(175 days)
No
The document describes a standard automated wet chemistry analyzer and reagent cartridges. There is no mention of AI, ML, or any features that would suggest the use of such technologies for data analysis, interpretation, or system control beyond basic automation and calculation based on absorbance measurements.
No
The device is an in vitro diagnostic (IVD) device used for quantitative measurements of various cholesterol levels and triglycerides in serum or plasma, which are used in the diagnosis and treatment of disorders. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Hitachi Clinical Analyzer with S TEST reagent cartridges... is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only." It further explains that the measurements are "used in the diagnosis and treatment of disorders."
No
The device description clearly outlines a physical analyzer unit with hardware components like a probe, incubation rotor, carousels, and a photometer, in addition to the software for operation and data display.
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 (CHO, HDL, LDL, TG) in biological specimens (serum or heparinized plasma). This is a core function of IVD devices.
- Clinical Context: The measurements are used in the "diagnosis and treatment" of various disorders, which is a key characteristic of IVD devices used to provide information for clinical decision-making.
- Care Setting: The device is intended for use in "clinical laboratories or physician office laboratories," which are typical settings for IVD testing.
- Device Description: The description details a system that analyzes biological samples using reagents and a photometer to determine analyte concentrations, consistent with IVD technology.
N/A
Intended Use / Indications for Use
The Hitachi Clinical Analyzer with S TEST reagent cartridges for total cholesterol (CHO), HDL cholesterol (HDL), LDL cholesterol (LDL), and triglycerides (TG) is intended for the quantitative measurements of CHO, HDL, LDL, and TG in serum or heparinized plasma. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
- Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood, and lipid and lipoprotein metabolism disorders.
- HDL measurements (lipoproteins) are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- LDL measurements (lipoproteins) are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
Product codes
CDT, CHH, LBS, MRR, JJE
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 heparin plasma and results are available in approximately 15 minutes per test. This submission is for the Lipid Panel, consisting of reagent cartridges for total cholesterol, HDL, LDL, and triglycerides.
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
A series of nonclinical studies were performed to evaluate analytical sensitivity (limits of detection), linearity, 20-day in-house precision, interference testing, in-house method comparisons, and matrices comparison between serum and heparin plasma.
Analytical Sensitivity (Limits of Detection): Followed CLSI EP17-A.
CHO: 0.7 mg/dL
HDL: 0.6 mg/dL
LDL: 0.8 mg/dL
TG: 2.5 mg/dL
Linearity: Followed CLSI EP-6A.
CHO: 1 mg/dL to 435 mg/dL
HDL: 4 mg/dL to 485 mg/dL
LDL: 3 mg/dL to 430 mg/dL
TG: 5 mg/dL to 848 mg/dL
20-day In-house Precision: Followed CLSI EP5-A2. Three or four levels of samples were each tested four times a day for 20 days (n=80 per level).
Total Cholesterol: Mean (mg/dL) 116.5 (Within-Run %CV 0.9, Total %CV 1.7), 182.8 (Within-Run %CV 0.8, Total %CV 1.5), 258.0 (Within-Run %CV 0.7, Total %CV 1.8).
HDL: Mean (mg/dL) 35.3 (Within-Run %CV 3.0, Total %CV 3.8), 60.0 (Within-Run %CV 2.4, Total %CV 3.1), 101.6 (Within-Run %CV 1.7, Total %CV 2.7).
LDL: Mean (mg/dL) 37.7 (Within-Run %CV 1.4, Total %CV 5.2), 104.3 (Within-Run %CV 1.6, Total %CV 3.5), 175.8 (Within-Run %CV 1.3, Total %CV 3.4), 299.3 (Within-Run %CV 1.0, Total %CV 2.7).
TG: Mean (mg/dL) 32.8 (Within-Run %CV 5.3, Total %CV 5.6), 129.7 (Within-Run %CV 2.0, Total %CV 2.6), 366.5 (Within-Run %CV 1.3, Total %CV 2.5), 620.1 (Within-Run %CV 1.4, Total %CV 2.4).
