(149 days)
Not Found
No
The description details a standard automated wet chemistry analyzer and reagent cartridges, with no mention of AI or ML in the device operation, data analysis, or performance studies.
No
The device is an in vitro diagnostic (IVD) tool designed for quantitative determination of specific biomarkers (LD and AMY) in serum and plasma, used in the diagnosis and treatment of diseases, rather than directly providing therapy.
Yes
The text explicitly states: "Measurements of LD are used in the diagnosis and treatment of liver and cardiac diseases." and "Measurements of AMY are mainly used in the diagnosis and treatment of pancreatic diseases." This indicates its purpose is to aid in diagnosis.
No
The device description clearly outlines a physical instrument (Hitachi Clinical Analyzer) and physical reagent cartridges, indicating it is a hardware-based system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Intended Use: The device is intended for the quantitative determination of specific analytes (Lactate Dehydrogenase and Amylase) in human biological samples (serum and plasma). This is a core function of IVD devices.
- Clinical Context: The measurements are used in the "diagnosis and treatment of liver and cardiac diseases" (LD) and "diagnosis and treatment of pancreatic diseases" (AMY). This indicates a medical purpose for the test results.
- 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 to measure analytes, which is consistent with an IVD system.
- Performance Studies: The document includes detailed performance studies (analytical sensitivity, linearity, precision, interference, method comparison, matrices comparison) which are required for the validation of IVD devices.
N/A
Intended Use / Indications for Use
The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for the quantitative determination of LD in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of LD are used in the diagnosis and treatment of heart, liver, kidney, and blood diseases.
The S TEST Reagent Cartridge Amylase (AMY) is intended for the quantitative determination of AMY in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Amylase (AMY) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of AMY are mainly used in the diagnosis and treatment of pancreatic diseases.
Product codes (comma separated list FDA assigned to the subject device)
CFJ, JFJ
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 ALP.
Chemistry reactions: (LD) Lactate dehydrogenase in samples catalyzes the reaction of converting lactic acid to pyruvic acid. During this reaction, NAD is converted into NADH with an increase in absorbance at 340 nm. The LD activity can be determined by measuring the production rate of the resulting NADH.
(AMY) Amylase in blood samples reacts with the substrate alfa-2-chloro-4-nitrophenyb]galactopyranosylmaltoside (Gal-G2-CNP), and the substrate is cleaved into 4galactopyranosylmaltose (Gal-G2) and 2-chloro-4-nitrophenol (CNP). Amylase activity is determined by measuring the production rate of CNP (yellow).
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:
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)- LD: The study followed CLSI EP17-A, and the limit of detection was found to be 7.9 U/L. The quantitation limit was found to be 10 U/L.
- Analytical Sensitivity (Limits of Detection)- AMY: The study followed CLSI EP17-A, and the limit of detection was found to be 2.2 U/L. The quantitation limit was found to be 4 U/L.
- Linearity- LD: The study followed CLSI EP-6A, and the range of linearity was 3 U/L to 1,196 U/L. The reportable range is 10 U/L to 1,000 U/L.
- Linearity- AMY: The study followed CLSI EP-6A, and the range of linearity was 3 U/L to 1,700 U/L. The reportable range is 4 U/L to 1,500 U/L.
- 20-day In-house Precision- LD: The studies followed CLSI EP5-A2, where three levels of samples were each tested in two runs, twice a day, for 20 days.
- LD- Low, Level 1, Mean: 108.2 U/L, SD: 5.24 U/L (Within-Run), 6.82 U/L (Total), %CV: 4.8% (Within-Run), 6.3% (Total)
- LD- Middle, Level 2, Mean: 159.3 U/L, SD: 9.15 U/L (Within-Run), 8.85 U/L (Total), %CV: 5.7% (Within-Run), 5.6% (Total)
- LD- High, Level 3, Mean: 628.0 U/L, SD: 20.0 U/L (Within-Run), 33.8 U/L (Total), %CV: 3.2% (Within-Run), 5.4% (Total)
- 20-day In-house Precision- AMY: The studies followed CLSI EPS-A2, where three levels of samples were each tested in two runs, twice a day, for 20 days.
