(212 days)
No
The summary describes a standard in vitro diagnostic assay kit for measuring carbon dioxide levels using chemical reagents and an analyzer. There is no mention of AI, ML, image processing, or any data-driven algorithms beyond standard statistical analysis for performance evaluation.
No.
This device is an in vitro diagnostic device used for quantitative determination of Carbon Dioxide in serum and plasma, which is used for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" states that "Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance." This directly indicates its role in diagnosis.
No
The device description explicitly states it is a "kit assay consists of ready to use reagent solutions," indicating it is a chemical reagent kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For the quantitative in vitro determination of Carbon Dioxide in serum and plasma." and "This in vitro diagnostic device is intended for Rx Only." This clearly indicates the device is used to test samples taken from the body (in vitro) to diagnose or treat medical conditions.
- Device Description: The description mentions "ready to use reagent solutions," which are typical components of IVD kits used for chemical analysis of biological samples.
- Summary of Performance Studies: The studies described (Precision, Linearity, Analytical Specificity, Method comparison, Matrix comparison) are standard performance evaluations conducted for IVD devices to demonstrate their accuracy, reliability, and equivalence to existing methods.
- Predicate Device(s): The mention of a predicate device (Siemens ADVIA Chemistry Carbon Dioxide Liquid (CO2 L)) is a strong indicator that this device is being compared to an already cleared IVD device for the same intended use.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative in vitro determination of Carbon Dioxide in serum and plasma. Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
This in vitro diagnostic device is intended for Rx Only.
Product codes (comma separated list FDA assigned to the subject device)
KHS
Device Description
The Liquid CO2-2 (LCO2-2) kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: CD8357
R1. Liquid CO2-2 Reagent 4 x 18 ml
CAL. Liquid CO2-2 Calibrator 1 x 10 ml
REAGENT COMPOSITION
Contents:
R1. Liquid CO2-2 Reagent
Phosphoenolpyruvate (PEP) 12.5 mmol/l
NADH analogue 0.6 mmol/l
Microbial Phosphoenolpyruvate Carboxylase (PEPC) >400 U/I
Mammalian Malate Dehydrogenase (MDH) >4100 U/I
Buffer pH 7.6
Sodium Azide 0.08%
CAL. Liquid CO2-2 Calibrator See Lot Specific Insert
MATERIALS REQUIRED BUT NOT PROVIDED
Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # K942458
0.9% NaCl solution for sample dilutions (if required)
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
Not Found
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)
a. Precision/Reproducibility:
Precision studies were performed by one operator on two RX Daytona plus systems using serum based control material and unaltered human serum samples that were spiked with carbon dioxide concentrations or diluted to achieve concentrations based on normal ranges 20 - 31 mEq/L. Testing was conducted for two reagent lots of liquid CO2-2 (LCO2-2), one lot on each RX Daytona plus system, twice per day for 20 non-consecutive days. Two replicates per run were performed for each sample. The assay was calibrated daily.
Key results are summarized in Table 2 Precision Summary with specific values for QC Level 3, QC Level 2, SP Level 1, SP Level 2, and SP Level 3 showing mean, within-run SD and CV, among-run SD and CV, among-day SD and CV, and total SD and CV.
b. Linearity/assay reportable range:
Linearity studies were performed at 11 levels. Randox used a low serum pool sample around 4.0 mEq/l analyte concentration and a serum pool with a high concentration approximately 55 mEq/l. The low and high pools were mixed to make nine intermediate levels. Each level was run in replicates of five on two lots of Liquid CO2-2 (LCO2-2) reagent on one RX Daytona plus system.
Key result: Linear Regression Y = 0.99 + 0.75, r = 0.999. The reportable range of the assay is 10 to 40 mEq/L.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
- Open vial stability: Samples were stored at +2 to +8°C for 28 days and tested for Carbon Dioxide. Acceptance criteria was ≤5% deviation. Current open vial studies support a reconstituted claim of 28 days when stored at +2°C to +8°C.
