DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

K082503 · Siemens Healthcare Diagnostics · DFH · Dec 19, 2008 · Immunology

Device Facts

• Record ID: K082503
• Device Name: DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL
• Applicant: Siemens Healthcare Diagnostics
• Product Code: DFH · Immunology
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5550
• Device Class: Class 2

Intended Use

The KAPPA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® Systems. Measurements of the various amounts of the different types of light chains aid in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus. The LAMBDA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type lambda in human serum and plasma on the Dimension Vista® Systems. Measurements of the various amounts of the differant types of light chains aid in the diagnosis of multiple myeloma cancer of antibody-forming cells) lymphocytic neoplasms ( cancer of lymohoid tissue), Waldenstom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Device Story

Device uses immunonephelometry to quantify kappa and lambda light chains in human serum/plasma. Input: patient sample mixed with rabbit polyclonal antisera; reaction forms immune complexes scattering light. Output: light intensity proportional to protein concentration. Used in clinical labs on Dimension Vista® Systems. Results aid clinicians in diagnosing multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, and connective tissue diseases. System provides automated quantitative analysis, replacing manual or older platform methods.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2; linearity per CLSI EP6-A; LoQ per CLSI EP17-A. Method comparison (n=66-93 samples) against predicate showed high correlation (R² ≥ 0.950). Matrix comparison (serum vs. plasma) confirmed recovery within acceptable limits. No clinical data required.

Technological Characteristics

Immunoturbidimetric assay principle. Reagents contain specific antibodies for light chain detection. Calibrators and controls are liquid human serum-based products. System utilizes light scattering measurement. Designed for use on Dimension Vista Systems.

Indications for Use

Indicated for quantitative measurement of kappa and lambda immunoglobulin light chains in human serum and plasma to aid in diagnosis of multiple myeloma, lymphocytic neoplasms, Waldenstrom's macroglobulinemia, and connective tissue diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).

Regulatory Classification

Identification

An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Predicate Devices

• Dade Behring N Antisera to Human Immunoglobulin/L-chains (K860894)
• N Protein Standard SL (K012470)
• N/T Protein Controls SL (K012468)

Submission Summary (Full Text)

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Korsosoz

### 510(k) Summary for

# DEC 1 9 2008

Dimension Vista® KAPPA Flex® reagent cartridge

Dimension Vista® LAMBDA Flex® reagent cartridge

Dimension Vista® Protein 1 Calibrator

Dimension Vista® Protein 1 Control L, M and H

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

## 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:

Manufacturer: Dade Behring Marburg GmbH

Emil-von-Behring Str. 76

35041 Marburg, Germany

Contact Information: Sicmens Healthcare Diagnostics.

500 GBC Drive, M/S 514

Newark, Delaware 19702

Attn: Anna Marie Kathleen Ennis

Tcl: 302-632-9352

Fax: [phone]

Preparation date: August 27, 2008

2. Device Name:

Dimension Vista® KAPPA Flex® reagent cartridge Dimension Vista® LAMBDA Flex® reagent cartridge

## Dimension Vista® PROT 1 CAL

Dimension Vista® PROT 1 CON, L, M and H

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Classification: Class II; Class II; Class I

Product Code: DEH, DFH, JIX, JJY

Panel: Immunology (82) and Clinical Chemistry (75)

## 3. Identification of the Legally Marketed Devices:

Dade Behring N Antisera to Human Immunoglobulin/L-chains - K860894

N Protein Standard SL - K012470

N/T Protein Controls SL - K012468

#### 4. Device Descriptions:

### Dimension Vista® KAPPA Flex® reagent cartridge

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

#### Dimension Vista® LAMBDA Flex® reagent cartridge

Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

## Dimension Vista® Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing: a1acid glycoprotein, a1 -antitrypsin, az- macroglobulin,b2-microglobulin, C3 complement, C4 complement, ccruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin light chains type kappa, immunoglobulin light chains type lambda, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin.

## Dimension Vista® Protein 1 Control L

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Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : a1-acid glycoprotein, a1 -antitrypsin, a-- macroglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, i mmunoglobulin light chains type kappa, immunoglobulin light chains type lambda, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin

## Dimension Vista® Protein 1 Control M and H

Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human serum based products containing: a1 -acid glycoprotein, a1 -antitrypsin, a2macroglobulin, b2 -microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocysteine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M. immunoglobulin light chains type kappa, immunoglobulin light chains type lambda. prealbumin, retinol binding protein, soluble transferrin receptor, and transferrin.