Interference Testing: Followed CLSI EP7-A2. No interference up to specified levels for Hemoglobin, Unconjugated bilirubin, Lipemia, and Ascorbic acid.
Method Comparisons (In-house): Evaluated a minimum of 109 serum samples with matched aliquots assayed on both Hitachi Clinical Analyzer and Roche/Hitachi cobas. Data analyzed by least squares linear regression.
Cholesterol (n=113): y = 0.98x + 2.2, r = 0.996. CI slope = 0.96 to 1.00, CI y-intercept = -1.7 to 6.1.
HDL (n=109): y = 0.99x + 5.4, r = 0.986. CI slope = 0.96 to 1.03, CI y-intercept = 3.6 to 7.3.
LDL (n=122): y = 0.94x + 7.6, r = 0.981. CI slope = 0.90 to 0.97, CI y-intercept = 3.0 to 12.1.
TG (n=111): y = 1.04x + 6.7, r = 0.998. CI slope = 1.03 to 1.05, CI y-intercept = 4.4 to 9.0.
Matrices Comparisons: Approximately 40 matched serum/plasma samples were assayed.
Cholesterol: y = 1.00x - 3.0, r = 0.999. CI slope = 0.99 to 1.01, CI y-intercept = -5.5 to -0.6.
HDL: y = 0.99x - 2.2, r = 0.999. CI slope = 0.96 to 1.00, CI y-intercept = -3.9 to -0.5.
LDL: y = 1.01x - 3.9, r = 0.999. CI slope = 0.99 to 1.02, CI y-intercept = -6.4 to -2.3.
TG: y = 1.00x - 1.3, r = 0.999. CI slope = 0.98 to 1.00, CI y-intercept = -4.7 to 2.1.
Clinical studies for precision and method comparisons (accuracy) were performed at three external POL-type sites.
External Site Precision Study: Each site received three blinded serum samples (A, B, C) for low, intermediate, and high concentrations. Each sample assayed six times per day for five days (30 results per level per analyte).
Total Cholesterol (n=30 replicates per sample per site):
Site 1: Sample A Mean 121.3, Within-run %CV 0.6%, Total %CV 0.7%; Sample B Mean 182.6, Within-run %CV 0.6%, Total %CV 0.7%; Sample C Mean 242.3, Within-run %CV 0.4%, Total %CV 0.5%.
Site 2: Sample A Mean 123.5, Within-run %CV 0.7%, Total %CV 1.0%; Sample B Mean 185.0, Within-run %CV 0.6%, Total %CV 0.7%; Sample C Mean 245.8, Within-run %CV 0.5%, Total %CV 0.6%.
Site 3: Sample A Mean 123.5, Within-run %CV 1.0%, Total %CV 1.2%; Sample B Mean 185.4, Within-run %CV 0.6%, Total %CV 0.7%; Sample C Mean 247.1, Within-run %CV 0.7%, Total %CV 1.4%.
HDL Cholesterol (n=30 replicates per sample per site):
Site 1: Sample A Mean 37.3, Within-run %CV 3.4%, Total %CV 4.5%; Sample B Mean 67.1, Within-run %CV 0.8%, Total %CV 1.0%; Sample C Mean 105.9, Within-run %CV 1.4%, Total %CV 1.9%.
Site 2: Sample A Mean 36.3, Within-run %CV 1.6%, Total %CV 2.0%; Sample B Mean 68.0, Within-run %CV 0.8%, Total %CV 1.6%; Sample C Mean 106.3, Within-run %CV 1.0%, Total %CV 1.3%.
Site 3: Sample A Mean 35.8, Within-run %CV 2.0%, Total %CV 3.7%; Sample B Mean 64.6, Within-run %CV 1.0%, Total %CV 1.3%; Sample C Mean 102.7, Within-run %CV 1.3%, Total %CV 1.6%.
