EXTC CAL is a liquid, human urine-based product containing weighed-in quantities of methylenedioxymethamphetamine. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B. EXTC CAL is ready for use (no preparation is required). The volume per vial is 2.3 mL. Intermediate levels are automatically prepared and corresponding values calculated by the Dimension Vista™ System.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance
Stability (Shelf Life)	Target shelf life for the Dimension Vista™ System Ecstasy Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20℃. Recovery versus time is monitored and percent change over time is determined where the allowable shelf life percent change is ≤ 10 %.	"Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc." (This implies that the 12-month target with ≤ 10% change was met, as the product received clearance for marketing with an assigned expiration date. While the explicit numerical performance over the 12 months isn't stated, the affirmation of "real-time data on file" supports meeting the criterion.)
Stability (On-board)	Vial punctured by the instrument and stored on board is stable for 24 hours.	Performance not explicitly stated in the provided text. The text only says "A vial punctured by the instrument and stored on board is stable for 24 hours." This is given as the criterion itself, not a result of a study.
Stability (Open Vial)	Open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 days.	Performance not explicitly stated in the provided text. The text only says "An open vial not on instrument, but recapped and stored in a refrigerator is stable for 31 days." This is given as the criterion itself, not a result of a study.
Traceability	The assigned values of the EXTC CAL are traceable to Methylenedioxymethamphetamine (99% purity) (Cerilliant, Inc.).	"The assigned values of the ECTX CAL is traceable to Methylenedioxymethamphetamine (99% purity) (Cerilliant, Inc., 811 Paloma Drive, suite A, Roundrock, TX 78664." (This directly states the criterion is met.)
Value Assignment	New calibrator Master Pool values are verified against a previously approved Master Pool lot and Gas Chromatography / Mass Spectrometry (GC/MS) testing. Stock solution concentration is verified by comparing them to Master Pool assigned bottle values. Commercial lot concentration of each level is verified to be within acceptable range using an instrument calibrated with Master Pools and by GC/MS testing.	The text describes the process used for value assignment which inherently acts as the performance demonstration that the values are assigned correctly and verified: "The Master Pool values are verified against the values of a previously approved Master Pool lot and Gas Chromatography / Mass Spectrometry (GC/MS) testing." and "The stock solution concentration is verified by comparing them to the Master Pool assigned bottle values." and "The concentration of each level of the commercial lot is verified to be within acceptable range by using an instrument calibrated with Master Pools and by GC/MS testing." (This indicates the procedure was followed successfully, implying the criterion was met.)

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

Test Set Sample Size: The document does not explicitly state a specific "test set" sample size in terms of number of samples or analytes tested. For stability testing, samples (vials) were subjected to different storage conditions (4°C, -20°C, on-board, open/re-capped). The testing involved "multiple calibrations."
Data Provenance: The data comes from prospective stability studies conducted by Dade Behring Inc. The text describes how "Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20℃" and that "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc." The studies were conducted at Dade Behring, Inc., Newark, DE.

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

This device is a calibrator for a clinical toxicology assay, not an imaging or diagnostic device that typically involves expert interpretation for ground truth.
For Value Assignment: The "ground truth" (or reference standard) is established by using Methylenedioxymethamphetamine (99% purity) from Cerilliant, Inc. as a primary reference material, and then verified through internal Master Pool lots and Gas Chromatography / Mass Spectrometry (GC/MS) testing. This suggests a rigorous chemical and analytical method for establishing the true concentration, rather than human expert consensus.
Qualifications: The document does not specify qualifications of individuals performing the GC/MS or Master Pool verification, but it can be assumed that these would be trained analytical chemists or laboratory personnel.

4. Adjudication Method for the Test Set:

No adjudication method is described, as the performance evaluation relies on objective analytical measurements (recovery percentages, GC/MS results) compared to predefined thresholds, rather than subjective interpretation by multiple human observers.

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:

No, an MRMC comparative effectiveness study was not done. This device is a calibrator, which provides a known concentration standard for an assay, and does not involve human interpretation or AI assistance in the way a diagnostic imaging device would.

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

This question is not applicable to a calibrator device. The "device" (calibrator) itself doesn't perform an algorithm or provide a diagnostic output independently. It's a reagent used by an instrument (Dimension Vista™ System) to perform an assay. Its performance is evaluated through its stability and accuracy in providing known concentrations.

7. The Type of Ground Truth Used:

The ground truth for the calibrator's value assignment is based on gravimetric addition of highly pure reference material (Methylenedioxymethamphetamine, 99% purity from Cerilliant) and verified by Gas Chromatography / Mass Spectrometry (GC/MS) testing and comparison to previously approved Master Pool lots. This is a highly accurate chemical/analytical ground truth.

8. The Sample Size for the Training Set:

The concept of a "training set" is not directly applicable to a chemical calibrator in the same way it would be for a machine learning algorithm.
The document describes the preparation of "Master Pool" lots (five levels) which are then used to verify new commercial calibrator lots. While these Master Pools serve a foundational role in establishing acceptable concentration ranges, they are not a "training set" in the AI sense. The number of samples for forming these Master Pools or for verifying them is not specified beyond "Five levels of Master Pool are prepared."

