(330 days)
No
The document describes a quantitative in vitro diagnostic test system and calibrator for measuring CK-MB concentration. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on standard analytical validation metrics for IVD assays (precision, linearity, detection limit, specificity, method comparison, matrix comparison, expected values).
No.
This device is an in vitro diagnostic (IVD) product used for the quantitative determination of CK-MB concentrations. It provides information for diagnosis and treatment, but it does not directly perform therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Measurements of CK-MB are used in the diagnosis and treatment of myocardial infarction (MI)." This indicates the device is used to diagnose a medical condition.
No
The device description clearly states that the product is supplied in a kit containing physical components (CK-MB Buffer, CK-MB Substrate, and a lyophilised calibrator). This indicates it is a reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device is "intended for the quantitative in vitro determination of CK-MB concentration in serum and plasma." It also describes the Randox CK-MB Calibrator as an "in vitro diagnostic product".
- Device Description: The description details reagents (CK-MB Buffer, CK-MB Substrate) and a calibrator used to perform the test on biological samples (serum and plasma).
- Purpose: The test is used "in the diagnosis and treatment of myocardial infarction (MI)", which is a medical condition.
- Setting: It is intended for use in "clinical laboratories only".
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
Randox Liquid CK-MB: The Randox Liquid CK-MB test system is a device intended for the guantitative in vitro determination of CK-MB concentration in serum and plasma. Measurements of CK-MB are used in the diagnosis and treament of myocardial infarction (MI). This product is suitable for use on the RX series instruments including the RX Daytona and the RX Imola.
Randox CK-MB Calibrator: The Randox CK-MB calibrator is an in vitro diugnostic product intended for use in the callbration of Randox CK-MB methods.
The Randox Liquid CK-MB test system for the RX Imola is a prescription use device intended to be used in clinical laboratories only.
Product codes (comma separated list FDA assigned to the subject device)
CGS, JIT
Device Description
Liquid CK-MB is supplied in a kit containing:
- 4 x 20.0 mL CK-MB Buffer
- 4 x 6.0 mL CK-MB Substrate.
The CK-MB calibrator is lyophilised, single analyte, human serum based product. The kit contains ten vials (single level) with 1.0 mL per vial. Double de-ionised water is required for reconstitution.
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
"for clinical laboratory use"
"intended for prescription use only and can only be used by professionals."
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 on the RX Daytona and RX Imola systems using control material and unaltered human serum samples that were spiked with CKMB concentrations of 10U/L, 50U/L, 250U/L, 450U/L and 1100U/L. Testing was conducted for one reagent lot of liquid CK-MB on one RX Daytona system and one RX Imola system, twice per day for 20 non-consecutive days. Two replicates per run was performed for each sample.
b. Linearity/assay reportable range: Linearity studies were performed using 11 levels of samples.
RX Daytona: Linearity 2000 U/L, Reportable Range 7 - 2000U/L
RX Imola: Linearity 1100 U/L, Reportable Range 6 - 1100U/L
Validated Extended Recovery for both RX Daytona and RX Imola: 10200 U/L ± 10%
d. Detection limit:
CKMB on the RX Daytona:
Limit of Detection (LoD): 5.06 U/L based on 300 determinations.
Limit of Blank (LoB): 2.91 U/L.
Limit of Quantitation (LoQ): 7.00 U/L.
CKMB on the RX Imola:
Limit of Detection (LoD): 2.41 U/L based on 300 determinations.
Limit of Blank (LoB): 0.87 U/L.
Limit of Quantitation (LoQ): 6.00 U/L.
e. Analytical Specificity: The effects of potential interferents were determined by calculating the mean value of the spiked interferent with the corresponding control solution. Potential interferents and some commonly used drugs and exogenous susbstances were spiked into two serum pools with a CK-MB concentration of approximately 20U/L and 415U/L. The spiked sample results were compared to control samples prepared without the potential interferents. Acceptance Criteria: % of Control ± 10%. No interference was observed at the concentrations listed in the table (see Table 7 CKMB Interference Summary).
a. Method comparison with predicate device: Correlation studies were carried out in accordance with C.L.S.I. guideline EP9-A2.
