(82 days)
No
The description details a standard wet chemistry analyzer and reagent cartridges, with no mention of AI or ML in the device operation, data processing, or performance studies.
No
The device is an in vitro diagnostic (IVD) system used for quantitative measurements of BUN and creatinine in blood samples, which are used to aid in the diagnosis and treatment of diseases, but the device itself does not provide therapy.
Yes
The intended use explicitly states that BUN and Creatinine measurements are used in the diagnosis and treatment of renal and metabolic diseases, and for monitoring renal dialysis. This indicates that the device provides information for diagnostic purposes.
No
The device description clearly outlines a physical analyzer unit with hardware components (probe, incubation rotor, carousels, photometer) and single-use reagent cartridges. This is a hardware-based in vitro diagnostic system, not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only."
- Intended Use: The device is intended for the quantitative measurement of analytes (BUN and Creatinine) in biological specimens (serum and plasma) to aid in the diagnosis and treatment of diseases (renal and metabolic diseases). This is a core function of an IVD.
- Care Setting: The device is intended for use in clinical laboratories or physician office laboratories, which are typical settings for performing in vitro diagnostic tests.
- Device Description: The description details a system that analyzes biological samples using reagents and a photometer to measure analyte concentrations, which is characteristic of an IVD system.
N/A
Intended Use / Indications for Use
The S TEST Reagent Cartridge Blood Urea Nitrogen (BUN) is intended for the quantitative measurement of BUN 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. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
The S TEST Reagent Cartridge Creatinine (CRE) is intended for the quantitative measurement of creatinine 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. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Product codes
CDN, CGX
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, 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 scrum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for glucose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratories or physician office laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Data:
- Analytical Sensitivity (Limits of Detection): The study followed CLSI EP17-A2. LoD for BUN was 0.8 mg/dL, and LoD for CRE was 0.1 mg/dL.
- Linearity/Reportable Range: The study followed CLSI EP-6A. BUN test is linear between 0.9 mg/dL and 110 mg/dL. CRE test is linear between 0.1 mg/dL and 31.3 mg/dL. Reportable range for BUN is 1.5 mg/dL to 80 mg/dL. Reportable range for CRE is 0.1 mg/dL to 25 mg/dL.
- 20-day In-house Precision: Studies followed CLSI EP5-A2. Sample size: n=80 per level for BUN (3 levels) and CRE (4 levels).
- BUN Total %CV: Level 1 (7.24 mg/dL) 5.0%; Level 2 (14.07 mg/dL) 2.7%; Level 3 (49.05 mg/dL) 2.3%.
- CRE Total %CV: Level 1 (0.59 mg/dL) 8.5%; Level 2 (1.75 mg/dL) 3.4%; Level 3 (6.55 mg/dL) 2.9%; Level 4 (20.34 mg/dL) 1.4%.
- Interference Testing: The studies followed CLSI EP7-A2. Two serum pools per analyte were spiked. Non-interference was defined as spiked samples quantitating within 10% of neat samples.
- BUN: No interference up to 1,000 mg/dL (Hemoglobin, Lipemia), 50 mg/dL (Unconjugated bilirubin, Ascorbic acid).
- CRE: No interference up to 250 mg/dL (Hemoglobin), 25 mg/dL (Unconjugated bilirubin, Ascorbic acid), 1,000 mg/dL (Lipemia).
- Method Comparison - BUN: Sample size: 162 clinical specimens (range 2.4 to 78.5 mg/dL). Comparison with a standard laboratory system. Linear regression: r=0.997, Slope=0.96 (95% CI: 0.95 to 0.97), y-intercept=-0.27 (95% CI: -0.64 to 0.10).
- Method Comparison - CRE: Sample size: 100 clinical specimens (range 0.5 to 24.7 mg/dL). Comparison with a standard laboratory system. Linear regression: r=0.999, Slope=0.99 (95% CI: 0.98 to 1.00), y-intercept=-0.13 (95% CI: -0.18 to -0.07).
