(38 days)
Not Found
No
The device description and performance studies detail a standard wet chemistry analyzer and reagent cartridge, with no mention of AI or ML algorithms for data processing, interpretation, or system control.
No.
The device is an in vitro diagnostic (IVD) device used for the quantitative determination of total bilirubin, which is used in the diagnosis and treatment of liver disorders, not for direct therapeutic treatment.
Yes
The intended use explicitly states "Total Billirubin measurements are used in the diagnosis and treatment of disorders of the liver," indicating its role in the diagnostic process. Furthermore, the device is described as being "For in vitro diagnostic use only."
No
The device described is a reagent cartridge for a clinical analyzer, which is a physical component used in a wet chemistry system. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use only." It also describes the intended use as the "quantitative determination of total bilirubin in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma" for use in "clinical laboratories or physician office laboratories." This clearly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description: The description details a reagent cartridge used with a clinical analyzer to perform a chemical reaction on a biological sample (serum or plasma) to measure an analyte (total bilirubin). This is a typical setup for an IVD.
- Chemistry Reaction: The description of the chemical reaction performed on the sample further confirms its IVD nature.
- Performance Studies: The inclusion of nonclinical and clinical performance data, including analytical sensitivity, linearity, precision, interference testing, and method comparison, are standard requirements for demonstrating the performance of an IVD.
- Predicate Device: The mention of a predicate device (Cobas c systems Total Bilirubin (BILTS)) with a K number indicates that this device is being compared to a previously cleared IVD.
All of these elements strongly indicate that the S TEST Reagent Cartridge Total Bilirubin is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The S TEST Reagent Cartridge Total Bilirubin (T-BIL) is intended for the quantitative determination of total bilirubin in serum, lithium heparinized plasma, and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Total Bilirubin is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Total bilirubin measurements are used in the diagnosis and treatment of disorders of the liver.
Product codes
CIG
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 Total Bilirubin.
Chemistry reaction: Nitrous acid method: Total bilirubin in samples is oxidized to biliverdin by the action of nitrous acid at pH 3.7. The concentration of total bilirubin can be determined by measuring the decrease of absorbance at a wavelength of 450nm .
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 Performance Studies:
- Analytical Sensitivity (Limits of Detection): Followed CLSI EP17-A. Limit of blank = 0.1 mg/dL; limit of detection = 0.2 mg/dL; limit of quantitation (LoQ) = 0.4 mg/dL with ±20%CV (evaluated three low level specimens in six runs over three instruments).
- Linearity- T-BIL: Followed CLSI EP-6A. 15 serial dilutions plus zero standard, assayed in triplicate. Linear regression equation: y = 1.0136x -0.0492; r=0.9998. Range of linearity: 0.1 to 42.1 mg/dL. Reportable range: 0.4 to 40.0 mg/dL.
- 20-day In-house Precision- T-BIL: Followed CLSI EP5-A2. Four levels of samples tested in two runs, twice a day, for 20 days with one lot of reagents and one analyzer. %CVs ranged from 2.4% to 8.8%.
- Interference Testing (per CLSI EP7-A2): Ascorbic acid and hemoglobin interference tested with two pools (approx. 1 and 4 mg/dL total bilirubin). Lack of interference defined as recoveries between 90% and 110% (or 0.1 mg/dL) of neat value. No interference up to 50 mg/dL ascorbic acid and up to 1,000 mg/dL hemoglobin. Lipids effect evaluated with three sets of serum samples with differing levels of natural triglyceride (TG) and similar levels of total bilirubin (TBIL). No interference with up to 580 mg/dL triglycerides.
- Method Comparison: 92 clinical specimens (0.4 to 36.6 mg/dL) assayed in singleton and blinded by Hitachi E40 system and a standard laboratory system. Linear regression: Slope = 0.94 (95% CI: 0.92 to 0.96), y-intercept = 0.40 (95% CI: 0.23 to 0.57), r = 0.994.
- Matrices Comparisons: 39 matched serum/plasma samples (0.4 to 37.0 mg/dL serum) for sodium citrate, EDTA, and lithium heparin plasma. Compared using linear regression (plasma = y-axis). Slopes (95% CIs) were 1.00 (0.99 to 1.02) for Heparinized Plasma, 1.02 (1.01 to 1.03) for K3 EDTA Plasma, and 1.01 (1.00 to 1.02) for Na Citrate Plasma. All r values were 0.999.
