HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)

K131051 · Hitachi Chemical Diagnostics, Inc. · JGQ · Jun 7, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131051
• Device Name: HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
• Applicant: Hitachi Chemical Diagnostics, Inc.
• Product Code: JGQ · Clinical Chemistry
• Decision Date: Jun 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1635
• Device Class: Class 2

Intended Use

The S TEST Reagent Cartridge Total Protein (TP) is intended for the quantitative determination of TP in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge TP is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. The S TEST Reagent Cartridge Albumin (ALB) is intended for the quantitative determination of ALB in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge ALB is intended for use in the clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver and kidneys.

Device Story

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system for clinical or physician office laboratories. It utilizes single-use plastic reagent cartridges containing two reservoirs (R1, R2) and a reaction cell/photometric cuvette. Operation involves automated pipetting of patient samples and reagents into the cuvette, mixing, and incubation. The system uses a multi-wavelength photometer to measure absorbance of the reaction product. For TP, biuret reagent forms a purple-red complex; for ALB, bromcresol green forms a blue-green dye conjugate. The analyzer calculates analyte concentration based on absorbance. Reagent cartridges include a dot code label with chemistry parameters and calibration factors. Results are available in approximately 15 minutes. Healthcare providers use these quantitative results to diagnose and monitor liver, kidney, and metabolic conditions.

Clinical Evidence

Clinical performance was evaluated at three physician office laboratory (POL) sites. Precision studies (n=30 replicates per sample) showed total precision %CVs ranging from 0.7% to 4.4% for TP and 0.0% to 4.8% for ALB. Method comparison studies (n=52-87 specimens per site) against a reference method yielded Deming regression slopes between 0.91 and 1.00 and correlation coefficients (r) between 0.975 and 0.996, confirming accuracy across the dynamic range.

Technological Characteristics

Photometric assay; Total Protein: biuret reagent (citric acid buffer, nonionic surfactant, copper sulfate pentahydrate); Albumin: bromcresol green dye-binding (citric acid buffer, nonionic surfactant); ready-to-use cartridge with 2D barcode for automated identification; standalone operation on Hitachi Clinical Analyzer E40; traceable to NIST SRM 927 (TP) and IRMM CRM470 (ALB).

Indications for Use

Indicated for quantitative determination of total protein and albumin in serum, lithium heparinized plasma, K3 EDTA plasma, and sodium citrate plasma for patients requiring diagnostic assessment of liver, kidney, bone marrow, or metabolic/nutritional disorders. For prescription use only in clinical or physician office laboratories.

Regulatory Classification

Identification

A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

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 § 862.9.

Predicate Devices

• Roche cobas c systems (k100853)

Submission Summary (Full Text)

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# JUN 0 7 2013

## SECTION 8 510(k) SUMMARY

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 K131051.

| 807.92 (a)(1): Name: | Address: | Hitachi Chemical Diagnostics<br>630 Clyde Court<br>Mountain View, CA 94043 |
|----------------------|----------|----------------------------------------------------------------------------|
| | Phone: | [phone] |
| | FAX: | [phone] |
| | Contact: | Mr. Charles Tsou |

#### 807.92 (a)(2): Device name- trade name and common name, and classification

Trade name:

S TEST Reagent Cartridge Total Protein (TP) S TEST Reagent Cartridge Albumin (ALB)

Common Name: Routine chemistry analyzer for TP Routine chemistry analyzer for ALB

Classifications: 21 CFR § 862.1635 Total Protein (TP) 21 CFR § 862.1035 Albumin (ALB)

#### 807.92 (a)(3): Identification of the legally marketed predicate devices

Cobas c systems TP2 (Roche Diagnostics, Inc., Indianapolis, IN)- K100853 Cobas c systems ALB2 (Roche Diagnostics, Inc., Indianapolis, IN)- K100853

#### 807.92 (a)(4): Device Description

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available.

The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric

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Hitachi Chemical Diagnostics, Inc.

630 Clyde Court. Mountain View. CA 94043-2239 Tel: [phone]

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cuvette. The cartridges also include a dot code label that contains all chemistry parameters. calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).

System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridges TP and ALB.

Chemistry reactions: (TP) Proteins in samples react with the biuret reagent to form a purplered complex. The concentration of total protein can be determined by measuring the absorbance of the purple-red substance.

(ALB) Albumin in the sample combines with bromcresol green to form a blue-green dye conjugate. The albumin concentration is directly proportional to the color intensity and can be determined photometrically by measuring the absorbance of this resulting blue-green color.

