K Number
K120945
Device Name
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
Date Cleared
2013-06-07

(435 days)

Product Code
Regulation Number
862.1030
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The S TEST Reagent Cartridge Alanine Amino Transferase (ALT) is intended for the quantitative measurement of the activity of the enzyme alanine amino transferase (ALT) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases. The S TEST Reagent Cartridge Aspartate Amino Transferase (AST) is intended for the quantitative measurement of the activity of the enzyme aspartate amino transferase (AST) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.
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 cartridge test systems for glucose.
More Information

Not Found

No
The description details a standard wet chemistry analyzer and reagent cartridges, with no mention of AI or ML in the device operation, data processing, or performance studies.

No

Explanation: This device is an in vitro diagnostic (IVD) device used for quantitative measurement of enzymes to aid in the diagnosis and treatment of diseases, not to directly treat a disease.

Yes
The "Intended Use / Indications for Use" section explicitly states that the ALT and AST measurements are "used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases." This indicates a diagnostic purpose.

No

The device description clearly outlines a hardware system (Hitachi Clinical Analyzer) and physical reagent cartridges, indicating it is not software-only.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
  • Intended Use: The device is intended for the quantitative measurement of enzyme activity (ALT and AST) in human biological samples (serum and plasma). This is a classic definition of an in vitro diagnostic test.
  • Clinical Purpose: The measurements are used "in the diagnosis and treatment of certain liver diseases... and heart diseases," indicating a medical purpose for the results obtained from testing samples outside the body.
  • Care Setting: The device is intended for use in "clinical laboratories or physician office laboratories," which are settings where IVD tests are typically performed.

N/A

Intended Use / Indications for Use

The S TEST Reagent Cartridge Alanine Amino Transferase (ALT) is intended for the quantitative measurement of the activity of the enzyme alanine amino transferase (ALT) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and circhosis) and heart diseases.

The S TEST Reagent Cartridge Aspartate Amino Transferase (AST) is intended for the quantitative measurement of the activity of the enzyme aspartate amino transferase (AST) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Product codes

CKA, CIT

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 cartridge test systems for glucose.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinical laboratories or physician office laboratories.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Nonclinical and clinical testing was performed for the Hitachi Clinical Analyzer with the S TEST ALT and AST reagent cartridges.

Nonclinical Data:
Study Type: Analytical Sensitivity (Limits of Detection); Sample Size: Not specified; Key results: The LoD for ALT was calculated to be 2.2 U/L and the LoD for AST was calculated to be 1.4 U/L.
Study Type: Linearity; Sample Size: Not specified; Key results: The ALT S TEST is linear between 6 and 400 U/L and the AST S Test is linear between 4 and 400 U/L.
Study Type: 20-day In-house Precision; Sample Size: n=80 per level for AST; Protocol: three levels of samples were each tested fourtimes a day for 20 days.
Study Type: Interference Testing; Protocol: followed CLSI EP7-A2.; Key results: The data demonstrated that the S TEST for ALT and the S Test for AST were not affected by high levels of various substances within specified concentrations.
Study Type: Method Comparisons (Accuracy); Sample Size: ALT: n=103; AST: n=169; Protocol: matched aliquots were assayed with both the Hitachi Clinical Analyzer with S TEST ALT and AST reagent cartridges and routine laboratory methods. Data analyzed by linear regression.
Study Type: Matrices Comparisons; Sample Size: Approximately 35 matched serum/plasma samples for ALT/AST; Protocol: Samples spanned dynamic ranges, assayed in singleton, and results compared using least squares linear regression (plasma = y-axis).

Clinical Data:
Study Type: External Site Precision Study (POL-type sites); Sample Size: 30 results per level per analyte, per site; Protocol: three blinded serum samples (low, intermediate, high concentrations) tested six times a day for five days.
Study Type: External Site Method Comparisons Studies (POL-type sites); Sample Size: 50 (ALT) to 60 (AST) blinded serum samples per site; Protocol: Samples representing a full range of analyte concentrations were assayed by the Hitachi system at POL sites and by traditional methods at a central laboratory. Results analyzed by least squares linear regression (Hitachi = y-axis).

Key results: The test systems were shown to be safe and effective for their intended uses.

