← Product Code [DLJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ) · K062182

# DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 (K062182)

_Dade Behring, Inc. · DLJ · Sep 14, 2006 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K062182

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [DLJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ.md)
- **Decision Date:** Sep 14, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3200
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## 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.

## Device Story

Dimension Vista™ System Ecstasy Calibrator (EXTC CAL) is a liquid, human urine-based product containing methylenedioxymethamphetamine. Used in clinical laboratories to calibrate the Ecstasy (EXTC) assay on the Dimension Vista™ System. The kit includes two levels of calibrators. The system automatically prepares intermediate levels and calculates corresponding values. The calibrator is ready-to-use; no preparation is required. By establishing a calibration curve, the device enables the system to quantify Ecstasy levels in patient urine samples, assisting clinicians in toxicology screening and decision-making.

## Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed 24-hour on-board stability (punctured), 31-day refrigerated stability (open), and 12-month closed stability. Value assignment verified via gravimetric preparation and GC/MS testing.

## Technological Characteristics

Liquid, multi-analyte, drug-free human urine matrix. Contains methylenedioxymethamphetamine. Two-level calibrator (0 ng/mL and 1000 ng/mL). Traceable to commercially available reference material (99% purity). Designed for use with the Dimension Vista System.

## Regulatory 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.)

## Special Controls

*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.

## Predicate Devices

- Syva EMIT II Plus Ecstasy calibrators/controls (k043028)

## Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k062182

B. Purpose for Submission:
New device

C. Measurand:
Methylenedioxymethamphetamine

D. Type of Test:
Calibrator Materials

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista System Ecstasy Calibrator (EXTC CAL - KC520)

G. Regulatory Information:
|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  Calibrators, Drug Specific (DLJ) | Class II | 21 CFR 862.3200, Clinical toxicology calibrator. | 91 Clinical toxicology (TX)  |

H. Intended Use:

1. Intended use(s):
Refer to indications for use below.

2. Indication(s) for use:
The EXTC CAL is an in vitro diagnostic product for the calibration Ecstasy (EXTC) method on the Dimension Vista™ System.

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3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

Dade Behring Dimension Vista™ System

I. Device Description:

The EXTC CAL is a liquid, multi-analyte, drug free human urine based calibrator consisting of 6 vials (three of calibrator A and three of calibrator B). Calibrator A vials and Calibrator B vials contain 2.3 mL. The component, constituent, and assigned values are listed in the table below. Intermediate levels are prepared and corresponding values calculated by the instrument.

|  Component | Source | Level A (ng/mL) | Level B (ng/mL)  |
| --- | --- | --- | --- |
|  Methylenedioxymethamphetamine | Methylenedioxymethamphetamine | 0 | 1000  |

J. Substantial Equivalence Information:

The predicate for the EXTC CAL is the Syva EMIT II Plus Ecstasy calibrators/controls (k043028). The EXTC CAL has the same intended use, analytes, form, matrix and traceability. The only noted difference is that the EXTC CAL has two levels whereas the predicate has four levels.

K. Standard/Guidance Document Referenced (if applicable):

|  STANDARDS  |
| --- |
|  Title and Reference Number  |
|  1) CEN 13540 Stability testing of In-Vitro Diagnostic Devices  |
|  2) ISO 14971: 2000 Medical devices-Application of risk management to medical devices.  |
|  Other Standards  |
|  GUIDANCE  |   |   |
| --- | --- | --- |
|  Document Title | Office Division | Web Page  |
|  Abbreviated 510k Submissions for In Vitro Diagnostic Calibrators | OIVD --- | http://www.fda.gov/cdrh/ode/calibrator.html  |
|  Guidance for Industry and FDA Staff; Use of Symbols on Labels and in Labeling of | CDRH CBER | http://www.fda.gov/cdrh/ocd/guidance/4444.html  |

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In Vitro Diagnostics Devices Intended for Professional Use.

L. Test Principle:
Not applicable (N/A)

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Traceability
The methylenedioxymethamphetamine reference material (99% purity) for the EXTC CAL are traceable to a commercially available provider.
Stability
The sponsor conducted real-time stability studies with the multi-drug calibrator. When punctured (open vial) by the instrument, the vial is stable on board for 24 hours. A non-punctured (open) vial is stable in the refrigerator for 31 days. The closed stability for the EXTC CAL is 12 months.
Value assignment
The new calibrator master lot is made by gravimetrically adding quantities of the reference material into drug free normal human urine. The master lot (5 levels) are stored at -70°C and verified by recovery and GC/MS testing. The commercial lot stock solution is prepared by gravimetrically adding the analytes to form the target concentration. The commercial stock solution concentration is verified by comparing the master lot assigned values. The commercial lot is prepared by adding calculated quantities of the commercial stock solution to drug free normal human urine to the two level target concentrations. The concentration of the commercial lot is verified to be within acceptable ranges using an instrument calibrated with the master lot

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and GC/MS testing.

d. Detection limit:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical Sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a. and b. are not applicable):
N/A

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
N/A

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N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K062182](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DLJ/K062182)

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