(40 days)
No
The device description and performance studies focus on standard wet chemistry analysis and photometric measurements, with no mention of AI/ML algorithms for data processing or interpretation.
No
This device is an in vitro diagnostic device used to measure carbon dioxide levels in blood samples, which aids in diagnosis but does not directly treat a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Carbon dioxide measurements are used in the diagnosis and treament of numerous potentially serious disorders associated with changes in body acid-base balance." This indicates that the device provides information used for diagnostic purposes.
No
The device described is a reagent cartridge for a clinical analyzer, which is a physical component used in a wet chemistry system. The submission is specifically for the reagent cartridge, not the software that runs the analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for the "quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma". This is a measurement performed in vitro (outside the body) on a biological sample.
- Purpose: The intended use also states that these measurements are "used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance." This clearly indicates a medical purpose related to diagnosis and treatment.
- Labeling: The document explicitly states "For in vitro diagnostic use only."
These points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for the quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma using the Hitachi Clinical Analyzer E40. Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance. The S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes
KHS
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 Carbon Dioxide.
Chemistry reaction: The carbon dioxide (in the form of bicarbonate HCO2) in the sample reacts with phosphoenolpyruvate (PEP) in the presence of phosphoenolpyruvate carboxylase (PEPC) and magnesium to vield oxaloacetic acid (OAA) and phosphate. In the second reaction, and in the presence of malate dehydrogenase (MDH), the reduced cofactor is oxidized by OAA. The reduced cofactor absorbs strongly at 405 nm. whereas its oxidized form does not. The difference in absorbance between the final reading and the blank, monitored bichromatically at 405 nm/508 nm, is directly proportional to the total carbon dioxide concentration in the sample.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories or physician office laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of nonclinical studies were performed that evaluated the following performance characteristics: analytical sensitivity (limits of detection), linearity, 20-day in-house precision, interference testing, in-house method comparison, and matrix comparison between serum and lithium heparin plasma.
Analytical Sensitivity (Limit of Detection)
The study followed CLSI EP17-A2 where 60 replicates of the reagent blank and 60 replicates of three low samples were tested.
- Limit of blank = 0.7 mmol/L
- Limit of detection = 0.9 mmol/L
- The limit of quantitation (LoQ) study evaluated three low level specimens in six runs with three instruments over three days. The LoQ was found to be approximately 4 mmol/L, with %CVs less than 11%.
Linearity
The study followed CLSI EP-6A where 10 serial dilutions, plus the zero standard (n = 11), were assayed in duplicate.
- Linear regression equation: y = 0.918x + 0.091; r2-0.9988.
- Range of linearity was 1.4 mmol/L to 44.0 mmol/L.
- Reportable range is 5 to 40 mmol/L.
20-day In-house Precision
The studies followed CLSI EPS-A2, where three levels of serum-based commercial controls were each tested in two runs, twice a day, for 20 days.
- Low Summary (Mean: 10.11 mmol/L): Within-Run SD: 0.13 mmol/L (1.3% CV), Total SD: 0.45 mmol/L (4.4% CV)
- Middle Summary (Mean: 19.41 mmol/L): Within-Run SD: 0.25 mmol/L (1.3% CV), Total SD: 0.72 mmol/L (3.7% CV)
- High Summary (Mean: 33.06 mmol/L): Within-Run SD: 0.40 mmol/L (1.2% CV), Total SD: 1.22 mmol/L (3.7% CV)
Interference Testing (per CLSI EP7-A2)
The data demonstrated no interference up to the noted levels for:
- Lipemia: 1,000 mg/dL Intralipid
- Ascorbic acid: 50 mg/dL
- Hemoglobin: 1,000 mg/dL
- Unconjugated bilirubin: 19.1 mg/dL
Lack of interference was defined as recoveries between 90% and 110% of the neat value.
Method Comparison
- Study type: Method Comparison
- Sample size: 96 clinical specimens (including 3 spiked and 3 diluted samples)
- Key results: Deming regression analysis comparing Hitachi E40 system to a standard laboratory system.
- n = 96
- r = 0.981
- Slope (95% CI): 1.03 (0.97 to 1.08)
- y-intercept (95% CI): 0.98 (-0.17 to 2.12)
- X mean: 22.54 mmol/L
- Y mean: 24.07 mmol/L
Matrix Comparison
- Study type: Matrix Comparison (serum vs. lithium heparin plasma)
- Sample size: 50 matched serum/plasma samples (including 2 spiked and 4 diluted samples)
- Key results: Linear regression analysis.
- N = 50
- Range (serum) = 5.4 to 38.6 mmol/L
- Slope (95% CIs): 1.00 (0.94 to 1.05)
- y-intercept (95% CIs): -0.34 (-1.97 to 1.30)
- r = 0.980
Clinical Data
Studies for precision and method comparison (accuracy) were performed at three external POL-type sites.