Key Metrics

ALT:
Analytical Sensitivity (LoD): 2.2 U/L
Linearity: 6-400 U/L
Precision (In-house): %CVs range from 2.3% to 5.6%
Interference: No interference up to 250 mg/dL Hemoglobin, 25 mg/dL Unconjugated bilirubin, 500 mg/dL Triglyceride, 50 mg/dL Ascorbic acid.
Method Comparison (Regression Statistics): n=103, r=0.999, Slope=1.09 (95% CI: 1.08 to 1.09), y-intercept=2.3 (95% CI: 1.4 to 3.3).
Matrices Comparison (Regression Statistics - Na Citrate Plasma): Slope=0.99x (0.97 to 1.01), y-intercept=0.2 (-1.9 to 2.3), r=0.998.
Matrices Comparison (Regression Statistics - Heparinized Plasma): Slope=1.02 (1.00 to 1.04), y-intercept=0.2 (-1.9 to 2.3), r=0.998.
Matrices Comparison (Regression Statistics - EDTA Plasma): Slope=1.01 (0.98 to 1.04), y-intercept=0.4 (-2.3 to 3.1), r=0.997.
External Site Precision (Site 1, Sample A): Mean 51.8, SD 2.0, %CV 3.9%.
External Site Method Comparison (Site 1): n=49, Range 8 to 238, y = 1.09x -0.8, r=0.998, CI Slope 1.07 to 1.11, CI Intercept -2.3 to 0.8.

AST:
Analytical Sensitivity (LoD): 1.4 U/L
Linearity: 4-400 U/L
Precision (In-house): %CVs range from 1.4% to 3.2%
Interference: No interference up to 31 mg/dL Hemoglobin (slight visual hemolysis) for ~40 U/L samples, 125 mg/dL (moderate visual hemolysis) for ~100 U/L samples, 50 mg/dL Unconjugated bilirubin, 500 mg/dL Triglyceride, 50 mg/dL Ascorbic acid.
Method Comparison (Regression Statistics): n=169, r=0.997, Slope=1.09 (95% CI: 1.08 to 1.10), y-intercept=-3.7 (95% CI: -4.8 to -2.7).
Matrices Comparison (Regression Statistics - Na Citrate Plasma): Slope=1.02 (1.00 to 1.04), y-intercept=-2.6 (-4.4 to -0.9), r=0.999.
Matrices Comparison (Regression Statistics - Heparinized Plasma): Slope=1.04 (1.02 to 1.06), y-intercept=0.6 (-1.1 to 2.2), r=0.999.
Matrices Comparison (Regression Statistics - EDTA Plasma): Slope=0.98 (0.94 to 1.02), y-intercept=3.0 (-1.0 to 7.0), r=0.992.
External Site Precision (Site 1, Sample A): Mean 76.3, SD 1.9, %CV 2.5%.
External Site Method Comparison (Site 1): n=64, Range 5 to 359, y = 1.00x -0.1, r=0.999, CI Slope 0.99 to 1.01, CI Intercept -1.5 to 1.4.

Predicate Device(s)

K974003, K100853

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.

(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

0

SECTION 8 510(k) SUMMARY

JUN 0 7 2013

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 K120945.

807.92 (a)(1): Name:Hitachi Chemical Diagnostics
Address:630 Clyde Court
Mountain View, CA 94043
Phone:(୧૨૦) ଜ୧୮୮ ୧૨૦)
FAX:(650) 969 2745
Contact:Mr. Charles Tsou

Regulatory Correspondent: Ms. Erika Ammirati

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

Trade name:

S TEST Reagent Cartridge Alanine Amino Transferase (ALT) S TEST Reagent Cartridge Aspartate Amino Transferase (AST)

Common Name: Routine chemistry analyzer for ALT and AST

  • Classification: ALT-21 CFR $862.1030, Class I with exemption by 21 CFR §862.9, product code CKA
    AST- 21 CRF $862.1100, Class II, product code CIT

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

ALT: K974003- ALT SL Assay (Sekisui Diagnostics, Ltd, PEI, Canada) AST: K100853- ASTL assay (cobas, Roche Diagnostics, Indianapolis, IN)

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.

. Page 1 of 8

1

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 cartridge test systems for glucose.

ALT Chemistry Reactions:

Alanine aminotransferase (ALT) catalyzes the reaction from L-alanine and alfa-ketoglutaric acid to pyruvic acid and glutamic acid. When the produced pyruvic acid is converted into lactic acid by lactate dehydrogenase (LD), NADH is converted into NAD with a decrease in absorbance at 340 nm. The ALT activity can be determined by measuring the decreased rate of NADH.