- Matrices Comparisons - BUN: Sample size: 36 matched serum/plasma samples (range 2.4 to 75.3 mg/dL). Compared serum with lithium heparin, K3 EDTA, and sodium citrate plasma. Slopes close to 1, r close to 0.999 for all plasma types.
- Matrices Comparisons - CRE: Sample size: 39 matched serum/plasma samples (range 0.1 to 24.5 mg/dL). Compared serum with lithium heparin, K3 EDTA, and sodium citrate plasma. Slopes close to 1, r close to 0.999 for all plasma types.
Clinical Data (performed at three external POL-type sites):
- External Site Precision Study: Each site received three blinded serum samples (low, middle, high concentrations). Each sample was assayed six times a day for five days, reporting 30 results per level.
- BUN (n=30 replicates per sample per site): Total %CV ranged from 0.6% to 3.6%.
- CRE (n=30 replicates per sample per site): Total %CV ranged from 0.0% to 6.8%.
- External Method Comparison Studies:
- BUN: Sample size: approx. 75 serum specimens per site (range 5.7 to 73.6 mg/dL). Linear regression "r" values were 0.999 for all three sites. Slopes ranged from 0.94 to 0.98.
- CRE: Sample size: approx. 45 serum specimens per site (range 0.6 to 24.1 mg/dL). Linear regression "r" values were 0.999 for all three sites. Slopes ranged from 0.96 to 0.98.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Analytical Sensitivity (Limits of Detection): BUN 0.8 mg/dL, CRE 0.1 mg/dL.
- Linearity: BUN 0.9-110 mg/dL, CRE 0.1-31.3 mg/dL.
- Reportable Range: BUN 1.5-80 mg/dL, CRE 0.1-25 mg/dL.
- Precision: In-house total %CVs range from 2.3% to 5.0% for BUN and 1.4% to 8.5% for CRE. Clinical site precision total %CVs for BUN ranged from 0.6% to 3.6% and for CRE from 0.0% to 6.8%.
- Method Comparison: BUN r=0.997, CRE r=0.999 (in-house). Clinical site r=0.999 for both BUN and CRE.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.
0
HITACHI
Inspire the Next
OCT 2 8 2013
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 K132462.
807.92 (a)(1): Name: Hitachi Chemical Diagnostics Address: c/o Erika Ammirati 575 Shirlynn Court Los Altos, CA 94022
Phone: FAX: Contact:
(650) 949-2768 (650) 949-5347
Erika Ammirati, Consultant to Hitachi Chemical Diagnostics, Inc.
807.92 (a)(2): Device name- trade name and common name, and classification
Trade name:
S TEST Reagent Cartridge Blood Urea Nitrogen (BUN) S TEST Reagent Cartridge Creatinine (CRE)
Common Name: Routine chemistry analyzer for blood urea nitrogen (BUN) Routine chemistry analyzer for creatinine (CRE)
Classification: Class II, 21 CFR § 862.1770- BUN test system (BUN) Class II. 21 CFR § 862.1225- creatinine test system (CRE)
807.92 (a)(3): Identification of the legally marketed predicate devices
Cobas c systems UREAL (Roche Diagnostics, Inc., Indianapolis, IN)- K100853 Cobas c systems CREJ2 (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.
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.
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O Hitachi Chemical Diagnostics, Inc. 630 Clyde Court, Mountain Viaw, CA 94043-2239 Jiel: 800-233-6278
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calibration factors, and other production-related information, c.g., expiration dating, 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 scrum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for glucose.
Chemistry reactions (BUN):
Urea is degraded by urcase into ammonia. When glutamate dehydrogenase (GLD) reacts with ammonia and alfa-ketoglutaric acid to produce glutamic acid. NADPH is converted into NADP with a decrease of absorbance at 340 mm. The concentration of urea nitrogen can be determined by measuring the amount of change in absorbance.
