DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA

K081299 · Siemens Healthcare Diagnostics, Inc. · DDG · Aug 8, 2008 · Immunology

Device Facts

• Record ID: K081299
• Device Name: DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: DDG · Immunology
• Decision Date: Aug 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5880
• Device Class: Class 2

Intended Use

Transferrin Flex® reagent cartridge: The TRF method is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine on the Dimension Vista™ System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for α₁-Acid Glycoprotein (A1AG), α₁- Antitrypsin (A1AT), β₂- 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*), Immunoglobulin G Subclass 1, (IGG1), Immunoglobulin G Subclass 2(IGG2), Immunoglobulin G Subclass 3 (IGG3), Immunoglobulin G Subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol binding Protein (RBP), soluble Transferrin Receptor (STFR), and Transferrin (TRF, TRF-U). Protein 3 Control: PROT3 CON is an assayed intra-laboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of α1 -Microglobulin, (A1MIC), Immunoglobulin G (IGG-C*), Microalbumin (MALB), specialty albumin (sALB*), and Transferrin (TRF-U**). * For cerebrospinal fluid ** For urine

Device Story

The Dimension Vista® System TRF Flex® reagent cartridge is an in vitro diagnostic test used on the Dimension Vista® System. It measures transferrin concentration in human serum, heparinized plasma, EDTA plasma, or urine. The device operates via an immunochemical reaction where proteins in the sample form immune complexes with specific antibodies; these complexes scatter a light beam passed through the sample. The intensity of scattered light is proportional to protein concentration. Results are evaluated by comparison with a known standard. The system is used in clinical laboratory settings by trained personnel. The output provides quantitative transferrin levels, which healthcare providers use to assist in diagnosing malnutrition, acute inflammation, infection, and iron deficiency anemia. The system also utilizes the Protein 1 Calibrator for system calibration and the Protein 3 Control for assessing precision and analytical bias.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (20 days, 2 runs/day). Linearity assessed per CLSI EP06-A (range 2.00-31.0 mg/L). LoQ established at 2 mg/L. Interference testing (hemoglobin, bilirubin, etc.) showed bias <10%. Method comparison with predicate (n=63 urine samples) yielded Passing-Bablok slope 0.983 and correlation coefficient 0.991. No clinical studies performed.

Technological Characteristics

Immunonephelometric assay. Reagents: rabbit polyclonal anti-human transferrin in plastic cartridge. Calibrator: human serum-based. Control: lyophilized, polygeline/rabbit albumin-based. Traceable to ERM®-DA470 (CRM 470). Instrument: Dimension Vista® System. Storage: 2-8°C.

Indications for Use

Indicated for quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma, or urine to aid in diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia. Prescription use only.

Regulatory Classification

Identification

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

Predicate Devices

• N Antisera to Human Transferrin (k053075)
• Protein Standard SL (k012470)
• Protein Control LC (k032237)

Submission Summary (Full Text)

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Siemens Healthcare Diagnostics Inc. 510(k) Notification 9 Free System TRF Flex® reagent cartridge
Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control

AUG - 8 2008

# 510(k) Summary for Dimension Vista® System TRF Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control

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: K081299

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

| Manufacturer: | Dade Behring Marburg GmbH A Siemens Company Emil-von-Behring Str. 76 35041 Marburg, Germany |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Siemens Healthcare Diagnostics Inc. 500 GBD Drive Newark, Delaware 19702 Attn: Radames Riesgo Tel: [phone] Fax: [phone] |
| Preparation date: | May 7, 2008 |

2.

| Device Name: | Dimension Vista® System TRF Flex® reagent cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | Class II; Class II; Class I |
| Product Code: | DDG; JIX; JJY |
| Panel: | Immunology (82) and Clinical Chemistry (75) |

### 3. Identification of the Legally Marketed Device:

Dade Behring N Antisera to Human Transferrin~ K053075 Dade Behring N Protein Standard SL – K012470 Dade Behring N/T Protein Control LC - K032237

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Siemens Healthcare Diagnostics Inc. 510(k) Notification e Poply Pictinous)
Dimension Vista® System Protein 1 Calibrator
Dimension Vista® System Protein 1 Calibrator
Dimension Vista® System Protein 1 Calibrator
Dimension Vista® Sy

### 4. Device Descriptions:

# Dimension Vista® System TRF 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® System Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing q acid glycoprotein, a-antitrypsin, ß2-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocystine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin.

# Dimension Vista System Protein 3 Control

Protrein 3 Control is a multi-analyte, lyophilized, polygeline and rabbit plasma albumin based product containing a - Microglobulin, albumin, immunoglobulin G and transferrin.

#### 5. Device Intended Uses:

# Dimension Vista System TRF Flex® reagent cartridge:

The TRF method is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.