## 5. Device Intended Uses

## Dimension Vista® KAPPA Flex® reagent cartridge:

The KAPPA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type kappa in human serum and plasma on the Dimension Vista® Systems. Measurements of the various amounts of the different types of light chains aid in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

## Dimension Vista® LAMBDA Flex® reagent cartridge:

The LAMBDA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type lambda in human serum and plasma on the Dimension Vista® Systems. Measurements of the various amounts of the differant types of light chains aid in the diagnosis of multiple myeloma cancer of antibody-forming cells) lymphocytic neoplasms ( cancer of lymohoid tissue), Waldenstom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

## Dimension Vista® PROT 1 CAL:

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2 -macroglobulin

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(A2MAC), b2 -Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG, IGG-C*. IGG-U**), Immunoglobulin G subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunglobulin (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF)

*For cerebrospinal fluid

** For urine

## Dimension Vista® Protein 1 Control L

PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® Systems in the quantitative determination of: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2 -Macroglobulin (A2MAC), C3 Complement (C3), C4 Complement (C4), Ccruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG), Immunoglobulin G subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), Immunoglobulin G subclass 4 (IGG4), Immunoglobulin light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF).

*For serum and plasma

## Dimension Vista® Protein 1 Control M and H

PROT1 CON M and PROT1 CON H are assayed, mid-level and high level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a2-Acid Glycoprotein (A1AG), a1 -Antitrypsin (A1AT), a2-Macroglobulin (A2MAC), b2 -Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4),Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA),Immunoglobulin E (IGE), Immunoglobulin G (IGG),Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G subclass 2 (IGG2), Immunoglobulin G subclass 3 (IGG3), lmmunoglobulin G subclass 4 (IGG4), Immunoglobulin light chains type kappa (KAPPA), Immunoglobulin light chains type lambda (LAMBDA), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP),soluble Transferrin Receptor (STFR), specialty Albumin (sALB) and Transferrin (TRF).

*For scrum and plasma

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## 6. Medical device to which equivalence is claimed and comparison information:

The Dimension Vista® KAPPA Flex® reagent cartridge, Dimension Vista® PROT 1 CAL and Dimension Vista® PROT 1 CON L, M and H are substantially equivalent to the Dade Behring N Antisera to Human Immunoglobulin/L-chains assay (K860894), N/T Protein Standard SL (K012470) and N Protein Controls SL (K012468). The Dimension Vista® KAPPA assay, like Dade Behring N Antisera to Human Immunoglobulin/Lchains, kappa type assay is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type kappa in human serum.

The Dimension Vista® LAMBDA Flex® reagent cartridge, Dimension Vista® PROT 1 CAL and Dimension Vista® PROT 1 CON L, M and H are substantially equivalent to the Dade Behring N Antisera to Human Immunoglobulin/1-chains assay (K860894), N/T Protein Standard SL (K012470) and N Protein Controls SL (K012468). The Dimension Vista® LAMBDA assay, like Dade Bchring N Antisera to Human Immunoglobulin/Lchains lambda type assay is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, type lambda in human scrum.

### 7. Device Performance Characteristics:

The Dimension Vista® KAPPA assay was compared to the Dade Behring N Antisera to Human Immunoglobulin/L-chains, kappa type assay on the BN ProSpec® System by evaluating serum samples with concentrations ranging from 31 - 863 mg/dL (0.31 - 8.63 g/L).

Regression analysis of these results vielded the following :

| Comparative Method | Slope | Intercept | Correlation<br>Coefficient<br>(r) | n |
|------------------------------------------------------------------|-------------|----------------|-----------------------------------|----|
| | mg/dL [g/L] | | | |
| Immunoglobulin/L-<br>chains, kappa type on<br>BN Prospec® System | 1.105 | - 4.2 [-0.042] | 0.998 | 66 |

The Dimension Vista® LAMBDA assay was compared to the Dade Behring N Antisera to Human Immunoglobulin/L-chains, lambda type assay on the BN ProSpec® System by evaluating serum samples with concentrations ranging from 24-401 mg/dL (0.24 -4.01g/L).