Image /page/1/Figure/5 description: This image shows two chemical reactions. In the first reaction, Urea is converted to NH3 and CO2 by Urease. In the second reaction, NH3, Alfa-ketoglutaric acid, and NADPH are converted to Glutamic acid, H2O, and NADP by GLD.
Chemistry reactions (CRE):
As the first reaction, creatine in samples is decomposed into water and oxygen by the action of creatinase, sarcosine oxidase, and catalase. Subsequently, as the second reaction, creatinine in samples is converted into creatine by the action of creatininase, and then sarcosine is formed by creatinase. Then, the quinone pigment is formed by oxidation condensation between N.N-Bis (4-suffobuty)-3-methylaniline disodium salt (TODB) and 4aminoantipyrine in the presence of peroxidase (POD) and hydrogen peroxide is by sarcosine oxidase. The concentration of creatinine is determined by measuring the absorbance of the resulting quinone pigment (purple-red).
The first reaction:
Image /page/1/Figure/9 description: This image shows three chemical reactions. In the first reaction, Creatine and H2O react in the presence of Creatinase to produce Sarcosine and Urea. In the second reaction, Sarcosine, O2, and H2O react in the presence of Sarcosine oxidase to produce Glycine, HCHO, and H2O2. In the third reaction, 2H2O2 reacts in the presence of Catalase to produce O2 and 2H2O.
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@ Hitachi Chemical Diagnostics, Inc. 630 Clyde Court, Mountain View, CA 94043-2239 Tol: B00 233 6278 Fax: 650 969 2745
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The second reaction:
Image /page/2/Figure/2 description: This image shows a series of chemical reactions. In the first reaction, Creatinine and H2O react with Creatininase to produce Creatine. In the second reaction, Creatine and H2O react with Creatinase to produce Sarcosine and Urea. In the third reaction, Sarcosine, O2, and H2O react with Sarcosine oxidase to produce Glycine, HCHO, and H2O2. In the fourth reaction, H2O2, TODB, and 4-aminoantipyrine react with POD to produce Quinone pigment (purple-red).
807.92 (a)(5): Intended Use (BUN and CRE)
The S TEST Reagent Cartridge Blood Urea Nitrogen (BUN) is intended for the quantitative measurement of BUN in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma on the Hitachi Clinical Analyzer E40. The test svstem is intended for use in clinical laboratories or physician office laboratories. For in viro diagnostic use only. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
The S TEST reagent cartridge Creatinine (CRE) is intended for the quantitative measurement of creatinine 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. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
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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/3/Picture/0 description: The image contains the logo for Hitachi. The word "HITACHI" is in bold, black letters at the top of the image. Below the company name is the slogan "Inspire the Next" in a smaller font. The background is white.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
| Characteristic | Hitachi S TEST Systems | PREDICATE(S) |
|---|---|---|
| Instrument Platform | Hitachi Clinical Analyzer | Roche cobas 8000 - K100853 |
| BUN Test System | K number- pending | Roche K-number- K100853 |
| Device Class. Regulation Code | Class II, 21 CFR 862.1770 | Same |
| Classification Product Code | CDN | Same |
| Intended Use | Quantitative measurement of BUN | Same |
| Testing Environment | Physician office or clinical lab | Clinical lab |
| Test Principle | Kinetic test (UV rate) with urease | |