Clinical Data:
- Precision study at three external POL-type sites: Each site received three blinded serum samples (low, middle, high concentrations). Each sample assayed six times per day for five days (30 results per level). Total precision %CVs ranged from 1.5% to 5.7%.
- Method comparison studies at three external POL-type sites: Approximately 50 serum specimens (0.4 to 38.1 mg/dL) assayed on Hitachi E40 Clinical Analyzer using S TEST Reagent Cartridge Total Bilirubin (y) and a comparative method (x). Linear regression analyses (least squares) yielded the following results:
- Site 1 (n=50, Range: 0.4 to 37.1 mg/dL): y = 0.94x +0.36, r = 0.995, Slope CI = 0.91 to 0.96, Intercept CI = 0.04 to 0.69.
- Site 2 (n=48, Range: 0.4 to 38.1 mg/dL): y = 0.96x +0.22, r = 0.988, Slope CI = 0.92 to 1.00, Intercept CI = -0.31 to 0.76.
- Site 3 (n=53, Range: 0.4 to 37.8 mg/dL): y = 0.91x +0.35, r = 0.993, Slope CI = 0.88 to 0.94, Intercept CI = 0.00 to 0.70.
Conclusion:
The test system was shown to be safe and effective for its intended use based on nonclinical and clinical testing.
Key Metrics
- %CVs: (Precision) Within-Run and Total %CVs ranging from 1.0% to 8.8% in in-house precision studies. %CVs ranging from 1.5% to 5.7% in external precision studies.
- Linear Regression: r values for in-house linearity 0.9998, for method comparison 0.994, for matrices comparison 0.999, and for POL accuracy data summary 0.988 to 0.995.
- Slope: 0.94 (in-house method comparison), 0.91 to 0.96 (POL accuracy data summary and matrices comparison).
- y-intercept: 0.40 (in-house method comparison), -0.31 to 0.76 (POL accuracy data summary and matrices comparison).
- Recovery: 90% to 110% (interference testing).
- Limit of Blank: 0.1 mg/dL
- Limit of Detection: 0.2 mg/dL
- Limit of Quantitation (LoQ): 0.4 mg/dL
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.
0
JUN 0 7 2013
SECTION 8 510(k) SUMMARY
· This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K131217.
| 807.92 (a)(1): Name: | Hitachi Chemical Diagnostics |
|---|---|
| Address: | 630 Clyde Court |
| Mountain View, CA 94043 |
Phone: (650) 961 5501 (650) 969 2745 FAX: Contact: Mr. Charles Tsou
Regulatory Correspondent: Erika Ammirati
807,92 (a)(2): Device name- trade name and common name, and classification
Trade name: S TEST Reagent Cartridge Total Bilirubin (T-BIL)
Common Name: Routine chemistry analyzer for total bilirubin
Classifications: Class II, 21 CFR § 862.1110- Bilirubin (total and direct), Product Code CIG
807.92 (a)(3): Identification of the legally marketed predicate devices
Cobas c systems Total Bilirubin (BILTS) (Roche Diagnostics, Inc., Indianapolis, IN) - K100853
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 7
O Hitachi Chemical Diagnostics, Inc. 630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278
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 Total Bilirubin.
Chemistry reaction: Nitrous acid method: Total bilirubin in samples is oxidized to biliverdin by the action of nitrous acid at pH 3.7. The concentration of total bilirubin can be determined by measuring the decrease of absorbance at a wavelength of 450nm .
807.92 (a)(5): Intended Use
The S TEST Reagent Cartridge Total Bilirubin (T-BIL) is intended for the quantitative determination of total bilirubin in serum, lithium heparinized plasma, and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Total Bilirubin is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Total bilirubin measurements are used in the diagnosis and treatment of disorders of the liver.
