The DRUG 2 CAL is an in vitro diagnostic product for the calibration of acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), Nacetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC) methods on the Dimension Vista TM System.

Device Description

DRUG 2 CAL is a multi-analyte, liquid, bovine serum based product containing acetaminophen, carbamazepine, digitoxin, gentamicin, lidocaine, N-acetylprocainamide, procainamide, tobramycin, valproic acid, and vancomycin. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the Dimension Vista™ System Drug 2 Calibrator (DRUG 2 CAL - KC420), based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Stability (Shelf-life)	* Target: 12 months. * Method: Comparison of product stored at 4°C with control stored at -20°C. * Acceptance Threshold: Percent change should be less than or equal to 5%. * Performance: Shelf-life stability (expiration) dating at commercialization reflects real-time data on file at Dade Behring, Inc. (Implies performance met the ≤ 5% change criteria for the assigned shelf life).
Stability (On-board)	* Acceptance Threshold: Stable for 24 hours when a vial is punctured by the instrument and stored on-board.
Stability (Open Vial - Recapped & Refrigerated)	* Acceptance Threshold: Stable for 31 days when an open vial is not on the instrument but recapped and stored in a refrigerator (2-8°C). * Test Points: Vials opened/punctured on day zero were tested on days 0, 1, 2, 8, and 32 against freshly opened vials.
Bottle Value Assignment (Verification of Master Pool values)	* Method: Master Pool values are compared against previously approved Master Pool values. * Performance: Previously approved Master Pool values were assigned with an instrument calibrated with the corresponding standard reference material. (Implies verification was successful.)
Bottle Value Assignment (Verification of Stock Solution)	* Method: Verified on an instrument calibrated with a previously approved Master Pool. (Implies verification was successful.)
Bottle Value Assignment (Commercial Lot Concentration Verification)	* Method: Verified by using an instrument calibrated with Master Pools. (Implies verification was successful.)
Bottle Value Assignment (Final Bottle Values)	* Method: Assigned and verified using multiple instruments by testing N = 20 replicates per level. A previously released commercial lot is used as a control. (Implies verification was successful based on the use of controls and multiple instruments.)
Traceability	* Acceptance Criteria: Traceable to United States Pharmacopeia (USP) Reference Materials for all analytes except NAPA, which is traceable to Alltech-Applied Sciences Reference Standards. * Performance: Met.

Study Details

Sample Size used for the test set and the data provenance:
- Stability Studies: Not explicitly stated as a single "test set" sample size for the entire study. Instead:
  - For shelf-life stability, the product was stored at 4°C and compared to a control stored at -20°C. The duration was determined to support a 12-month shelf life.
  - For open vial/on-board stability, vials were opened/punctured on day zero and tested on days 0, 1, 2, 8, and 32. The number of vials or samples per time point is not specified beyond "a quantity sufficient for multiple calibrations."
- Bottle Value Assignment: N = 20 replicates per level were tested for the final bottle value assignment of the commercial lot. The text doesn't specify if these 20 replicates were from one lot or across multiple lots for performance evaluation, but it was for each level of a commercial lot.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal validation studies conducted by Dade Behring Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground truth for this device (a calibrator) is established through traceability to reference materials and gravimetric preparation rather than expert consensus on clinical readings.
- The "experts" in this context would be the analytical chemists or personnel responsible for weighing reference materials (USP and Alltech-Applied Sciences), preparing master pools and stock solutions, and performing calibrations, whose qualifications are not detailed in this summary.
Adjudication method for the test set:
- Not applicable in the traditional sense of human reader adjudication for diagnostic imaging or clinical interpretation. Performance is assessed against quantitative analytical criteria (e.g., percent change, recovery, comparison to reference materials).
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. This is a calibrator for in vitro diagnostic tests, not an AI-powered diagnostic device requiring human interpretation of results.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. While the Dimension Vista™ System is an automated instrument, this submission is for the calibrator material used by the system, not the system's analytical algorithm itself. The calibrator's performance is standalone in the sense that it meets specifications independent of user intervention once used correctly, but it's not an algorithm.
The type of ground truth used:
- Reference Materials: The primary ground truth for the analytes is established through United States Pharmacopeia (USP) Reference Materials (for most analytes) and Alltech-Applied Sciences Reference Standards (for NAPA). These are highly purified, well-characterized chemical substances used as analytical standards.
- Gravimetric Preparation: Concentrations of stock solutions and commercial lots are based on precise gravimetric (weighing) additions of these reference materials.
- Previously Approved Master Pools: For verification steps, comparison against "previously approved Master Pool values" established using the corresponding standard reference material serves as a form of internal ground truth or validated standard.
The sample size for the training set:
- Not applicable. This is a calibrator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a product involves establishing the manufacturing process, quality control, and ensuring consistency with reference standards.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device. The accuracy of the calibrator relies on the traceability of its components to internationally recognized reference standards (USP) and carefully controlled gravimetric preparation.