LDL Cholesterol (n=30 replicates per sample per site):
Site 1: Sample A Mean 41.0, Within-run %CV 1.5%, Total %CV 1.7%; Sample B Mean 108.9, Within-run %CV 1.2%, Total %CV 1.3%; Sample C Mean 183.5, Within-run %CV 1.4%, Total %CV 1.7%.
Site 2: Sample A Mean 42.5, Within-run %CV 1.9%, Total %CV 1.8%; Sample B Mean 112.3, Within-run %CV 1.4%, Total %CV 1.5%; Sample C Mean 191.3, Within-run %CV 1.2%, Total %CV 1.8%.
Site 3: Sample A Mean 41.3, Within-run %CV 2.0%, Total %CV 2.0%; Sample B Mean 109.1, Within-run %CV 2.1%, Total %CV 2.0%; Sample C Mean 181.2, Within-run %CV 1.4%, Total %CV 1.7%.
Triglycerides (n=30 replicates per sample per site):
Site 1: Sample A Mean 32.1, Within-run %CV 2.6%, Total %CV 3.4%; Sample B Mean 115.0, Within-run %CV 2.6%, Total %CV 3.0%; Sample C Mean 291.0, Within-run %CV 0.7%, Total %CV 1.2%.
Site 2: Sample A Mean 33.6, Within-run %CV 3.3%, Total %CV 3.3%; Sample B Mean 120.2, Within-run %CV 1.2%, Total %CV 1.3%; Sample C Mean 301.5, Within-run %CV 1.2%, Total %CV 1.2%.
Site 3: Sample A Mean 31.4, Within-run %CV 4.0%, Total %CV 4.1%; Sample B Mean 115.4, Within-run %CV 1.9%, Total %CV 2.4%; Sample C Mean 289.1, Within-run %CV 0.9%, Total %CV 1.1%.
External Site Method Comparisons: Approximately 50 blinded serum samples were assayed by the Hitachi system at POL sites and by the Roche cobas 6000 (predicate system) at a central laboratory. Results analyzed by least squares linear regression (Hitachi = y-axis).
Total Cholesterol:
Site 1 (n=52): y = 0.97x + 2.5, r = 0.99. CI Slope = 0.95 to 0.98, CI Intercept = -1.1 to 6.1.
Site 2 (n=50): y = 0.98x + 4.1, r = 0.99. CI Slope = 0.95 to 1.00, CI Intercept = -1.0 to 9.3.
Site 3 (n=51): y = 1.00x + 0.7, r = 0.97. CI Slope = 0.94 to 1.08, CI Intercept = -13.7 to 15.2.
HDL:
Site 1 (n=52): y = 0.96x + 7.6, r = 0.98. CI Slope = 0.91 to 1.00, CI Intercept = 4.9 to 10.3.
Site 2 (n=50): y = 0.97x + 7.9, r = 0.98. CI Slope = 0.91 to 1.03, CI Intercept = 4.8 to 11.0.
Site 3 (n=51): y = 0.93x + 7.8, r = 0.99. CI Slope = 0.89 to 0.98, CI Intercept = 5.3 to 10.3.
LDL:
Site 1 (n=52): y = 0.94x + 3.8, r = 0.99. CI Slope = 0.90 to 0.99, CI Intercept = -1.7 to 9.4.
Site 2 (n=50): y = 0.95x + 3.6, r = 0.98. CI Slope = 0.89 to 1.01, CI Intercept = -3.5 to 10.8.
Site 3 (n=51): y = 0.93x + 6.4, r = 0.98. CI Slope = 0.89 to 0.98, CI Intercept = 0.6 to 12.3.
TG:
Site 1 (n=52): y = 1.05x + 4.9, r = 0.99. CI Slope = 1.04 to 1.07, CI Intercept = 1.4 to 8.4.
Site 2 (n=52): y = 0.94x + 3.3, r = 0.99. CI Slope = 0.93 to 0.96, CI Intercept = 0.1 to 6.5.
Site 3 (n=51): y = 1.07x - 6.5, r = 0.99. CI Slope = 1.05 to 1.10, CI Intercept = -10.1 to -2.9.