CKMB on the RX Daytona v the predicate device: 90 serum patient samples spanning the range 8.88 to 1931.75 U/L were analyzed. Linear regression equation: Y = 0.95 + 0.59. Correlation coefficient: r = 0.999.
CKMB on the RX Imola v the predicate device: 93 serum patient samples spanning the range 6.64 to 992.31 U/L were analyzed. Linear regression equation: Y = 0.96 + 2.36. Correlation coefficient: r = 0.999.
b. Matrix comparison: Matrix method comparisons for the CKMB assay on the RX Daytona and RX Imola systems were assessed. Both serum, lithium heparin and potassium EDTA plasma were conducted.
CKMB Matrix comparison on the RX Daytona (Lithium Heparin): Minimum of 72 matched patient sample pairs spanning the range 9.09 to 1931.8U/L. Linear regression equation: Y = 1.01x + -0.19. Correlation coefficient: r = 1.000.
CKMB Matrix comparison on the RX Daytona (Potassium EDTA): Minimum of 71 matched patient sample pairs spanning the range 9.09 to 1931.9 U/L. Linear regression equation: Y = 1.03x -1.92. Correlation coefficient: r = 0.999.
CKMB Matrix comparison on the RX Imola (Lithium Heparin): Minimum of 71 matched patient sample pairs spanning the range 6.81 to 992.31U/L. Linear regression equation: Y = 1.00x + 0.37. Correlation coefficient: r = 0.999.
CKMB Matrix comparison on the RX Imola (Potassium EDTA): Minimum of 71matched patient sample pairs spanning the range 6.64 to 992.31 U/L. Linear regression equation: Y = 1.01x + 0.90. Correlation coefficient: r = 1.000.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (LoD): RX Daytona: 5.06 U/L; RX Imola: 2.41 U/L.
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).
Not Found
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
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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.
2. SUBMITTER NAME AND ADDRESS
Name: Randox Laboratories Limited
Address: 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.
Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912
Contact: Dr Pauline Armstrong E-mail: Pauline.Armstrong@randox.com
3. 510k NUMBER, DEVICE PROPRIETARY NAME, COMMON NAME, PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL. PRODUCT CODE AND 21 CFR NUMBER
510k No: K123977
Device Proprietary Name: Randox Liquid CK-MB, Randox CK-MB Calibrator
Common Name: Liquid CK-MB, CK-MB Calibrator
Purpose for Submission: New Device
Regulatory Classification: Class II
Panel: Clinical Chemistry
21 CFR Number: 21 CFR 862.1215
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RANDOX
K123977 510(K) Summary Randox Liquid CK-MB, Randox CK-MB Calibrator
4. PREDICATE DEVICE PROPRIETARY NAME AND 510 (k) NUMBER
Predicate Device Proprietary Name: Roche Diagnostics CK-MB reagent, Roche Diagnostics CK-MB calibrator for automated systems.
510 (k) Number: K003158
5. INTENDED USE
The CK-MB test system is a device intended for the quantitative in vitro determination of CK-MB concentration in serum and plasma. Measurements of CK-MB are used in the diagnosis and treatment of myocardial infarction (MI). This product is suitable for use on the RX series instruments including the RX Daytona and RX Imola. The Randox liquid CK-MB is for clinical laboratory use and not for point-of-care use.
The Randox CK-MB calibrator is an in vitro diagnostic product intended for use in the calibration of Randox CK-MB methods.
The Randox CK-MB control is an in vitro diagnostic product intended for use in the quality control of Randox CK-MB methods. This product was approved previously with the following 510(k) number: K951223
The Randox Tri-level Cardiac Controls is an in vitro diagnostic product intended for use in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems. This product was approved previously with the following 510(k) number: K041361
These in vitro diagnostic devices are intended for prescription use only and can only be used by professionals.
6. DEVICE DESCRIPTION
Liquid CK-MB is supplied in a kit containing:
- . 4 x 20.0 mL CK-MB Buffer
- 4 x 6.0 mL CK-MB Substrate. .
The CK-MB calibrator is lyophilised, single analyte, human serum based product. The kit contains ten vials (single level) with 1.0 mL per vial. Double de-ionised water is required for reconstitution.
November 12, 2013
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PREDICATE DEVICE COMPARISON TABLE 7.