- Real Time Testing: Kits were stored at +2 to +8°C and tested at various time points. Acceptance criteria that all controls should be within range. Current Real Time studies support a 2 year shelf life.
d. Detection limit:
A Limit of Blank (L.o.B.), a Limit of Detection (L.o.D.) and a Limit of Quantification were performed on two lots of reagents tested by two operators on one RX Daytona Plus system.
Key results: The Limit of Detection (LoD) for Carbon Dioxide on the RX Daytona Plus is 1.98 mEq/L based on 240 determinations, with 4 low level samples. The Limit of Blank (LoB) is 0.97 mEq/L. The Limit of Quantitation (LoQ) is 4.5 mEq/L.
e. Analytical Specificity:
Interference studies were conducted. The criteria for no significant interference is recovery within ±10% of the initial value of Carbon Dioxide concentration of 20 mEq/L and 35 mEq/L.
Key results: No significant interference up to 1000mg/dL for Hemoglobin, up to 60mg/dL for Total Bilirubin, up to 30mg/dL for Conjugate Bilirubin, up to 2000mg/dL for Triglycerides and Intralipid®, and up to 6.0mg/dL for Ascorbic Acid.
f. Method comparison with predicate device:
Correlation studies were carried out. 97 serum patient samples spanning the range 12.5 to 39.4 mEq/L were tested by one operator on two lots of Liquid CO2-2 (LCO2-2) reagent on one RX Daytona plus analyzer and the predicate device tested on one ADVIA 1650 system across 3 working days with each sample tested in singlicate.
Key result: The test method was compared to the predicate device and the linear regression equation Y = 0.97x - 0.11 was obtained with a correlation coefficient of r = 0.994.
q. Matrix comparison:
Matrix method comparisons for Liquid CO2-2 (LCO2-2) assay was tested by one operator on one RX Daytona plus system and was assessed for two lots of reagents. Both serum and lithium heparin plasma were tested.
Key result: 50 matched patient sample pairs (serum (x) and lithium heparin plasma (y)) were analyzed spanning the 13.9 to 38.1 mEq/L. The linear regression equation Y = 0.97x + 0.94 was obtained with a correlation coefficient of r = 0.984.
Expected values/Reference range:
A reference interval for Carbon Dioxide was verified using NCCLS C28-A3 guidelines with 30 normal donors.
Key result: Expected Values for Carbon Dioxide are 20 – 31 mEq/L, referenced from Tietz NW.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. The document only lists analytical sensitivity as "Limit of Detection".
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
§ 862.1160 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/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three human profiles facing right. The caduceus is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
RANDOX LABORATORIES LTD PAULINE ARMSTRONG QA/RA MANAGER 55 DIAMOND ROAD ARDMORE BT29 4QY,GREAT BRITAIN
February 24, 2016
Re: K152085
Trade/Device Name: LIOUID CO2-2 (LCO2-2) Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide test system Regulatory Class: II Product Code: KHS Dated: January 20, 2015 Received: January 27, 2015
Dear Pauline Armstrong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K152085
Device Name LIQUID CO2-2 (LCO2-2)
Indications for Use (Describe)
For the quantitative in vitro determination of Carbon Dioxide in serum and plasma. Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
This in vitro diagnostic device is intended for Rx Only.
Type of Use (Select one or both, as applicable)
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
FORM FDA 3881 (8/14)
Page 1 of 1
3
510(K) SUMMARY, LIQUID CO2-2 (LCO2-2)
1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92 STATEMENT
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirement 21 CFR 807.92.
SUBMITTER NAME AND ADDRESS 2.
Name: Dr Pauline Armstrong
Address: Randox Laboratories Limited 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.
Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com
Date of Summary Preparation: February 9, 2016
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER
510k No: K152085
Device Proprietary Name: Liquid CO2-2 (LCO2-2)
Common Name: Liquid CO2-2 (LCO2-2)
Purpose for Submission: New Device
| Product
| Code | Regulation Name | Classification | Regulation Section | Panel |
|---|---|---|---|---|
| KHS | Bicarbonate/ | |||
| Carbon Dioxide | ||||
| test system | Class II | 21 CFR | ||
| 862.1160 | Clinical | |||
| Chemistry | ||||
| (75) |
4
4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS
Predicate Device Proprietary Name:
Siemens ADVIA Chemistry Carbon Dioxide Liquid (CO2 L)
510 (k) Number: K100289
5. INTENDED USE
For the quantitative in vitro determination of Carbon Dioxide in serum and plasma. Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acidbase balance.