#### 807.92 (a)(5): Intended Use

The S TEST Reagent Cartridge Total Protein (TP) is intended for the quantitative determination of TP in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge TP is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

The S TEST Reagent Cartridge Albumin (ALB) is intended for the quantitative determination of ALB in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge ALB is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

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(2) Hitachi Chemical Diagnostics, Inc. 630 Clyde Court, Mountain View, CA 94043-2239 Tel: [phone]

www.hcdlagnostics.com

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# 807.92 (a)(6): Technological Similarities and Differences to the Predicate

The following chart describes similarities and differences between the TP test systems.

| Characteristic | Hitachi S TEST Systems | PREDICATE |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Instrument Platform | Hitachi Clinical Analyzer<br>(originally cleared under K111753) | Roche cobas c systems - K100853 |
| Total Protein (TP) | K number- 131051 | Roche K number- K100853 |
| Device Class, Regulation Code | Class II, Exempt, Reserved, 21 CFR<br>862.1635 | Same, except Exempt (not POC) |
| Classification Product Code | JGQ | Same |
| Intended Use | Quantitative determination of TP | Same |
| Testing Environment | Physician office or clinical lab | Clinical lab |
| Test Principle | Proteins in samples react with the<br>biuret reagent to form a purple-red<br>complex. The concentration of total<br>protein can be determined by<br>measuring the absorbance of the<br>purple-red substance. | Divalent copper reacts with protein<br>peptide bonds to form the<br>characteristic purple-colored biuret<br>complex. The color intensity is<br>directly proportional to the protein<br>concentration which is determined<br>photometrically |
| Specimen Type | Human serum or plasma | Same |
| Reportable Range | 0.2 to 11.0 g/dL | 0.2 to 12.0 g/dL |
| Detection Wavelength | 546/700 nm | Same |
| Detection Limit | 0.2 g/dL | Same |
| Linearity | 0.2 to 11.0 g/dL | 0.2 to 12.0 g/dL |
| Precision | %CVs range from 1.8% to 2.5% | %CVs range from 0.9% to 2.5% |

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( Hitachi Chemical Diagnostics, Inc.

630 Clyde Court, Mountain View, CA 94043-2239 Tel: [phone] Fax: [phone]

-------www.hcdiagnostics.com ﺐ ﺑﺎﻟﻤ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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| Characteristic | Hitachi S TEST Systems | PREDICATE |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Instrument Platform | Hitachi Clinical Analyzer<br>(originally cleared under K111753) | Roche cobas c systems - K100853 |
| Albumin (ALB) | | |
| Device Class, Regulation Code | K number- K131051 | Roche K number- K100853 |
| Classification Product Code | Class II, 21 CFR 862.1035 | 'Same' |
| Intended Use | CIX | 'Same' |
| Testing Environment | Quantitative determination of ALB | 'Same' |
| Test Principle | Physician office or clinical lab | Clinical lab |
| | Albumin in the sample combines<br>with bromcresol green to form a<br>blue-green dye conjugate. The<br>albumin concentration is directly<br>proportional to the color intensity<br>and can be determined<br>photometrically by measuring the<br>absorbance of this resulting blue-<br>green color. | 'Same' |
| Specimen Type | Human serum or plasma | Human serum, plasma, or urine |
| Reportable Range | 0.5 to 7.1 g/dL | 0.2 to 6.0 g/dL |
| Detection Wavelength | 660/700 nm | 570/505 nm |
| Detection Limit | 0.1 g/dL | 0.2 g/dL |
| Linearity | 0.1 to 8.0 g/dL | 0.2 to 6.0 g/dL |
| Precision | %CVs range from 1.6% to 4.8% | %CVs range from 0.7% to 1.2% |

The following chart describes similarities and differences between the ALB test systems.

## 807.92 (b)(1): Brief Description of Nonclinical Data

A series of studies were performed that evaluated the following nonclinical performance characteristics for each analytical sensitivity (limits of detection), linearity, 20-day in-house precision, interference testing, in-house method comparisons, and matrices comparison between serum and various plasma types.

#### Analytical Sensitivity (Limits of Detection)- TP

The study followed CLSI EP17-A, and the limit of detection was found to be 0.2 g/dL. The quantitation limit was found to be 0.2 g/dL

#### Analytical Sensitivity (Limits of Detection)- ALB

The study followed CLSI EP17-A, and the limit of detection was found to be 0.1 g/dL. The quantitation limit was found to be 0.5 g/dL.

#### Linearity- TP

The study followed CLSI EP-6A, and the range of linearity was 0.2 to 11.0 g/dL. The reportable range is 0.2 to 11.0 g/dL.