Image /page/1/Figure/5 description: This image shows two chemical reaction equations and a timeline. The first reaction shows L-Alanine and Alfa-Ketoglutaric acid converting into Pyruvic acid and Glutamic acid with the enzyme ALT. The second reaction shows Pyruvic acid and NADH converting into Lactic acid and NAD with the enzyme LD. The timeline shows the addition of Reagent 1/Sample (200 µL / 15 μι) at 0 minutes, Reagent 2 (100 µL) at 7.5 minutes, and measurement at 8.5 minutes, with enzyme activity calculation at 12.5 minutes.

AST Chemistry Reactions:

Aspartate aminotransferase (AST) catalyzes a reaction from L-aspartic acid and aketogulutaric acid to oxaloacetic acid and glutamic acid. When the produced oxaloacetic acid is converted into malic acid by malate dehydrogenase (MD), NADH is converted into NAD with a decrease in absorbance at 340 nm. The AST activity can be determined by measuring the decreased rate of NADH.

Image /page/1/Figure/10 description: This image shows two chemical reactions. The first reaction shows L-Aspartic acid and Alfa-Ketoglutaric acid reacting with AST to produce Oxaloacetic acid and Glutamic acid. The second reaction shows Oxaloacetic acid and NADH reacting with MD to produce Malic acid and NAD. The image also contains the text 'Page 2 of 8'.

2

AST (Continued)

Image /page/2/Figure/1 description: This image shows a timeline of an experiment. At time zero, Reagent 1 and a sample are combined in volumes of 200 μL and 15 μL, respectively. At time 7.5, 100 μL of Reagent 2 is added, and measurements are taken at 8.5. The enzyme activity is calculated at 12.5 minutes, and the measurement is 340/546 nm.

807.92 (a)(5): Intended Use

S TEST Reagent Cartridge Alanine Amino Transferase ALT

Indications for Use:

The S TEST Reagent Cartridge Alanine Amino Transferase (ALT) is intended for the quantitative measurement of the activity of the enzyme alanine amino transferase (ALT) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and circhosis) and heart diseases.

S TEST Reagent Cartridge Aspartate Amino Transferase AST

Indications for Use:

The S TEST Reagent Cartridge Aspartate Amino Transferase (AST) is intended for the quantitative measurement of the activity of the enzyme aspartate amino transferase (AST) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

3

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

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

CharacteristicHitachi S TEST SystemsPREDICATE(S)
ALT Test SystemK number- K120945Sekisui ALT-SL- K974003
Device Class, Regulation CodeClass I (reserved), 21 CFR 862.1030Class I, 21 CFR 862.1030
Classification Product CodeCKASame
Intended UseQuantitative determination of ALTSame
Testing EnvironmentPhysician office or clinical labClinical lab
Test PrincipleNADH oxidation of pyruvate formed
by L-alanine and alpha-ketoglutarate
in the presence of ALTSame
Specimen TypeHuman serum or plasmaHuman serum
Reportable Range6 to 400 U/L10 to 600 U/L
Detection Wavelength340/546 nm340/415 nm
Detection Limit2.2 U/L10 U/L
Linearity6 to 400 U/L10 to 600 U/L
Precision%CVs range from 2.3% to 5.6%%CVs range from 2.4% to 3.6%
AST Test SystemK number- K120945Roche cobas K number- K100853
Device Class, Regulation CodeClass II, 21 CFR 862.1100Same
Classification Product CodeCITSame
Intended UseQuantitative determination of ASTSame
Testing EnvironmentPhysician office or clinical labClinical lab
Test PrincipleNADH oxidation of pyruvate formed
by L-aspartate and alpha-
ketoglutarate in the presence of ASTNADH oxidation of pyruvate formed
by L-aspartate and 2-oxyglutarate in
the presence of AST
Specimen TypeHuman serum or plasmaHuman serum or plasma
Reportable Range4 to 400 U/L5 to 700 U/L
Detection Wavelength340/546 nm700/340 nm
Detection Limit1.4 U/L5 U/L
Linearity4 to 400 U/L5 to 700 U/L
Precision%CVs range from 1.4% to 3.2%%CVs range from 0.4% to 3.1%

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

A series of studies were performed that evaluated the following nonclinical performance characteristics for ALT and AST: 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 options.

4

Analytical Sensitivity (Limits of Detection)

The studies followed CLSI EP17. The LoD for ALT was calculated to be 2.2 U/L and the LoD for AST was calculated to be 1.4 U/L

Linearitv

The studies followed CLSI EP-6A. The ALT S TEST is linear between 6 and 400 U/L and the AST S Test is linear between 4 and 400 U/L.