This in vitro diagnostic device is intended for Rx only.
6. DEVICE DESCRIPTION
The Liquid CO2-2 (LCO2-2) kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: CD8357
| R1. Liquid CO2-2 Reagent | 4 x 18 ml |
|---|---|
| CAL. Liquid CO2-2 Calibrator | 1 x 10 ml |
REAGENT COMPOSITION
| Contents | Concentration in the test |
|---|---|
| R1. Liquid CO₂-2 Reagent | |
| Phosphoenolpyruvate (PEP) | |
| NADH analogue | |
| Microbial Phosphoenolpyruvate Carboxylase | |
| (PEPC) | |
| Mammalian Malate Dehydrogenase (MDH) | |
| Buffer | |
| Sodium Azide | 12.5 mmol/l |
| 0.6 mmol/l |
400 U/I
4100 U/I
pH 7.6
0.08% |
| CAL. Liquid CO₂-2 Calibrator | See Lot Specific Insert |
MATERIALS REQUIRED BUT NOT PROVIDED
Randox Assayed Multisera Level 2 (Cat. No. HN 1530) and Level 3 (Cat. No. HE 1532); 510(k) # K942458 0.9% NaCl solution for sample dilutions (if required)
5
7. PREDICATE DEVICE COMPARISON TABLE
Table 1 Comparison of Liquid CO2-2 test system for the RX Daytona plus to predicate device
| CHARACTERISTICS | Liquid CO2-2 (LCO2-2) Assay for
RX daytona plus
(New Device) | Siemens ADVIA Chemistry Carbon
Dioxide Liquid (CO2_L)
ADVIA SYSTEMS K100289
(Predicate Device) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Similarities | | |
| INTENDED USE | For the quantitative in vitro determination of
Carbon Dioxide in serum and plasma. Carbon
Dioxide measurements are used in the
diagnosis and treatment of numerous
potentially serious disorders associated with
changes in body acid-base balance | Same |
| ASSAY PROTOCOL | Enzymatic Method | Same |
| INSTRUMENT
MODE | Automatic Instrument | Same |
| STORAGE
(UNOPENED) | Reagents are stable up to the expiry date
when stored unopened at +2 to +8°C | Same |
| CALIBRATION
FREQUENCY | Everyday, with a change of
reagent lot or as indicated by quality control
procedures. | Same |
| SAMPLE TYPE | Serum, heparinized plasma samples are
suitable. | Same |
| TEST RANGE | 10 - 40 mEq/L | Same |
| Differences | |
|---|---|
| REAGENT | |
| COMPOSITION | |
| Liquid CO2-2 Reagent | |
| Phosphoenolpyruvate (PEP) | |
| NADH analogue | |
| Microbial Phosphoenolpyruvate | |
| Carboxylase (PEPC) | |
| Mammalian Malate | |
| Dehydrogenase (MDH) | |
| Buffer | |
| Sodium Azide |
CAL. Liquid CO2-2 Calibrator
See Lot Specific Insert | 1.Buffer
Buffer
pH 6.5
Phosphoenolpyruvate (PEP) 63 mmol/l
NADH analogue 3.0 mmol/l
Microbial Phosphoenolpyruvate
Carboxylase (PEPC) ≥2000 U/I
Mammalian Malate
Dehydrogenase (MDH) ≥20000 U/I
Sodium Azide 0.08% |
| | 12.5 mmol/l |
| | 0.6 mmol/l |
| | >400 U/I |
| | >4100 U/I
pH 7.6
0.08% |
| CONTROL
FREQUENCY | |
| Two levels of control should be assayed
at least once a day | Follow laboratory accreditation requirements. |
6
8. TEST PRINCIPLE (1,2)
PEPC + Mg++ Phosphoenolpyruvate + HCO3 Oxaloacetate + H2PO4 MDH Oxaloacetate + NADH analogue + H* ______ Malate + NAD* analogue
The reduction in absorbance at 415 nm caused by the oxidation of NADH analogue is proportional to the bicarbonate concentration in the sample.
