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.

AI/ML Overview

The Hitachi Chemical Diagnostics S TEST Reagent Cartridges for Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) underwent nonclinical and clinical testing to demonstrate their safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Characteristic	Acceptance Criteria (Implicit from Predicate/Standard)	S TEST ALT Performance (Reported)	S TEST AST Performance (Reported)
Analytical Sensitivity (LoD)	Comparable to predicate (10 U/L for ALT, 5 U/L for AST) or lower	2.2 U/L	1.4 U/L
Linearity/Reportable Range	Comparable to predicate (10 to 600 U/L for ALT, 5 to 700 U/L for AST)	6 to 400 U/L	4 to 400 U/L
Precision	Comparable to predicate (%CVs 2.4-3.6% for ALT, 0.4-3.1% for AST)	2.3% to 5.6% (%CVs for ALT)	1.4% to 3.2% (%CVs for AST)
Interference	No significant interference from common substances at specified levels	No interference up to: Hemoglobin 250 mg/dL, Unconjugated bilirubin 25 mg/dL, Triglyceride 500 mg/dL, Ascorbic acid 50 mg/dL	No interference up to: Hemoglobin 31-125 mg/dL, Unconjugated bilirubin 50 mg/dL, Triglyceride 500 mg/dL, Ascorbic acid 50 mg/dL
Method Comparison (Correlation with Predicate/Reference Method)	High correlation (implied by r > 0.99) and acceptable slope/intercept	Internal: r=0.999, Slope 1.09, y-intercept 2.3	Internal: r=0.997, Slope 1.09, y-intercept -3.7
	External (POL Sites): High correlation and acceptable slope/intercept across sites	Site 1: r=0.998, y=1.09x-0.8Site 2: r=0.997, y=1.05x+0.1Site 3: r=0.997, y=1.11x+0.2	Site 1: r=0.999, y=1.00x-0.1Site 2: r=0.998, Y=1.04x-0.3Site 3: r=0.999, y=1.05x+0.7
Matrices Comparison	Acceptable correlation (r) and slope/intercept when comparing plasma types to serum	Na Citrate Plasma: r=0.998, Slope 0.99Heparinized Plasma: r=0.998, Slope 1.02EDTA Plasma: r=0.997, Slope 1.01	Na Citrate Plasma: r=0.999, Slope 1.02Heparinized Plasma: r=0.999, Slope 1.04EDTA Plasma: r=0.992, Slope 0.98

2. Sample Sizes Used for the Test Set and Data Provenance:

Nonclinical Studies (Internal):
- Analytical Sensitivity (LoD): Sample sizes not explicitly stated for individual calculations beyond "followed CLSI EP17."
- Linearity: Sample sizes not explicitly stated beyond "followed CLSI EP-6A."
- 20-day In-house Precision: 80 replicates per level for AST (ALT not clearly defined due to formatting issues in the document but likely similar).
- Interference Testing: Sample sizes not explicitly stated.
- Method Comparisons: 103 serum samples for ALT, 169 serum samples for AST.
- Matrices Comparisons: Approximately 35 matched serum/plasma samples (28-31 for ALT, 38-39 for AST) per plasma type.
Clinical Studies (External POL-type sites):
- External Precision Study: 30 replicates per sample per site (6 times a day for 5 days) for 3 sample levels (A, B, C or D, E, F) at each of 3 sites.
- External Method Comparisons: 49-50 blinded serum samples for ALT per site; 62-64 blinded serum samples for AST per site tested at 3 POL sites.
Data Provenance: The document does not explicitly state the country of origin for the data. The studies were conducted internally ("in-house") and at "three external POL-type sites," suggesting the data is retrospective as it was collected before submission.

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

For the nonclinical and clinical method comparison studies, the "ground truth" was established by "routine laboratory methods" or "traditional methods at the central laboratory."
The document does not specify the number or qualifications of experts involved in performing these reference methods. It relies on the established accuracy and widely accepted nature of these "traditional" or "routine" methods.

4. Adjudication Method for the Test Set:

No explicit adjudication method is described. The "ground truth" was derived from measurements by established laboratory methods, and the Hitachi device's results were compared to these.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on the analytical performance of an in vitro diagnostic (IVD) device (reagent cartridges for an analyzer), not a diagnostic imaging or AI-driven decision-support system that typically involves human reader performance. Therefore, there is no mention of human readers, AI assistance, or effect sizes related to human improvement.

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

Yes, this entire submission is effectively a standalone performance study. The device itself is an automated chemical analyzer with reagent cartridges. The studies evaluate the analytical performance of this automated system directly (e.g., sensitivity, linearity, precision, method comparison to reference methods). There is no "human-in-the-loop" component in the operational use or performance evaluation of the ALT/AST test results themselves, beyond the initial sample loading and result interpretation by laboratory personnel.

7. The Type of Ground Truth Used:

The ground truth used for method comparison and accuracy studies was established by measurements from "routine laboratory methods" or "traditional methods at the central laboratory." This implies a highly accurate and well-established chemical assay, which serves as the reference standard for the analyte concentration or activity.

8. The Sample Size for the Training Set:

This submission describes a premarket notification (510(k)) for an IVD device (reagent cartridges). It does not involve a machine learning or AI algorithm that typically requires a distinct "training set." Therefore, no training set sample size is reported or relevant in this context. The "training" of the device is inherent in its chemical design and calibration, not in data-driven machine learning.