20-day In-house Precision

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

Precision Summary:

| | | /TT/T
Mean (U/L | Within-Run
0/al
( | .
1%CV
Total . |
|------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 1
1
| Level | 00 0
and and the been and the best of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state of the state o | | |
| per level | evel | 70 | Acres of the cases of a career a

    •                                                                                                                                            | l (
      

i |
|
. | t
l'evel . | 706 7
LOU. |

| to to

  •       |
    
Mean (U/LWithin-Run %CTotal %CV
ASTLevel--------C
ic
And Chand
n= 80 per levelLevel 2109.61
of the control of children and the different of the different of the different of the different of the different of the different of the different of the different of the difLevel 3304.2, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Interference Testing

The studies followed CLSI EP7-A2. The data demonstrated that the S TEST for ALT and the S Test for AST were not affected by high levels of the following substances at the levels noted:

ALT

  • Hemoglobin: no interference up to 250 mg/dL .
  • Unconjugated bilirubin no interference up to 25 mg/dL .
  • Triglyceride: no interference up to 500 mg/dL .
  • Ascorbic acid: no interference up to 50 mg/dL .

AST

  • Hemoglobin: no interference up to 31 mg/dL (slight visual hemolysis) for samples at . approximately 40 U/L, and up to 125 mg/dL (moderate visual hemolysis) for samples at approximately 100 U/L
  • Unconjugated bilirubin no interference up to 50 mg/dL .
  • Triglyceride: no interference up to 500 mg/dL .
  • Ascorbic acid: no interference up to 50 mg/dL .

Method Comparisons

Method comparison studies evaluated at least serum samples; matched aliquots were assayed with both the Hitachi Clinical Analyzer with S TEST ALT and AST reagent cartridges and routine laboratory methods. The data were analyzed by linear regression (Hitachi = y-axis), and the results were as follows:

Page 5 of 8

5

Image /page/5/Picture/0 description: The image shows the word "HITACHI" in large, bold, black letters. Below the word "HITACHI" is the phrase "Inspire the Next" in a smaller, black font. The text is simple and clear, with a focus on the brand name and a tagline.

ALT (U/L) Regression Statistics (range = 12 to 392 U/L) :

nrSlope (95% CI)y-intercept (95% CI)
1030.9991.09 (1.08 to 1.09)2.3 (1.4 to 3.3)

AST (U/L) Regression Statistics (range = 5 to 369 U/L):

nrSlope (95% CI)y-intercept (95% CI)
1690.9971.09 (1.08 to 1.10)-3.7 (-4.8 to -2.7)

Matrices Comparisons

A study was performed to validate the use of sodium citrate, lithium heparinized, and K3 EDTA plasma as alternatives to serum for the Hitachi Clinical Analyzer with S TEST ALT and AST reagent cartridges Approximately 35 matched serum/plasma samples that spanned the ALT and AST dynamic ranges were assayed in singleton and the results were compared using least squares liner regression (plasma = y-axis). The performance characteristics were as follows.

ALT Range (serum) = 6-392 U/L

Na Citrate Plasma n = 28Heparinized Plasma n = 31EDTA Plasma = 30
Slope (95% CIs)0.99x (0.97 to 1.01)1.02 (1.00 to 1.04)1.01 (0.98 to 1.04)
y-intercept (95% CIs)0.2 (-1.9 to 2.3)0.2 (-1.9 to 2.3)0.4 (-2.3 to 3.1)
r0.9980.9980.997

AST Range (serum) = 5 to 369 U/L

Na Citrate Plasma n = 38Heparinized Plasma n = 38EDTA Plasma n = 39
Slope (95% CIs)1.02 (1.00 to 1.04)1.04 (1.02 to 1.06)0.98 (0.94 to 1.02)
y-intercept (95% CIs)-2.6 (-4.4 to -0.9)0.6 (-1.1 to 2.2)3.0 (-1.0 to 7.0)
r0.9990.9990.992

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 Clinical Analyzer with S TEST ALT and AST reagent cartridges 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 that were chosen to represent low, intermediate, and high concentrations of each analyte. Each sample was assaved six times per day for five days, reporting 30 results per level per analyte. Precision estimates for within-run precision and total precision were as follows (NOTE: precision samples at Site 3 were different than the precision samples at Sites 1 and 2, as materials had been consumed):

Precision Samples at Sites 1 and 2: A, B, and C Precision samples at Site 3: D, E, and F