- AMY- Low, Level 1, Mean: 54.1 U/L, SD: 0.94 U/L (Within-Run), 1.45 U/L (Total), %CV: 1.7% (Within-Run), 2.7% (Total)
- AMY- Middle, Level 2, Mean: 188.5 U/L, SD: 1.50 U/L (Within-Run), 6.99 U/L (Total), %CV: 0.8% (Within-Run), 3.7% (Total)
- AMY- High, Level 3, Mean: 1126.8 U/L, SD: 8.85 U/L (Within-Run), 39.5 U/L (Total), %CV: 0.8% (Within-Run), 3.5% (Total)
- Interference Testing (per CLSI EP7-A2):
- LD: Not affected by Unconjugated bilirubin (up to 50 mg/dL), Lipemia (up to 1,000 mg/dL), Ascorbic acid (up to 50 mg/dL). Positive interference from Hemoglobin from 31mg/dL.
- AMY: Not affected by Hemoglobin (up to 500 mg/dL), Unconjugated bilirubin (up to 50 mg/dL), Lipemia (up to 2,000 mg/dL), Ascorbic acid (up to 50 mg/dL).
- Method Comparison - LD: 106 clinical specimens (13 to 959 U/L) were assayed in singleton by Hitachi E40 and a standard laboratory system. r=0.991, Slope=1.01 (0.99 to 1.04), y-intercept=5.4 (-3.8 to 14.6).
- Method Comparison - AMY: 105 clinical specimens (5 to 1,443 U/L) were assayed in singleton by Hitachi E40 and a standard laboratory system. r=0.997, Slope=1.08 (1.06 to 1.10), y-intercept=-3.3 (-8.7 to 2.1).
- Matrices Comparisons- LD: 39 matched serum/plasma samples (32 to 804 U/L) were assayed. Heparinized Plasma: Slope 0.99 (0.97 to 1.01), y-intercept -5.5(-10.7 to -0.3), r 0.998. K3 EDTA Plasma: Slope 0.97 (0.94 to 1.00), y-intercept 0.1 (-8.9 to 9.0), r 0.994.
- Matrices Comparisons- AMY: Approximately 43 matched serum/plasma samples (5 to 1,494 U/L) were assayed. Heparinized Plasma: Slope 1.02 (1.00 to 1.04), y-intercept -8.4 (-17.2 to 0.3), r 0.998. K3 EDTA Plasma: Slope 0.97 (0.95 to 0.99), y-intercept -6.6 (-14.3 to 1.0), r 0.999.
Clinical Data:
Studies for precision and method comparison (accuracy) were performed at three external POL-type sites.
- External site precision study (LD): Each sample was assayed six times per day for five days, reporting 30 results per level.
- Site 1 (Low): Mean 47.3 U/L, Total SD 4.42 U/L, Total %CV 9.3%.
- Site 2 (Low): Mean 49.8 U/L, Total SD 3.20 U/L, Total %CV 6.4%.
- Site 3 (Low): Mean 45.7 U/L, Total SD 3.82 U/L, Total %CV 8.4%.
- Site 1 (Middle): Mean 161.9 U/L, Total SD 6.45 U/L, Total %CV 4.0%.
- Site 2 (Middle): Mean 161.6 U/L, Total SD 6.25 U/L, Total %CV 3.9%.
- Site 3 (Middle): Mean 155.7 U/L, Total SD 9.63 U/L, Total %CV 6.2%.
- Site 1 (High): Mean 498.1 U/L, Total SD 15.10 U/L, Total %CV 3.0%.
- Site 2 (High): Mean 488.5 U/L, Total SD 35.20 U/L, Total %CV 7.2%.
- Site 3 (High): Mean 497.0 U/L, Total SD 20.55 U/L, Total %CV 4.1%.
- External site precision study (AMY): Each sample was assayed six times per day for five days, reporting 30 results per level.
- Site 1 (Low): Mean 53.2 U/L, Total SD 2.44 U/L, Total %CV 4.6%.
- Site 2 (Low): Mean 50.4 U/L, Total SD 1.74 U/L, Total %CV 3.5%.
- Site 3 (Low): Mean 51.2 U/L, Total SD 1.93 U/L, Total %CV 3.8%.
- Site 1 (Middle): Mean 116.9 U/L, Total SD 1.65 U/L, Total %CV 1.4%.
- Site 2 (Middle): Mean 111.5 U/L, Total SD 2.11 U/L, Total %CV 1.9%.
- Site 3 (Middle): Mean 113.3 U/L, Total SD 3.51 U/L, Total %CV 3.1%.
- Site 1 (High): Mean 1527.4 U/L, Total SD 15.51 U/L, Total %CV 1.0%.