External Site Precision Study
- Study type: Precision study at 3 external POL sites
- Sample size: 3 blinded serum samples (low, middle, high concentrations), each assayed 6 times per day for 5 days, totaling 30 results per level per site.
- Key results:
- Site 1: Sample A (8.75 mean) Total %CV: 4.1; Sample B (15.27 mean) Total %CV: 4.8; Sample C (29.46 mean) Total %CV: 3.2
- Site 2: Sample A (7.29 mean) Total %CV: 6.0; Sample B (15.01 mean) Total %CV: 4.4; Sample C (29.47 mean) Total %CV: 3.7
- Site 3: Sample A (8.06 mean) Total %CV: 3.1; Sample B (16.25 mean) Total %CV: 1.9; Sample C (31.01 mean) Total %CV: 3.7
External Method Comparison Studies
- Study type: Method comparison (accuracy) at 3 external POL sites
- Sample size: 47 serum specimens (including 3 spiked and 4 diluted samples) per site (Site 2 had 45 samples due to 2 excluded samples).
- Key results: Deming regression analysis comparing Hitachi E40 system with S TEST Reagent Cartridge Carbon Dioxide (y) to a comparative method (x).
- Site 1: n = 47, Range: 6.6 to 36.8 mmol/L, Regression Equation: y = 0.91x + 1.49, r = 0.984, CI Slope: 0.87 to 0.95, CI Intercept: 0.67 to 2.32
- Site 2: n = 45, Range: 5.5 to 34.4 mmol/L, Regression Equation: y = 0.92x + 0.56, r = 0.970, CI Slope: 0.80 to 1.04, CI Intercept: -2.31 to 3.43
- Site 3: n = 47, Range: 5.1 to 35.5 mmol/L, Regression Equation: y = 0.92x + 0.79, r = 0.982, CI Slope: 0.87 to 0.97, CI Intercept: -0.43 to 2.01
Stability
Real time stability testing is ongoing. Stability testing has been performed to support a shelf life of 6 months at 2-8°C.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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).
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§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the text "510(k) SUMMARY" in a bold, sans-serif font. The text is centered and appears to be the title or heading of a document. The letters are black against a white background, providing a clear contrast.
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 K140248.
| 807.92 (a)(1): Name: | Hitachi Chemical Diagnostics, Inc. |
|---|---|
| Address: | 630 Clyde Court |
| Mountain View, CA 94043 | |
| Phone: | (650) 961 5501 |
| FAX: | (650) 969 2745 |
| Contact: | Mr. Charles Tsou |
Official Correspondent: Erika Ammirati Regulatory Consultant to Hitachi Chemical Diagnostics, Inc. Phone: (650) 949-2768 FAX: (650) 949-5347
Date Prepared: February 19, 2014
807.92 (a)(2): Device name- trade name and common name, and classification
Trade name:
S TEST Reagent Cartridge Carbon Dioxide (CO2)
Common Name: Routine chemistry analyzer for carbon dioxide
Classification: 21 CFR § 862.1160- Bicarbonate/carbon dioxide test system, Class II, Product Code KHS
807.92 (a)(3): Identification of the legally marketed predicate devices
Carbon Dioxide L.3K Assay, Sekisui Diagnostics, PEI, Inc., Canada- K042362
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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Tal: 800 233 6278
1
The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) × 28 mm (D) × 20.2 mm (H).
System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for Reagent Cartridge Carbon Dioxide.
Chemistry reaction: The carbon dioxide (in the form of bicarbonate HCO2) in the sample reacts with phosphoenolpyruvate (PEP) in the presence of phosphoenolpyruvate carboxylase (PEPC) and magnesium to vield oxaloacetic acid (OAA) and phosphate. In the second reaction, and in the presence of malate dehydrogenase (MDH), the reduced cofactor is oxidized by OAA. The reduced cofactor absorbs strongly at 405 nm. whereas its oxidized form does not. The difference in absorbance between the final reading and the blank, monitored bichromatically at 405 nm/508 nm, is directly proportional to the total carbon dioxide concentration in the sample.