Table 1 Predicate Comparison
| CHARACTERISTICS | RANDOX LIQUID CK-MB | ROCHE DIAGNOSTIC
SYSTEMS Inc. CK-MB
REAGENT K003158 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | The CK-MB test system is a
device intended for the
quantitative in vitro determination
of CK-MB concentration in serum
and plasma. Measurements of
CK-MB are used in the diagnosis
and treatment of myocardial
infarction (MI). This product is
suitable for use on the RX series
instruments including the RX
Daytona and RX Imola.. | The Roche Diagnostic Systems Inc.
CK-MB reagent is an immunoinhibition
assay for the quantitative in vitro
determination of the MB isoenzyme of
creatine kinase in human serum and
plasma on Roche automated clinical
chemistry analysers. |
| ASSAY PROTOCOL | Immunoinhibition Assay | UV assay with immunological inhibition
of CK-M |
| FORMAT | Liquid which are ready to use | Liquids which are ready to use |
| KEY MATERIAL | Mouse anti-human CK-M
monoclonal antibody | Mouse anti-human CK-M monoclonal
antibody |
| STORAGE
(unopened) | Reagents are stable up to the
expiry date when stored
unopened at +2 to +8°C | Reagents are stable up to the
expiry date when stored unopened
at +2 to +8°C |
| Sample Type | Plasma and serum | Plasma and serum |
| Sample Tubes | Heparin, EDTA | Heparin, EDTA |
| Control
(Frequency) | -Randox CK-MB Control
-Randox Tri-level Cardiac
Controls levels 2 and 3
-Two levels of control should be | -Precinorm CK-MB Control
-Precipath CK-MB
-PreciControl ClinChem Multi 1
-Control interval per institution |
| | assayed at least once a day | requirements |
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K123977 510(K) Summary Randox Liquid CK-MB, Randox CK-MB Calibrator
Table 1 Predicate Comparison Continued.
| CHARACTERISTICS | RANDOX CK-MB
CALIBRATOR | ROCHE DIAGNOSTIC
SYSTEMS Inc. CK-MB
CALIBRATOR
K003158 |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | The Randox CK-MB calibrator is
an in vitro diagnostic product
intended for use in the calibration
of Randox CK-MB methods. | C.f.a.s (Calibrator for automated
systems) CK-MB is for use in the
calibration of Roche methods for the
quantitative determination of CK-MB on
Roche clinical chemistry analysers as
specified in the value sheets. |
| ANALYTE | CK-MB | CK-MB |
| MATRIX | Human serum | Human serum |
| FORM | Lyophilised | Lyophilised |
| STORAGE (opened) | Stability of components in the
reconstituted calibrator:
At +25°C 8 hours
At +4°C 5 days
At -20°C 4 weeks when frozen
once | Stability of components in the
reconstituted calibrator:
At 15-25°C 24 hours
At 2-8°C 2 days
At (-15)-(-25)°C 4 weeks when frozen
once |
| (Unopened) | Stable to the expiration date at 2-
8oC | Stable to the expiration date at 2-8oC |
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8. TEST PRINCIPLE (1)
RANDOX
Immunoinhibition Assay: An antibody is incorporated into the CK reagent. This antibody will bind to and inhibit the activity of the M subunit of CK-MB. This means that only the activity of the B subunit in serum is measured. If the activity is multiplied by a factor of 2, it will give the activity of CK-MB in serum.
(1) WURBURG, U., ET AL., CLIN. CHEM. 1976; 54: 357.
The R1 reagent contains anti CK-MM antibody which binds the M subunit of CK in the serum sample thereby inhibiting the activity of the CK- M subunit. The CK-B activity is determined by the CK NAC method.
Creatine phosphate + ADP -> Creatine + ATP
Glucose + ATR > Glucose-6-P + ADP
Glucose-6-P + NADP =========================================================================================================================================================== - Gluconate-6-P + NADPH + H*
The rate of increase of absorbance at 340/700 nm due to the formation of NADPH is directly proportional to the activity of CK in the sample and if the activity is multiplied by a factor of two it will give the activity of CK-MB in the sample.