- Site 2 (High): Mean 1428.6 U/L, Total SD 29.24 U/L, Total %CV 2.0%.
- Site 3 (High): Mean 1465.4 U/L, Total SD 19.10 U/L, Total %CV 1.3%.
- POL ACCURACY DATA SUMMARY- LD:
- Site 1: n=87, Range 16 to 938 U/L, y = 0.96x + 2.5, r=0.997, CI Slope 0.94 to 0.97, CI Intercept -2.3 to 7.4.
- Site 2: n=78, Range 23 to 877 U/L, y = 0.96x + 4.7, r=0.998, CI Slope 0.94 to 0.97, CI Intercept 0.6 to 8.9.
- Site 3: n=86, Range 17 to 914 U/L, y = 0.91x +13.5, r=0.999, CI Slope 0.90 to 0.93, CI Intercept 9.6 to 17.4.
- POL ACCURACY DATA SUMMARY- AMY:
- Site 1: n=76, Range 29 to 1134 U/L, y = 1.05x - 1.2, r=0.999, CI Slope 1.04 to 1.06, CI Intercept -4.6 to 2.2.
- Site 2: n=69, Range 27 to 1146 U/L, y = 1.00x - 0.5, r=0.995, CI Slope 0.98 to 1.03, CI Intercept -6.6 to 5.7.
- Site 3: n=71, Range 29 to 1112 U/L, y = 0.98x + 3.3, r=0.995, CI Slope 0.95 to 1.00, CI Intercept -3.2 to 9.8.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Precision data provided as %CV. Accuracy data provided as linear regression statistics (slope, y-intercept, r).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.
0
130683
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 K130685.
| 807.92 (a)(1): Name: | Hitachi Chemical Diagnostics |
|---|---|
| Address: | 630 Clyde Court |
| Mountain View, CA 94043 | |
| Contact: | Erika Ammirati, Ammirati Regulatory Consulting |
| Consultant to Hitachi Chemical Diagnostics, Inc. | |
| Address: | 575 Shirlynn Court |
| Los Altos, CA 94022 | |
| Phone: | (650) 949-2768 |
| FAX: | (650) 949-5347 |
807.92 (a)(2): Device name- trade name and common name, and classification
Trade name:
S TEST Reagent Cartridge Lactate Dehydrogenase (LD) S TEST Reagent Cartridge Amylase (AMY)
Common Name: Routine chemistry analyzer for LD Routine chemistry analyzer for AMY
Classifications: 21 CFR § 862.1440 Lactate Dehydrogenase (LD) 21 CFR § 862.1070 Amylase (AMY)
807.92 (a)(3): Identification of the legally marketed predicate devices
Cobas c systems LDHI2 (Roche Diagnostics, Inc., Indianapolis, IN)- K100853 Cobas c systems AMYL2 (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.
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O Hitachi Chemical Diagnostics, Inc. 630 Clyde Court. Mountain View. CA 84043-2239 Tel: 800 233 6278 Fax: 650 969 2745
| www.hcdiagnostics.com | |
|---|---|
| ----------------------- | -- |
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 ALP.
Chemistry reactions: (LD) Lactate dehydrogenase in samples catalyzes the reaction of converting lactic acid to pyruvic acid. During this reaction, NAD is converted into NADH with an increase in absorbance at 340 nm. The LD activity can be determined by measuring the production rate of the resulting NADH.
(AMY) Amylase in blood samples reacts with the substrate alfa-2-chloro-4-nitropheny]galactopyranosylmaltoside (Gal-G2-CNP), and the substrate is cleaved into 4galactopyranosylmaltose (Gal-G2) and 2-chloro-4-nitrophenol (CNP). Amylase activity is determined by measuring the production rate of CNP (yellow).
807.92 (a)(5): Intended Use
The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for the quantitative determination of LD in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Measurements of LD are used in the diagnosis and treatment of heart, liver, kidney, and blood diseases.
The S TEST Reagent Cartridge Amylase (AMY) is intended for the quantitative determination of AMY in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Amylase (AMY) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Measurements of AMY are mainly used in the diagnosis and treatment of pancreatic diseases.