Key Metrics
Sensitivity, Linearity, Precision, Correlation Coefficient (r)
Predicate Device(s)
K060373, K031824, K033610, K012287, K972250
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
DEC 1 4 2011
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 K11753.
| 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 Cholesterol (CHO)
- · Hitachi Clinical Analyzer S TEST Reagent Cartridge High Density Lipoprotein Cholesterol (HDL) . . . . . .. .. ﺎ . . . . . . . . . . . .
- · Hitachi Clinical Analyzer S TEST Reagent Cartridge Low Density Lipoprotein Cholesterol (LDL)
- · Hitachi Clinical Analyzer S TEST Reagent Cartridge Triglycerides (TG)
Common Name: Routine chemistry analyzer for lipid panel: total cholesterol (CHO), HDL, LDL, and triglycerides (TG)
Classifications: 21 CFR § 862.1175- Cholesterol (total) test system 21 CFR § 862.1475- Lipoprotein (HDL, LDL) test system 21 CFR § 862.1705- Triglyceride test system All Class I Reserved, per 21 CFR 862.9(c)(4)
807.92 (a)(3): Identification of the legally marketed predicate devices
Instrument portion: Roche/Hitachi cobas 6000- K060373 Total cholesterol: Roche/Hitachi test reagent- K031824 HDL: Roche/Hitachi test reagent- K033610 LDL: Roche/Hitachi test reagent- K012287
Page 1 of 14
Chemical Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA. 94043-2239 Tel: 800 233 6278 Fax: 650.969 2745
1
TG: Roche/Hitachi test reagent- K972250
Integrated system (instrument and lipid panel); Alfa Wasserman S40 system-K091413
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, 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 heparin plasma and results are available in approximately 15 minutes per test. This submission is for the Lipid Panel, consisting of reagent cartridges for total cholesterol, HDL, LDL, and triglycerides.
1 1 - and v 2 - 1 - 1 -
Chemistry reactions:
Cholesterol
The cholesterol in the sample is cleaved into cholesterol esters and free cholesterol. The cholesterol esters become free cholesterol through the action of cholesterol esterase (CE). The free cholesterol is then oxidized by cholesterol oxidase (COD) to produce hydrogen peroxide, esters and free cholesterol. The cholesterol esters become free cholesterol through the action of cholesterol esterase (CE). The hydrogen peroxide oxidizes and condenses 4aminoaminoantipyrine and N-ethyl-N-sulfobutyl-m-toluidine (ESBmT) under the influence of peroxidase (POD) to produce "a" reddish-purple pigment. "Total cholesterol concentration is determined by measuring the absorbance of this reddish-purple pigment. The difference in absorbance, monitored bichromatically at 600 nm/800 nm, is directly proportional to the cholesterol concentration in the sample.
HDL
Page 2 of 14
Hitachi Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
2
By using a special surface-active agent that preferentially solubilizes HDL and not other lipoproteins (LDL, VLDL, and chylomicrons), the HDL cholesterol is measured via a quickly initiated enzymatic reaction. Therefore, only HDL cholesterol is specifically measured. The released hydrogen peroxide oxidizes and condenses 4-aminoaminoantipyrine and N.N-bis(4sulfobutyl)-m-toluidine disodium salt (DSBmT) in the presence of peroxidase (POD) to produce a reddish-purple pigment. HDL cholesterol concentration is determined by measuring the absorbance of this reddish-purple pigment. The difference in absorbance, monitored bichromatically at 600 nm/700 nm is directly proportional to the HDL concentration in the sample.
LDL
The method, using a combination of two surfactants, is based on the principle that each lipoprotein reacts with different surfactants, depending on their intrinsic physicochemical property. In the first reaction, Surfactant 1 changes the structure of only those lipoproteins other than LDL (i.e., chylomicron [CM], VLDL, and HDL), and the resulting micellar cholesterol is consumed by the cholesterol oxidase and the cholesterol esterase in a colorless reaction. In the second reaction, the remaining LDL is modified by Surfactant 2, and that form of cholesterol is measured in a color reaction.