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#### O Hitachi Chemical Diagnostics

630 Clyde Court, Mountain View, CA 94043-2239 Tel: [phone] Fax: [phone]

www.hcdiagnostics.com

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## Linearity- ALB

The study followed CLSI EP-6A, and the range of linearity was 0.1 to 8.0 g/dL. The reportable range is 0.5 to 8.0 g/dL.

#### 20-day In-house Precision- TP

The studies followed CLSI EP5-A2, where three levels of samples were each tested in two runs, twice a day, for 20 days. The results were as follows:

## Precision Summary:

## TP- Low, Level 1, Summary

| TP | Within-Run | Total |
|-------------|------------|-------|
| Mean (g/dL) | 4.19 | 4.19 |
| SD (g/dL) | 0.05 | 0.09 |
| %CV | 1.1% | 2.1% |

#### TP- Middle, Level 2, Summary

| TP | Within-Run | Total |
|-------------|------------|-------|
| Mean (g/dL) | 5.51 | 5.51 |
| SD (g/dL) | 0.08 | 0.14 |
| %CV | 1.4% | 2.5% |

# TP- High, Level 3, Summary

| TP | Within-Run | Total |
|-------------|------------|-------|
| Mean (g/dL) | 7.19 | 7.19 |
| SD (g/dL) | 0.07 | 0.13 |
| %CV | 1.0% | 1.8% |

## 20-day In-house Precision- ALB

The studies followed CLSI EP5-A2, where three levels of samples were each tested in two runs, twice a day, for 20 days. The results were as follows:

## Precision Summary:

## ALB- Low, Level 1, Summary

| ALB | Within-Run | Total |
|-------------|------------|-------|
| Mean (g/dL) | 2.28 | 2.28 |
| SD (g/dL) | 0.04 | 0.11 |
| %CV | 1.5% | 4.8% |

## Page 5 of 9

#### O Hitachi Chemical Diagnostics, Inc.

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| ALB | Within-Run | Total |
|-------------|------------|-------|
| Mean (g/dL) | 4.72 | 4.72 |
| SD (g/dL) | 0.07 | 0.13 |
| %CV | 1.4% | 2.8% |

## ALB- Middle, Level 2, Summary

## ALB- High, Level 3, Summary

| ALB | Within-Run | Total |
|-------------|------------|-------|
| Mean (g/dL) | 6.01 | 6.01 |
| SD (g/dL) | 0.07 | 0.09 |
| %CV | 1.2% | 1.6% |

Interference Testing (per CLSI EP7-A2)

The data demonstrated that the TP test system was not affected by high levels of the following substances at the levels noted:

Unconjugated bilirubin: no interference up to 50 mg/dL Lipemia: no interference up to 500 mg/dL Ascorbic acid: no interference up to 50 mg/dL Hemoglobin: no interference up to 1,000 mg/dL

Lack of interference was defined as recoveries between 90% and 110% of the neat value, and assay performance claims were established on the HITACHI Clinical Analyzer by testing two serum pools containing approximately 4.0 and 6.5 g/dL TP.

The data demonstrated that the ALB test system was not affected by high levels of the following substances at the levels noted:

Hemoglobin: no interference up to 250 mg/dL Unconjugated bilirubin: no interference up to 12.5 mg/dL Lipemia: no interference up to 500 mg/dL Ascorbic acid: no interference up to 50 mg/dL

Lack of interference was defined as recoveries between 90% and 110% of the neat value, and assay performance claims were established on the HITACHI Clinical Analyzer by testing two serum pools containing approximately 2.5 and 4.0 g/dL ALB

#### Method Comparison - TP

A total of 115 clinical specimens spanning the dynamic range (0.8 g/dL to 10.9 g/dL), were assayed in singleton and in a blinded fashion by both the Hitachi E40 system and a standard laboratory system. The comparative data were analyzed by Deming regression and are shown below. (CI = confidence interval)

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## TP Regression Statistics:

| n | r | Slope<br>(95% CI) | y-intercept<br>(95% CI) | X mean | Y mean |
|-----|-------|------------------------|-------------------------|--------|--------|
| 115 | 0.989 | 1.02<br>(1.01 to 1.04) | 0.01<br>(-0.13 to 0.15) | 7.0 | 7.2 |

### Method Comparison - ALB

A total of 118 clinical specimens spanning the dynamic range (0.5 g/dL to 6.4 g/dL), were assayed in singleton and in a blinded fashion by both the Hitachi E40 system and a standard laboratory system. The comparative data were analyzed by Deming regression and are shown below. (CI = confidence interval)