| and glutamate dehydrogenase | Kinetic test with urease and | |
| glutamate dehydrogenase | ||
| Specimen Type | Human serum or plasma | Human serum, plasma, or urine |
| Reportable Range | 1.5 to 80.0 mg/dL | 1.4 to 112 mg/dL |
| Detection Wavelength | 340/546 nm (main/sub) | 700/340 nm (sub/main) |
| Detection Limit | 0.8 mg/dL | 1.4 mg/dL |
| Linearity | 0.9 to 110 mg/dL | 1.4 to 112 mg/dL. |
| Precision | %CVs range from 2.3% to 5.0% | %CVs range from 0.9% to 1.3% |
| (from product labeling) | ||
| CRE Test System | K number- pending | Roche K-number- K100853 |
| Device Class. Regulation Code | Class II, 21 CFR 862.1225 | Same |
| Classification Product Code | CGX | Same |
| Intended Use | Quantitative measurement of CRE | Same |
| Testing Environment | Physician office or clinical lab | Clinical lab- cobas |
| Test Principle | Enzymatic with creatinase and | |
| formation of quinone pigment | Kinetic colorimetric assay based on | |
| Jaffe method | ||
| Specimen Type | Human serum or plasma | Human serum, plasma, or urine |
| Reportable Range | 0.1 to 25.0 mg/dL. | 0.2 to 24.9 mg/dL |
| Detection Wavelength | 546/700 nm (main/sub) | 570/505 nm (sub/main) |
| Detection Limit | 0.1 mg/dL. | 0.2 mg/dL. |
| Linearity | 0.1 to 31.3 mg/dL | 0.2 to 24.9 mg/dL. |
| Precision | %CVs range from 1.4% to 8.5% | %CVs range from 1.1% to 5.0% |
| (from product labeling) |
The following chart describes similarities and differences between the two test systems.
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.
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Analytical Sensitivity (Limits of Detection)
The sudy followed CLSI EP17-A2. The sensitivity/limit of detection (LoD) for BUN was calculated to be 0.8 mg/dL, and the LoD for CRE was calculated to be 0.1 mg/dL.
Linearity/Reportable Range
The study followed CLSI EP-6A. The BUN test is linear between 0.9 mg/dL and 110 mg/dL. and the CRE test is linear between 0.1 mg/dL and 31.3 mg/dL. The reportable range for BUN is 1.5 mg/dL to 80 mg/dL, and the reportable range for CRE is 0.1 mg/dL to 25 mg/dL.
20-dav In-house Precision
The studies followed CLSI EP5-A2, where three (BUN) or four (CRE) levels of samples were each tested four times a day for 20 days. The results were as follows:
| Mean (mg/dL) | Within-Run %CV | Total %CV | ||
|---|---|---|---|---|
| BUN | Level 1 | 7.24 | 3.0 | 5.0 |
| n= 80 per level | Level 2 | 14.07 | 1.6 | 2.7 |
| Level 3 | 49.05 | 1.2 | 2.3 | |
| CRE | Level 1 | 0.59 | 6.8 | 8.5 |
| n= 80 per level | Level 2 | 1.75 | 2.3 | 3.4 |
| Level 3 | 6.55 | 1.2 | 2.9 | |
| Level 4 | 20.34 | 0.9 | 1.4 |
Precision Summary:
Interference Testing
The studies followed CLSI EP7-A2. Two serum pools per analyte were spiked with increasingly high concentrations of substances. The data demonstrated that the BUN and CRE systems were not affected by high levels of the following substances at the levels noted. Non interference was defined as spiked samples quantitating within 10% of the neat samples,
BUN (serum pools: ~ 12 mg/dL and 30 mg/dL)
- Hemoglobin: no interference up to 1,000 mg/dL .
- Unconjugated bilirubin: no interference up to 50 mg/dL .
- . Lipemia (Intralipid ®): no interference up to 1,000 mg/dL
- Ascorbic acid: no interference up to 50 mg/dL .
CRE (serum pools: ~1.5 mg/dL and 5.7 mg/dL)
- Hemoglobin: no interference up to 250 mg/dL .
- Unconjugated bilirubin no interference up to 25 mg/dL .
- Lipemia (Intralipid ®): no interference up to 1,000 mg/dL .
- Ascorbic acid: no interference up to 25 mg/dL .
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Hitachi Chemical Diagnostics, Inc.