I. Jacobs, N., et al "Laboratory Test Handbook" 2nd. ed., Williams and Wilkins 1990.
- Forrester, R.L., Wataji, L.J., Silverman, D.A., Pierre K.J., Clin, Chem. 1976; 22/2: 243-245.
9. PERFORMANCE CHARACTERISTICS
Analytical performance:
a. Precision/Reproducibility:
Precision was evaluated consistent with C.L.S.I documents EP5-A2 Precision studies were performed by one operator on two RX Daytona plus systems using serum based control material and unaltered human serum samples that were spiked with carbon dioxide concentrations or diluted to achieve concentrations based on normal ranges 20 - 31 mEq/L. Testing was conducted for two reagent lots of liquid CO2-2(LCO2-2), one lot on each RX Daytona plus system, twice per day for 20 non-consecutive days. Two replicates per run were performed for each sample. The assay was calibrated daily. The results of Lot 1 which is representative of both lots of Liquid CO2-2 (LCO2-2) reagent is summarized in the following table
| Lot 1 | MEAN | Within Run | Among Run | Among Day | Total | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Method | Product | N | (mEq/L) | SD | CV | SD | CV | SD | CV | SD | CV |
| LCO2 | QC Level 3 | 80 | 17.7 | 0.41 | 2.3 | 0.68 | 3.8 | 0.05 | 0.3 | 0.79 | 4.5 |
| LCO2 | QC Level 2 | 80 | 11.4 | 0.32 | 2.8 | 0.53 | 4.6 | 0.12 | 1.1 | 0.63 | 5.5 |
| LCO2 | SP Level 1 | 80 | 11.1 | 0.22 | 2.0 | 0.67 | 6.0 | 0.25 | 2.2 | 0.75 | 6.7 |
| LCO2 | SP Level 2 | 80 | 18.8 | 0.42 | 2.2 | 0.83 | 4.4 | 0.00 | 0.0 | 0.93 | 5.0 |
| LCO2 | SP Level 3 | 80 | 35.4 | 0.59 | 1.7 | 1.00 | 2.8 | 0.66 | 1.9 | 1.33 | 3.8 |
| Table 2 Precision Summary | ||
|---|---|---|
7
b. Linearity/assay reportable range:
Linearity studies have been carried out in accordance with C.L.S.I. standard EP6-A. Linearity studies were performed at 11 levels to determine the analytical range of an assay - that is the range where the reported result is a linear function to the analyte concentration (or where deviation from linearity is less than 5%).
The linearity samples were prepared at 11 levels. Randox used a low serum pool sample around 4.0 mEq/l analyte concentration and a serum pool with a high concentration approximately 55 mEq/l using low and high serum pools. The low and high pools were mixed to make nine intermediate levels. Each level was run in replicates of five on two lots of Liquid CO2-2 (LCO2-2) reagent on one RX Daytona plus system. The observed values were compared to the expected values; the linear regression correlation between the expected values and the observed values are summarized in the following table:
Table 3 Linearity Summary including Regression equation and correlation coefficient.
| Analyte Tested | CO2 (mEq/L) |
|---|---|
| Linear Regression | $Y = 0.99 + 0.75$ |
| r | 0.999 |
The reportable range of the assay is 10 to 40 mEq/L
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Refer to K942458 Controls for Carbon Dioxide
The Liquid CO2-2 Calibrator is traceable to an internal master reference material that in turn is traceable to Sodium Carbonate NIST reference material 351. Calibrators are value assigned using one instrument and multiple repetitions. The mean, standard deviation and %CV are calculated and evaluated against acceptance criteria.
Open vial stability
Open vial stability of the Liquid CO2-2 Calibrator was assessed by preparing the material according to the package insert. Samples were stored at +2 to +8°C for 28 days and tested for Carbon Dioxide.
The acceptance criteria state the percentage deviation of stable to fresh should be ≤5%.
8
Current open vial studies support a reconstituted claim of 28 days when stored at +2°C to +8°C.
