(94 days)
Not Found
No
The description details a standard wet chemistry analyzer and reagent system. There is no mention of AI/ML in the device description, intended use, or performance studies. The calculations are based on measuring absorbance and applying standard chemical principles.
No.
This device is an in vitro diagnostic (IVD) device used for quantitative measurement of glucose, which aids in diagnosis and treatment, but does not directly provide therapy.
Yes
The device is described as "For in vitro diagnostic use only" and states that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia." This explicitly indicates its use in diagnosis.
No
The device description clearly outlines a hardware system (Hitachi Clinical Analyzer) that includes physical components like a probe, incubation rotor, carousels, photometer, and reagent cartridges. The software is part of this larger hardware system, not a standalone software-only device.
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 glucose in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma". These are biological samples taken from the body, and the test is performed in vitro (outside the body).
- Purpose: The glucose measurements are used in the "diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia." This directly relates to diagnosing and managing medical conditions, which is a core function of IVDs.
- Device Description: The description details a "wet chemistry system" that analyzes samples and reagents to determine analyte concentration. This is a typical setup for an IVD.
- Chemistry Reactions: The description of the enzymatic reactions used to measure glucose further confirms that this is a chemical test performed on biological samples in vitro.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
CFR
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
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 Data:
- 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.
- 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.
- Level 1: Mean (mg/dL) 73.0, Within-Run %CV 3.9%, Total %CV 3.9%
- Level 2: Mean (mg/dL) 213.8, Within-Run %CV 1.5%, Total %CV 2.1%
- Level 3: Mean (mg/dL) 306.1, Within-Run %CV 1.1%, Total %CV 3.0%
- Interference Testing: The studies followed CLSI EP7-A2. No interference up to specified levels for Hemoglobin, Unconjugated bilirubin, Triglyceride, and Ascorbic acid.
- Method Comparisons: Evaluated 100 serum samples. Hitachi = y-axis, Roche/Hitachi cobas 6000 = x-axis. 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: 38 matched serum/plasma samples (sodium citrate, lithium heparinized, and K3 EDTA plasma) were assayed in singleton and compared against serum.
- Na Citrate Plasma: Slope 0.98 (0.96 to 1.00), y-intercept -4.6 (-8.2 to -0.8), r 0.998.
- Heparinized Plasma: Slope 1.00 (0.98 to 1.02), y-intercept -2.1 (-5.8 to 1.6), r 0.998.
- EDTA Plasma: Slope 1.00 (0.99 to 1.02), y-intercept -0.3 (-3.1 to 2.6), r 0.999.
Clinical Data:
- External site precision study: Three external POL-type sites, three blinded serum samples (A, B, C) tested six times a day for five days (30 results per level per analyte).
- Site 1, Sample A: Mean 59.3, Within-run %CV 4.5%, Total %CV 4.6%
- Site 2, Sample A: Mean 59.1, Within-run %CV 1.1%, Total %CV 1.7%
- Site 3, Sample A: Mean 59.1, Within-run %CV 2.1%, Total %CV 2.3%
- Site 1, Sample B: Mean 117.3, Within-run %CV 3.4%, Total %CV 3.7%
- Site 2, Sample B: Mean 117.7, Within-run %CV 0.8%, Total %CV 1.1%
- Site 3, Sample B: Mean 114.9, Within-run %CV 1.4%, Total %CV 1.7%
- Site 1, Sample C: Mean 358.7, Within-run %CV 3.2%, Total %CV 3.6%
- Site 2, Sample C: Mean 354.8, Within-run %CV 1.0%, Total %CV 1.9%
- Site 3, Sample C: Mean 343.9, Within-run %CV 2.1%, Total %CV 3.0%
- External site method comparisons study: Each POL site received approximately 50 blinded serum samples; a central laboratory received matched aliquots. Hitachi system vs. Roche cobas 6000 (predicate system).
- Site 1: n=53, Range 75 to 375, 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, Range 69 to 361, 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, Range 75 to 399, y = 1.05x -2.5, r = 0.99, CI Slope 1.03 to 1.07, CI Intercept -5.1 to 0.1.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY 1 0 2012
HITACHI
Inspire the Next
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 Diagnostics
630 Clyde Court
Mountain 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
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.
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O Hitachi Chemical Diagnostics Inc.
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.
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
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.
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Hitachi Chemical Diagnostics, Inc 630 Clyde Court, Mountain Vlew, CA 94043-2239 Tel: 800 233 6278
| The Concerner of Children of Concerners of College of Conferences of College of Concession of Concession Commended on Commended Commended of Commended of Commended of Commend | |||
|---|---|---|---|
| www.hcdiagnostics.com | |||
| . | |||
| المواقع الموارد الموارد الموارد المواقع الموارد والمصنع الموارد الموضوع الموضوع الموضوع الموضوع الموضوع المواضيع والارات المستوى الموارك المستقب المواقع الموسم الموارك الأور | |||
2
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 - K100853 |
| also, 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 of | |
| glucose | Same | |
| Testing Environment | Physician office or clinical lab | Clinical lab- cobas |
| POL/Clin Lab - Alfa Wasserman | ||
| Test Principle | Enzymatic method (Hexokinase | |
| method) | UV Test- enzymatic reference | |
| method 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 | ||
|---|---|---|
| Carrent States | ||
| www.hcdiaonostics.com | ||
| ിപ്പോൾ പ്രവേഹം കോലത്തെ സമ്മിച്ച സമ്പ്രശസ്തിക വേടിയ എന്നും പ്രത്തിക കോഴ്ച്ചു തന്നെ പ്രത്തിക പ്രത്തിന്റെ പ്രത്തിന്റെ പ്രത്തിന്റെ പ്രത്തിക വേണ്ടിക്കുന്നത്. പ്രാവസ്ഥ പ്രവേശമാനവു |
3
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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|---|---|---|---|
| www.hcdiaonostics.com | |||
| Comments of the comments of the contract of the contract of the contribute the month of the more the more the comments of the comments of the comments of the comments of the | |||
4
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% |
liantes now
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.
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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. | ||
5
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).
6
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,
N
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
7
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:
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.
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
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