#### ALB Regression Statistics:

| n | r | Slope<br>(95% CI) | y-intercept<br>(95% CI) | X mean | Y mean |
|-----|-------|------------------------|-------------------------|----------|-----------|
| 118 | 0.975 | 1.01<br>(0.96 to 1.06) | 0.24<br>(0.06 to 0.41) | 4.0 g/dL | 4.3 g/dL. |

## Matrices Comparisons- TP

A study was performed to validate the use of three plasma types as an alternative to serum for the Hitachi Clinical Analyzer with S TEST Reagent Cartridge TP. The plasma types were sodium citrate, K3 EDTA, and lithium heparin. Forty-five (45) matched serum/plasma samples that spanned the dynamic range (0.5 to 10.5 g/dL) were assayed in singleton and the results were compared using linear regression (plasma = y-axis, each type). The performance characteristics were as follows.

#### n = 45, range (serum) = 0.5 to 10.5 g/dL TP

| | Heparinized Plasma | EDTA Plasma | Na Citrate Plasma |
|-----------------------|-----------------------|-----------------------|-----------------------|
| Slope (95% CIs) | 1.00 (0.96 to 1.04) | 1.00 (0.96 to 1.04) | 0.98 (0.93 to 1.03) |
| y-intercept (95% CIs) | -0.11(-0.43 to -0.21) | -0.06 (-0.33 to 0.22) | -0.09 (-0.45 to 0.26) |
| r | 0.989 | 0.992 | 0.987 |

#### Matrices Comparisons- ALB

A study was performed to validate the use of three plasma types as an alternative to serum for the Hitachi Clinical Analyzer with S TEST Reagent Cartridge ALB. The plasma types were sodium citrate, K3 EDTA, and lithium heparin. Forty-one (41) matched serum/plasma samples that spanned the dynamic range (1.0 to 7.1 g/dL) were assayed in singleton and the results were compared using linear regression (plasma = y-axis, each type). The performance characteristics were as follows.

#### N = 41, Range (serum) = 1.0 to 7.1 g/dL ALB

| | Heparinized Plasma | EDTA Plasma | Na Citrate Plasma |
|-----------------------|-----------------------|---------------------|------------------------|
| Slope (95% CIs) | 0.99 (0.95 to 1.03) | 0.95 (0.92 to 0.98) | 1.00 (0.94 to 1.05) |
| y-intercept (95% CIs) | -0.01 (-0.20 to 0.18) | 0.22 (0.08 to 0.36) | -0.22 (-0.48 to -0.03) |
| r | 0.992 | 0.995 | 0.986 |

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#### Hitachi Chemical Diagnostics, Inc.

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## 807.92 (b)(2): Brief Description of Clinical Data

Studies for precision and method comparison (accuracy) were performed at three external POL-type sites to evaluate the Hitachi E40 Clinical Analyzer with S TEST Reagent Cartridges TP and ALB in one of its targeted intended use environments, the physician's office laboratory.

For the external site precision study, each site received three blinded serum samples (the Precision Panel, labeled A, B, and C) that were chosen to represent low, middle, and high concentrations of TP or ALB. Each sample was assayed six times per day for five days, reporting 30 results per level. Precision estimates for total precision were as follows:

| Site # | Sample | Mean<br>(g/dL) | Within-run Precision | | Total Precision | |
|--------|--------|----------------|----------------------|------|-----------------|------|
| | | | SD (g/dL) | %CV | SD (g/dL) | %CV |
| 1 | A | 4.1 | 0.05 | 1.2% | 0.07 | 1.6% |
| 2 | A | 4.1 | 0.05 | 1.1% | 0.07 | 1.6% |
| 3 | A | 3.8 | 0.05 | 1.4% | 0.13 | 3.5% |
| 1 | B | 5.5 | 0.05 | 0.8% | 0.06 | 1.1% |
| 2 | B | 5.5 | 0.06 | 1.2% | 0.07 | 1.2% |
| 3 | B | 5.0 | 0.04 | 0.9% | 0.20 | 4.0% |
| 1 | C | 7.1 | 0.05 | 0.7% | 0.05 | 0.7% |
| 2 | C | 7.1 | 0.06 | 0.8% | 0.07 | 0.9% |
| 3 | C | 6.5 | 0.07 | 1.1% | 0.28 | 4.4% |