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Hitachi Chemical Diagnostics In Clyde Court. Mountain Viaw. CA 94043-2239 Tel. 800-233-6278
2
807.92 (a)(6): Technological Similarities and Differences to the Predicate
The following chart describes similarities and differences between the LD test systems.
| Characteristic | Hitachi S TEST Systems | PREDICATE |
|---|---|---|
| Instrument Platform | Hitachi Clinical Analyzer | |
| (originally cleared under K111753) | Roche cobas c systems - K100853 | |
| Lactate Dehydrogenase (LD) | K number- K130685 | Roche K number- K100853 |
| Device Class, Regulation Code | Class II, Reserved, 21 CFR 862.1440 | Same, except Exempt (not POC) |
| Classification Product Code | CFJ | CFJ |
| Intended Use | Quantitative determination of LD | Same |
| Testing Environment | Physician office or clinical lab | Clinical lab |
| Test Principle | LD in the sample catalyzes the conversion of lactic acid to pyruvic acid. NAD is converted to NADH with an increase in absorbance. | UV assay- LD catalyzes the conversion of L-lactate to pyruvate (pyruvic acid); NAD is reduced to NADH in the process. |
| Specimen Type | Human serum or plasma | Same |
| Reportable Range | 10 to 1,000 U/L | Same |
| Detection Wavelength | 340/546 nm | 700/340 nm |
| Detection Limit | 10 U/L | Same |
| Linearity | 10 to 1,000 U/L | Same |
| Precision | %CVs range from 5.4% to 6.3% | %CVs range from 0.4% to 2.7% |
| (from product labeling) |
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ത്ര Hitachi Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6276 Fax: 650 969 2745
3
| Characteristic | Hitachi S TEST Systems | PREDICATE |
|---|---|---|
| Instrument Platform | Hitachi Clinical Analyzer | |
| (originally cleared under K111753) | Roche cobas c systems - K100853 | |
| Amylase (AMY) | K number-K130685 | Roche K number- K100853 |
| Device Class, Regulation Code | Class II, 21 CFR 862.1070 | Same |
| Classification Product Code | JFJ | Same |
| Intended Use | Quantitative determination of AMY | Same |
| Testing Environment | Physician office or clinical lab | Clinical lab |
| Test Principle | Alpha amylases in blood samples react with the substrate alfa-2-chloro-4-nitrophenyl-galactopyranosylmaltoside (Gal-G2-CNP), and the substrate is cleaved into 4-galactopyranosylmaltose (Gal-G2) and 2-chloro-4-nitrophenol (CNP). Amylase activity is determined by measuring the production rate of CNP (yellow) | Defined oligosaccharides are cleaved under the catalytic action of alpha amylases. The fragments formed are completely hydrolyzed to p-nitrophenol (p-NP) and glucose by alpha-glucosidase. The color intensity of the p-NP formed is directly proportional to the amylase activity and is determined by measuring the increase in absorbance |
| Specimen Type | Human serum or plasma | Human serum, plasma, or urine |
| Reportable Range | 4 to 1,500 U/L | 3 to 1,500 U/L |
| Detection Wavelength | 405/546 nm | 700/415 nm |
| Detection Limit | 4 U/L | 3 U/L |
| Linearity | 3 to 1,700 U/L | 3 to 1,500 U/L |
| Precision | %CVs range from 2.7% to 3.7% | %CVs range from 0.7% to 2.4% |
| (from product labeling) |
The following chart describes similarities and differences between the AMY 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 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)- LD
The study followed CLSI EP17-A, and the limit of detection was found to be 7.9 U/L. The quantitation limit was found to be 10 U/L.
Analytical Sensitivity (Limits of Detection)- AMY
The study followed CLSI EP17-A, and the limit of detection was found to be 2.2 U/L. The quantitation limit was found to be 4 U/L.
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itachi Chemical Diagnostic
Fax: 650 969 2745 View, CA 94043-2239 Tel: 800 233 6278
4
Linearity- LD
The study followed CLSI EP-6A, and the range of linearity was 3 U/L to 1,196 U/L. The reportable range is 10 U/L to 1,000 U/L.
Linearity- AMY
The study followed CLSI EP-6A, and the range of linearity was 3 U/L to 1,700 U/L. The reportable range is 4 U/L to 1,500 U/L.