Summary

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Kouzi21

AUG 25 2006

510(k) Summary for the Dimension Vista™ System Drug 2 Calibrator (DRUG 2 CAL - KC420)

A. 510(k) Number:

B. Analytes:	Acetaminophen (ACTM), carbamazepine (CRBM), digitoxin(DGTX), gentamicin (GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide (PROC), tobramycin(TOBR), valproic acid (VALP), and vancomycin (VANC).
C. Type of Test:	Calibrator Material
D. Applicant:	Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101Victor M. Carrio, Regulatory Affairs and Compliance ManagerOffice: (302) 631-0376 Fax: (302) 631-6299

E. Proprietary and Established Names:

Dimension Vista™ System Drug 2 Calibrator (DRUG 2 CAL - KC420)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862.3200 -- Clinical Toxicology Calibrator
1. Classification: Class II
1. Product Code: DKB Calibrator, Drug Mixture
1. Panel: Toxicology
G. Intended Use: The DRUG 2 CAL is an in vitro diagnostic product for the calibration of acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), Nacetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC) methods on the Dimension Vista TM System.

H. Device Description:

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The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

I. Substantial Equivalence Information:

	New Device	Predicate Device
Item	Dimension Vista™ SystemDrug 2 Calibrator	Dimension® Drug Calibrator IIK033809
IntendedUse	The DRUG 2 CAL is an in vitro diagnosticproduct for the calibration ofacetaminophen (ACTM), carbamazepine(CRBM), digitoxin (DGTX), gentamicin(GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide(PROC), tobramycin (TOBR), valproic acid(VALP), and vancomycin (VANC) methodson the Dimension Vista™ System.	Drug Calibrator II is an in vitro diagnosticproduct intended for the calibration of thefollowing methods packaged in Flex®reagent cartridges: acetaminophen (ACTM),carbamazepine (CRBM), digitoxin(DGTX), gentamicin (GENT), lidocaine(LIDO), N-acetylprocainamide (NAPA),procainamide (PROC), tobramycin(TOBR), valproic acid (VALP),vancomycin (VANC).
Analytes	Acetaminophen (ACTM), carbamazepine(CRBM), digitoxin (DGTX), gentamicin(GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide(PROC), tobramycin (TOBR), valproic acid(VALP), and vancomycin (VANC).	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	USP¹ for all analytes except NAPA.NAPA - Alltech-Applied SciencesReference Standards.	USP¹ for all analytes except NAPA.NAPA - Alltech-Applied SciencesReference Standards.
Matrix	Bovine serum based.	Bovine serum based.
Number ofLevels	Two levels².	Five levels.

' United States Pharmacopeia.

2 Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

J. Standard/Guidance Document Referenced:

1. Guidance: Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final, 02/22/1999 Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, 11/30/2004
1. Standards: CEN 13640 Stability testing of In-Vitro Diagnostic Devices ISO 14971:2000 Medical devices -Application of risk management to medical devices

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K. Performance Characteristics:

Target shelf life for the Dimension Vista™ System Drug 2 1. Stability: Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20°C. The method is calibrated from this stored material. The 4℃ material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined. Percent change should be less than or equal to 5%. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc. A vial punctured by the instrument and stored on board is stable for 24 hours. An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 days. For testing, vials are opened /punctured on day zero. A quantity
sufficient for multiple calibrations is removed and the vials are recapped and stored at 2 - 8 °C. Opened/punctured vials are tested on days 0, 1, 2, 8, and 32 versus freshly opened vials.
1. Traceability: The assigned values of the DRUG 2 CAL are traceable to United States Pharmacopeia Reference Materials except for NAPA, which is traceable to Alltech-Applied Sciences Reference Standards.
1. Bottle Value Assignment:

Acetaminophen, Carbamazepine, Digitoxin, Gentamicin, Lidocaine, N-acetylprocainamide, Procainamide, Tobramycin, Valproic Acid and Vancomycin Reference Material is weighed into bovine serum albumin at six levels and stored frozen. The verification of the Master Pool values are compared against previously approved Master Pool values. The approved Master Pool values were assigned with an instrument calibrated with the corresponding standard reference material. The stock solution is made by adding Acetaminophen. Carbamazepine, Digitoxin, Gentamicin, Lidocaine, Nacetylprocainamide, Procainamide, Tobramycin, Valproic Acid and Vancomycin Reference Materials gravimetrically to stock solution at target concentrations and verified on an instrument calibrated with a previously approved Master Pool. The commercial lot is made by adding calculated quantities of stock solution to bovine serum albumin in appropriate concentrations for each of the calibrator levels. The concentration

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of each level is verified by using an instrument calibrated with Master Pools.

The final bottle values for each level of the commercial lot is assigned and verified using multiple instruments by testing N = 20 replicates per level. A previously released commercial lot is used as a control.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 5 2006

Mr. Victor M. Carrio RA/OS Compliance Manager Dade Behring, Inc. P.O. Box 6101 Mailstop 514 Newark, DE, 19714-6101

K062121 Re:

Trade/Device Name: Dimension Vista™ Drug 2 Calibrator (KC420) Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical Toxicology Calibrator Regulatory Class: Class II Product Code: DKB Dated: July 24, 2006 Received: July 25, 2006

Dear Mr. Carrio:

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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Alberto Guti

Alberto Guticarez, Ph.D. 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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Indications for Use

510(k) Number (if known): K062121

Device Name:

Dimension Vista™ Drug 2 Calibrator (KC420)

Indications For Use:

The DRUG 2 CAL is an in vitro diagnostic product for the calibration of acetaminophen (ACTM), carbamazepine (CRBM), digitoxin (DGTX), gentamicin (GENT), lidocaine (LIDO), N-acetylprocainamide (NAPA), procainamide (PROC), tobramycin (TOBR), valproic acid (VALP), and vancomycin (VANC) methods on the Dimension Vista™ System.

Prescription Use

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of 1

K062121

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.