807.92 (a)(5): Intended Use
The S TEST Reagent Carbon Dioxide (CO2) is intended for the quantitative determination of carbon dioxide concentration in serum or lithium heparin plasma using the Hitachi Clinical Analyzer E40. Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance. The S TEST Reagent Cartridge Carbon Dioxide (CO2) is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
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CA 94043-2239 Tal: 800 233 6278 Fax: 850,989 2745
2
807.92 (a)(6): Technological Similarities and Differences to the Predicate
The following chart describes similarities and differences between the carbon dioxide test systems.
| Characteristic | Hitachi S TEST Systems | PREDICATE |
|---|---|---|
| Instrument Platform | Hitachi Clinical Analyzer | |
| (originally cleared under K111753) | Olympus/Beckman AU400 | |
| (originally cleared under K981743) | ||
| Carbon Dioxide | K140248 | Sekisui K number- K042362 |
| Device Class, Regulation Code | Class II, 21 CFR 862.1160 | Same |
| Classification Product Code | KHS | Same |
| Intended Use | Quantitative determination of | |
| carbon dioxide | Same | |
| Testing Environment | Physician office or clinical lab | Clinical lab |
| Test Principle | Carbon dioxide (in the form of | |
| bicarbonate HCO3-) reacts with | ||
| phosphoenolpyruvate in the presence | ||
| of phosphoenolpyruvate carboxylase | ||
| (and magnesium) to yield | ||
| oxaloacetic acid (OAA). In the | ||
| presence of malate dehydrogenase, | ||
| reduced cofactor is oxidized by | ||
| OAA. The decrease in the | ||
| concentration of reduced cofactor is | ||
| monitored, and is proportional to the | ||
| carbon dioxide concentration in the | ||
| sample. | Same | |
| Specimen Type | Human serum or lithium heparin | |
| plasma | Same | |
| Reportable Range | 5.0 to 40.0 mmol/L | 2.9 to 50.0 mmol/L |
| Detection Wavelength | 405/508 nm | 405/415 nm |
| Detection Limit (LoQ) | 1.3 mmol/L | 2.9 mmol/L |
| Linearity | 1.4 to 44.0 mmol/L | 2.9 to 50.0 mmol/L |
| Precision | %CVs range from 1.9% to 6.0% | |
| (POL testing) | %CVs range from 1.1% to 1.7% | |
| (from product labeling) |
807.92 (b)(1): Brief Description of Nonclinica! Data
A series of studies were performed that evaluated the following nonclinical performance characteristics: analytical sensitivity (limits of detection), linearity, 20-day in-house precision, interference testing, in-house method comparison, and matrix s comparison between serum and lithium heparin plasma.
C Hitachi Chemical Diagnostics, Inc. 630 Cryde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 850 980 2745
3
Analytical Sensitivity (Limit of Detection)
The study followed CLSI EP17-A2 where 60 replicates of the reagent blank and 60 replicates of three low samples were tested. The following results were reported: limit of blank = 0.7 mmol/L; limit of detection = 0.9 mmol/L; the limit of quantitation (LoQ) study evaluated three low level specimens in six runs with three instruments over three days. The LoQ was found to be approximately 4 mmol/L, with %CVs less than 11%.
Linearity
The study followed CLSI EP-6A where 10 serial dilutions, plus the zero standard (n = 11), were assayed in duplicate and the results were averaged. The expected values (x-axis) were compared to the observed values (y-axis). The data showed the following linear regression equation: y = 0.918x + 0.091; r2-0.9988. The range of linearity was 1.4 mmol/L to 44.0 mmol/L. The reportable range is 5 to 40 mmol/L.
20-dav In-house Precision
The studies followed CLSI EPS-A2, where three levels of serum-based commercial controls were each tested in two runs, twice a day, for 20 days. The results were as follows:
| Carbon Dioxide- Low Summary | ||
|---|---|---|
| Carbon Dioxide | Within-Run | Total |
| Mean (mmol/L) | 10.11 | 10.11 |
| SD (mmol/L) | 0.13 | 0.45 |
| %CV | 1.3% | 4.4% |
Precision Summaries:
Carbon Dioxide- Middle Summary
| Carbon Dioxide | Within-Run | Total |
|---|---|---|
| Mean (mmol/L) | 19.41 | 19.41 |
| SD (mmol/L) | 0.25 | 0.72 |
| %CV | 1.3% | 3.7% |
Carbon Dioxide- High Summary
| Carbon Dioxide | Within-Run | Total |
|---|---|---|
| Mean (mmol/L) | 33.06 | 33.06 |
| SD (mmol/L) | 0.40 | 1.22 |
| %CV | 1.2% | 3.7% |
Interference Testing (per CLSI EP7-A2)
The data demonstrated that the carbon dioxide test system was not affected by high levels of the following substances at the levels noted:
Lipemia: no interference up to 1,000 mg/dL Intralipid
Ascorbic acid: no interference up to 50 mg/dL
Hemoglobin: no interference up to 1,000 mg/dL
Unconjugated bilirubin: no interference up to 19.1 mg/dL
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® Hitachi Chemical Diagnostics, Inc.
630 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 850.969 2745
4
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 17 and 30 mmol/L carbon dioxide.