20-day In-house Precision- LD
The studies followed CLSI EP5-A2, where three levels of samples were each tested in two runs, twice a day, for 20 days. The results were as follows:
Precision Summary:
LD- Low, Level 1, Summary
| LD | Within-Run | Total |
|---|---|---|
| Mean (U/L) | 108.2 | 108.2 |
| SD (U/L) | 5.24 | 6.82 |
| %CV | 4.8% | 6.3% |
LD- Middle, Level 2, Summary
| LD | Within-Run | Total |
|---|---|---|
| Mean (U/L) | 159.3 | 159.3 |
| SD (U/L) | 9.15 | 8.85 |
| %CV | 5.7% | 5.6% |
LD- High, Level 3, Summary
| LD | Within-Run | Total |
|---|---|---|
| Mean (U/L) | 628.0 | 628.0 |
| SD (U/L) | 20.0 | 33.8 |
| %CV | 3.2% | 5.4% |
20-day In-house Precision- AMY
The studies followed CLSI EPS-A2, where three levels of samples were each tested in two runs, twice a day, for 20 days. The results were as follows:
Precision Summary:
AMY- Low, Level 1, Summary
| AMY | Within-Run | Total |
|---|---|---|
| Mean (U/L) | 54.1 | 54.1 |
| SD (U/L) | 0.94 | 1.45 |
| %CV | 1.7% | 2.7% |
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chi Chemical Diagnostics, Inc
yde Court, Mountain View, CA 84043-2239 Tel: 800 233 6278 Fax: 650 969 2745
| man relations and consistencies and controllation and production promotives processional production promotive promotive processorial con un minimalize provincial pro 1971-194 | ||
|---|---|---|
| www.hcdlagnostics.com | ||
| Репейского поставления и в сельно в присание пристемента в «Мении Как «Спостика» в «Макси Самиранские по собращенность по собращенности с мористика мести се подорение можени |
5
| AMY | Within-Run | Total |
|---|---|---|
| Mean (U/L) | 188.5 | 188.5 |
| SD (U/L) | 1.50 | 6.99 |
| %CV | 0.8% | 3.7% |
AMY- Middle, Level 2, Summary
AMY- High, Level 3, Summary
| AMY | Within-Run | Total |
|---|---|---|
| Mean (U/L) | 1126.8 | 1126.8 |
| SD (U/L) | 8.85 | 39.5 |
| %CV | 0.8% | 3.5% |
Interference Testing (per CLSI EP7-A2)
The data demonstrated that the LD test system was not affected by high levels of the following substances at the levels noted:
Unconjugated bilirubin: no interference up to 50 mg/dL
Lipemia: no interference up to 1,000 mg/dL
Ascorbic acid: no interference up to 50 mg/dL
Hemoglobin: Positive interference (increase in concentration) from hemolysis occurred at levels as low as 31mg/dL hemoglobin. Any level of hemolysis may cause interference. Do not use hemolyzed specimens.
Lack of interference was defined as recoveries between 90% and 110% of the neat value, and assay performance claims were established on the HITACHI Clinical Analyzer by testing two serum pools containing approximately 100 and 350 U/L LD.
The data demonstrated that the AMY test system was not affected by high levels of the following substances at the levels noted:
Hemoglobin: no interference up to 500 mg/dL Unconjugated bilirubin: no interference up to 50 mg/dL Lipemia: no interference up to 2,000 mg/dL Ascorbic acid: no interference up to 50 mg/dL
Lack of interference was defined as recoveries between 90% and 110% of the neat value, and assay performance claims were established on the HITACHI Clinical Analyzer by testing two serum pools containing approximately 150 and 300 U/L AMY.
