The UDAT CAL is an in vitro diagnostic product for the calibration of Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Methaqualone (MTQ), Opiates (OPI), Phencyclidine (PCP), Propoxyphene (PRX), and Cannabinoids (THC) methods on the Dimension Vista™ System.

Device Description

UDAT CAL is a liquid, multi-analyte, drug free human urine based product containing: D-methamphetamine, Secobarbital, Lormetazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, 11-nor- $\Delta$ 9-THC-9-COOH, Propoxyphene, and Methylqualone. 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 for Calibrator A and 2.6 mL for Calibrator B. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

AI/ML Overview

The provided text describes a 510(k) submission for the Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510). This is a calibrator material, not an AI/ML-driven device, so many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable or directly addressed in the context of typical AI/ML device evaluations.

However, based on the performance characteristics provided for this calibrator material, here's an attempt to structure the information as requested, highlighting where the AI/ML specific criteria do not apply.

Acceptance Criteria and Device Performance for Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510)

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Stability (Shelf Life)	Target shelf life for the calibrator is nine months. Percent change over time should be less than or equal to 10% when comparing results of product stored at 4°C with control stored at -20°C.	Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc. (Implies satisfactory performance against the 10% change criterion for 9 months).
Punctured Vial Stability (On-instrument)	A vial punctured by the instrument and stored on board is stable for 24 hours.	Stated as "stable for 24 hours." (Implies satisfactory performance).
Opened Vial Stability (Recapped, Refrigerated)	An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 days.	Stated as "stable for 31 days." (Implies satisfactory performance).
Traceability	Assigned values of the UDAT CAL are traceable to specified reference materials (USP for most analytes, Cerilliant for others).	The document explicitly lists the specific USP standards or Cerilliant sources for each analyte's constituent. (Implies successful traceability).
Bottle Value Assignment (Verification)	Master Lot values are verified against previously approved Master Lot values and GC/MS testing. The approved Master Lot values are assigned with an instrument calibrated with the corresponding standard reference material. Commercial lot concentrations are verified using an instrument calibrated with Master Lot and GC/MS testing. Values are approved if acceptable ranges are met.	The description details the multi-step verification process, including GC/MS testing and calibration against Master Lot values to ensure concentrations are within acceptable ranges. (Implies this process is followed and criteria met).

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

This is not an AI/ML device testing data set in the traditional sense. The "testing" refers to internal validation studies of the calibrator's performance characteristics like stability and value assignment.

Sample Size for Test Set: Not explicitly stated as a single "test set" sample size. Stability testing involved multiple vials over time (e.g., punctured vials tested on Day 0, 1, 2, and 8; manually opened vials on Day 32). Bottle value assignment involved testing stock solutions and commercial lots.
Data Provenance: The data is internally generated by Dade Behring, Inc. as part of their product development and validation. This would be considered prospective in the context of their internal studies for product validation. The country of origin is implicitly the USA, where Dade Behring Inc. is located.

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

This is not applicable as this is not an AI/ML device requiring expert interpretation of output. The "ground truth" for calibrators is established through analytical and metrological methods, primarily using highly pure reference materials (like USP standards and Cerilliant pure substances) and quantitative analytical techniques such as GC/MS. The "experts" involved would be analytical chemists or equivalent personnel qualified in laboratory methods and metrology. Their number and specific qualifications (e.g., years of experience) are not detailed as they are for clinical expert reviews.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for a calibrator's performance; it's based on objective analytical measurements against defined specifications.

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

No, this is not an AI/ML device or an imaging device, therefore an MRMC study is not relevant or performed for a calibrator.

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

Not applicable. This is a physical calibrator material, not a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth for the analyte concentrations in the calibrator material is established through:

Reference Materials: Highly characterized chemical reference materials (e.g., USP standards, Cerilliant 99% purity analytes).
Gravimetric Preparation: Exact weighing of these reference materials into drug-free human urine to create stock solutions and master lots.
Analytical Verification: Confirmation of concentrations using established analytical methods like Gas Chromatography/Mass Spectrometry (GC/MS), which provides highly accurate and specific quantification.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set." The product is manufactured and its performance characteristics (stability, accuracy of value assignment) are validated.

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

Not applicable, as there is no training set. The "ground truth" for the calibrator's values is established from the reference materials, gravimetric preparation, and analytical verification methods described in point 7.

Summary

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

K062/62

SEP 1 4 2006

510(k) Summary for the Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510)

A. 510(k) Number:

B. Analytes:	Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Methaqualone (MTQ), Opiates (OPI), Phencyclidine (PCP), Propoxyphene (PRX), and Cannabinoids (THC).
C. Type of Test:	Calibrator Material
D. Applicant:	Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Regulatory Affairs and Compliance Manager Office: (302) 631-0376 Fax: (302) 631-6299

E. Proprietary and Established Names:

Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862-1150 Calibrator
1. Classification: Class II
1. Product Code: DKB Calibrator, Drug Mixture
1. Panel: Toxicology
G. Intended Use: The UDAT CAL is an in vitro diagnostic product for the calibration of Amphetamines /Methamphetamines (AMPH), Barbiturates (BARB), Benzodiazepines (BENZ), Cocaine Metabolite (COC), Methadone (METH), Methaqualone (MTO), Opiates (OPI), Phencyclidine (PCP), Propoxyphene (PRX), and Cannabinoids (THC) methods on the Dimension Vista TM System.

