The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO), Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista™ System.

Device Description

DRUG 1 CAL is a liquid, multi-analyte, human serum based product containing digoxin, lithium, phenobarbital, phenytoin, and theophylline. 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). This same product, the Dimension VistaTM System Drug 1 Calibrator (KC410), was previously cleared (K051087) for the calibration of the Phenobarbital (PHNO) method on the Dimension Vista™ System. The calibrator formulation has not changed. However, additional analytes are being assigned values and included in the intended use. The volume in the vials has also changed from 2.0 mL to 2.5 mL and the claim for punctured vial shelf life is reduced to one day.

AI/ML Overview

This document describes the Dimension Vista™ System Drug 1 Calibrator (DRUG 1 CAL - KC410), which is an in vitro diagnostic product used for the calibration of Digoxin, Lithium, Phenobarbital, Phenytoin, and Theophylline methods on the Dimension Vista System. The information provided focuses on the performance characteristics, particularly stability and traceability, rather than a clinical study involving human patients or complex AI algorithms. Therefore, some of the requested information types (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance for an algorithm, training set details) are not directly applicable to this type of device and study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The main performance characteristic discussed is shelf-life stability.

Analyte	Acceptance Criteria (Allowable Shelf Life Percent Change)	Reported Device Performance (Implied)
Digoxin	≤ 4%	Met (As implied by substantial equivalence and clearance)
Phenytoin	≤ 8%	Met (As implied by substantial equivalence and clearance)
Theophylline	≤ 8%	Met (As implied by substantial equivalence and clearance)
Lithium	≤ 5%	Met (As implied by substantial equivalence and clearance)
Phenobarbital	≤ 8%	Met (As implied by substantial equivalence and clearance)

Additional Stability Claims:

Target Shelf Life: 12 months (determined by real-time data on file at Dade Behring, Inc.)
Punctured Vial (on instrument): 1 day
Open Vial (recapped, refrigerated): 31 days

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

Test Set (for stability testing): The document states that for stability testing, "The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined."
- For the main shelf-life study, specific sample sizes (e.g., number of calibrator vials or measurements) are not explicitly stated in the provided text. However, for the bottle value assignment, it mentions "N = 45 replicates per level" for verifying the final assigned values of a commercial lot. This is for manufacturing quality control rather than a clinical test set.
Data Provenance: The studies are internal performance evaluations conducted by Dade Behring Inc. for regulatory submission. Details on country of origin are not specified, but it's an industry setting. It is a prospective study in the sense that they are testing the stability of newly manufactured calibrator lots over time.

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

This section is not applicable. For a calibrator, the "ground truth" for the analyte concentrations is established through traceability to recognized standards and gravimetric preparation, not through expert interpretation in the way it would be for a diagnostic image or clinical case.

4. Adjudication Method for the Test Set

This section is not applicable as there is no expert adjudication process for calibrator stability and value assignment. The assessment is based on quantitative measurements against pre-defined criteria.

5. 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

This section is not applicable. The device is a calibrator, not an AI-powered diagnostic device, and therefore, an MRMC study and AI performance metrics are not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable, as this is a calibrator (a consumable chemical reagent) and not an algorithm or software.

7. The Type of Ground Truth Used

The ground truth for the calibrator values is established through traceability to reference materials and gravimetric preparation:

Analyte Source: Digoxin, Phenobarbital, Phenytoin, Theophylline are traced to USP (United States Pharmacopeia) reference materials. Lithium is traced to NIST SRM (National Institute of Standards and Technology Standard Reference Material) 924.
Master Pool and Stock Solution Preparation: Made by "weighing in" or "adding reference materials gravimetrically" to drug-free normal human serum.
Verification: Master Pool values are compared against "previously approved Master Pool values," and stock solution values are verified against "previously approved Master Pool values."

8. The Sample Size for the Training Set

This section is not applicable. This device is a calibrator, not a machine learning model, so there is no "training set" in the context of AI or algorithm development. The manufacturing process involves controls and verification, which is distinct from training an algorithm.

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

This section is not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

K062034

510(k) Summary for the Dimension Vista™ System Drug 1 Calibrator (DRUG 1 CAL - KC410)

SEP - 6 2006

A. 510(k) Number:

B. Analytes:	Digoxin (DIG), Lithium (LI), Phenytoin (PTN), Theophylline(THEO), and Phenobarbital (PHNO)1.
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 1 Calibrator (DRUG 1 CAL-KC410)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862-1150 Calibrator
1. Classification: Class II
1. Product Code: JIX Calibrator, Multi-Analyte Mixture
1. Panel: Clinical Chemistry
G. Intended Use: The DRUG 1 CAL is an in vitro diagnostic product for the calibration of Digoxin (DIG), Lithium (LI), Phenobarbital (PHNO) , Phenytoin (PTN) and Theophylline (THEO) methods on the Dimension Vista 10 System.

