed Dade Behring Dimension® Drug Calibrator II (DC49C) product and the predicate Dimension® Drug Calibrator II product (DC49B) [K990255] is provided in the following chart:

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ProposedDade BehringDrug Calibrator II (DC49C)		CurrentDade BehringDrug Calibrator II (DC49B)
Intended Use:	For calibration of the followingnine (9) Dimension® Flex® methods:	For calibration of the followingseven (7) Dimension® Flex® methods:
	Acetaminophen (ACTM)Carbamazepine (CRBM)Digitoxin (DGTX)Gentamicin (GENT)N-acetylprocainamide (NAPA)Procainamide (PROC)Tobramycin (TOBR)Valproic acid (VALP)Vancomycin (VANC)	Acetaminophen (ACTM)Carbamazepine (CRBM)Digitoxin (DGTX)Gentamicin (GENT)Tobramycin (TOBR)Valproic acid (VALP)Vancomycin (VANC)
Matrix:	Bovine serum base	Bovine serum base
Form:	Liquid	Liquid
Package:	Ten vials -five levels,two vials/level,5.0 mL/vial	Ten vials - five levels,two vials/level,5.0 mL/vial
ValueAssignment:	USP standards or highest-orderpurity material available	USP standards or highest-orderpurity material available

Comments on Substantial Equivalence:

Both the proposed Dade Behring Dimension® Drug Calibrator II (DC49B) and the existing Dade Behring Dimension® Drug Calibrator II (DC49B) [K990255] are in vitro diagnostic products intended as calibrators for the specified Dimension® Flex® methods on Dade Behring Dimension® clinical chemistry analyzer systems.

The only difference in the product offerings is that the proposed Dimension® Drug Calibrator II (DC49C) has value assignments for the calibration of the additional Dade Behring Dimension® N-acety|procainamide (NAPA) and Procainamide (PROC) Flex® reagent cartridge methods.

Conclusion:

Based on the same design, manufacture and intended use as described above, the multianalyte, five level, bovine serum base Dimension® Drug Calibrator II products (DC49C and DC49B) are substantially equivalent. The only difference is the assigned values for the two additional analytes (procainamide and n-acetylprocainamide).

Richard M. Vaught Regulatory Affairs and Compliance Manager August 19, 2003

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 6 2003

Mr. Richard M. Vaught Regulatory Affairs and Compliance Manager Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714

Re: K032574

Trade/Device Name: Dimension® Drug Calibrator II (DC49C) Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: August 19, 2003 Received: August 20, 2003

Dear Mr. Vaught:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Dimension® Drug Calibrator II (DC49C) Device Name:

Indications for Use:

Acetaminophen (ACTM) Carbamazepine (CRBM) Digitoxin (DGTX) Gentamicin (GENT) N-acetylprocainamide (NAPA) Procainamide (PROC) Tobramycin (TOBR) Valproic acid (VALP) Vancomycin (VANC)
RmVlVaught

hard M Venoht Regulatory Affairs and Compliance Manager

August 19, 2003

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-counter Use

(Optional format 1-2-96)

Carol C Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 32574

000004

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.