DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)

K061923 · Dade Behring, Inc. · JIX · Aug 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061923
• Device Name: DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The ENZ 1 CAL is an in vitro diagnostic product for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase (PCHE) methods on the Dimension Vista™ System.

Device Story

ENZ 1 CAL is a liquid, multi-analyte, bovine serum albumin-based calibrator kit; contains amylase (human saliva), GGT (bovine kidney), LDH (chicken heart), lipase (porcine pancreas), and pseudocholinesterase (horse serum). Kit includes six vials (three of Calibrator A, three of Calibrator B); ready-to-use. Used in clinical laboratory settings by trained personnel to calibrate the Dimension Vista System. Output is a set of assigned values used to establish the calibration curve for specific enzyme assays on the instrument. Enables accurate quantitative measurement of patient enzyme levels, supporting clinical diagnosis and monitoring of related metabolic or organ-specific conditions.

Clinical Evidence

No clinical data. Bench testing only. Traceability of assigned values was verified using the Dimension Vista System calibrated with an approved Master Pool. Stability testing (real-time) was conducted to support a 12-month shelf life at 4°C, with specific stability claims for on-board (1 day) and open-vial (30 days) storage.

Technological Characteristics

Liquid, multi-analyte calibrator. Matrix: Bovine serum albumin base. Analytes: Amylase (human saliva), GGT (bovine kidney), LDH (chicken heart), lipase (porcine pancreas), PCHE (horse serum). Traceability: Master Pool, Dimension clinical chemistry system. Stability: 12-month shelf life; 31-day open-vial stability (refrigerated); 7-day on-instrument stability. Complies with CEN 13640 and ISO 14971.

Indications for Use

Indicated for the calibration of Amylase, GGT, LDH, Lipase, and Pseudocholinesterase assays on the Dimension Vista System. For professional, prescription use only.

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)
• Dimension® Lipase Calibrator (K952815)
• Dimension® PCHE Verifier (K883891)

Submission Summary (Full Text)

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

A. 510(k) Number:
k061923

B. Purpose for Submission:
New Device

C. Measurand:
Calibrator materials for Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase (PCHE)

D. Type of Test:
Not Applicable

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista Enzyme 1 Calibrator, (KC310)

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.

2. Indication(s) for use:

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The ENZ 1 CAL is an in vitro diagnostic product for the calibration of Amylase (AMY), Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase (LDH), Lipase (LIP), and Pseudocholinesterase (PCHE) methods 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:

ENZ 1 CAL is a liquid, multi-analyte, bovine serum albumin based product containing amylase (human saliva), gamma-glutamyl transferase (bovine kidney), lactate dehydrogenase (chicken heart), lipase (porcine pancreas), and pseudocholinesterase (horse serum). 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 2.5 mL.

J. Substantial Equivalence Information:

| | Device | Predicate Devices | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Item | Dimension Vista™ System Chemistry 1 Calibrator | Chem I Calibrator K860021 (URCA-k862359) | Chemistry II Calibrator k861700 | Cholesterol Calibrator k861700 | Troxine Calibrator k862359 | Thyroxine Uptake Calibrator k862359 |
| Intended Use | The CHEM I CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Tyrosine Uptake (TU), Blood Urea Nitrogen (BUN)2 and Uric Acid (URCA) methods on the Dimension Vista Systems. | The Dimension® Chemistry I Calibrator is an in vitro diagnostic product used to calibrate the Dimension® clinical chemistry system for the Calcium (CA), Creatinine (CREA), Glucose (GLU/GLUC), Lactic Acid (LA), Urea Nitrogen (BUN) and Uric Acid (URCA) methods. | Chem II Calibrator is and in vitro diagnostic product to be used to calibrate the Dimension® clinical chemistry system for the Magnesium (MG), phosphorus (PHOS) and Triglycerides (TRIG) methods. | The Dimension® Cholesterol Calibrator is an in vitro diagnostic product to be used to calibrate the Dimension® clinical chemistry system for the Cholesterol (CHOL) method. | The Dimension® Thyroxine Calibrator is and in vitro diagnostic product to be used to calibrate the Dimension® clinical chemistry system for the Thyroxine (T4) method. | The Dimension® Thyroxine Uptake is an in vitro diagnostic product to be used to calibrate the Dimension® clinical chemistry system for the Thyroxine (T4) method. |

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| | Device | Predicate Devices | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Item | Dimension Vista™ System Chemistry 1 Calibrator | Chem I Calibrator K860021 (URCA-k862359) | Chemistry II Calibrator k861700 | Cholesterol Calibrator k861700 | Troxine Calibrator k862359 | Thyroxine Uptake Calibrator k862359 |
| Analytes | Calcium (CA, Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) | Calcium (CA, Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Blood Urea Nitrogen (BUN) and Uric Acid (URCA) | Magnesium (MG) | Cholesterol (CHOL) | Thyroxin (T4) | Thyronine Uptake (TU) |
| Form | Liquid | Lyophilized | Liquid | Lyophilized | Lyophilized | Lyophilized |
| Trace-a bility | Bun – NIST SRM 912², CA – Abell Kendall (CDC-NCEP), CREA-NIST SRM 914, GLU-NIST SRM 917, LA-Lactic Acid-lithium salt A-Grade, MG-NIST SRM 929A, T4-USP, TU-Calculated value, URCA-NIST SRM 913 | BUN- NIST SRM 912, CA-NIST SRM 915, CREA-NIST SRM 915, CREA-NIST SRM 914, GLU-NIST SRM 917, LA- Lactic Acid- lithium salt A-Grade, URCA-NIST SRM 913 | MG- NIST SRM 924A | CHOL-NIST SRM 911 | T4-Thyroxine Master Pool | TU- Thyronine Uptake Master Pool |
| Matrix | Bovine serum albumin based product. | Bovine serum albumin based product. | Pure magnesium dissolved in a dilute solution of HCL, reagent grade potassium dihydrogen phosphate and reagent grade glycerol | Bovine serum albumin based product | Human serum base product | Human serum base product |
| Number of Levels | Two levels | Three levels | Three levels | Three levels | Five levels | Five 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) |

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| 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 Enzyme 1 Calibrator were verified on a Dimension® Vista™ System calibrated with an approved Master Pool. Master Pool values were assigned on multiple Dimension® clinical chemistry instruments. According to the sponsor the traceability of the assigned values of the Enzyme 1 Calibrator was standardized to the below table of assigned values.

| Analyte | Reference System | Master Pool Levels |
| --- | --- | --- |
| Amylase (AMY) | Dimension® clinical chemistry system | 3 |
| γ-Glutamyl Transferase (GGT) | Dimension® clinical chemistry system | 3 |
| Lactic Dehydrogenase (LDH) | Dimension® clinical chemistry system | 3 |

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| Lipase (LIP) | Dimension® clinical chemistry system | 4 |
| --- | --- | --- |
| Pseudocholinesterase (PCHE) | Dimension® clinical chemistry system | 3 |

Stability: The target shelf life for the Dimension Vista™ Chemistry I Calibrator is 12 months. The sponsor’s shelf life was determined by comparing results of the product stored at 4°C with control stored at -20°C. Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.

A vial punctured by the instrument and stored on board has a stability claim of one day.

An open vial not on instrument, but recapped and stored is a refrigerator has a stability claim of 30 days.

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:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

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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 equivalent decision.

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