630 Clyde Court, Mountain Vlow, CA 94043-2239 Tel: 800 233 6278
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Method Comparison - BUN
A total of 162 clinical specimens spanning the dynamic range (2.4 to 78.5 mg/dL), were assayed in singleton and in a blinded fashion by both the Hitachi E40 system (y-axis) and a standard laboratory system (x-axis). The comparative data were analyzed by linear regression and are shown below. (CI = confidence interval)
BUN Regression Statistics:
| n | r | Slope
(95% CI) | y-intercept
(95% CI) | X mean | Y mean |
|-----|-------|------------------------|--------------------------|------------|------------|
| 162 | 0.997 | 0.96
(0.95 to 0.97) | -0.27
(-0.64 to 0.10) | 27.2 mg/dL | 25.8 mg/dL |
Method Comparison - CRE
A total of 100 clinical specimens spanning the dynamic range (0.5 to 24.7 me/dL) were assayed in singleton and in a blinded fashion by both the Hitachi E40 system (v-axis) and a standard laboratory system (x-axis). The comparative data were analyzed by lincar regression and are shown below. (CI = confidence interval)
CRE Regression Statistics:
| 0 | | Stope
(95% CI) | y-intercept
(95% Cl) | X mean | Y mean |
|-----|-------|------------------------|---------------------------|-------------|------------|
| 100 | 0.999 | 0.99
(0.98 to 1.00) | -0.13
(-0.18 to -0.07) | 4.26 mg/dl. | 4.09 mg/dL |
Matrices Comvarisons- BUN
A study was performed to validate the use of three plasma types as an alternative to serum for S TEST Reagent Cartridge BUN. The plasma types were lithium heparin, KS EDTA, and sodium citrate. Thirty-six (36) matched serum/plasma samples that spanned the dynamic range (2.4 to 75.3 mg/dL) were assayed in singleton and the results were compared using linear regression (plasma = y-axis, each type). The performance characteristics were as follows.
BUN: n = 36. range (serum) = 2.4 to 75.3 mg/dL
| Heparinized Plasma | EDTA Plasma | Na Citrate Plasma | |
|---|---|---|---|
| Slope (95% CIs) | 1.01 (1.00 to 1.03) | 1.01(1.00 to 1.03) | 0.99 (0.97 to 1.01) |
| v-intercept (95% CIs) | -0.56 (-0.84 to -0.28) | -0.61 (-0.94 to -0.27) | -0.98 (-1.42 to -0.54) |
| r | 0.999 | 0.999 | 0.998 |
Matrices Comparisons- CRE
A study was performed to validate the use of three plasma tvpes as an alternative to serum for S TEST Reagent Cartridge CRE. The plasma types were lithium heparin, K3 EDTA, and sodium citrate. Thirty-nine (39) matched serum/plasma samples that spanned the dynamic range (0.1 to 24.5 mg/dL) were assayed in singleton and the results were compared using linear regression (plasma = y-axis, each type). The performance characteristics were as follows.
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Hitachi Chemical Diagnostics, Inc
630 Clyde Court, Mountain View, CA 94043-2239 Tol: 800 233 6278 Fax: 650 969 2745
| Comments of the controlled on the controlled on the month of the month of the province of the many of the comments of the consistence in | ||||
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Image /page/6/Picture/0 description: The image contains the logo for Hitachi, a Japanese multinational conglomerate. The logo consists of the word "HITACHI" in bold, uppercase letters. Below the company name is the slogan "Inspire the Next" in a smaller font size. The logo is simple and modern, and it is likely used in a variety of contexts, such as on the company's website, in its marketing materials, and on its products.
| CRE: n = 39, range (serum) = 0.1 to 24.5 mg/dL | ||
|---|---|---|
| Heparinized Plasma | EDTA Plasma | Na Citrate Plasma | |
|---|---|---|---|
| Slope (95% Cls) | 0.99 (0.98 to 1.00) | 1.01 (1.00 to 1.02) | 1.00 (0.99 to 1.02) |
| y-intercept (95% CIs) | -0.02 (-0.08 to 0.05) | -0.06 (-0.15 to 0.03) | -0.05 (-0.14 to 0.05) |
| r | 0.999 | 0.999 | 0.999 |
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 Cartridges for BUN and CRE in one of its targeted intended use environments, the physician's office laboratory.