TG
Free glycerol in the sample is converted to glycerol-3-phosphoric acid through the action of glycerol kinase (GK) and the adenosine triphosphate (ATP) substrate. Glycerol-3-phosphoric acid is converted to hydrogen peroxide via the action of glycerol-3-phosphate oxidase (GPO); peroxide is then decomposed into water and oxygen via the action of catalase. The neutral fat in the sample is quickly hydrolyzed into glycerol and fatty acid by the lipoprotein lipase (LPL) contained in the second reagent. The glycerol product is converted to glycerol-3-phosphoric acid via the action of GK and the ATP substrate, which in turn produces hydrogen peroxide via the action of GPO. The hydrogen peroxide oxidizes/condenses 4-aminoantipyrine and N-ethy-Nsulfobutyl-m-toluidine (ESBmT), via the action of peroxidase (POD) to produce a reddish purple pigment. The original neutral fat concentration (triglyceride) is determined by measuring the absorbance of the reddish purple pigment produced. The difference in absorbance between the final reading and the blank,"monitored bichromatically at 600 nm/800 nm, is directly proportional to the triglyceride concentration.
807.92 (a)(5): Intended Use
The Hitachi Clinical Analyzer with S TEST reagent cartridges for total cholesterol (CHO), HDL cholesterol (HDL), LDL cholesterol (LDL), and triglycerides (TG) is intended for the quantitative measurements of CHO, HDL, and TG in serum or heparinized plasma. The test system is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
- Cholesterol measurements are used in the diagnosis and treatment of disorders involving . excess cholesterol in the blood, and lipid and lipoprotein metabolism disorders.
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Page 3 of 14
Hitachi Chemical Diagnostics, Inc. 630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 8278 . 】 1.3. . . .
3
- HDL measurements (lipoproteins) are used in the diagnosis and treatment of lipid disorders . (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- LDL measurements (lipoproteins) are used in the diagnosis and treatment of lipid disorders . (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
- Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes . mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
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 6000 - K060373 |
| also, Alfa Wasserman S40- K091413 | ||
| Cholesterol | K number- K111753 | Roche K number- K031824 |
| Device Class, Regulation Code | Class I (reserved), 21 CFR 862.1175 | Same |
| Classification Product Code | CHH | Same |
| Intended Use | Quantitative determination of total | |
| cholesterol | Same | |
| Testing Environment | Physician office (POL) or clinical lab | Clinical lab- cobas |
| POL/Clin Lab - Alfa Wasserman | ||
| Test Principle | Enzymatic method (COD-POD | |
| method) | Enzymatic (cholesterol esterase and | |
| cholesterol oxidase) | ||
| Specimen Type | Serum and heparinized plasma | Same |
| Reportable Range | 4 to 400 mg/dL | 3.86 to 800 mg/dL |
| Detection Wavelength | 600/800 nm | 700/505 nm |
| Detection Limit | 0.7 mg/dL | 3.86 mg/dL |
| Linearity | 1 to 435 mg/dL | 3.86 to 800 mg/dL |
| Precision | %CVs range from 0.5% to 1.4% | |
| (POL testing) | %CVs range from 1.4% to 1.6% | |
| (from product labeling) | ||
| HDL | K number- K111753 | Roche K number- K033610 |
| Device Class, Regulation Code | Class I (reserved), 21 CFR 862.1475 | Same |
| Classification Product Code | LBS | Same |
| Intended Use | Quantitative determination of HDL | |
| cholesterol | Same | |
| Testing Environment | Physician office or clinical lab | Clinical lab- cobas |
| POL/Clin Lab - Alfa Wasserman |
Page 4 of 14
്ര Hitach! Chemical Diagnostics, Inc. 630 Clyde Court, Mountain Vlew, CA 94043-2239 Tel: 800 233 6278
{
Fax: 650 969 2745
4
Image /page/4/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 size. The text is all in black and the background is white.
