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.

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 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.

AI/ML Overview

The provided document is a 510(k) summary for the Hitachi S TEST Reagent Cartridge Total Protein (TP) and Albumin (ALB). It details the nonclinical and clinical studies performed to demonstrate the safety and effectiveness of these in-vitro diagnostic devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a singular, formal table. Instead, performance characteristics are presented as results from various studies, often implicitly comparing them to the predicate device or general industry standards (e.g., CLSI guidelines). The performance characteristics are reported as the outcome of the tests performed.

Below is a table summarizing the reported device performance for both TP and ALB, drawing from the "Technological Similarities and Differences to the Predicate" section and the "Brief Description of Nonclinical Data" and "Brief Description of Clinical Data" sections. Implicit acceptance is typically shown by these results being deemed "safe and effective for their intended uses."

Hitachi S TEST Reagent Cartridge: Reported Device Performance

Performance Characteristic	Total Protein (TP) Reported Performance	Albumin (ALB) Reported Performance
Analytical Sensitivity (Limits of Detection)	0.2 g/dL	0.1 g/dL
Quantitation Limit	0.2 g/dL	0.5 g/dL
Linearity/Reportable Range	0.2 to 11.0 g/dL	0.1 to 8.0 g/dL (Linearity) / 0.5 to 8.0 g/dL (Reportable Range)
In-house Precision (%CV Total)	1.0% to 2.5%	1.6% to 4.8%
External Site Precision (%CV Total)	0.7% to 4.4% (across 3 sites)	0.0% to 4.8% (across 3 sites)
Interference (Recovery 90-110%) TP	Unconjugated bilirubin: up to 50 mg/dL Lipemia: up to 500 mg/dL Ascorbic acid: up to 50 mg/dL Hemoglobin: up to 1,000 mg/dL	Not applicable
Interference (Recovery 90-110%) ALB	Not applicable	Hemoglobin: up to 250 mg/dL Unconjugated bilirubin: up to 12.5 mg/dL Lipemia: up to 500 mg/dL Ascorbic acid: up to 50 mg/dL
Method Comparison (n, r, Slope CI, Y-intercept CI) - Internal	n=115, r=0.989, Slope=1.02 (1.01-1.04), Y-intercept=0.01 (-0.13-0.15)	n=118, r=0.975, Slope=1.01 (0.96-1.06), Y-intercept=0.24 (0.06-0.41)
Method Comparison (n, r, Regression Eq.) - External POL Sites	Site 1: n=52, r=0.996, y=0.98x+0.14 Site 2: n=52, r=0.994, y=1.00x-0.07 Site 3: n=53, r=0.996, y=0.96x+0.03	Site 1: n=87, r=0.982, y=0.99x+0.24 Site 2: n=81, r=0.979, y=0.95x+0.30 Site 3: n=81, r=0.985, y=0.91x+0.35
Matrices Comparison (n, r, Slope CI, Y-intercept CI) - TP	Heparinized: n=45, r=0.989, Slope=1.00 (0.96-1.04), Y-int=-0.11 (-0.43-0.21) EDTA: n=45, r=0.992, Slope=1.00 (0.96-1.04), Y-int=-0.06 (-0.33-0.22) Na Citrate: n=45, r=0.987, Slope=0.98 (0.93-1.03), Y-int=-0.09 (-0.45-0.26)	Not applicable
Matrices Comparison (n, r, Slope CI, Y-intercept CI) - ALB	Not applicable	Heparinized: n=41, r=0.992, Slope=0.99 (0.95-1.03), Y-int=-0.01 (-0.20-0.18) EDTA: n=41, r=0.995, Slope=0.95 (0.92-0.98), Y-int=0.22 (0.08-0.36) Na Citrate: n=41, r=0.986, Slope=1.00 (0.94-1.05), Y-int=-0.22 (-0.48-0.03)

2. Sample Size Used for the Test Set and Data Provenance

The document describes test sets for various studies:

Method Comparison (Internal):
- TP: 115 clinical specimens
- ALB: 118 clinical specimens
- Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Described as "clinical specimens."
Matrices Comparison:
- TP: 45 matched serum/plasma samples
- ALB: 41 matched serum/plasma samples
- Provenance: Not explicitly stated.
External Site Precision Study:
- TP: 3 "blinded serum samples" (low, middle, high) at each of 3 sites. Each sample assayed 30 times (6 times/day for 5 days). So, 3 samples * 30 replicates * 3 sites = 270 measurements per analyte for total precision.
- ALB: 3 "blinded serum samples" (low, middle, high) at each of 3 sites. Each sample assayed 30 times (6 times/day for 5 days). So, 3 samples * 30 replicates * 3 sites = 270 measurements per analyte for total precision.
- Provenance: "three external POL-type sites," implying clinical settings, likely within the US given the submission to the FDA. Retrospective/prospective not specified for the samples, but the testing itself was prospective within the study timeframe.
External Method Comparison Studies (POL Accuracy Data Summary):
- TP: Approximately 50-80 serum specimens per site (n=52, 52, 53). Total around 157.
- ALB: Approximately 50-80 serum specimens per site (n=87, 81, 81). Total around 249.
- Provenance: "three external POL-type sites," implying clinical settings, likely within the US. Retrospective/prospective not specified for samples but the comparative testing was prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This document describes a diagnostic device for quantitative determination of Total Protein and Albumin. For such devices, "ground truth" is typically established by recognized reference methods, not by expert consensus (e.g., radiologists).

Method Comparison (Internal and External): The comparison was made against a "standard laboratory system" or "comparative method as the reference method (x)." The specific details of this reference method are not given beyond its use for comparison. No information is provided about human expert involvement in establishing this ground truth.

4. Adjudication Method for the Test Set

Not applicable. Diagnostic devices like this establish their accuracy against a reference method, not through human adjudication of results.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is an in-vitro diagnostic device that provides quantitative measurements. MRMC studies are relevant for imaging devices or those requiring human interpretation.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, all studies described (analytical sensitivity, linearity, precision, interference, method comparisons, matrices comparisons) represent the standalone performance of the device (Hitachi Clinical Analyzer E40 with S TEST Reagent Cartridges) in measuring TP and ALB concentrations in samples. These are automated processes without direct human interpretation of results for the purpose of the measurement itself. Human operators are involved in running the analyzer, but the "performance" here refers to the device's analytical capability.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established using:

Reference Methods/Standard Laboratory Systems: For method comparison studies, the device's results (Y) were compared to a "standard laboratory system" or "comparative method" (X). This is a common approach for establishing accuracy of new in-vitro diagnostic devices.
CLSI Guidelines: Studies like Analytical Sensitivity, Linearity, and Precision followed CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP17-A, EP-6A, EP5-A2). These guidelines define how to determine these performance characteristics, often involving reference materials or established statistical methods for calculation rather than external ground truth.
Defined Concentrations: For precision and interference studies, samples were used that represented specific (low, middle, high) or known concentrations of the analytes.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a traditional in-vitro diagnostic device based on chemical reactions and photometric measurements. Its "development" would involve optimizing reagents and calibration, not "training" an algorithm in the AI sense. Therefore, the concept of a training set as understood in AI/ML is not applicable here.

9. How the Ground Truth for the Training Set Was Established

As noted in #8, there is no "training set" in the context of AI/ML for this device. The ground truth for developing and calibrating such devices typically relies on:

Primary Reference Materials: Highly characterized materials with known concentrations of analytes.
Secondary Reference Materials: Materials traceable to primary reference materials.
Validated Reference Methods: Established and highly accurate methods, often more complex or expensive, used to assign values to control or calibration materials.

The document implicitly refers to these as part of "assay performance claims were established on the HITACHI Clinical Analyzer."

Summary

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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 Diagnostics630 Clyde CourtMountain View, CA 94043
	Phone:	(650) 961 5501
	FAX:	(650) 969 2745
	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 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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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).

807.92 (a)(5): Intended Use

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.

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

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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(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 CFR862.1635	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 thebiuret reagent to form a purple-redcomplex. The concentration of totalprotein can be determined bymeasuring the absorbance of thepurple-red substance.	Divalent copper reacts with proteinpeptide bonds to form thecharacteristic purple-colored biuretcomplex. The color intensity isdirectly proportional to the proteinconcentration which is determinedphotometrically
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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630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745

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Characteristic	Hitachi S TEST Systems	PREDICATE
Instrument Platform	Hitachi Clinical Analyzer(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 combineswith bromcresol green to form ablue-green dye conjugate. Thealbumin concentration is directlyproportional to the color intensityand can be determinedphotometrically by measuring theabsorbance of this resulting blue-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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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%

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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

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(95% CI)	y-intercept(95% CI)	X mean	Y mean
115	0.989	1.02(1.01 to 1.04)	0.01(-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(95% CI)	y-intercept(95% CI)	X mean	Y mean
118	0.975	1.01(0.96 to 1.06)	0.24(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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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(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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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(g/dL)	RegressionEquation	"r"	CI*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 (800) 638-2041 or (301) 796-7100 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:

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.

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

Page 1 of 1

Regulation Number and Section

§ 862.1635 Total protein test system.

(a)
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.(b)
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.