DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H

K072435 · Dade Behring, Inc. · JIX · Oct 17, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072435
• Device Name: DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
• Applicant: Dade Behring, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

PROT3 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for the a1 -Microglobulin (A1MIC), Cystatin C(CYSC), Microalbumin (MALB) and specialty Albumin (sALB)* methods. * For serum, plasma and cerebrospinal fluid. PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of a 1-Microglobulin (A IMIC), specialty Albumin (sAlb)** and Microalbumin (MALB) on the Dimension Vista System. ** For cerebrospinal fluid (CSF). PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) soluble Transferrin Receptor (sTFR) specialty Albumin (sALB)*** Transferrin (TRF). PROT1 CON M and PROT1 CON H are assayed, mid-level and high level respectively, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista System in the quantitative determination of: a1-Acid Glycoprotein (A1AG) a1-Antitrypsin (A1AT) B2-Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Homocysteine (HCYS) Immunoglobulin A (IGA) Immunoglobulin E (IGE) Immunoglobulin G (IGG) Immunoglobulin M (IGM) Prealbumin (PREALB) specialty Albumin (sALB)*** soluble Transferrin Receptor (sTFR) Transferrin (TRF). *** For serum and plasma.

Device Story

Dimension Vista® Protein Controls and Calibrator are human-derived, liquid or lyophilized products used to calibrate and monitor the performance of the Dimension Vista® System. Controls (L, M, H) assess precision and analytical bias; Calibrator (PROT3 CAL) establishes system calibration. Used in clinical laboratories by technicians; output is used by healthcare providers to verify assay accuracy and ensure reliable patient test results for protein analytes. Benefits include standardized diagnostic testing and improved clinical decision-making through validated system performance.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Multi-analyte, lyophilized or liquid formulations based on polygeline or human serum. Contains human-derived proteins. Designed for use on the Dimension Vista System. No specific materials standards or software algorithms described.

Indications for Use

Indicated for use as intralaboratory quality control and calibration material for the Dimension Vista® System to assess precision, analytical bias, and calibration for various serum, plasma, and cerebrospinal fluid protein analytes.

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 Vista® Protein 3 Calibrator (K063508)
• Dimension Vista® Protein 3 Control (K063508)
• Dimension Vista® Protein 1 Control L (K063663)
• Dimension Vista® Protein 1 Control M (K063663)
• Dimension Vista® Protein 1 Control H (K063663)

Submission Summary (Full Text)

{0}

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

A. 510(k) Number:
k072435

B. Purpose for Submission:
This submission is for the addition of albumin to the Dimension Vista® Protein Control 1 L, M, H; Dimension Vista® Protein 3 Control; and Dimension Vista® Protein 3 Calibrator

C. Measurand:
None – submission is for clearance of calibrator and control material

D. Type of Test:
Calibrators and Controls

E. Applicant:
Dade Behring, Inc.

F. Proprietary and Established Names:
Dimension Vista® Protein 1 Control L (low)
Dimension Vista® Protein 1 Control M (medium)
Dimension Vista® Protein 1 Control H (high)
Dimension Vista® Protein 3 Calibrator
Dimension Vista® Protein 3 Control

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150 – Calibrator
21 CFR § 862.1660 – Quality Control material (assayed and unassayed)

{1}

2. Classification:
Class II (calibrator)
Class I, reserved (control—assayed and unassayed)

3. Product code:
JIX – Calibrator, multi-analyte,
JJY – Control, assayed and unassayed

4. Panel:
Clinical Chemistry (75)

H. Intended Use:

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

2. Indication(s) for use:
PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-Acid Glycoprotein (A1AG), α₁-Antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), Albumin (sALB)*, soluble Transferrin receptor (STFR), Transferrin (TRF).

*For serum and plasma
PROT1 CON M is an assayed, mid-level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-Acid Glycoprotein (A1AG), α₁-Antitrypsin (A1AT), β₂-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), Albumin (sALB)*, soluble Transferrin receptor (STFR), Transferrin (TRF).

*For serum and plasma
PROT1 CON H is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: α₁-Acid Glycoprotein (A1AG), α₁-Antitrypsin (A1AT), β₂-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS),

{2}

Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), Albumin (sALB)*, soluble Transferrin receptor (STFR), Transferrin (TRF).

*For serum and plasma

PROT3 CON is an assayed intralaboratory quality control, for assessment of precision and analytical bias in the determination of $\alpha_{1}$-Microglobulin (A1MIC), Albumin (sALB)$^{1}$ and Microalbumin (MALB) on the Dimension Vista$^{\text{®}}$ System.

$^{1}$For cerebrospinal fluid

PROT3 CAL is an *in vitro* diagnostic product for the calibration of the Dimension Vista$^{\text{®}}$ System for the $\alpha_{1}$-Microglobulin (A1MIC), Cystatin C (CYSC), Microalbumin (MALB) and Albumin (sALB)* methods.

*For serum, plasma and cerebrospinal fluid

3. Special conditions for use statement(s):

For prescription use.