| Test Principle | Enzymatic direct method | Enzymatic (cholesterol esterase and cholesterol oxidase) after removal of LDL and VLDL |
|---|---|---|
| Specimen Type | Serum and heparinized plasma | Same |
| Reportable Range | 8 mg/dL to 150 mg/dL | 3 to 121 mg/dL |
| Detection Wavelength | 600/700 nm | 700/600 nm |
| Detection Limit | 0.6 mg/dL | 3 mg/dL |
| Linearity | 4 mg/dL to 485 mg/dL | 3 to 121 mg/dL |
| Precision | %CVs range from 1.0% to 4.5% | |
| (from POL testing) | %CVs range from 0.9% to 1.5% | |
| (from product labeling) |
Comparative chart- continued
| Characteristic | Hitachi S TEST Systems | PREDICATE(S) |
|---|---|---|
| LDL | K number- K111753 | Roche K number- K033610 |
| Device Class, Regulation Code | Class I (reserved), 21 CFR 862.1475 | Same |
| Classification Product Code | MRR | Same |
| Intended Use | Quantitative determination of LDL | |
| cholesterol | Same | |
| Testing Environment | Physician office or clinical lab | Clinical lab- cobas |
| POL/Clin Lab - Alfa Wasserman | ||
| Test Principle | Enzymatic direct method | Homogeneous enzymatic |
| colorimetric | ||
| Specimen Type | Serum and heparinized plasma | Same |
| Reportable Range | 8 to 400 mg/dL | 3.86 to 548 mg/dL |
| Detection Wavelength | 546/660 nm | 700/600 nm |
| Detection Limit | 0.8 mg/dL | 3.86 mg/dL |
| Linearity | 3 to 430 mg/dL | 3.86 to 548 mg/dL |
| Precision | %CVs range from 1.3% to 2.0% | |
| (from POL testing) | %CVs range from 1.9% to 2.7% | |
| (from product labeling) | ||
| Triglycerides | K number- K111753 | Roche K number- K972250 |
| Device Class, Regulation Code | Class I (reserved), 21 CFR 862.1705 | Same |
| Classification Product Code | CDT | Same |
| Intended Use | Quantitative determination of | |
| triglycerides | Same | |
| Testing Environment | Physician office or clinical lab | Clinical lab- cobas |
| POL/Clin Lab - Alfa Wasserman | ||
| Test Principle | Enzymatic method | Enzymatic and colorimetric |
. . . . . . . . . . . . . .
Page 5 of 14
Hitachi Chemical Diagnostics, Inc.
·
@ Hittachl Chemical Diagnostics, Inc. (
5
| Specimen Type | Serum and heparinized plasma | Same (plus EDTA plasma) |
|---|---|---|
| Reportable Range | 7 mg/dL to 800 mg/dL | 8.85 to 885 mg/dL |
| Detection Wavelength | 570/700 nm | 700/505 nm |
| Detection Limit | 2.5 mg/dL | 8.85 mg/dL |
| Linearity | 2 to 848 mg/dL | 8.85 to 885 mg/dL |
| Precision | %CVs range from 1.1% to 4.1% | |
| (from POL testing) | %CVs range from 1.6% to 2.0% | |
| (from product labeling) |
1000 - 1000
・.
Page 6 of 14
ത്ര Hitachi Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
6
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 inhouse precision, interference testing, in-house method comparisons, and matrices comparison between serum and heparin plasma.
Analytical Sensitivity (Limits of Detection)
The studies followed CLSI EP17-A for each analyte. The sensitivities were as follows:
CHO: 0.7 mg/dL HDL: 0.6 mg/dL LDL: 0.8 mg/dL TG: 2.5 mg/dL
Linearity
The studies followed CLSI EP-6A for each analyte. The ranges of linearity were as follows:
CHO: 1 mg/dL to 435 mg/dL
HDL: 4 mg/dL to 485 mg/dL
LDL: 3 mg/dL to 430 mg/dL
TG:
5 mg/dL to 848 mg/dL ...... . . . .
