DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)

K061818 · Dade Behring, Inc. · JIT · Jul 18, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061818
• Device Name: DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330)
• Applicant: Dade Behring, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista™ System.

Device Story

Dimension Vista ALP Calibrator (KC330) is a liquid, bovine protein-based product containing porcine kidney-derived alkaline phosphatase; used for calibrating ALP assays on Dimension Vista clinical chemistry systems. Kit consists of three ready-to-use vials (1.0 mL each); system water serves as the zero calibrator. Device is used by laboratory professionals in clinical settings to ensure accurate quantitative measurement of ALP. Calibration process involves instrument-based analysis of calibrator levels to establish assay performance parameters. Proper calibration enables clinicians to obtain reliable ALP measurements for patient diagnostic assessment.

Clinical Evidence

No clinical data. Bench testing only. Stability testing performed per ISO 13640; shelf-life stability validated via comparison of -70°C vs -20°C storage (percent change ≤ 6%). Open vial stability established at 7 days on-instrument and 30 days refrigerated. Value assignment verified via N=45 replicates on multiple instruments.

Technological Characteristics

Liquid bovine protein-based matrix containing porcine kidney-derived alkaline phosphatase. Ready-to-use. Traceable to Master Pool, Dimension clinical chemistry system values. Stability tested per CEN 13640. Risk management per ISO 14971:2000.

Indications for Use

Indicated for the calibration of the Alkaline Phosphatase (ALP) assay 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.

Predicate Devices

• Dimension® Enzyme Verifier (k860021)
• VITROS Chemistry Products Calibrator Kit 3

Submission Summary (Full Text)

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

A. 510(k) Number:
k061818

B. Purpose for Submission:
New device

C. Measurand:
Alkaline Phosphatase

D. Type of Test:
Calibrator material

E. Applicant:
Dade Behring Inc.

F. Proprietary and Established Names:
Dimension Vista™ System Alkaline Phosphatase Calibrator (ALP CAL – KC330)

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| Calibrator, secondary (JIT) | Class II | 21 CFR 862.1150 Calibrator | 75 Clinical Chemistry (CH) |

H. Intended Use:

1. Intended use(s):
The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista™ System.

2. Indication(s) for use:
See Intended use above

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3. Special conditions for use statement(s):

Prescription use only

4. Special instrument requirements:

Dimension Vista

I. Device Description:

The ALP CAL is a liquid bovine protein product containing alkaline phosphatase from porcine kidney. The kit consists of three vials of Calibrator A. The volume per vial is 1.0 mL. ALP CAL is ready for use, no preparation is required. System water is used as the ALP zero calibrator (Level 1) for the Dimension Vista™ System.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Dimension® Enzyme Verifier (DC19) and VITROS Chemistry Products Calibrator Kit 3.

2. Predicate K number(s):

k860021 for Dimension® clinical chemistry system.

3. Comparison with predicate:

| Item | Dimension Vista™ System ALP Calibrator (New device) | Dimension® Enzyme Verifier (Predicate device) |
| --- | --- | --- |
| Intended Use | The ALP Calibrator is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALP) 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. |
| Analytes | Alkaline phosphatase (ALP). | Alkaline phosphatase (ALP), Amylase (AMY) g-glutamyl transferase (GGT), Aspartame aminotransferase (AST), Alanine aminotransferase (ALT), Lactic dehydrogenase (LDH). |
| Form | Liquid. | Lyophilized |
| Traceability | Master Pool, Dimension® clinical chemistry system values. | Master Pool, Dimension® clinical chemistry system values. |
| Matrix | Bovine protein, porcine kidney based product. | Human serum, bovine kidney based product. |
| Calibration / Verification Levels | One level. | Three levels. |

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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) |

Other Standards

| 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 |

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 Alkaline Phosphatase Calibrator are traceable to Master Pool, Dimension® Clinical Chemistry System.

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# Stability:

Target shelf life for the ALP calibrator is 12 months. Calibrator shelf life (long term) stability is determined by comparing results of the product stored at -70°C with control stored at -20°C. Percent change should be less than or equal to 6%. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc. Open vial (in use) stability is 7 days if kept on the instrument and 30 days if stored in the refrigerator.

# Value Assignment:

The new calibrator Master Pool is made by gravimetrically adding quantities of alkaline phosphatase to StabilZyme® AP to target concentrations. Three levels of Master Pool are prepared and stored at -70°C. The concentrations are verified using a previously approved Master Pool lot as a control. The final bottle value for the Master Pool is assigned for each level by testing N = 45 replicates on multiple instruments. A stock solution is prepared for the new commercial calibrator lot by gravimetrically adding alkaline phosphatase to StabilZyme® AP to target concentration. The stock solution concentration is verified by comparing the Master Pool assigned bottle values. For the commercial calibrator lot, calculated quantity of the stock solution is added to StabilZyme® AP to target concentrations. The concentration of the commercial lot is verified to be within acceptable range by using an instrument calibrated with Master Pools. The final bottle value is assigned to the commercial lot level and verified using a previously released commercial lot of calibrator on multiple instruments for N = 45 total replicates.

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

b. Matrix comparison:

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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):
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.