H. Device Description:

1 The Dimension Vista™ System Drug 1 Calibrator was previously cleared for the calibration of Phenobarbital (PHNO) method in the Dimension Vista™ System under K051087.

{1}------------------------------------------------

formulation has not changed. However, additional analytes are being assigned values and included in the intended use. The volume in the vials has also changed from 2.0 mL to 2.5 mL and the claim for punctured vial shelf life is reduced to one day.

I. Substantial Equivalence Information:

	Device	Predicate
Item	Dimension Vista™ System Drug1 Calibrator¹	Dimension® Drug Calibrator(K011035)
IntendedUse	The DRUG 1 CAL is an in vitrodiagnostic product for the calibrationof Digoxin (DIG), Lithium (LI),Phenobarbital (PHNO)¹, Phenytoin(PTN) and Theophylline (THEO)methods on the Dimension Vista™System.	The Drug Calibrator is an in vitrodiagnostic product to be used tocalibrate the Digoxin (DGNA), Lithium(LI), Phenobarbital (PHNO), Phenytoin(PTN), and Theophylline (THEO)methods on the Dimension® clinicalchemistry system.
Analytes	Digoxin (DIG), Lithium (LI),Phenytoin (PTN), Theophylline(THEO), and Phenobarbital(PHNO)¹.	Digoxin (DGNA), Lithium (LI),Phenobarbital (PHNO), Phenytoin(PTN), and Theophylline (THEO).
Form	Liquid.	Liquid.
Traceability	DIG, PHNO, PTN, THEO – USP².LI – NIST SRM³.	DIG, PHNO, PTN, THEO – USP².LI – NIST SRM³.
Matrix	Human serum based product.	Human serum based product.
Number ofLevels	Two levels.	Five levels.

The Dimension Vista™ System Drug 1 Calibrator was previously cleared for the calibration of Phenobarbital (PHNO) method in the Dimension Vista™ System under K051087.

2 USP - United States Pharmacopeia.

3 NIST SRM - National Institute of Standards and Technology Standard Reference Material.

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

K. Performance Characteristics:

1. Stability: Target shelf life for the Dimension Vista™ Drug 1 Calibrator is 12 months. Calibrator shelf life is determined by comparing results of

{2}------------------------------------------------

the product stored at 4℃ with control stored at -20℃. The method is calibrated from this stored material. The 4°C material values are recovered versus the calibration. Recovery versus time is monitored and percent change over time is determined where the aflowable shelf life percent change should be less than or equal to:

Analyte	Allowable Shelf lifepercent change
Digoxin	≤ 4%.
Phenytoin	≤ 8 %
Theophylline	≤ 8 %
Lithium	≤ 5%
Phenobarbital1	≤ 8 %

T The Dimension Vista™ System Drug 1 Calibrator was previously cleared for the calibration of Phenobarbital (PHNO) method in the Dimension VistaTM System under K051087.

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 has a stability claim of one day.

An open vial not on instrument, but recapped and stored in a refrigerator has a stability claim of 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, 8 hrs, 2, 8, 32 versus freshly opened vials.

1. Traceability: The assigned values of the Drug 1 Calibrator are standardized to the enclosed table of assigned values:

Analyte	Reference Material
Digoxin	USP2 120000
Phenytoin	USP 1535507
Theophylline	USP 1653004
Lithium	NIST SRM3 924
Phenobarbital1	USP 1524001

The Dimension Vista™ System Drug 1 Calibrator was previously cleared for the calibration of Phenobarbital (PHNO) method in the Dimension VistaTM System under K051087

2 United States Pharmacopeia.

3 National Institute of Standards and Technology - Standard Reference Material.

1. Bottle Value Assignment:
  A Master Pool is manufactured by weighing in Phenobarbital, Digoxin, Phenytoin, Lithium and Theophylline reference material into drug free normal human serum at five levels and stored frozen at -20° C.

{3}------------------------------------------------

The verification of the Master Pool assigned values are compared against previously approved Master Pool values.

The stock solution is made by adding reference materials gravimetrically to stock solution at target concentrations. The stock solution values are verified versus previously approved Master Pool values.

The commercial lot is made by adding calculated quantities of stock solution to drug free normal human serum in appropriate concentrations for two calibrator levels. The concentration 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 = 45 replicates per level.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

SEP - 6 2006

Re: K062034

Trade/Device Name: Dimension Vista™ Drug 1 Calibrator (KC410) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 18, 2006 Received: July 19, 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).

Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

{5}------------------------------------------------

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-frec 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 Gutié

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications For Use Statement

510(k) Number (if known): Kd6203

Device Name:

Dimension Vista™ Drug 1 Calibrator (KC410)

Indications for Usc:

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (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)

Carole Benson

Division Sign-Off

Office of in Vitro Dlagnostic Device Evaluation and Safety

510(k) K062034

Regulation Number and Section

§ 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.