← Product Code [DKB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB) · K062162

# DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) (K062162)

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

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K062162

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [DKB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB.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 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. For prescription use only.

## Device Story

UDAT CAL is a liquid, multi-analyte, human urine-based calibrator; consists of 6 vials (three Level A, three Level B). Used on Dade Behring Dimension Vista System; calibrates assays for Amphetamines, Barbiturates, Benzodiazepines, Cocaine metabolite, Methadone, Methaqualone, Opiates, Phencyclidine, Propoxyphene, and Cannabinoids. Level A contains 0 ng/mL; Level B contains specific concentrations of analytes. Intermediate levels are calculated by the instrument. Used in clinical toxicology settings by laboratory professionals. Provides reference points for instrument calibration to ensure accurate patient sample testing.

## Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed 24-hour on-board stability (punctured), 31-day refrigerated stability (open), and 9-month closed-vial stability. Value assignment verified via gravimetric preparation, recovery testing, and GC/MS analysis.

## Technological Characteristics

Liquid, multi-analyte, human urine-based calibrator. Traceable to USP reference materials or high-purity (99%) standards. Two-level kit (A and B). Automated intermediate level preparation via Dimension Vista System. Stability: 9 months shelf life; 24-hour on-board stability; 31-day open-vial stability.

## 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® Calibrators/Controls ([K993755](/device/K993755.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

1

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

A. 510(k) Number:
k062162

B. Purpose for Submission:
New device

C. Measurand:
Amphetamines/ Methamphetamines, Barbiturates, Benzodiazepines, Cocaine metabolite, Methadone, Methaqualone, Opiates, Phencyclidine, Propoxyphene, and Cannabinoids

D. Type of Test:
Calibrator Materials

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista System Drugs of Abuse Calibrator (UDAT CAL - KC510)

G. Regulatory Information:
|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  Calibrators, Drug Mixture (DKB) | 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:

{1}

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.

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

Dade Behring Dimension Vista System

I. Device Description:

The UDAT 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 contain 2.5 mL and Calibrator B vials contain 2.6 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)  |
| --- | --- | --- | --- |
|  Amphetamines 300 | d-methamphetamine | 0 | 1000  |
|  Amphetamines 500 | d-methamphetamine | 0 | 1000  |
|  Amphetamines 1000 | d-methamphetamine | 0 | 2000  |
|  BARB | Secobarbital | 0 | 800  |
|  BENZ | Lormetazepam | 0 | 1000  |
|  COC 150 | Benzoylecogonine | 0 | 1000  |
|  COC 300 | Benzoylecogonine | 0 | 1000  |
|  METH | Methadone | 0 | 1000  |
|  MTQ | Methaqualone | 0 | 1000  |
|  OPI 300 | Morphine | 0 | 2000  |
|  OPI 2000 | Morphine | 0 | 4000  |
|  PCP | Phencyclidine | 0 | 75  |
|  PRX | Propoxyphene | 0 | 500  |
|  THC | 11-nor-delta 9-THC-9-COOH | 0 | 100  |

J. Substantial Equivalence Information:

The predicate for the UDAT CAL is the Syva EMIT Calibrators/controls (k993755). The UDAT CAL has the same intended use, analytes, form, matrix and traceability.

{2}

The only noted difference is that the UDAT CAL has two levels whereas the predicate has six 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 In Vitro Diagnostics Devices Intended for Professional Use. | CDRH CBER |  | http://www.fda.gov/cdrh/ocd/guidance/4444.html  |

## 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

All analytes used in the UDAT CAL are traceable to commercially available USP reference material and/or Cerilliant reference material.

{3}

4

# 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 UDAT CAL is 9 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 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:

{4}

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

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.

---

**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K062162](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K062162)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com