Regression analysis of these results yielded the following :

| Comparative<br>Method | Slope | Intercept | Correlation<br>Coefficient | n |
|------------------------------------------|-------|----------------|----------------------------|----|
| | | mg/dL [g/L] | (r) | |
| Immunoglobulin/L-<br>chains, lambda type | 1.045 | - 1.5 [-0.015] | 0.993 | 66 |

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on BN Prospec® System

## 8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human Immunoglobulin/L-chains, kappa type assay and the Dimension Vista® KAPPA assay; and between the Dade Behring N Antisera to Human Immunoglobulin/L-chains, lambda type assay and the Dimension Vista® LAMBDA assay.

്ഥ

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing strokes, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## DEC 1 9 2008

Siemens Healthcare Diagnostics c/o Ms. Anna Marie Kathleen Ennis Senior Regulatory Affairs and Compliance Spec. 500 GBC Drive P.O. Box 6101 Newark, DE, 19741-6101

(

Re: k082503 Trade/Device Name: Dimension Vista® KAPPA Flex® reagent cartridge Dimension Vista® LAMBDA Flex® reagent cartridge Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L Dimension Vista® Protein 1 Control M Dimension Vista® Protein 1 Control H Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (Light Chain Specific) Immunological Tcst system Regulatory Class: Class II Product Code: DEH, DFH, JIX, JJY Dated: December 4, 2008 Received: December 8, 2008

Dear Ms. Ennis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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### Page 2 - Siemens Healthcare Diagnostics

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

ia m chan

Maria M. Chan. Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Dimension Vista® KAPPA Flex® reagent cartridge Device Name:

Indications For Use:

Dimension Vista® KAPPA Flex® reagent cartridge:

The KAPPA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, kappa type in human serum and plasma on the Dimension Vista® System. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Joughine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety

510(k) K08

{9}------------------------------------------------

510(k) Number (if known): K082503

#### Device Name: Dimension Vista® PROT 1 CAL

Indications For Use:

#### Dimension Vista® PROT 1 CAL:

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a1-Acid Glycoprotein (A1AG) Immunoglobulin A (IGA) a1-Antitrypsin (A1AT) Immunoglobulin E (IGE) a2- Macroglobulin (A2MAC) Immunoglobulin G (IGG, IGG-C*, IGG-U**) B2-Microglobulin (B2MIC) Immunoglobulin G Subclass 1 (IGG1) C3 Complement (C3) Immunoglobulin G Subclass 2 (IGG2) C4 Complement (C4) Immunoglobulin G Subclass 3 (IGG3) Ceruloplasmin (CER) Immunoglobulin G Subclass 4 (IGG4) Haptoglobin (HAPT) lmmunoglobulin M (IGM) Hemopexin (HPX) Prealbumin (PREALB) Homocysteine (HCYS) Retinol binding Protein (RBP) Ig light chains, type Kappa (KAPPA) soluble Transferrin Receptor (STFR) Ig light chains, type Lambda (LAMBDA) Transferrin (TRF) *For cerebrospinal fluid (CSF) ** For urine

Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Josephine Bautista

vision Sign Off

of In Vitro Diagnostic Device icn and Sa

K of 2503

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510(k) Number (if known):

k082503

#### Dimension Vista® PROT 1 CON M Device Name:

#### Indications For Use:

PROT1 CON M is an assayed, mid-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of:

| α₁-Acid Glycoprotein (A1AG) | Immunoglobulin E (IGE) |
|---------------------------------------|-------------------------------------|
| α₁-Antitrypsin (A1AT) | Immunoglobulin G (IGG, IGG-C*) |
| α₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 1 (IGG1) |
| β₂-Microglobulin (B2MIC) | Immunoglobulin G Subclass 2 (IGG2) |
| C3 Complement (C3) | Immunoglobulin G Subclass 3 (IGG3) |
| C4 Complement (C4) | Immunoglobulin G Subclass 4 (IGG4) |
| Ceruloplasmin (CER) | Immunoglobulin M (IGM) |
| Haptoglobin (HAPT) | Prealbumin (PREALB) |
| Hemopexin (HPX) | Retinol binding Protein (RBP) |
| Homocysteine (HCYS) | soluble Transferrin Receptor (STFR) |
| Ig light chains, type Kappa (KAPPA) | specialty Albumin (sALB) |
| Ig light chains, type Lambda (LAMBDA) | Transferrin (TRF) |
| Immunoglobulin A (IGA) | |

