DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
Applicant
Dade Behring, Inc.
Product Code
JIX · Clinical Chemistry
Decision Date
Jul 5, 2006
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1150
Device Class
Class 2
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.
Indications for Use
Indicated for the calibration of ALT and AST assays on the Dimension Vista™ System in a clinical laboratory setting.
Regulatory Classification
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.
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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.