O Hitachi Chemical Diagnostics Inc. 630 Clyde Court, Mountaln View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Image /page/2/Picture/0 description: The image contains the logo for Hitachi. The word "HITACHI" is written in large, bold, black letters. Below the company name is the slogan "Inspire the Next" in a smaller font. The text is black and the background is white.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
r
The following chart describes similarities and differences between the two total bilirubin test systems. :
| Characteristic | Hitachi S TEST Systems | PREDICATE |
|---|---|---|
| Instrument Platform | Hitachi Clinical Analyzer | |
| (originally cleared under K111753) | Roche cobas c systems - K100853 | |
| Total Bilirubin | K number- K131217 | Roche K number- K100853 |
| Device Class, Regulation Code | Class II, 21 CFR 862.1110 | Same |
| Classification Product Code | CIG | Same |
| Intended Use | Quantitative determination of T-BIL | Same |
| Testing Environment | Physician office or clinical lab | Clinical lab |
| Test Principle | Nitrous acid method: Total bilirubin | |
| in samples is oxidized to biliverdin | ||
| by the action of nitrous acid at pH | ||
| 3.7. The concentration of total | ||
| bilirubin can be determined by | ||
| measuring the decrease of | ||
| absorbance at a wavelength of | ||
| 450nm . | Diazo method: Total bilirubin, in the | |
| presence of solubilizing agent, is | ||
| coupled with a diazonium ion in a | ||
| strongly acidic medium. The | ||
| intensity of the color of the | ||
| azobilirubin produced in proportional | ||
| to the total bilirubin concentration | ||
| and can be measured | ||
| photometrically. | ||
| Specimen Type | Human serum or plasma | Same |
| Reportable Range | 0.4 to 40.0 mg/dL | 0.1 to 35.1 mg/dL |
| Detection Wavelength | 450/546 nm | 546/600 nm |
| Detection Limit | 0.2 mg/dL | 0.1 mg/dL |
| Linearity | 0.2 to 40.0 mg/dL | 0.1 to 35.1 mg/dL |
| Precision | %CVs range from 2.4% to 8.8% | %CVs range from 0.9% to 4.6% |
| (from product labeling) |
Page 3 of 7
ලි Hitach! Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
| unute horigano | For help management on the program of the compressional come promotive of encontribution of only of the form of the commendent of only of the commendent of only of the commen | THE PERSONAL PROPERTY OF COLLECTION OF CONSULTION OF CONSULTION OF CHARAL | ||
|---|---|---|---|---|
3
807.92 (b)(1): Brief Description of Nonclinical Data
A series of studies were performed that evaluated the following nonclinical performance characteristics for each analytical sensitivity (limits of detection), linearity, 20-day in-house precision, interference testing, in-house method comparisons, and matrices comparison between serum and various plasma types.
Analytical Sensitivity (Limits of Detection)
The study followed CLSI EP17-A with the following results: limit of blank = 0.1 mg/dL; limit of detection = 0.2 mg/dL; the limit of quantitation (LoQ) study evaluated three low level specimens in six runs over three with three instruments; the LoQ was found to be 0.4 mg/dL with ±20%CV.
Linearity- T-BIL
The study followed CLSI EP-6A where 15 serial dilution, plus the zero standard, were assayed in triplicate and the results were averaged. The data showed the following linear regression equation was y = 1.0136x -0.0492; r=0.9998. The range of linearity was 0.1 to 42.1 mg/dL. The reportable range is 0.4 to 40.0 mg/dL.