* For serum and plasma

| Prescription Use | <ins>X</ins> |
|----------------------------|--------------|
| (Per 21 CFR 801 Subpart D) | |

Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

| Page 1 of | Concurrence of CDRH, Office of Device Evaluation |
|-----------|--------------------------------------------------|
|-----------|--------------------------------------------------|


Division Sign Off
Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K082503 |
|--------|---------|
|--------|---------|

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510(k) Number (if known):

Dimension Vista® LAMBDA Flex® reagent cartridge Device Name:

Indications For Use:

## Dimension Vista® LAMBDA Flex® reagent cartridge:

The LAMBDA method is an in vitro diagnostic test for the quantitative measurement of immunoglobulin light chains, lambda type in human serum and plasma on the Dimension Vista® System. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation

Jorphine Bautton
Division Sign-Off

Office of In Vitro Diagnostic Device Craluation and Safety

K082503

{12}------------------------------------------------

510(k) Number (if known):

k082503

#### Dimension Vista® PROT 1 CON L Device Name:

#### Indications For Use:

PROT1 CON L is an assayed, low-level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of:

| α₁-Acid Glycoprotein (A1AG) | Immunoglobulin E (IGE) |
|---------------------------------------|-------------------------------------|
| α₁-Antitrypsin (A1AT) | Immunoglobulin G (IGG, IGG-C*) |
| α₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 1 (IGG1) |
| C3 Complement (C3) | Immunoglobulin G Subclass 2 (IGG2) |
| C4 Complement (C4) | Immunoglobulin G Subclass 3 (IGG3) |
| Ceruloplasmin (CER) | Immunoglobulin G Subclass 4 (IGG4) |
| Haptoglobin (HAPT) | Immunoglobulin M (IGM) |
| Hemopexin (HPX) | Prealbumin (PREALB) |
| Homocysteine (HCYS) | Retinol binding Protein (RBP) |
| Ig light chains, type Kappa (KAPPA) | soluble Transferrin Receptor (STFR) |
| Ig light chains, type Lambda (LAMBDA) | Specialty Albumin (sALB) |
| Immunoglobulin A (IGA) | Transferrin (TRF) |

AND/OR

* For serum and plasma

Prescription Use × (Per 21 CFR 801 Subpart D)

Over-The-Counter-Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Page 1 of

Division Sign Off

Office of In Vitro Diagnostic Device Evaluation and Saf-

K082803

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510(k) Number (if known): k 082503

#### Dimension Vista® PROT 1 CON H Device Name:

### Indications For Use:

PROT1 CON H is an assayed, high -level, intralaboratory quality control for the assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of:

| α₁-Acid Glycoprotein (A1AG) | Immunoglobulin E (IGE) |
|---------------------------------------|-------------------------------------|
| α₁-Antitrypsin (A1AT) | Immunoglobulin G (IGG, IGG-C*) |
| α₂-Macroglobulin (A2MAC) | Immunoglobulin G Subclass 1 (IGG1) |
| β₂-Microglobulin (B2MIC) | Immunoglobulin G Subclass 2 (IGG2) |
| C3 Complement (C3) | Immunoglobulin G Subclass 3 (IGG3) |
| C4 Complement (C4) | Immunoglobulin G Subclass 4 (IGG4) |
| Ceruloplasmin (CER) | Immunoglobulin M (IGM) |
| Haptoglobin (HAPT) | Prealbumin (PREALB) |
| Hemopexin (HPX) | Retinol binding Protein (RBP) |
| Homocysteine (HCYS) | soluble Transferrin Receptor (STFR) |
| Ig light chains, type Kappa (KAPPA) | specialty Albumin (sALB) |
| Ig light chains, type Lambda (LAMBDA) | Transferrin (TRF) |
| Immunoglobulin A (IGA) | |

* For serum and plasma

Prescription Use × (Per 21 CFR 801 Subpart D) Over-The-Counter-Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation

Josephine Bautista

ce of In Vitro Diagnostic Device luation and Safe

K082503