The S TEST reagent cartridge for glucose is intended for the quantitative measurement of glucose in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.

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.

Chemistry reactions: Glucose is phosphorylated to glucose-6-phosphate by hexokinase (HK) in the presence of ATP. When the glucose-6-phosphate is converted into 6-phosphogluconic acid by glucose-6phosphate dehydrogenase (G6PD), NADP is converted into NADPH with an increase in absorbance at 340 nm. The concentration of glucose can be determined by measuring the amount of change in absorbance of NADPH.

HK Glucose + ATP Glucose-6-phosphate + ADP Mg2+ GRPD

Glucose-6-phosphate + NADP 6-Phosphogluconic acid + NADPH

AI/ML Overview

The provided text describes the 510(k) summary for the Hitachi Clinical Analyzer S TEST Reagent Cartridge for Glucose. It details various performance studies conducted to demonstrate its safety and effectiveness.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" as pass/fail thresholds for each metric. Instead, it presents the results of various performance studies and implies that these results demonstrate substantial equivalence to the predicate devices. The information available allows for a comparison of the Hitachi S TEST and the predicate device's listed performance.

Performance Metric	Acceptance Criteria (Implied / Predicate)	Reported Hitachi S TEST Performance
Analytical Sensitivity (Detection Limit)	Predicate: 2 mg/dL	Calculated: 0.3 mg/dL. Limit of Quantitation (LoQ): 5 mg/dL.
Linearity (Reportable Range)	Predicate: 2 to 750 mg/dL	5 to 500 mg/dL
Precision (In-house)	Predicate: %CVs range from 0.7% to 1.3% (from product labeling) (Lower %CV is better)	Within-Run %CV: Level 1: 3.9%, Level 2: 1.5%, Level 3: 1.1%Total %CV: Level 1: 3.9%, Level 2: 2.1%, Level 3: 3.0%
Precision (External POL)	(Not explicitly stated, but clinical acceptability is implied by comparison to predicate)	Site 1: A: 4.6% (Total %CV), B: 3.7% (Total %CV), C: 3.6% (Total %CV)Site 2: A: 1.7% (Total %CV), B: 1.1% (Total %CV), C: 1.9% (Total %CV)Site 3: A: 2.3% (Total %CV), B: 1.7% (Total %CV), C: 3.0% (Total %CV)
Method Comparison (Accuracy)	Implied acceptable correlation (e.g., r > 0.97, slope close to 1, intercept close to 0)	In-house (vs. cobas 6000): n=100. y=0.99x -2.7, r=0.994. 95% CI slope: 0.98 to 1.02, 95% CI y-intercept: -5.5 to 0.8.External POL (vs. cobas 6000):Site 1 (n=53): y=1.01x -1.1, r=0.99. CI Slope: 0.99 to 1.02, CI Intercept: -2.7 to 0.6.Site 2 (n=52): y=0.97x -0.1, r=0.99. CI Slope: 0.96 to 0.99, CI Intercept: -2.1 to 1.9.Site 3 (n=51): y=1.05x -2.5, r=0.99. CI Slope: 1.03 to 1.07, CI Intercept: -5.1 to 0.1.
Interference	No significant interference at specified levels of common interfering substances.	Not affected by Hemoglobin (up to 1000 mg/dL for ~200 mg/dL glucose, up to 500 mg/dL for ~50 mg/dL glucose), Unconjugated bilirubin (up to 50 mg/dL for ~200 mg/dL glucose, up to 6.25 mg/dL for ~50 mg/dL glucose), Triglyceride (up to 800 mg/dL), Ascorbic acid (up to 50 mg/dL).
Matrices Comparison	Acceptable correlation/equivalence between serum and plasma types.	Na Citrate Plasma: Slope: 0.98 (0.96-1.00), y-intercept: -4.6 (-8.2 to -0.8), r=0.998.Heparinized Plasma: Slope: 1.00 (0.98-1.02), y-intercept: -2.1 (-5.8 to 1.6), r=0.998.EDTA Plasma: Slope: 1.00 (0.99-1.02), y-intercept: -0.3 (-3.1 to 2.6), r=0.999.

2. Sample Sizes and Data Provenance

The document does not explicitly state the "test set" in the context of an AI/ML device, as this is a traditional in-vitro diagnostic device. However, studies were performed to validate its performance.