H. Device Description:

UDAT CAL is a liquid, multi-analyte, drug free human urine based product containing:

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

Analyte	Constituent
Amphetamine/Methamphetamine	D-methamphetamine
Barbiturate	Secobarbital
Benzodiazepines	Lormetazepam
Cocaine Metabolite	Benzoylecgonine
Methadone	Methadone
Opiates	Morphine
Phencyclidine	Phencyclidine
Cannabinoids	11-nor- $Δ9$ -THC-9-COOH
Propoxyphene	Propoxyphene
Methylqualone	Methylqualone

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 for Calibrator A and 2.6 mL for Calibrator B. 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™ SystemDrugs of Abuse Calibrator	Syva® EMIT®Calibrators/ControlsK993755
IntendedUse	The UDAT CAL is an in vitro diagnosticproduct for the calibration ofAmphetamines /Methamphetamines(AMPH), Barbiturates (BARB),Benzodiazepines (BENZ), CocaineMetabolite (COC), Methadone (METH),Methaqualone (MTQ), Opiates (OPI),Phencyclidine (PCP), Propoxyphene (PRX),and Cannabinoids (THC) methods on theDimension Vista™ System.	The Emit® Calibrators/Controls are used inthe calibration of the Emit® II PlusAmphetamines, Barbiturate,Benzodiazepine, Cannabinoid, CocaineMetabolite, Ecstasy, Methadone,Methaqualone, MonoclonalAmphetamine/Methamphetamine, Opiates,Phencyclidine, and Propoxyphene Assays.
Analytes	Amphetamines /Methamphetamines(AMPH), Barbiturates (BARB),Benzodiazepines (BENZ), CocaineMetabolite (COC), Methadone (METH),Methaqualone (MTQ), Opiates (OPI),Phencyclidine (PCP), Propoxyphene (PRX),and Cannabinoids (THC).	Amphetamines, Barbiturate,Benzodiazepine, Cannabinoid, CocaineMetabolite, Ecstasy, Methadone,Methaqualone, MonoclonalAmphetamine/Methamphetamine, Opiates,Phencyclidine, and Propoxyphene.
Form	Liquid.	Liquid.
Traceability	USP1 for all analytes except:BENZ - Benzodiazepine (99% purity)(Cerilliant)2.COC - Cocaine (99% purity) (Cerilliant).THC - Cannabinoids (99% purity)(Cerilliant).	USP for all analytes except:BENZ - Benzodiazepine (99% purity)(Cerilliant).COC - Cocaine (99% purity) (Cerilliant).THC - Cannabinoids (99% purity)(Cerilliant). Standards.
Matrix	Human urine based.	Human urine based.
Number ofLevels	Two levels3.	Six levels.

1 United States Pharmacopeia.

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

2 Cerilliant Inc. 811 Paloma Drive, Suite A Roundrock, TX 78664

3 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

K. Performance Characteristics:

1. Stability: Target shelf life for the Dimension Vista™ System Drugs of Abuse Calibrator is nine 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 10%. 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. For punctured vials, a quantity of calibrator sufficient for multiple calibrations is removed and the vials are recapped, punctured and stored at 2-8°C. Punctured vials are tested on Day 0. 1. 2. and 8 vs. freshly opened vials. For manually opened vials, half of the volume is removed and vials are recapped and tested on day 32 vs. freshly opened vials.

The assigned values of the UDAT CAL are traceable to: 2. Traceability:

Analyte	Constituent	Reference Material
Amphetamine /Methamphetamine	D-methamphetamine	USP1 1429000; USP1399001
Barbiturate	Secobarbital	USP 1611004

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

Benzodiazepines	Lormetazepam	Benzodiazepine (99%purity) (Cerilliant)2
Cocaine Metabolite	Benzoylecgonine	Cocaine (99% purity)(Cerilliant)
Methadone	Methadone	USP 1398009
Opiates	Morphine	USP 1448005
Phencyclidine	Phencyclidine	USP 1516003
Cannabinoids	11-nor- $\Delta$ 9-THC-9-COOH	Cannabinoids (99%purity) (Cerilliant)
Propoxyphene	Propoxyphene	USP 1404000
Methylqualone	Methylqualone	USP 1575000

United States Pharmacopeia.

2 Cerilliant Inc. 811 Paloma Drive, Suite A Roundrock, TX 78664

1. Bottle Value Assignment:
  D-Methamphetamine, Secobarbital, Lormetazepam, Benzovlecgonine. Methadone, Morphine, Phencyclidine. l 1-nor-A -THC-9-COOH, Propoxyphene, and Methylqualone Reference Material is weighed into drug free normal human urine at five levels and stored at -70° C. The verification of the Master Lot values are compared against previously approved Master Lot values and GC/MS' testing. The

approved Master Lot values were assigned with an instrument calibrated with the corresponding standard reference material.

The stock solution is made by adding D-Methamphetamine, Secobarbital, Lormetazepam, Benzoylecgonine, Methadone, Morphine, Phencyclidine, 11-nor-A-THC-9-COOH, Propoxyphene, and Methylqualone Reference Materials gravimetrically to stock solution at target concentrations and verified on an instrument calibrated with a previously approved Master Lot.

The commercial lot is made by adding calculated quantities of stock solution to drug free normal human urine in appropriate concentrations for each of the calibrator levels. The concentration of each level is verified using an instrument calibrated with Master Lot and GC/MS testing of each analyte in the Commercial lot. Values for each analyte are approved once the acceptable ranges for each analyte are met. The commercial lot is then filled, capped, labeled, and packaged.

1 Gas Chromatography / Mass Spectrometry.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three bars extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

SEP 1 4 2006

Mr. Victor Carrio Dade Behring, Inc. P.O. Box 6101 Newark, DE 19714

Re: K062162

Trade/Device Name: Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510) Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DKB Dated: July 27, 2006 Received: July 28, 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).

{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-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 Gutierrez

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):

Device Name:

Dimension Vista™ System Drugs of Abuse Calibrator (UDAT CAL - KC510)

Indications for Use:

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)

Carol Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KOG2162 510(k)

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.