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

As noted above, a traditional "training set" for an algorithm is not present. However, the foundational "ground truth" for the calibrator's concentration, against which all subsequent production lots are validated, is established through:
- Gravimetric addition of a precisely weighed, high-purity reference material (Methylenedioxymethamphetamine, 99% pure) to drug-free human urine to create the Master Pools. This is the primary method of establishing the "true" concentration.
- Verification against previously approved Master Pool lots.
- Verification using Gas Chromatography / Mass Spectrometry (GC/MS) testing. GC/MS is a highly accurate analytical technique for identifying and quantifying substances.

Summary

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K062182

510(k) Summary for the Dimension Vista™ System Ecstasy Calibrator (EXTC CAL - KC520)

SEP 1 4 2006

A. 510(k) Number:

B. Analyte:	Ecstasy (EXTC)
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 Ecstasy Calibrator (EXTC CAL - KC520)

F. Regulatory Information:

1. Regulation section: 21 CFR § 862.3200 Clinical toxicology calibrator
1. Classification: Class II
1. Product Code: DLJ Calibrator, Drug Specific
1. Panel: Toxicology
G. Intended Use: The EXTC CAL is an in vitro diagnostic product for the calibration of the Ecstasy (EXTC) method on the Dimension Vista™ System.

H. Device Description:

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I. Substantial Equivalence Information:

1. Predicate Device: SYVA® EMIT® II Plus Ecstasy Calibrators/Controls cleared under K043028.
1. Comparison with Predicate:

	New Device	Predicate Device
Item	Dimension Vista™ SystemEcstasy Calibrator	SYVA® EMIT® II Plus EcstasyCalibrators/Controls(K043028)
Intended Use	The EXTC CAL is an in vitrodiagnostic product for thecalibration of the Ecstasy (EXTC)method on the Dimension Vista™System.	The Emit® II Plus Ecstasy Calibrators/Controlsare used in the calibration of the Emit® II PlusEcstasy Assay. These standards may also be usedas quality control materials based on the specificEcstasy Assay cutoff.
Analytes	Methylenedioxymethamphetamine.	Methylenedioxymethamphetamine
Form	Liquid.	Liquid.
Traceability	Methylenedioxymethamphetamine(99% purity) (Cerilliant)a.	Methylenedioxymethamphetamine (MDMA)
Matrix	Human urine.	Human urine.
Calibration /VerificationLevels	Two levelsb.	Four levels.

ªCerilliant Inc., 811 Paloma Drive, suite A, Roundrock, TX 78664.

· 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 InVitro Diagnostic Calibrators; Final, 02/22/1999Guidance for Industry and FDA Staff - Use of Symbols on Labelsand in Labeling of In Vitro Diagnostic Devices Intended forProfessional Use, 11/30/2004
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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 Ecstasy Calibrator is 12 months. Calibrator shelf life is determined by comparing results of the product stored at 4℃ with control stored at -20℃. 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

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determined where the allowable shelf life percent change is ≤ 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. 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, and 8 and opened vials are also tested at 32 days versus freshly opened vials.

Traceability: The assigned values of the ECTX CAL is traceable to Methylenedioxymethamphetamine (99% purity) (Cerilliant, Inc., 811 Paloma Drive, suite A, Roundrock, TX 78664.

1. Value Assignment:
  The new calibrator Master Pool is made by adding weighed quantities of Methylenedioxymethamphetamine Reference Material to drug free human urine. Five levels of Master Pool are prepared and stored at -70° C. The Master Pool values are verified against the values of a previously approved Master Pool lot and Gas Chromatography / Mass Spectrometry (GC/MS) testing.

A stock solution is prepared for the new commercial calibrator lot by gravimetrically adding Methylenedioxymethamphetamine to stock solution at target concentration. The stock solution concentration is verified by comparing them to the Master Pool assigned bottle values.

For the commercial calibrator lot, calculated quantity of the stock solution is added to drug free human urine to target concentrations for two calibrator levels. The concentration of each level of the commercial lot is verified to be within acceptable range by using an instrument calibrated with Master Pools and by GC/MS testing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 pattern around the caduceus symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 4 2006

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

Re: K062182

Trade/Device Name: Dimension Vista™ System Ectasy Calibrator Regulation Number: 21 CFR 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Code: DLJ Dated: July 28, 2006 Received: July 31, 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 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

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Indications For Use Statement

510(k) Number (if known):

Device Name:

Dimension Vista™ System Ecstasy Calibrator (EXTC CAL - KC520)

Indications for Use:

The EXTC CAL is an in vitro diagnostic product for the calibration of the Ecstasy (EXTC) method on the Dimension Vista™ System.

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)

월 20일 중국 지문서쌍 % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % % %

Carol C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K06218

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.