DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H

K071980 · Dade Behring, Inc. · JJY · Sep 11, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071980
• Device Name: DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H
• Applicant: Dade Behring, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

PROT1 Cal is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: α₁-acid glycoprotein, α₁ antitrypsin, β₂-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin. PROT1 CON L is an assayed, low level, intra-laboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-acid glycoprotein, α₁ antitrypsin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin. PROT1 CON M and H are assayed, mid- and high level, intra-laboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-acid glycoprotein, α₁-antitrypsin, β₂-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.

Device Story

Multi-analyte, liquid, human serum-based calibrator and quality control materials; used for calibration and assessment of precision/analytical bias on the Dimension Vista System; contains sodium azide preservative; provides reference values for specific proteins including hemopexin, IgG subclasses, and retinol binding protein; used by laboratory personnel in clinical settings to ensure accuracy of automated turbidimetric immunoassays.

Clinical Evidence

No clinical data. Bench testing only. Stability studies conducted over 24 months; value assignment validated against ERM-DA470 and highly purified protein preparations.

Technological Characteristics

Liquid, human serum-based multi-analyte products. Calibrator and controls are designed for use on the Dimension Vista System. No specific materials or software algorithms described for the calibrator/control products themselves.

Indications for Use

Indicated for use as calibrators and quality control materials for the quantitative determination of specific proteins on the Dade Behring Dimension Vista System. For prescription use only.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Dimension Vista® Protein 1 Calibrator and Protein 1 Control L, M, and H (k063663)

Submission Summary (Full Text)

{0}

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

A. 510(k) Number:
k071980

B. Purpose for Submission:
Add additional analytes to existing multi-analyte calibrator and controls

C. Measurand:
New analytes added: Hemopexin (HPX), immunoglobulin IgG subclasses (IgG1, IgG2, IgG3 and IgG4), and retinol binding protein

D. Type of Test:
Calibrator and controls for an automated turbidimetric immunoassay

E. Applicant:
Dade Behring

F. Proprietary and Established Names:
Dade Behring Dimension Vista® Protein 1 Calibrator (Prot1 Cal) and Dimension Vista® Protein 1 Control L, M, and H (Prot1 control L, M, or H)

G. Regulatory Information:
1. Regulation section:
CFR 862.1150 Calibrator
CFR 862.1660 Quality control materials (assayed and unassayed)
2. Classification:
Calibrator: Class II
Controls: Class I
3. Product code:
JIX Calibrator, multi-analyte mixture
JJY Multi-analyte controls, all kinds (assayed and unassayed)
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
PROT1 Cal is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: α₁-acid glycoprotein, α₁ antitrypsin, β₂-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.
PROT1 CON L is an assayed, low level, intra-laboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-acid glycoprotein, α₁ antitrypsin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.
PROT1 CON M and H are assayed, mid- and high level, intra-laboratory quality

{1}

controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: $\alpha_{1}$-acid glycoprotein, $\alpha_{1}$-antitrypsin, $\beta_{2}$-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.

2. Indication(s) for use:
Same as the Intended Uses

3. Special conditions for use statement(s):
For prescription use only

4. Special instrument requirements:
Dade Behring Dimension Vista System

I. Device Description:

PROT1 CAL is a multi-analyte, liquid, human serum based product containing: $\alpha_{1}$-acid glycoprotein, $\alpha_{1}$-antitrypsin, $\beta_{2}$-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin. It is ready to use and contains sodium azide (<0.1%) as a preservative.

PROT1 CON L, M, or H are multi-analyte, liquid, human serum based product containing: $\alpha_{1}$-acid glycoprotein, $\alpha_{1}$-antitrypsin, $\beta_{2}$-microglobulin (PROT1 CON M and H only), C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, IgA, IgE, IgG, IgG subclasses (IgG1, IgG2, IgG3, and IgG4), IgM, prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin. These reagents are ready to use and contain sodium azide (<0.1%) as a preservative.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Dimension Vista® Protein 1 Calibrator and Protein 1 Control L, M, and H

2. Predicate K number(s):
k063663

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | 1) Calibration of the Dimension Vista System 2) Assessment of precision and analytical bias | Same |
| Matrix | Liquid, human serum | Same |
| Levels | 1 calibrator level
3 control levels | Same |
| Preservative | Sodium azide | Same |
| Source material | Homocysteine – purified S-adenosylhomocysteine; All other analytes – human | Same |

{2}

| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | Addition of **hemopexin**, **IgG subclasses (IgG1, IgG2, IgG3, and IgG4)**, **IgM**, **retinol binding protein** to predicate list of analytes. | α_{1}-acid glycoprotein, α_{1}-antitrypsin, β_{2}-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, homocysteine, IgA, IgE, IgG, IgM, prealbumin, soluble transferrin receptor, and transferrin |

K. Standard/Guidance Document Referenced (if applicable):
None referenced

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 of Added Constituents:
| Analyte | Traceability to: |
| --- | --- |
| IgG subclasses (IgG1, IgG2, IgG3, and IgG4) | ERM-DA470 (CRM 470) |
| Hemopexin, retinol binding protein | Highly purified protein |

Stability:
The calibrators and controls follow the same stability protocol. Products are stored at 2-8° C and the stability studies are conducted for 24 months using 3 vials and 3 replicates per vial. Testing cycles are 0, 12, 18, and 24 months. Additional stress testing is done at 6 months after storing the product at 37° C for 2 weeks then testing at 1 and 2 weeks. Open/punctured vial testing is performed at the mid-point of the shelf life study period. Vials are stored on board the instrument and contents are tested in duplicate on days 0, 4, 7, 9, 11 and 14. Acceptance criteria must be met.

Value assignment:
The calibrator master lot values for IgG 1-4 are assigned versus ERM-DA 470 (CR 470) using independently determined values for subclasses compared to

{3}

total IgG value of the reference material. The master calibrator lot values for hemopexin and retinol binding protein are assigned versus highly purified protein preparations. Commercial lot values are then assigned versus Master Calibrators with 3 reference curves, 4 runs, 3 vials, 4 replicates per vial tested on two nephelometric systems for a total of 144 values. The sum of IgG 1-4 must be $\pm 20\%$ of the total IgG.

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
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.