20-day In-house Precision
The studies followed CLSI EP5-A2, where three or four levels of samples were each tested fourtimes a day for 20 days. The results were as follows:
| Mean (mg/dL) | Within-Run %CV | Total %CV | ||
|---|---|---|---|---|
| Total Cholesterol | Level 1 | 116.5 | 0.9 | 1.7 |
| n= 80 per level | Level 2 | 182.8 | 0.8 | 1.5 |
| Level 3 | 258.0 | 0.7 | 1.8 | |
| HDL | Level 1 | 35.3 | 3.0 | 3.8 |
| n= 80 per level | Level 2 | 60.0 | 2.4 | 3.1 |
| Level 3 | 101.6 | 1.7 | 2.7 | |
| LDL | Level 1 | 37.7 | 1.4 | 5.2 |
| n= 80 per level | Level 2 | 104.3 | 1.6 | 3.5 |
| Level 3 | 175.8 | 1.3 | 3.4 | |
| Level 4 | 299.3 | 1.0 | 2.7 | |
| TG | Level 1 | 32.8 | 5.3 | 5.6 |
| n= 80 per level | Level 2 | 129.7 | 2.0 | 2.6 |
| Level 3 | 366.5 | 1.3 | 2.5 | |
| Level 4 | 620.1 | 1.4 | 2.4 |
Precision Summary:
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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tachi Chemical Diagnostics, Inc.
de Court, Mountain Vlew, CA 94043-2239 Tel: 800 233 6278
| and a provent of the comprehensive for any and the comments of the comments of the | No. of Children of Children of Children of Children and Children and Children and Children and Children and Children Comments of Children | |||||
|---|---|---|---|---|---|---|
| www.hcdiagnostics.com | ||||||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Company of the consisted on the consideration of the | THE LE LEASE LA CONSULTION CONSULTION AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND A CHANAL A CHANAL A CHANAL A CHARACT AND A CHARA A CHARA A CHARA A C | ||||
| with and and more of Acres, And Any And Any, And Any, And An | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Page 8 of 14
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@ Hittachl Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA. 84043-2239 Tel: 800 233 6278 Fax: 850 969 2745
·
:
·
8
Interference Testing
The studies followed CLSI EP7-A2. The data demonstrated that none of the four analytes were affected by high levels of the following substances at the levels noted:
Hemoglobin: no interference up to 1000 mg/dL for CHO and LDL: 500 mg/dL for HDL and TG Unconjugated bilirubin no interference up to 50 mg/dL for CHO, HDL, and TG: 25 mg/dL for LDL Lipemia: no interference up to 2000 mg/dL for CHO; up to 725 mg/dL for HDL and up to 614 mg/dL for LDL (TG: N/A)
Ascorbic acid: no interference up to 50 mg/dL with any of the four test systems
Method Comparisons
The method comparison studies evaluated a minimum of 109 serum samples; matched aliquots were assayed with both the Hitachi Clinical Analyzer with S TEST reagent cartridges for CHO, HDL, LDL, and TG and the Roche/Hitachi cobas. The data were analyzed by least squares linear regression (Hitachi = y-axis), and the results were as follows:
Cholesterol (mg/dL) n= 113 v = 0.98x + 2.2 correlation coefficient (r) = 0.996 95% confidence interval of the slope = 0.96 to 1.00 95% confidence interval of the y-intercept = -1.7 to 6.1 HDL (mg/dL) applies (1) ================================================================================================================================================================== n = 109 y = 0.99x +5.4 correlation coefficient (r) = 0.986 95% confidence interval of the slope = 0.96 to 1.03 95% confidence interval of the "iop" - 0.50 to 1.05
95% confidence interval of the "i-intercept = 3.6 to 7.3 = " " = " = " = " = " = " = " = " = " = " = " = " = " = " = " = " LDL (mg/dL) n = 122 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . y = 0.94x + 7.6 correlation coefficient (r) = 0.981 95% confidence interval of the slope = 0.90 to 0.97 95% confidence interval of the y-intercept = 3.0 to 12.1