Real Time Testing
This study was designed to verify and validate the predicted or desirable shelf life of the Liquid CO2-2 (LCO2-2) reagent and calibrator. Kits were stored at the routinely stored temperature of +2 to +8°C and tested at various time points. The acceptance criteria states that the all controls should be within range.
Current Real Time studies support a 2 year shelf life.
d. Detection limit:
Sensitivity studies have been carried out in accordance with C.L.S.I. guideline EP17-A2 'Evaluation of detection capability for clinical laboratory measurement procedures; Approved Guideline Second Edition'. A Limit of Blank (L.o.B.), a Limit of Detection (L.o.D.) and a Limit of Quantification were performed on two lots of reagents tested by two operators on one RX Daytona Plus system.
The Limit of Detection (LoD) for Carbon Dioxide on the RX Daytona Plus is 1.98 mEq/L based on 240 determinations, with 4 low level samples.
The Limit of Blank (LoB) is 0.97 mEq/L.
The Limit of Quantitation (LoQ) is 4.5 mEq/L as determined by the lowest concentration at which precision is still met.
e. Analytical Specificity:
Interference studies have been carried out in accordance with C.L.S.I. guideline EP7-A2 'Interference testing in clinical chemistry; Approved Guideline Second Edition' The effects of potential interferents were determined by calculating the mean value of the spiked interferent with the corresponding control solution. The spiked sample results were compared to control samples prepared without the potential interferents.
Acceptance Criteria:
The criteria for no significant interference is recovery within ±10% of the initial value of Carbon Dioxide concentration of 20 mEq/L and 35 mEq/L
Haemoqlobin No significant interference up to 1000mg/dL Total Bilirubin No significant interference up to 60mg/dL Conjugate Bilirubin No significant interference up to 30mg/dL
9
| Triglycerides | No significant interference up to 2000mg/dL |
|---|---|
| Intralipid® | No significant interference up to 2000mg/dL |
| Ascorbic Acid | No significant interference up to 6.0mg/dL |
f. Method comparison with predicate device:
Correlation studies were carried out in accordance with C.L.S.I. guideline EP9-A2 'Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second Edition'.
97 serum patient samples spanning the range 12.5 to 39.4 mEq/L were tested by one operator on two lots of Liguid CO2-2 (LCO2-2) reagent on one RX Daytona plus analyzer and the predicate device tested on one ADVIA 1650 system across 3 working days with each sample tested in singlicate. The test method was compared to the predicate device and the following linear regression equation was obtained:
Y = 0.97x - 0.11 Correlation coefficient of r = 0.994
q. Matrix comparison:
Matrix method comparisons for Liquid CO2-2 (LCO2-2) assay was tested by one operator on one RX Daytona plus system and was assessed for two lots of reagents. Both serum and lithium heparin plasma were tested to determine whether method accuracy with plasma specimens are equivalent to serum results and that lithium heparin plasma does not interfere with either the method or the system.
Liquid CO2-2 (LCO2-2) matrix comparison on the RX Daytona plus (Lithium Heparin)
Patient samples were drawn in matched pairs - one sample serum (x) and the second sample lithium heparin plasma (v). 50 matched patient sample pairs were analyzed spanning the 13.9 to 38.1 mEq/L and the following linear regression equation was obtained:
Y = 0.97x + 0.94 Correlation coefficient of r = 0.984
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Expected values/Reference range:
Referenced from literature
A reference interval for Carbon Dioxide was verified using NCCLS C28-A3 guidelines. In a study, human serum from 30 normal donors were tested in singlicate on the RX daytona plus. The results obtained were ordered from lowest to highest before being examined for outliers using the Dixon test.
Upon confirmation there were no outliers; the values were compared to the quoted ranges for Carbon Dioxide. Results of the study indicate that all values reported in the range for Healthy Individuals.
Table 4 Reference Ranges
| Analyte | Expected Values |
|---|---|
| Carbon Dioxide (3) | 20 – 31 mEq/L |
- Tietz NW. Clinical Guide to Laboratory Tests. 3rd ed. Philadelphia, PA: WB Saunders Company; 1995:110-111.
10. CONCLUSION
Testing results indicate that the proposed device is substantially equivalent to the predicate device.