Analytical Sensitivity (Limits of Detection):
- One experiment: "sensitivity for glucose was calculated to be 0.3 mg/dL." (Exact sample size not specified for this calculation).
- Second experiment: "three low-level samples assayed 6 times a day for 3 days on three separate analyzers" (54 measurements per sample, total 162 measurements).
Linearity: "The S TEST glucose is linear between 5 and 500 mg/dL." (Exact sample size not specified, but followed CLSI EP-6A which typically uses multiple levels and replicates).
20-day In-house Precision: 80 measurements per level (3 levels), total 240 measurements.
Interference Testing: "not affected by high levels of the following substances at the levels noted" (Number of samples for each interference test not explicitly stated, but followed CLSI EP7-A2).
Method Comparison (In-house): 100 serum samples.
Matrices Comparisons: 38 matched serum/plasma samples (sodium citrate, lithium heparin, K3 EDTA).
External POL Precision Study: Each of the 3 sites received 3 blinded serum samples (A, B, C). Each sample was assayed 6 times per day for 5 days, resulting in 30 results per level per analyte per site (3 sites * 3 levels * 30 results = 270 measurements for precision).
External POL Method Comparisons Study: Each of the 3 POL sites received approximately 50 blinded serum samples (Total ~150 samples).

Data Provenance: The studies were conducted "in-house" (Hitachi Chemical Diagnostics) and at "three external POL-type sites" (Physician Office Laboratories). The central laboratory for predicate comparisons was likely in the US, but specific country of origin is not mentioned. All studies appear to be prospective as they are designed to evaluate the performance of the device.

3. Number of Experts and Qualifications for Ground Truth

This is an in-vitro diagnostic device (chemistry analyzer) measuring a biological analyte (glucose). The ground truth is established by quantitative measurement methods rather than expert interpretation of images or clinical data.

Ground Truth for Method Comparison: The "ground truth" or reference method for comparison was primarily the Roche/Hitachi cobas 6000, which is a legally marketed predicate device (K100853). The cobas 6000 itself is a chemistry analyzer, not a human expert.
Ground Truth for Matrices Comparison: The reference for plasma samples was serum samples.

Therefore, the concept of "number of experts used to establish the ground truth" and "qualifications of those experts" as it might apply to image-based diagnostics or disease diagnosis is not directly applicable here. The ground truth accuracy is against established, validated methods.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when multiple human readers interpret results. This is an automated quantitative measurement device. Therefore, no adjudication method as described would be applicable or necessary. The comparisons are statistical (linear regression, correlation) between two quantitative measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for AI systems that assist human readers in tasks like image interpretation to evaluate the impact of AI assistance on human performance (e.g., accuracy, efficiency). The Hitachi Clinical Analyzer is a standalone automated diagnostic device, not an AI-assisted human reading system.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The entire performance evaluation described (analytical sensitivity, linearity, precision, interference, method comparison, matrices comparison) demonstrates the performance of the Hitachi Clinical Analyzer S TEST Reagent Cartridge for Glucose as a standalone automated system, without human-in-the-loop performance modifications or assistance once the samples are loaded and the test initiated.

7. Type of Ground Truth Used

The primary ground truth used for comparison and validation was:

Comparison to a Legally Marketed Predicate Device: Specifically, the Roche/Hitachi cobas 6000 (a chemistry analyzer with a glucose module), which itself has established performance characteristics. This is a form of reference method comparison.
Internal reference (e.g., serum for plasma matrices): For the matrices comparison, serum was used as the reference against different plasma types.
Defined reference standards/controls: For precision, linearity, and sensitivity, the device was tested against samples with known or precisely characterized glucose concentrations, which serves as the "ground truth" for those specific studies.

This is not "expert consensus," "pathology," or "outcomes data" in the typical sense, but rather comparison against established analytical chemical methods and reference materials.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here. This is a traditional in-vitro diagnostic device (chemistry analyzer) and not an AI/ML algorithm that undergoes a "training" phase with data. The device's calibration, which is somewhat analogous to initial setup/tuning, would be done using calibrator materials provided or specified by the manufacturer, but this is not "data training" in the AI sense.

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

As mentioned above, there is no "training set" in the AI/ML context for this traditional IVD device.

Summary

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MAY 1 0 2012

HITACHI
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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 K120369.

