← Product Code [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX) · K061390

# DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 (K061390)

_Dade Behring, Inc. · JIX · Jul 5, 2006 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K061390

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX.md)
- **Decision Date:** Jul 5, 2006
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1150
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for Use

The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension Vista™ System.

## Device Story

Enzyme 2 Calibrator is a liquid, multi-analyte, bovine serum albumin-based product containing porcine heart-derived ALT and AST. Used on the Dimension Vista™ System to calibrate ALT and AST assays. Kit includes six ready-to-use vials (three of Calibrator A, three of Calibrator B). Provides traceability to ALT/AST Master pool values. Used by clinical laboratory professionals to ensure accurate instrument calibration for diagnostic testing.

## Clinical Evidence

No clinical data. Bench testing only. Stability testing (12-month shelf life, 7-day on-board stability) performed per ISO 13640. Traceability verified against Master pool values on Dimension® instruments.

## Technological Characteristics

Liquid, bovine serum albumin-based matrix; contains porcine heart-derived ALT and AST. Two-level calibration system. Ready-to-use. Traceable to Dimension® clinical chemistry system Master pool values. Complies with ISO 14971:2000 risk management standards.

## Regulatory 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.)

## 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

- Dimension® Enzyme Verifier ([K860021](/device/K860021.md))

## Submission Summary (Full Text)

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

A. 510(k) Number:
k061390

B. Purpose for Submission:
New Device

C. Measurand:
Calibrator for Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)

D. Type of Test:
Not Applicable

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista™ Enzyme 2 Calibrator (ENZ 2 Cal –KC320)

G. Regulatory Information:

|  Product Code | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  Calibrator, Multi-Analyte Mixture (JIX) | Class II | 21 CFR 862.1150, Calibrator | 75 Clinical Chemistry (CH)  |

H. Intended Use:

1. Intended use(s):
See below indications(s) for use.

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2. Indication(s) for use:

The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension Vista™ System

3. Special conditions for use statement(s):

For Prescription use.

4. Special instrument requirements:

Dimension Vista™ System

I. Device Description:

The Enzyme 2 Calibrator is a liquid, multi-analyte, bovine serum albumin based product containing alanine aminotransferase (ALT) and aspartate aminotransferase (AST) from porcine heart.

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 1.5 mL.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Dimension(R) Clinical Chemistry System calibrator

2. Predicate 510(k) number(s):

k860021

3. Comparison with predicate:

|  Item | Similarities | Differences  |
| --- | --- | --- |
|  Analytes | Both device and predicate are to be used on the AST and ALT assays. | Device does not include: Alkaline phosphatase (ALP), Amylase (AMY) g-glutamyl transferase (GGT), or Lactic dehydrogenase (LDH)  |
|  Form | None | Device is liquid while predicate is lyophilized.  |

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|  Item | Similarities | Differences  |
| --- | --- | --- |
|  Intended Use | Both device and predicate are to be used on the AST and ALT assays. | The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) on the Dimension Vista™ System. Enzyme Verifier is an in vitro diagnostic product to be used to verify alkaline phosphatase (ALP), amylase (AMY), g-glutamyl transferase (GGT), aspartame aminotransferase (AST), alanine aminotransferase (ALT) and lactic dehydrogenase (LDH) method performance on the Dimension® clinical chemistry system.  |
|  Traceability | Both device and predicate are traceable to ALT/AST Master pool Dimension® clinical chemistry system values. | None  |
|  Matrix | Both device and predicate have porcine heart product in base. | Device - Bovine serum and porcine heart based product.
Predicate - Human serum and porcine heart based product  |
|  Calibration / Verification Levels | None | Device has two levels where predicate has three levels.  |

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

|  STANDARDS  |
| --- |
|  Title and Reference Number  |
|  Stability Testing of In Vitro Diagnostic Reagents (13640)  |
|  Medical devices - Application of risk management to medical devices (14971:2000)  |
|  GUIDANCE  |   |   |   |
| --- | --- | --- | --- |
|  Document Title | Office | Division | Web Page  |
|  Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final | 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 Diagnostic Devices Intended for Professional Use |  |  | http://www.fda.gov/cdrh/ocd/guidance/4444.html  |

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L. Test Principle:

Not applicable.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability: The assigned values of the Enzyme 2 Calibrator are verified on a Dimension® instrument calibrated with an approved Master Pool. Master Pool values is assigned on multiple Dimension® clinical chemistry instruments.

Stability: Calibrator shelf life for the Dimension Vista™ Enzyme 2 Calibrator was determined to be 12 months. A vial that has been punctured (opened) by the instrument and stored on board has a seven day stability claim. Stability study protocols and acceptance criteria were described and found to be acceptable.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device:

Not applicable

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b. Matrix comparison:
Not applicable

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

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

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/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K061390](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K061390)

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