4. Special instrument requirements:

For use with the Dade Behring Dimension Vista$^{\text{®}}$ System

I. Device Description:

Dimension Vista® Protein 1 Control L (low): PROT1 CON L is a multi-analyte, low level liquid human serum based product containing human $\alpha_{1}$-acid glycoprotein, albumin, $\alpha_{1}$-antitrypsin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin M, prealbumin, soluble transferrin receptor, transferrin, and purified S-adenosylhomocysteine.

Dimension Vista® Protein 1 Control M (medium): PROT1 CON M is a multi-analyte, mid-level liquid human serum based product containing human $\alpha_{1}$-acid glycoprotein, albumin, $\alpha_{1}$-antitrypsin, $\beta_{2}$-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin M, prealbumin, soluble transferrin receptor, transferrin, and purified S-adenosylhomocysteine.

Dimension Vista® Protein 1 Control H (high): PROT1 CON H is a multi-analyte, high level liquid human serum based product containing human $\alpha_{1}$-acid glycoprotein, albumin, $\alpha_{1}$-antitrypsin, $\beta_{2}$-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin M, prealbumin, soluble transferrin receptor, transferrin, and purified S-adenosylhomocysteine.

Dimension Vista® Protein 3 Control: PROT3 CON is a multi-analyte, low level lyophilized, polygeline and rabbit albumin based product containing urinary $\alpha_{1}$-

{3}

microglobulin and serum albumin of human origin.

Dimension Vista® Protein 3 Calibrator: PROT3 CAL is a multi-analyte, lyophilized, polygeline based product containing urinary $\alpha_{1}$-microglobulin, cystatin C and serum albumin of human origin.

Each donor or donor unit was tested and found to be negative for human immunodeficiency virus (HIV) 1 and 2, Hepatitis B virus (HBV), and Hepatitis C virus (HCV) using either tests found to be in conformance with the In Vitro Diagnostic Directive in the EU or FDA approved tests. Because no known test can offer complete assurance of the absence of infectious agents, all human derived products should be handled with caution.

The previously cleared analytes for the calibrators and controls were cleared under k061990, k063351, k063508, k051087, k061338, k061845, k061852, k062055, k063206, k063222, k063425, k063508, k063610, k063655, k063663, k063272, and k071980.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

Dimension Vista® Protein 1 Control L (low)

Dimension Vista® Protein 1 Control M (medium)

Dimension Vista® Protein 1 Control H (high)

Dimension Vista® Protein 3 Calibrator

Dimension Vista® Protein 3 Control

2. Predicate K number(s):

k063508, k063663

3. Comparison with predicate:

Dimension Vista® Protein 3 Calibrator

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Form | Lyophilized polygelene human based albumin | Lyophilized polygelene human based albumin |
| Traceability to | ERM®-DA470(C470) | ERM®-DA470(C470) |

{4}

Dimen sion Vista® Protein 3 Control

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Form | Lyophilized polygelene human based albumin | Lyophilized polygelene human based albumin |
| Traceability to | ERM®-DA470(C470) | ERM®-DA470(C470) |

Dimen sion Vista® Protein 1 Control L

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | Albumin, α1-Microglobulin, Microalbumin, Cystatin C | α1-Microglobulin, Microalbumin, Cystatin C |
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Form | Human source material | Human source material |
| Constituents | A1-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), soluble Transferrin receptor (STFR), Transferrin (TRF). | α1-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), soluble Transferrin receptor (STFR), Transferrin (TRF). |

{5}

Dimension Vista® Protein 1 Control M, H

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | Albumin, α1-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), β2-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), soluble Transferrin receptor (STFR), Transferrin (TRF). | α1-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), soluble Transferrin receptor (STFR), Transferrin (TRF). |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | Albumin, α1-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), β2-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), soluble Transferrin receptor (STFR), Transferrin (TRF). | α1-Acid Glycoprotein (A1AG), α1-Antitrypsin (A1AT), β2-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), soluble Transferrin receptor (STFR), Transferrin (TRF). |

{6}

| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | Albumin, α_{1}-Acid Glycoprotein (A1AG), α_{1}-Antitrypsin (A1AT), β_{2}-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), soluble Transferrin receptor (STFR), Transferrin (TRF). | α_{1}-Acid Glycoprotein (A1AG), α_{1}-Antitrypsin (A1AT), β_{2}-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Homocysteine (HCYS), Immunoglobulins A (IGA), E (IGE), G (IGG), M (IGM), Prealbumin (PREALB), soluble Transferrin receptor (STFR), Transferrin (TRF). |

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

Not Applicable

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

{7}

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

Traceability

| Control or Calibrator | Standard for Traceability |
| --- | --- |
| Protein Control 1 (L, M, H), Protein Control 3, Protein Calibrator 3 | Protein reference preparation ERM® - DA470 (CRM 470) |

## Stability

The calibrators and controls are tested per the same stability protocol. The stability protocols and acceptance criteria were reviewed and found to be acceptable.

## Value Assignment

The calibrator master lot value is assigned vs. ERM®-DA470 (CRM470). Values assigned to the controls are calibrated by reference to protein standard preparations and are lot-dependent.

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

{8}

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.