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

As stated above, this is an IVD device, not an AI/ML-driven device. Thus, the concept of a "training set" and associated ground truth establishment for such a set does not apply. The device's performance is validated against established laboratory standards and reference methods as described in point 7.

Summary

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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

. Page 1 of 8

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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'.

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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:

S TEST Reagent Cartridge Aspartate Amino Transferase AST

Indications for Use:

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

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

Characteristic	Hitachi S TEST Systems	PREDICATE(S)
ALT Test System	K number- K120945	Sekisui ALT-SL- K974003
Device Class, Regulation Code	Class I (reserved), 21 CFR 862.1030	Class I, 21 CFR 862.1030
Classification Product Code	CKA	Same
Intended Use	Quantitative determination of ALT	Same
Testing Environment	Physician office or clinical lab	Clinical lab
Test Principle	NADH oxidation of pyruvate formedby L-alanine and alpha-ketoglutaratein the presence of ALT	Same
Specimen Type	Human serum or plasma	Human serum
Reportable Range	6 to 400 U/L	10 to 600 U/L
Detection Wavelength	340/546 nm	340/415 nm
Detection Limit	2.2 U/L	10 U/L
Linearity	6 to 400 U/L	10 to 600 U/L
Precision	%CVs range from 2.3% to 5.6%	%CVs range from 2.4% to 3.6%

AST Test System	K number- K120945	Roche cobas K number- K100853
Device Class, Regulation Code	Class II, 21 CFR 862.1100	Same
Classification Product Code	CIT	Same
Intended Use	Quantitative determination of AST	Same
Testing Environment	Physician office or clinical lab	Clinical lab
Test Principle	NADH oxidation of pyruvate formedby L-aspartate and alpha-ketoglutarate in the presence of AST	NADH oxidation of pyruvate formedby L-aspartate and 2-oxyglutarate inthe presence of AST
Specimen Type	Human serum or plasma	Human serum or plasma
Reportable Range	4 to 400 U/L	5 to 700 U/L
Detection Wavelength	340/546 nm	700/340 nm
Detection Limit	1.4 U/L	5 U/L
Linearity	4 to 400 U/L	5 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.

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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/TMean (U/L	Within-Run0/al(	.1%CVTotal .
11	Level	00 0and 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
.	tl'evel .	706 7LOU.	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	to to-

		Mean (U/L	Within-Run %C	Total %CV
AST	Level	--------	Ci	cAnd Chand
n= 80 per level	Level 2	109.6		1
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 dif	Level 3	304.2	ﺮ	, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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:

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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) :

n	r	Slope (95% CI)	y-intercept (95% CI)
103	0.999	1.09 (1.08 to 1.09)	2.3 (1.4 to 3.3)

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

n	r	Slope (95% CI)	y-intercept (95% CI)
169	0.997	1.09 (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 = 28	Heparinized Plasma n = 31	EDTA 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)
r	0.998	0.998	0.997

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

	Na Citrate Plasma n = 38	Heparinized Plasma n = 38	EDTA 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)
r	0.999	0.999	0.992

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

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Site	Sample	Mean	Within-run Precision		Total Precision
			SD (U/L)	%CV	SD (mg/dL)	%CV
Site 1	A	51.8	2.0	3.9%	2.0	3.9%
Site 2	A	51.7	2.4	4.7%	2.4	4.7%
Site 3	D	24.3	0.9	3.8%	1.4	5.7%
Site 1	B	143.8	2.2	1.5%	3.4	2.4%
Site 2	B	139.5	2.5	1.8%	2.8	2.0%
Site 3	E	77.4	1.1	1.4%	2.0'	2.6%
Site 1	C	319.7	3.8	1.2%	5.0	1.6%
Site 2	C	305.9	4.1	1.3%	7.7	2.5%
Site 3	F	194.4	2.2	1.1%	4.3	2.2%

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

AST (U/L)

n = 30 replicates per sample per site
Site	Sample	Mean	Within-run Precision		Total Precision
			SD (U/L)	%CV	SD (mg/dL)	%CV
Site 1	A	76.3	1.9	2.5%	2.0	2.7%
Site 2	A	75.4	1.7	2.2%	1.6	2.1%
Site 3	D	41.0	0.9	2.2%	0.9	2.1%
Site 1	B	156.8	2.1	1.3%	3.8	2.4%
Site 2	B	154.4	2.5	1.6%	4.1	2.7%
Site 3	E	106.1	0.9	0.8%	2.0	1.9%
Site 1	C	356.0	5.8	1.6%	6.9	1.9%
Site 2	C	348.9	7.3	2.1%	20.6	5.9%
Site 3	F	256.9	2.6	1.0%	4.9	1.9%

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	RegressionEquation	"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

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	Range	Regression	46 - 99	Cl*	CI Intercept
		Equation		Slope
64	5 to 359	y = 1.00x -0.1	0.999	0.99 to 1.01	-1.5 to 1.4
62	6 to 383	Y = 1.04x -0.3	0.998	1.02 to 1.05	-2.1 to 1.5
64	5 to 375	y = 1.05x +0.7	0.999	1.04 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.

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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:

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

Page 1 of 1

Regulation Number and Section

§ 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.