# Dimension Vista® System Protein 1 Calibrator:

Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Dimension Vista® System for:

| α₁-Acid Glycoprotein<br>(A1AG) | Immunoglobulin G (IGG) [serum/plasma] and<br>(IGG-C) [cerebrospinal fluid] |
|--------------------------------|----------------------------------------------------------------------------|
| α₁-Antitrypsin (A1AT) | 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) |
| Immunoglobulin A (IGA) | Transferrin (TRF) [serum/plasma] and<br>(TRF-U) [urine] |
| Immunoglobulin E (IGE) | |

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Siemens Healthcare Diagnostics Inc. 510(k) Notification e : < + )
Dimension Vista® System TFRF Flex® reagent cartridge
Dimension Vista® System Protein 1 Calibrator
Dimension Vista® System Protein 3 Control

# Dimension Vista® System Protein 3 Control:

PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of α -Microglobulin (A1MIC), specialty Albumin (sALB*), Immunoglobulin G (IGG -C*), Microalbumin (MALB) and Transferrin (TRF-U**).

* For Cerebrospinal fluid (CSF)

** For urine

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

The Dimension Vista® System TRF assay, Dimension Vista® System Protein 1 Calibrator and Dimension Vista® System Protein 3 Control are substantially equivalent and have the same intended uses to the Dade Behring N Antisera to Human Transferrin (K053075), Dade Behring N Protein Standard SL (K012470) and Dade Behring N/T Protein Control LC (K032237), respectively.

### 7. Device Performance Characteristics:

The Dimension Vista® System TRF assay was compared to the Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System by evaluating urine samples with concentrations ranging from 2.0 to 24.4 mg/L. Regression analysis of these results yielded the following equation:

| A START A ST A ST A ST A FOR SELL CON PARTY CONTRACT COLLECTION COLLECTION COLLEGION COLLECTION COLLEGION COLLEGION COLLEGION COLLEGION COLLECTION COLLEGION COLLECTION COLLEC<br>.<br>ALB (UAP) - " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "<br>44 - - AVASAPAYAYAYAYAYAYAYA<br>いついつかりとなるとなるとなるとなる | VAVATAVA | <br>C | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-------|--|
| Human<br>ﮯ<br>Antisera to | | | |
| on t | | | |

## Method Comparison Study

### 8. Conclusion:

The modified Dimension Vista System TRF assay, modified Dimension Vistas System
Protein 1 Calibrator and modified Dimension Vista "System Protein 3 Control are substantially equivalent to the legally marketed devices based upon the correlation studies and the information above.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body, symbolizing service to the nation. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Siemens Healthcare Diagnostics Inc. c/o Mr. Radames Riesgo Regulatory Affairs and Compliance Manager 500 GBC Drive MS 514 Newark, DE 19702

AUG - 8 2008

Re: k081299

Trade/Device Name: Dimension Vista® System TRF Flex Reagent Cartridge Dimension Vista® System Protein 1 Calibrator Dimension Vista® System Protein 3 Control with models K7072, KC710 and KC775 Regulation Number: 21 CFR 866.5880 Regulation Name: Transferrin immunological test system Regulatory Class: Class II Product Code: DDG, JIX, JJY Dated: July 7, 2008 Received: July 8, 2008

Dear Mr. Ricsgo:

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 adultcration.

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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Pagc 2 -

CFR Part 807); labeling (21 CFR Part 801); 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" (21 CFR 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 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Maria 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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# Indications for Use

510(k) Number (if known):

# Device Name:

Dimension Vista® System TRF Flex® reagent cartridge

# Indications for Use:

The TRF method is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.

Prescription Use X (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Maria M Chan

---

**Division Sign-Off**

Office of In Vitro Diagnostic

Device Evaluation and Safety

5100: KOf/297

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# Indications for Use

510(k) Number (if known):

Device Name: Dimension Vista® System Protein 3 Control

# Indications for Use:

PROT3 CON is an assayed intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of a -Microglobulin (A1MIC), specialty Albumin (sALB*), Immunoglobulin G (IGG -C*), Microalbumin (MALB) and Transferrin (TRF-U**).

* For Cerebrospinal fluid (CSF)

** For urine

Prescription Use X (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Maria m Chan
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(K) K081299

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# Indications for Use

# 510(k) Number (if known):

# Device Name:

Dimension Vista® System Protein 1 Calibrator

## Indications for Use:

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for:

α -Acid Glycoprotein (A1AG) a -Antitrypsin (A1AT) ß -Microglobulin (B2MIC) C3 Complement (C3) C4 Complement (C4) Ceruloplasmin (CER) Haptoglobin (HAPT) Hemopexin (HPX) Homocysteine (HCYS) lmmunoqlobulin A (IGA) Immunoglobulin E (IGE)

Immunoglobulin G (IGG) [serum/plasma] and (IGG-C) [cerebrospinal fluid] Immunoglobulin G Subclass 1 (IGG1) Immunoglobulin G Subclass 2 (IGG2) Immunoglobulin G Subclass 3 (IGG3) Immunoglobulin G Subclass 4 (IGG4) Immunoglobulin M (IGM) Prealbumin (PREALB) Retinol Binding Protein (RBP) soluble Transferrin Receptor (STFR) Transferrin (TRF) [serum/plasma] and (TRF-U) [urine]

Mana Mckon

Division Sian-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K0811299

Prescription Use X (Part 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)