Method Comparison - LD
A total of 106 clinical specimens spanning the dynamic range (13 to 959 U/L), were assayed in singleton and in a blinded fashion by both the Hitachi E40 system and a standard
Page 6 of 9
◎ Hitachi Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 969 2745
.hcdiagnostics.com
6
laboratory system. The comparative data were analyzed by linear regression and are shown below. (CI = confidence interval)
LD Regression Statistics:
| n | r | Slope
(95% CI) | y-intercept
(95% CI) | X mean | Y mean |
|-----|-------|------------------------|-------------------------|---------|---------|
| 106 | 0.991 | 1.01
(0.99 to 1.04) | 5.4
(-3.8 to 14.6) | 288 U/L | 297 U/L |
Method Comparison - AMY
A total of 105 clinical specimens spanning the dynamic range (5 to 1,443 U/L), 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)
AMY Regression Statistics:
| n | r | Slope
(95% CI) | y-intercept
(95% CI) | X mean | Y mean |
|-----|-------|------------------------|-------------------------|---------|---------|
| 105 | 0.997 | 1.08
(1.06 to 1.10) | -3.3
(-8.7 to 2.1) | 218 U/L | 232 U/L |
Matrices Comparisons- LD
A study was performed to validate the use of two plasma types as an alternative to serum for the Hitachi Clinical Analyzer with S TEST Reagent Cartridge LD. The plasma types were K3 EDTA and lithium heparin. Thirty-nine (39) matched serum/plasma samples that spanned the dynamic range (13 to 967) were assayed 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) = 32 to 804 U/L
| LD | Heparinized Plasma | K3 EDTA Plasma |
|---|---|---|
| Slope (95% CIs) | 0.99 (0.97 to 1.01) | 0.97 (0.94 to 1.00) |
| y-intercept (95% CIs) | -5.5(-10.7 to -0.3) | 0.1 (-8.9 to 9.0) |
| r | 0.998 | 0.994 |
Matrices Comparisons- AMY
A study was performed to validate the use of two plasma types as an alternative to serum for the Hitachi Clinical Analyzer with S TEST Reagent Cartridge AMY. The plasma types were K3 EDTA and lithium heparin. Approximately 43matched serum/plasma samples that spanned the dynamic range (5 to 1,494) were assayed in singleton and the results were compared using linear regression (plasma = y-axis, each type). The performance characteristics were as follows.
N = 43 (serum) Range (serum) = 5 to 1,494 U/L
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chi Chemical Diagnostics Inc
t. Mountain View. CA 94043-2239 Tel: 800-233 6278 Fax: 650 969 2745
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|---|---|---|
| www.hcdiaonostics.com | ||
| within the many and every and every of the count of the count of the first of the first of the first of the first of the first of the first of the first of the first of the f |
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Image /page/7/Picture/0 description: The image shows the word "HITACHI" in bold, black letters. Below the word "HITACHI" is the phrase "Inspire the Next" in a smaller font size. The text is all aligned to the left and the background is white.
| AMY | Heparinized Plasma | K3 EDTA Plasma | |
|---|---|---|---|
| Slope (95% Cls) | 1.02 (1.00 to 1.04) | 0.97 (0.95 to 0.99) | |
| y-intercept (95% Cls) | -8.4 (-17.2 to 0.3) | -6.6 (-14.3 to 1.0) | |
| r | 0.998 | 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 LD and AMY 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 LD or AMY. Each sample was assayed six times per day for five days, reporting 30 results per level. Precision estimates for total precision were as follows:
| n = 30 replicates per sample per site | ||||||
|---|---|---|---|---|---|---|
| Site | Sample | Mean | Within-run Precision | Total Precision | ||
| SD (U/L) | %CV | SD (U/L) | %CV | |||
| Site 1 | Low | 47.3 | 3.83 | 8.1 | 4.42 | 9.3 |
| Site 2 | Low | 49.8 | 3.00 | 6.0 | 3.20 | 6.4 |
| Site 3 | Low | 45.7 | 3.69 | 8.1 | 3.82 | 8.4 |
| Site 1 | Middle | 161.9 | 5.60 | 3.5 | 6.45 | 4.0 |
| Site 2 | Middle | 161.6 | 6.01 | 3.7 | 6.25 | 3.9 |
| Site 3 | Middle | 155.7 | 8.90 | 5.7 | 9.63 | 6.2 |
| Site 1 | High | 498.1 | 12.70 | 2.6 | 15.10 | 3.0 |
| Site 2 | High | 488.5 | 20.29 | 4.2 | 35.20 | 7.2 |
| Site 3 | High | 497.0 | 14.71 | 3.0 | 20.55 | 4.1 |
LD (U/L) n = 30 replicates per sample per site
AMY (U/L)
| n = 30 replicates per sample per site | |
|---|---|
| --------------------------------------- | -- |
| Site | Sample | Mean | Within-run Precision | Total Precision | ||
|---|---|---|---|---|---|---|
| SD (U/L) | %CV | SD (U/L) | %CV | |||