20-day In-house Precision- T-BIL
The studies followed CLSI EP5-A2, where four levels of samples were each tested in two runs, twice a day, for 20 days with one lot of reagents and one analyzer. The results were as follows:
Precision Summaries:
| Total Bilirubin- Low, Level 1, Summary | ||
|---|---|---|
| Total Bilirubin | Within-Run | Total |
| Mean (mg/dL) | 0.68 | 0.68 |
| SD (mg/dL) | 0.04 | 0.06 |
| %CV | 5.8% | 8.8% |
Total Bilirubin - Middle, Level 2, Summary
| Total Bilirubin | Within-Run | Total |
|---|---|---|
| Mean (mg/dL) | 3.19 | 3.19 |
| SD (mg/dL) | 0.04 | 0.13 |
| %CV | 1.3% | 4.1% |
Total Bilirubin - High, Level 3, Summary
| Total Bilirubin | Within-Run | Total |
|---|---|---|
| Mean (mg/dL) | 7.47 | 7.47 |
| SD (mg/dL) | 0.08 | 0.23 |
| %CV | 1.1% | 3.1% |
Page 4 of 7
C Hitachi Chemical Diagnostics, Inc
630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233
4
| Total Bilirubin | Within-Run | Total |
|---|---|---|
| Mean (mg/dL) | 27.29 | 27.29 |
| SD (mg/dL) | 0.27 | 0.65 |
| %CV | 1.0% | 2.4% |
Total Bilirubin - Very High, Level 4, Summary
Interference Testing (per CLSI EP7-A2)
The interference study for ascorbic acid and hemoglobin included two pools (approx. 1 and 4 mg/dL total bilirubin) where increasing levels of interferents were spiked into the pools. The spiked samples were tested in triplicate, and the mean results were compared to the neat samples. (no interferent). Lack of interference was defined as recoveries between 90% and 110% (or 0.1 mg/dL) of the neat value, and the data demonstrated that the total bilirubin test system was not affected by high levels of the following substances at the levels noted:
Ascorbic acid: no interference up to 50 mg/dL Hemoglobin: no interference up to 1,000 mg/dL
The effect from lipids was evaluated in a different experiment. In this study, three sets of serum samples with differing levels of natural triglyceride (TG, neat) and similar levels of total bilirubin (TBIL, low, middle, and high) were tested, along with three sets of serum samples with low TG and similar levels of total bilirubin. Patient specimens with TG ranging from 530 mg/dL to 580 mg/dL were matched with similar total bilirubin concentrations, but with lower (less than 100 mg/dL) TG levels.
The samples were tested with S TEST TBIL and TG on the Hitachi Clinical Analyzer E40 on all dilutions in triplicate. TBIL target levels on the intermediate were calculated using the means values of the highest and lowest dilutions and the dilution ratios. The recovery at all levels was calculated.
The data demonstrated no interference with up to 580 mg/dL triglycerides for total bilirubin.
Other interferences from medications or endogenous substances may affect results and the sponsor refers user to the literature for more information in the labeling. Literature cited: Young, D.S. Effects of Preanalytical Variables on Clinical Laboratory Tests, 2nd ed. Washington DC: AACC Press; 1997:3-85
Method Comparison
A total of 92 clinical specimens spanning the dynamic range (0.4 to 36.6 mg/dL), were assayed in singleton and in a blinded fashion by both the Hitachi E40 system and a standard laboratory system. The comparative data were analyzed by linear regression and are shown below. (CI = confidence interval)
Page 5 of 7
Hitachi Chemical Diagnostics, Inc.
30 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
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5
Regression Statistics:
| n | r | Slope
(95% CI) | y-intercept
(95% CI) | X mean | Y mean |
|----|-------|------------------------|-------------------------|-----------|-----------|
| 92 | 0.994 | 0.94
(0.92 to 0.96) | 0.40
(0.23 to 0.57) | 3.5 mg/dL | 3.7 mg/dL |
Matrices Comparisons
A study was performed to validate the use of three plasma types as an alternative to serum for the Hitachi Clinical Analyzer with S TEST Reagent Cartridge Total Bilirubin. The plasma types were sodium citrate, EDTA, and lithium heparin. Thirty-nine (39) matched serum/plasma samples that spanned the dynamic range (0.4 to 37.0 mg/dL, serum) were assaved in singleton and the results were compared using linear regression (plasma = y-axis, each type). The performance characteristics were as follows.
N = 39
Range (serum) = 0.4 to 37.0 mg/dL total bilirubin
| Heparinized Plasma | K3 EDTA Plasma | Na Citrate Plasma | |
|---|---|---|---|
| Slope (95% CIs) | 1.00 (0.99 to 1.02) | 1.02 (1.01 to 1.03) | 1.01 (1.00 to 1.02) |
| y-intercept (95% CIs) | 0.07 (-0.11 to 0.25) | 0.02 (-0.09 to 0.14) | 0.02 (-0.12 to 0.16) |
| r | 0.999 | 0.999 | 0.999 |
Expected values/Reference range:
The expected values as stated within the labeling are based on the literature. The manufacturer recommends each laboratory determine the expected values for its particular population.
Reference range: 0.3 - 1.2 mg/dL'
- Tietz, Fundamentals of Clinical Chemistry, 4th Edition, WB Saunders Company, 1996.