For the external site precision study. cach 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 BUN or CRE. Each sample was assayed six times per day for five days, reporting 30 results per level. Precision estimates for total precision were as follows:
| Site # | Sample | Mean
(mg/dL) | Within-run Precision | | Total Precision | |
|--------|--------|-----------------|----------------------|-----|-----------------|-----|
| | | | SD (mg/dL) | %CV | SD (mg/dL) | %CV |
| 1 | A | 12.04 | 0.13 | 1.1 | 0.22 | 1.8 |
| 2 | A | 10.92 | 0.26 | 2.3 | 0.39 | 3.6 |
| 3 | A | 11.68 | 0.24 | 2.0 | 0.23 | 2.0 |
| 1 | B | 46.94 | 0.37 | 0.8 | 0.69 | 1.5 |
| 2 | B | 45.40 | 0.48 | 1.1 | 0.65 | 1.4 |
| 3 | B | 46.40 | 0.48 | 1.0 | 0.66 | 1.4 |
| 1 | C | 75.68 | 0.71 | 0.9 | 0.69 | 0.9 |
| 2 | C | 74.29 | 0.60 | 0.8 | 0.85 | 1.2 |
| 3 | C | 75.23 | 0.41 | 0.5 | 0.47 | 0.6 |
BUN (mg/dL) n = 30 replicates per sample per site
| n = 30 replicates per sample per site | ||||||
|---|---|---|---|---|---|---|
| Site # | Sample | Mean | ||||
| (mg/dL) | Within-run Precision | Total Precision | ||||
| SD (mg/dL) | %CV | SD (mg/dL) | %CV | |||
| 1 | A | 0.58 | 0.03 | 5.0 | 0.04 | 6.8 |
| 2 | A | 0.60 | 0.00 | 0.0 | 0.00 | 0.0 |
| 3 | A | 0.51 | 0.03 | 6.7 | 0.03 | 6.7 |
| 1 | B | 1.80 | 0.03 | 1.8 | 0.07 | 3.8 |
| 2 | B | 1.80 | 0.03 | 1.8 | 0.07 | 3.8 |
| 3 | B | 1.61 | 0.03 | 2.0 | 0.07 | 4.4 |
| 1 | C | 6.52 | 0.05 | 0.7 | 0.13 | 2.1 |
| 2 | C | 6.38 | 0.05 | 0.8 | 0.08 | 1.2 |
| 3 | C | 5.95 | 0.07 | 1.2 | 0.31 | 5.2 |
CRE (mg/dL)
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O Hitachl Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
| Company of the control of the status and the first to the first to the first and the | собразования продажения продавания продавания по приведельные в принамента в глада на при выпания | the contract and the control control and the program and the program and the comments of the comments of the comments of the comments of the comments of the contribution of t | ||
|---|---|---|---|---|
| www.hcdiaonostics.com | ||||
| 1 · 1479 · Pent meet meet and the manufacture and the production of a provincial in a provincial of a provincial of a program and service of a program a program a program a p |
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For the BUN external method comparison studies, a series of approximately 75 serum specimens with BUN values ranging from 5.7 mg/dL to 73.6 mg/dL, were assayed on the Hitachi Clinical Analyzer E40 at three sites using S TEST Reagent Cartridge BUN (v) and a comparative method as the reference method (x). The same study design was used for the S TEST Reagent CRE, using approximately 45 serum specimens ranging from 0.6 mg/dL to 24.1 mg/dL CRE. Linear regression analyses (least squares) vielded the following results.