TG (mg/dL) n = 111 y = 1.04x +6.7 correlation coefficient (r) = 0.998 | ` 95% confidence interval of the slope = 1.03 to 1.05
Page 9 of 14
Hitachi Chemical Diagnostics, Inc. 10 Clyde Court, Mountain View, CA . 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
| www.hcdiaonostics.com | (4) LA BRANCHELLERY (1) LE MILLIO (4) LE (1) LE (1) LE (1) (1) LE (1) (1) LE (1) (1) LE (1) (1) LE (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) | |||||
|---|---|---|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------ | The first of the many of the first of the first of the first of the first of the first of the first and the first and the first and the first and | - AND A B A . A . AN . AND . AND . AND AND CAN CAN | The Call Comments of Children Comments of Children Comments of Children | ||
| the country of the country of the country of the country | A |
9
95% confidence interval of the y-intercept = 4.4 to 9.0
Matrices Comparisons
A study was performed to validate the use of heparinized plasma as well as serum for the Hitachi Clinical Analyzer with S TEST reagent cartridges for CHO, HDL, and TG. Approximately 40 matched serum/plasma samples that spanned the four dynamic ranges were assayed in singleton and the results were compared using least squares liner regression (plasma = y-axis). The performance characteristics were as follows.
Cholesterol (mg/dL) y = 1.00x -3.0 correlation coefficient (r) = 0.999 95% confidence interval of the slope = 0.99 to 1.01 95% confidence interval of the y-intercept = - 5.5 to -0.6
HDL (mg/dL)
y = 0.99x -2.2 correlation coefficient (r) = 0.999 95% confidence interval of the slope = 0.96 to 1.00 95% confidence interval of the y-intercept = - 3.9 to -0.5
LDL (mg/dL) y = 1.01x -3.9 11 11 11 11 11 11 11 11 11 correlation coefficient (r) = 0.999 15 173 31 11:12 11 11:2 95% confidence interval of the slope = 0.99 to 1.02 95% confidence interval of the y-intercept -6.4 to -2.3 . ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
TG (mg/dL) y = 1.00x -1.3 correlation coefficient (r) = 0.999
95% confidence interval of the slope = 0.98 to 1.00 95% confidence interval of the y-intercept = - 4.7 to 2.1
807.92 (b)(2): Brief Description of Clinical Data
Studies for precision and method comparisons (accuracy) were performed at three external POLtype sites to evaluate the Hitachi Clinical Analyzer with S TEST reagent cartridges for CHO, HDL, LDL, and TG in one of its targeted intended use environments, the physician's office laboratory.
i "i,i,i,i,i,
Page 10 of 14
O Hitachi Chemical Diagnostics, Inc.
630 Clyde Court, Mountain Vlew, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
10
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:
| n = 30 replicates per sample per site | ||||||
|---|---|---|---|---|---|---|
| Site | Sample | Mean | Within-run Precision | Total Precision | ||
| SD (mg/dL) | %CV | SD (mg/dL) | %CV | |||
| Site 1 | A | 121.3 | 0.8 | 0.6% | 0.8 | 0.7% |
| Site 2 | A | 123.5 | 0.9 | 0.7% | 1.2 | 1.0% |
| Site 3 | A | 123.5 | 1.2 | 1.0% | 1.5 | 1.2% |
| Site 1 | B | 182.6 | 1.1 | 0.6% | 1.3 | 0.7% |
| Site 2 | B | 185.0 | 1.1 | 0.6% | 1.3 | 0.7% |
| Site 3 | B | 185.4 | 1.2 | 0.6% | 1.3 | 0.7% |
| Site 1 | C | 242.3 | 0.9 | 0.4% | 1.1 | 0.5% |
| Site 2 | C | 245.8 | 1.2 | 0.5% | 1.4 | 0.6% |
| Site 3 | C | 247.1 | 1.8 | 0.7% | 3.4 | 1.4% |
Total Cholesterol (mg/dL)
. . !! .