807.92 (b)(2): Brief Description of Clinical Data
Studies for precision and method comparison (accuracy) were performed at three external POL-type sites to evaluate the Hitachi E40 Clinical Analyzer with S TEST Reagent Cartridge Total Bilirubin in one of its targeted intended use environments, the physician's office laboratory.
For the external site precision study, each site received three blinded serum samples (the Precision Panel, labeled A. B. and C) that were chosen to represent low, middle, and high concentrations of total bilirubin. Each sample was assayed six times per day for five days, reporting 30 results per level. Precision estimates for total precision were as follows:
Page 6 of 7
O Hitachi Chemical Diagnostics, Inc.
630 Clyde Court, Mountaln View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
6
| Site | Sample | Mean | Within-run Precision | Total Precision | ||
|---|---|---|---|---|---|---|
| SD (mg/dL) | %CV | SD (mg/dL) | %CV | |||
| 1 | A | 0.71 | 0.04 | 5.5 | 0.04 | 5.7 |
| 2 | A | 0.68 | 0.04 | 5.5 | 0.04 | 5.6 |
| 3 | A | 0.71 | 0.04 | 6.0 | 0.04 | 5.6 |
| 1 | B | 3.23 | 0.06 | 2.0 | 0.09 | 2.8 |
| 2 | B | 3.20 | 0.06 | 1.8 | 0.06 | 1.9 |
| 3 | B | 3.02 | 0.06 | 2.1 | 0.10 | 3.5 |
| 1 | C | 7.77 | 0.12 | 1.5 | 0.17 | 2.2 |
| 2 | C | 7.74 | 0.10 | 1.3 | 0.12 | 1.5 |
| 3 | C | 7.24 | 0.12 | 1.6 | 0.30 | 4.1 |
Total Bilirubin (mg/dL) n = 30 replicates per sample per site
For the external method comparison studies, a series of approximately 50 serum specimens with total bilirubin values ranging from 0.4 to 38.1 mg/dL, were assayed on the Hitachi E40 Clinical Analyzer at three sites using S TEST Reagent Cartridge Total Bilirubin (y) and a comparative method as the reference method (x). Linear regression analyses (least squares) yielded the following results:
| Site # | n | Range
(mg/dL) | Regression
Equation | “r” | SE
(mg/dL) | CI*
Slope | CI Intercept |
|--------|----|------------------|------------------------|-------|---------------|--------------|---------------|
| 1 | 50 | 0.4 to 37.1 | y = 0.94x +0.36 | 0.995 | - 0.95 | 0.91 to 0.96 | 0.04 to 0.69 |
| 2 | 48 | 0.4 to 38.1 | y = 0.96x +0.22 | 0.988 | 1.52 | 0.92 to 1.00 | -0.31 to 0.76 |
| 3 | 53 | 0.4 to 37.8 | y = 0.91x +0.35 | 0.993 | 1.07 | 0.88 to 0.94 | 0.00 to 0.70 |
POL ACCURACY DATA SUMMARY- Total Bilirubin (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 E40 with Reagent Cartridge Total Bilirubin. The test system was shown to be safe and effective for its intended use.
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O Hitachi Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is black and the background is white. The text is centered in the image.
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare. The symbol is composed of three curved lines that converge at the bottom.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2013
Hitachi Chemical Diagnostics Inc. C/O Erika Ammirati 630 Clyde Court MOUNTAIN VIEW CA 94043
Re: K131217
Trade/Device Name: S TEST Reagent Cartridge Total Bilirubin (T-BIL) Regulation Number: 21 CFR 862.1100 Regulation Name: Bilirubin (total or direct) test system Regulatory Class: II Product Code: CIG Dated: April 26, 2013 Received: April 30, 2013
Dear Ms. Ammirati:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. . Please note: 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
8
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if Known): K131217
Device Name:
S TEST Reagent Cartridge Total Bilirubin (T-BIL)
Indications for Use:
The S TEST Reagent Cartridge Total Bilirubin (T-BIL) is intended for the quantitative determination of total bilirubin in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma using the Hitachi Clinical Analyzer E40. The S TEST Reagent Cartridge Total Bilirubin is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Total Billirubin measurements are used in the diagnosis and treatment of disorders of the liver.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
_Yung William__S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K131217
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