| Site # | n | Range
(mg/dL) | Regression
Equation | "r" | CI*
Slope | CI*
Intercept |
|--------|----|------------------|------------------------|-------|--------------|------------------|
| 1 | 75 | 6.0 to 73.6 | $y = 0.98x - 0.23$ | 0.999 | 0.96 to 0.99 | -0.59 to 0.13 |
| 2 | 74 | 5.7 to 69.3 | $y = 0.94x - 0.24$ | 0.999 | 0.93 to 0.95 | -0.50 to 0.01 |
| 3 | 73 | 5.7 to 70.8 | $y = 0.95x - 0.05$ | 0.999 | 0.93 to 0.96 | -0.41 to 0.32 |
POL ACCURACY DATA SUMMARY- BUN (mg/dL)
*95% Confidence Interval
| Sile | n | | Kange
(mg/dl.) | Regression
Equation | ﺗﺄﺳﻴﺴﺎﺕ ﺳﻨﺔ 1992 ﻓﻲ ﺇﺳﺒﺎﻧﻴﺎ، ﻭﺃﻧﺎ ﻳﻜﻮﻥ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | Cl *
Slope | Cl*
Intercept |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|------------------|
| | ને રે | | 0.6 to 23.5 | v = ().97x - 0.06 | 0.999 | 0.96 to 0.98 | -(). 13 to 0.02 |
| | में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में में म | 0.6 to 24.1 | | v = 0.98x - 0.09 | 0.999 | 0.96 to 0.99 | -0.19 to 0.02 |
| | 47 | | 0.6 to 22.8 | v= 0.96x - 0.04 | 0.999 | 0.95 to 0.96 | -0.10 to 0.02 |
| . A comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contri | | | | | | | |
POL ACCURACY DATA SUMMARY- CRE (mg/dL)
*95% Confidence Interval
807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing
Nonclinical and clinical testing was performed for the S TEST Reagent Cartridge BUN and CRE. The test system was shown to be safe and effective for its intended use.
Chitachi Chemical Dlagnostics, Inc.
630 Clyde Court, Mountain Vlew, CA 94043-2239 Tol: 800 233 6278 Fax: 650 969 2745
| - Le de de la mini de la mini de man de man de mana de mana de mana de mana de mana de mana de mana de mana mana mana mana mana mana mana mana mana mana mana mana mana mana m | W. Ann a localified to Manhanting agallanting again the Philipping and the man has | ||
|---|---|---|---|
| www.hcdiagnostics.com | |||
| Comments of the comments of the comments of the program and the program and the research and one of the contraction of the consistence of contraction of consequence of conseq |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo features the department's seal, which includes the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized representation of three lines, possibly symbolizing people or services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2013
Hitachi Chemical Diagnostics, Inc. c/o Erika Ammirati Ammirati Regulatory Consulting 575 Shirlynn Court LOS ALTOS CA 94022
Re: K132462
Trade/Device Name: S TEST Reagent Cartridge Blood Urea Nitrogen (BUN) S TEST Reagent Cartridge Creatinine (CRE) Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: II Product Code: CDN, CGX Dated: August 6, 2013 Received: August 12, 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 Parts 801 and 809); 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Carol||G, 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): K132462
Device Name:
S TEST Reagent Cartridge Blood Urea Nitrogen (BUN) S TEST Reagent Cartridge Creatinine (CRE)
Indications for Use:
The S TEST Reagent Cartridge Blood Urea Nitrogen (BUN) is intended for the quantitative measurement of BUN 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. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
The S TEST Reagent Cartridge Creatinine (CRE) is intended for the quantitative measurement of creatinine 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. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis. and as a calculation basis for measuring other urine analytes.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use . (21 CFR Part 801 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)
Ruth A. Chesler -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR)
510(k)_k132462
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