TP (g/dL) n = 30 renlicates ner sample per site

ALB (g/dL) n = 30 replicates per sample per site

| Site # | Sample | Mean | Within-run Precision | | Total Precision | |
|--------|--------|--------|----------------------|------|-----------------|------|
| | | (g/dL) | SD (g/dL) | %CV | SD (g/dL) | %CV |
| 1 | A | 0.88 | 0.03 | 3.9% | 0.04 | 4.8% |
| 2 | A | 0.80 | 0.00 | 0.0% | 0.00 | 0.0% |
| 3 | A | 0.81 | 0.02 | 2.8% | 0.04 | 4.5% |
| 1 | B | 4.67 | 0.05 | 1.0% | 0.04 | 1.3% |
| 2 | B | 4.60 | 0.05 | 1.6% | 0.06 | 1.7% |
| 3 | B | 4.47 | 0.12 | 2.7% | 0.13 | 2.8% |
| 1 | C | 7.03 | 0.05 | 0.8% | 0.18 | 2.5% |
| 2 | C | 6.93 | 0.06 | 0.8% | 0.11 | 1.6% |
| 3 | C | 6.72 | 0.08 | 1.2% | 0.16 | 2.3% |

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#### C Hitachl Chemical Diagnostics, Inc.

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For the external method comparison studies, a series of approximately 50 - 80 serum specimens with TP values ranging from 0.6 to 10.9 g/dL, and ALB values ranging from 0.5 to 6.7 g/dL, were assayed on the Hitachi E40 Clinical Analyzer at three sites using S TEST Reagent Cartridges TP and ALB (y) and a comparative method as the reference method (x). Deming regression analyses yielded the following results:

| Site # | n | Range<br>(g/dL) | Regression<br>Equation | "r" | CI*<br>Slope | CI Intercept |
|--------|----|-----------------|------------------------|-------|--------------|---------------|
| 1 | 52 | 0.8 to 10.8 | y = 0.98x + 0.14 | 0.996 | 0.96 to 1.01 | 0.00 to 0.29 |
| 2 | 52 | 0.8 to 10.9 | y = 1.00x - 0.07 | 0.994 | 0.97 to 1.03 | -0.31 to 0.16 |
| 3 | 53 | 0.6 to 10.5 | y = 0.96x + 0.03 | 0.996 | 0.93 to 0.98 | -0.14 to 0.19 |

## POL ACCURACY DATA SUMMARY- TP (g/dL)

*95% Confidence Interval

| Site # | n | Range (g/dL) | Regression Equation | "r" | CI* Slope | CI Intercept |
|--------|----|--------------|---------------------|-------|--------------|---------------|
| 1 | 87 | 0.5 to 6.7 | y = 0.99x + 0.24 | 0.982 | 0.92 to 1.06 | -0.06 to 0.53 |
| 2 | 81 | 0.5 to 6.6 | y = 0.95x + 0.30 | 0.979 | 0.88 to 1.02 | 0.00 to 0.61 |
| 3 | 81 | 0.9 to 6.1 | y = 0.91x + 0.35 | 0.985 | 0.85 to 0.97 | 0.10 to 0.60 |

## POL ACCURACY DATA SUMMARY- ALB (g/dL)

*95% Confidence Interval

### 807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing

Nonclinical and clinical testing was performed for the Hitachi E40 Clinical Analyzer with Reagent Cartridges TP and ALB. The test systems were shown to be safe and effective for their intended uses.

## Page 9 of 9

## O Hitachi Chemical Diagnostics, inc.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol consists of three ascending lines that curve and resemble a stylized human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 7, 2013

Hitachi Chemical Diagnostics, Inc C/O Erika Ammirati 575 Shirlynn Court LOS ALTOS CA 94022

Re: K131051

Trade/Device Name: Hitachi S TEST Reagent Cartridge Total Protein (TP) Hitachi S TEST Reagent Cartridge Albumin (ALB)

Regulation Number: 21 CFR 862.1035

Regulation Name: Albumin test system

Regulatory Class: II

Product Code: CIX, JGQ Dated: April 12, 2013 Received: April 17, 2013

Dear Ms. Ammirati:

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.-- Please note:- GDRH-does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2-Ms. Ammirati

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Carol Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health . Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

## Device Name: S TEST Reagent Cartridge Total Protein (TP) S TEST Reagent Cartridge Albumin (ALB)

Indications For Use:

The S TEST Reagent Cartridge Total Protein (TP) is intended for the quantitative determination of TP in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge TP is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Total protein measurements are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

The S TEST Reagent Cartridge Albumin (ALB) is intended for the quantitative determination of ALB in serum, lithium heparinized plasma, K3 EDTA plasma and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge ALB is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

YungW.Chan-S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k): k131051

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