807.92 (a)(1): Name:Address:	Hitachi Chemical Diagnostics630 Clyde CourtMountain View, CA 94043
Phone:	(650) 961 5501
FAX:	(650) 969 2745
Contact:	Mr. Bunichiro Nakajima

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

Trade name:

Hitachi Clinical Analyzer S TEST Reagent Cartridge for Glucose

Common Name: Routine chemistry analyzer for glucose (GLU)

Classification: 21 CFR § 862.1345- glucose test system (GLU)

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

Instrument portion: Roche/Hitachi cobas 8000 (c502 module)- K100853 Reagent Test Systems: Roche/Hitachi cobas 8000 (c502 module)- K100853, includes glucose

Integrated system (instrument): Alfa Wasserman S40 system- K072140

807.92 (a){4): Device Description

Page 1 of 5

O Hitachi Chemical Diagnostics Inc.

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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).

Chemistry reactions:

Glucose is phosphorylated to glucose-6-phosphate by hexokinase (HK) in the presence of ATP. When the glucose-6-phosphate is converted into 6-phosphogluconic acid by glucose-6phosphate dehydrogenase (G6PD), NADP is converted into NADPH with an increase in absorbance at 340 nm. The concentration of glucose can be determined by measuring the amount of change in absorbance of NADPH.

HK Glucose + ATP Glucose-6-phosphate + ADP Mg2+ GRPD

Glucose-6-phosphate + NADP 6-Phosphogluconic acid + NADPH

Image /page/1/Figure/7 description: This image shows a timeline of a chemical reaction. Reagent 1 and a sample are combined in volumes of 200 microliters and 5 microliters, respectively, at time zero. At 7 minutes, a measurement is taken at 340/450 nm, and at 7.5 minutes, 50 microliters of Reagent 2 is added. Finally, at 12.5 minutes, another measurement is taken at 340/450 nm, and the concentration is calculated.

807.92 (a)(5): Intended Use

Page 2 of 5

Hitachi Chemical Diagnostics, Inc 630 Clyde Court, Mountain Vlew, CA 94043-2239 Tel: 800 233 6278

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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)
Instrument Platform	Hitachi Clinical Analyzer	Roche cobas 8000 - K100853also, Alfa Wasserman S40- K072140
Glucose Test System	K number- K120369	Roche K number- K100853
Device Class, Regulation Code	Class II, 21 CFR 862.1345	Same
Classification Product Code	CFR	Same
Intended Use	Quantitative determination ofglucose	Same
Testing Environment	Physician office or clinical lab	Clinical lab- cobasPOL/Clin Lab - Alfa Wasserman
Test Principle	Enzymatic method (Hexokinasemethod)	UV Test- enzymatic referencemethod with hexokinase
Specimen Type	Human serum or plasma	Human serum, plasma, CSF, or urine
Reportable Range	5 to 500 mg/dL	2 to 750 mg/dL
Detection Wavelength	340/450 nm	700/340 nm
Detection Limit	5 mg/dL	2 mg/dL
Linearity	5 to 500 mg/dL	2 to 750 mg/dL
Precision	%CVs ranged from 2.1% to 3.9%	%CVs range from 0.7% to 1.3%(from product labeling)

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

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

Analytical Sensitivity (Limits of Detection)

The study followed CLSI EP17. The sensitivity for glucose was calculated to be 0.3 mg/dL. In a second experiment with three low-level samples assayed 6 times a day for 3 days on three separate analyzers, the limit of quantitation (LoQ) was determined to be 5 mg/dL.

Linearity

The study followed CLSI EP-6A. The S TEST glucose is linear between 5 and 500 mg/dL.

Page 3 of 5

Hitachi Chemical Diagnostics, Inc. 630 Clyde Court, Mountain Vlew; CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745

Production Comments of Collection of Children and Children Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Comments o
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www.hcdiaonostics.com

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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:

		Mean (mg/dL)	Within-Run %CV	Total %CV
Glucose	Level 1	73.0	3.9%	3.9%
n= 80 per level	Level 2	213.8	1.5%	2.1%
	Level 3	306.1	1.1%	3.0%

Interference Testing

The studies followed CLSI EP7-A2. The data demonstrated that the S TEST for glucose was not affected by high levels of the following substances at the levels noted:

Hemoglobin: no interference up to 1000 mg/dL hemoglobin for glucose around 200 . mg/dL and up to 500 mg/dL hemoglobin for low glucose levels (~50 mg/dL).
Unconjugated bilirubin no interference up to 50 mg/dL bilirubin for glucose around 200 . mg/dL and up to 6.25 mg/dL bilirubin for low glucose levels (~50 mg/dL).
Triglyceride: no interference up to 800 mg/dL triglycerides. .
Ascorbic acid: no interference up to 50 mg/dL ascorbic acid. ●

Method Comparisons

The method comparison study evaluated 100 serum samples; matched aliquots were assayed with both the Hitachi Clinical Analyzer with S TEST GLU reagent cartridge and the Roche/Hitachi cobas 6000. The data were analyzed by least squares linear regression (Hitachi = y-axis), and the results were as follows:

Glucose (mg/dL)

n= 100 y=0.99x -2.7 correlation coefficient (r) = 0.994 95% confidence interval of the slope = 0.98 to 1.02; 95% confidence interval of the yintercept = - 5.5 to 0.8

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 GLU reagent cartridges Thirty-eight (38) matched serum/plasma samples that spanned the glucose dynamic range were assayed in singleton and the results were compared using least squares liner regression (plasma = y-axis). The performance characteristics were as follows.

N = 38

Range (serum) = 12 to 441 mg/dL
	Na Citrate Plasma	Heparinized Plasma	EDTA Plasma
Slope (95% CIs)	0.98 (0.96 to 1.00)	1.00 (0.98 to 1.02)	1.00 (0.99 to 1.02)
y-intercept (95% CIs)	-4.6 (-8.2 to -0.8)	-2.1 (-5.8 to 1.6)	-0.3 (-3.1 to 2.6)
r	0.998	0.998	0.999

Page 4 of 5

litachi Chemical Diagnostics, Inc.

630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745

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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 Clinical Analyzer with S TEST GLU reagent cartridge 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, intermediate, and high concentrations of each analyte. Each sample was assayed 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:

Site	Sample	Mean	Within-run Precision		Total Precision
			SD (mg/dL)	%CV	SD (mg/dL)	%CV
Site 1	A	59.3	2.6	4.5%	2.8	4.6%
Site 2	A	59.1	0.7	1.1%	1.0	1.7%
Site 3	A	59.1	1.2	2.1%	1.4	2.3%
Site 1	B	117.3	4.0	3.4%	4.4	3.7%
Site 2	B	117.7	0.9	0.8%	1.3	1.1%
Site 3	B	114.9	1.6	1.4%	1.7	1.7%
Site 1	C	358.7	11.5	3.2%	12.8	3.6%
Site 2	C	354.8	3.5	1.0%	6.8	1.9%
Site 3	C	343.9	7.1	2.1%	10.2	3.0%

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Glucose (mg/dL)

For the external site method comparisons study, each POL site received approximately 50 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 the Roche cobas 6000 (predicate system) 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	53	75 to 375	$y = 1.01x -1.1$	0.99	0.99 to 1.02	-2.7 to 0.6
2	52	69 to 361	$y = 0.97x -0.1$	0.99	0.96 to 0.99	-2.1 to 1.9
3	51	75 to 399	$y = 1.05x -2.5$	0.99	1.03 to 1.07	-5.1 to 0.1

POL ACCURACY DATA SUMMARY- GLU mg/dL

*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 GLU reagent cartridge. The test system was shown to be safe and effective for its intended use.

Page 5 of 5

Hitachi Chemical Diagnostics Inc

630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278

10-11-11 - 11-11-11 - 11-11-2017 - 11-12-2017 - 11-12-2017 - 11-22 - 11-22 - 11-22 - 11-22 - 11-2 - 11-2 - 11-2 - 11-2 - 11-2 - 11-2 - 11-2 - 11-2 - 11-2 - 11-2 - 11-2 - 11-2

www.hcdiaonostics.com.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Hitachi Chemical Diagnostics, Inc. c/o Erika B. Ammirati 575 Shirlynn Court Los Altos, CA 94022

MAY 1 0 2012

Re: K120369 Trade Name: Hitachi Clinical Analyzer S TEST Reagent Cartridge for Glucose Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CFR Dated: April 20, 2012 Received: April 23, 2012

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 prease note the rogalizers regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely vours,

Counnev H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

K120369 510(k) Number (if Known):

Device Name:

Hitachi Clinical Analyzer S TEST Reagent Cartridge for Glucose (GLU)

Indications for Use:

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

Over - The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Rute Chuler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 120369

Page 1 of 1

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.