Method Comparison
A total of 96 clinical specimens (including 3 spiked and 3 diluted samples) spanning the dynamic range (5.0 to 40.0 mmol/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 Deming regression and are shown below. (CI = confidence interval).
Regression Statistics:
| n | r | Slope
(95% CI) | y-intercept
(95% CI) | X mean | Y mean |
|----|-------|------------------------|-------------------------|--------------|--------------|
| 96 | 0.981 | 1.03
(0.97 to 1.08) | 0.98
(-0.17 to 2.12) | 22.54 mmol/L | 24.07 mmol/L |
Matrix Comparison
A study was performed to validate the use of lithium heparin plasma as an alternative to serum for the Hitachi Clinical Analyzer with S TEST Reagent Cartridge Carbon Dioxide. Fifty (50) matched serum/plasma samples (including 2 spiked and 4 diluted samples) that spanned the dynamic range (5.0 to 40.0 mmol/L, serum) were assayed in singleton and the results were compared using linear regression (plasma = y-axis). The performance characteristics were as follows.
N = 50 Range (serum) = 5 4 to 38 6 mmol/L. carbon dioxide
| Lithium Heparinized Plasma | |
|---|---|
| Slope (95% CIs) | 1.00 (0.94 to 1.05) |
| y-intercept (95% CIs) | -0.34 (-1.97 to 1.30) |
| r | 0.980 |
Reference Range
Reference range: 22 - 29 mmol/L 1
- Tietz, Fundamentals of Clinical Chemistry, 4th Edition, WB Saunders Company, (1996)
Traceability/Calibration
Each lot of S TEST Reagent Cartridge Carbon Dioxide (CO2) is calibrated by the manufacturer prior to shipment using material referenced to a standard which is traceable to American Chemical Society (ACS) reagent grade sodium carbonate alkalimetric standard. The 2D code printed on each cartridge provides the analyzer with lot-specific calibration data.
Stabilitv
Real time stability testing is ongoing. Stability testing has been performed to support a shelf life of 6 months at 2-8°C.
Hitachi Chemical Diagnostics, Inc.
330 Clyde Court, Mountain View, CA 94043-2239 Tel: 800 233 6278 Fax: 850 969 2745
5
807.92 (b)(2): Brief Description of Clinical Data
Studies for precision and method comparison (accuracy) were performed at three external POL-type sites to evaluate the Hitachi E40 Clinical Analyzer with S TEST Reagent Cartridge Carbon Dioxide 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 carbon dioxide. 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 | Within-run Precision | Total Precision | ||
|---|---|---|---|---|---|---|
| SD (mmol/L) | %CV | SD (mmol/L) | %CV | |||
| 1 | A | 8.75 | 0.16 | 1.8 | 0.36 | 4.1 |
| 2 | A | 7.29 | 0.33 | 4.6 | 0.44 | 6.0 |
| 3 | A | 8.06 | 0.23 | 2.9 | 0.25 | 3.1 |
| 1 | B | 15.27 | 0.35 | 2.3 | 0.74 | 4.8 |
| 2 | B | 15.01 | 0.23 | 1.5 | 0.67 | 4.4 |
| 3 | B | 16.25 | 0.27 | 1.7 | 0.30 | 1.9 |
| 1 | C | 29.46 | 0.51 | 1.7 | 0.94 | 3.2 |
| 2 | C | 29.47 | 0.81 | 2.7 | 1.08 | 3.7 |
| 3 | C | 31.01 | 0.58 | 1.9 | 1.16 | 3.7 |
Carbon Dioxide (mmol/L) n = 30 replicates per sample per site
For the external method comparison studies, a series of 47 serum specimens (including three spiked and four diluted samples) with carbon dioxide values ranging from 5.1 to 36.8 mmol/L, were assayed on the Hitachi E40 Clinical Analyzer at three sites using S TEST Reagent Cartridge Carbon Dioxide (y) and a comparative method as the reference method (x). Deming regression vielded the following results:
| Site # | n | Range
(mmol/L) | Regression
Equation | "r" | CI**
Slope | CI Intercept |
|--------|-----|-------------------|------------------------|-------|---------------|---------------|
| 1 | 47 | 6.6 to 36.8 | y = 0.91x + 1.49 | 0.984 | 0.87 to 0.95 | 0.67 to 2.32 |
| 2 | 45* | 5.5 to 34.4 | y = 0.92x + 0.56 | 0.970 | 0.80 to 1.04 | -2.31 to 3.43 |
| 3 | 47 | 5.1 to 35.5 | y = 0.92x + 0.79 | 0.982 | 0.87 to 0.97 | -0.43 to 2.01 |
POL ACCURACY DATA SUMMARY- Carbon Dioxide (mmol/L)
- 2 samples at Site 2 quantitated below to dynamic range ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
*An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.