| Site 1 | Low | 53.2 | 2.43 | 4.6 | 2.44 | 4.6 |
| Site 2 | Low | 50.4 | 1.44 | 2.8 | 1.74 | 3.5 |
| Site 3 | Low | 51.2 | 2.08 | 4.1 | 1.93 | 3.8 |
| Site 1 | Middle | 116.9 | 1.58 | 1.4 | 1.65 | 1.4 |
| Site 2 | Middle | 111.5 | 1.73 | 1.6 | 2.11 | 1.9 |
| Site 3 | Middle | 113.3 | 2.29 | 2.0 | 3.51 | 3.1 |
Page 8 of 9
O Hitachi Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA 84043-2239 Tel: 800 233 6278 Fax: 650 969 2745
8
| Site 1 | High | 1527.4 | 7.19 | 0.5 | 15.51 | 1.0 |
|---|---|---|---|---|---|---|
| Site 2 | High | 1428.6 | 16.06 | 1.1 | 29.24 | 2.0 |
| Site 3 | High | 1465.4 | 13.51 | 0.9 | 19.10 | 1.3 |
For the external method comparison studies, a series of approximately 70-80 serum specimens with LD values ranging from 16 to 938 U/L, and AMY values ranging from 27 to 1,146 U/L, were assayed on the Hitachi E40 Clinical Analyzer at three sites using S TEST Reagent Cartridges LD and AMY (y) and a comparative method as the reference method (x). Linear regression analyses (least squares) yielded the following results:
| Site # | n | Range
(U/L) | Regression
Equation | “r” | CI*
Slope | CI Intercept |
|--------|----|----------------|------------------------|-------|--------------|--------------|
| 1 | 87 | 16 to 938 | y = 0.96x + 2.5 | 0.997 | 0.94 to 0.97 | -2.3 to 7.4 |
| 2 | 78 | 23 to 877 | y = 0.96x + 4.7 | 0.998 | 0.94 to 0.97 | 0.6 to 8.9 |
| 3 | 86 | 17 to 914 | y = 0.91x +13.5 | 0.999 | 0.90 to 0.93 | 9.6 to 17.4 |
POL ACCURACY DATA SUMMARY- LD (U/L)
*95% Confidence Interval
| Site # | n | Range (U/L) | Regression Equation | "r" | CI* Slope | CI* Intercept |
|---|---|---|---|---|---|---|
| 1 | 76 | 29 to 1134 | $y = 1.05x - 1.2$ | 0.999 | 1.04 to 1.06 | -4.6 to 2.2 |
| 2 | 69 | 27 to 1146 | $y = 1.00x - 0.5$ | 0.995 | 0.98 to 1.03 | -6.6 to 5.7 |
| 3 | 71 | 29 to 1112 | $y = 0.98x + 3.3$ | 0.995 | 0.95 to 1.00 | -3.2 to 9.8 |
POL ACCURACY DATA SUMMARY- AMY (UL)
*95% Confidence Interval
807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing
Nonclinical and clinical testing was performed for the Hitachi E40 Clinical Analyzer with the S TEST Reagent Cartridge Lactate Dehydrogenase (LD) and the S TEST Reagent Cartridge Amylase (AMY). The test systems were shown to be safe and effective for their intended uses.
Page 9 of 9
C Hitachi Chemical Diagnostics, Inc. 630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 650 989 2745
9
Image /page/9/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-(1609 Silver Spring, MD 20993-00012
August 9, 2013
August 9, 2013
Hitachi Chemical Diagnostics, Inc. C/O Erika Ammirati President, Ammirati Regulatory Consulting 575 Shirlynn Court LOS ALTOS CA 94022
Re: K130685
Trade/Device Name: S TEST Reagent Cartridge Amylase (AMY) S TEST Reagent Cartridge Lactate Dehydrogenase (LD)
Regulation Number: 21 CFR 862.1070 Regulation Name: Amylase test system Regulatory Class: II Product Codc: JFJ, CFJ Dated: July 29, 2013 Received: July 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 is 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 practive requirements as set forth in the quality systems (QS) regulation (2) 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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Page 2-Ms. Ammirati
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 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 C. 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
11
INDICATIONS FOR USE
510(k) Number (if Known): K130685
Device Name: S TEST Reagent Cartridge Lactate Dehydrogenase (LD) S TEST Reagent Cartridge Amylase (AMY)
Indications for Use:
The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for the quantitative determination of LD in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Lactate Dehydrogenase (LD) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of LD are used in the diagnosis and treatment of liver and cardiac diseases.
The S TEST Reagent Cartridge Amylase (AMY) is intended for the quantitative determination of AMY in serum and plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Amylase (AMY) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Measurements of AMY are mainly used in the diagnosis and treatment of pancreatic diseases.
Prescription Use ________________ And/Or (21 CFR Part 801 Subpart D)
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)
YungWDchan-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health (OIR)
510(k)