6

16

SiteSampleMeanWithin-run PrecisionTotal Precision
SD (U/L)%CVSD (mg/dL)%CV
Site 1A51.82.03.9%2.03.9%
Site 2A51.72.44.7%2.44.7%
Site 3D24.30.93.8%1.45.7%
Site 1B143.82.21.5%3.42.4%
Site 2B139.52.51.8%2.82.0%
Site 3E77.41.11.4%2.0'2.6%
Site 1C319.73.81.2%5.01.6%
Site 2C305.94.11.3%7.72.5%
Site 3F194.42.21.1%4.32.2%

ALT (U/L) = 30 renlicates ner sample ner site

AST (U/L)

n = 30 replicates per sample per site
SiteSampleMeanWithin-run PrecisionTotal Precision
SD (U/L)%CVSD (mg/dL)%CV
Site 1A76.31.92.5%2.02.7%
Site 2A75.41.72.2%1.62.1%
Site 3D41.00.92.2%0.92.1%
Site 1B156.82.11.3%3.82.4%
Site 2B154.42.51.6%4.12.7%
Site 3E106.10.90.8%2.01.9%
Site 1C356.05.81.6%6.91.9%
Site 2C348.97.32.1%20.65.9%
Site 3F256.92.61.0%4.91.9%

For the external site method comparisons studies, each POL site received 50 (ALT) to 60 (AST) blinded serum samples that were chosen to represent as full a range of analyte concentrations as possible, and a central laboratory received a matched aliquot for each serum sample. Each sample was assayed by the Hitachi system at the POL sites, and by traditional methods at the central laboratory. The results were analyzed by least squares linear regression (Hitachi = y-axis), and the performance characteristics were as follows:

| Site # | n | Range | Regression
Equation | "r" | CI*
Slope | CI Intercept |
|--------|----|----------|------------------------|-------|--------------|--------------|
| 1 | 49 | 8 to 238 | y = 1.09x -0.8 | 0.998 | 1.07 to 1.11 | -2.3 to 0.8 |
| 2 | 50 | 9 to 227 | y = 1.05 x +0.1 | 0.997 | 1.03 to 1.07 | -1.7 to 1.9 |
| 3 | 50 | 8 to 244 | y = 1.11x +0.2 | 0.997 | 1.08 to 1.14 | -2.0 to 2.3 |

CV DATA SUMMARY- ALT (I/L)

*95% Confidence Interval

7

Site #RangeRegression46 - 99Cl*CI Intercept
EquationSlope
645 to 359y = 1.00x -0.10.9990.99 to 1.01-1.5 to 1.4
626 to 383Y = 1.04x -0.30.9981.02 to 1.05-2.1 to 1.5
645 to 375y = 1.05x +0.70.9991.04 to 1.06-1.1 to 2.5

POL ACCURACY DATA SUMMARY- AST (U/L)

*95% Confidence Interval

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

Nonclinical and clinical testing was performed for the Hitachi Clinical Analyzer with the S TEST ALT and AST reagent cartridges. The test systems were shown to be safe and effective for their intended uses.

8

Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered on the image and is the only element present. The image is simple and straightforward.

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

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 Charles Tsou 630 Clyde Court MOUNTAIN VIEW CA 94043

Re: K120945

Trade/Device Name: S TEST Reagent Cartridge Aspartate Amino Transferase (AST) S TEST Reagent Cartridge Alanine Amino Transferase (ALT) Regulation Number: 21 CFR 862.1100 Regulation Name: Aspartate amino transferase (AST/SGOT) test system Regulatory Class: II Product Code: CIT, CKA Dated: June 04, 2013 Received: June 05, 2013

Dear Mr. Tsou:

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: - CDRH 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-Mr. Tsou

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/ucm 1 15809.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 C. 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): K120945

Device Name:

S TEST Reagent Cartridge Alanine Amino Transferase (ALT) S TEST Reagent Cartridge Aspartate Amino Transferase (AST)

Indications for Use:

The S TEST Reagent Cartridge Alanine Amino Transferase (ALT) is intended for the quantitative measurement of the activity of the enzyme alanine amino transferase (ALT) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. ALT measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

The S TEST Reagent Cartridge Aspartate Amino Transferase (AST) is intended for the quantitative measurement of the activity of the enzyme aspartate amino transferase (AST) in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. AST measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

Prescription Use (Part 21 CFR 801 Subpart D) 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)

AND/OR

YungW.Chan-S

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

510(k) K120945

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