9. PERFORMANCE CHARACTERISTICS
Analytical performance:
a. Precision/Reproducibility:
Precision was evaluated consistent with C.L.S.I documents EP5 Precision studies were performed on the RX Daytona and RX Imola systems using control material and unaltered human serum samples that were spiked with CKMB concentrations of 10U/L, 50U/L, 250U/L, 450U/L and 1100U/L. Testing was conducted for one reagent lot of liquid CK-MB on one RX Daytona system and one RX Imola system, twice per day for 20 non-consecutive days. Two replicates per run was performed for each sample. No assay re-calibrations was required throughout the duration of the study. The results are summarized in the following tables.
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K123977 510(K) Summary Randox Liquid CK-MB, Randox CK-MB Calibrator
Table 2 CKMB RX Daytona Precision Summary
| All Data | Within Run | Between Run | Between Day | Total | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| System | Method | Product | Data | # Day | # Run | # Rep | MEAN | SD | CV | SD | CV | SD | CV | SD | CV |
| Rx Daytona | CKMB | Human Serum 1 | All | 21 | 40 | 80 | 9.90 | 1.01 | 10.2 | 0.00 | 0.0 | 0.39 | 4.0 | 1.08 | 10.9 |
| Rx Daytona | CKMB | Human Serum 5 | All | 21 | 40 | 80 | 1011.98 | 17.60 | 1.7 | 15.61 | 1.5 | 17.19 | 1.7 | 29.14 | 2.9 |
| Rx Daytona | CKMB | Human Serum 3 | All | 21 | 40 | 80 | 244.85 | 4.29 | 1.8 | 2.70 | 1.1 | 3.34 | 1.4 | 6.07 | 2.5 |
| Rx Daytona | CKMB | Human Serum 4 | All | 21 | 40 | 80 | 437.45 | 7.49 | 1.7 | 5.16 | 1.2 | 8.02 | 1.8 | 12.13 | 2.8 |
| Rx Daytona | CKMB | Human Serum 2 | All | 21 | 40 | 80 | 47.53 | 1.00 | 2.1 | 0.78 | 1.6 | 0.89 | 1.9 | 1.55 | 3.3 |
| Rx Daytona | CKMB | CKMB Calibrator | All | 21 | 40 | 80 | 189.65 | 3.20 | 1.7 | 1.78 | 0.9 | 2.96 | 1.6 | 4.71 | 2.5 |
| Rx Daytona | CKMB | CKMB control | All | 21 | 40 | 80 | 137.45 | 2.79 | 2.0 | 3.11 | 2.3 | 1.43 | 1.0 | 4.42 | 3.2 |
Table 3 CKMB RX Imola Precision Summary
| All Data | Within Run | Between Run | Between Day | Total | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| System | Method | Product | Data | # Day | # Run | # Rep | MEAN | SD | CV | SD | CV | SD | CV | SD | CV |
| Rx Imola | CKMB | Human Serum 1 | All | 20 | 40 | 80 | 10.38 | 1.24 | 12.0 | 0.00 | 0.0 | 0.49 | 4.7 | 1.33 | 12.5 |
| Rx Imola | CKMB | Human Serum 5 | All | 20 | 40 | 80 | 1001.29 | 18.07 | 1.8 | 33.15 | 3.3 | 14.51 | 1.4 | 40.45 | 4.0 |
| Rx Imola | CKMB | Human Serum 3 | All | 20 | 40 | 80 | 245.62 | 4.84 | 2.0 | 3.98 | 1.6 | 5.54 | 2.3 | 8.36 | 3.4 |
| Rx Imola | CKMB | Human Serum 4 | All | 20 | 40 | 80 | 437.83 | 8.51 | 1.9 | 6.23 | 1.4 | 9.98 | 2.3 | 14.52 | 3.3 |
| Rx Imola | CKMB | Human Serum 2 | All | 20 | 40 | 80 | 47.43 | 1.53 | 3.2 | 1.42 | 3.0 | 1.12 | 2.4 | 2.37 | 5.0 |
| Rx Imola | CKMB | CKMB Calibrator | All | 20 | 40 | 80 | 186.69 | 5.05 | 2.7 | 0.00 | 0.0 | 3.46 | 1.9 | 6.12 | 3.3 |
| Rx Imola | CKMB | CKMB control | All | 20 | 40 | 80 | 135.57 | 3.70 | 2.7 | 0.39 | 0.3 | 0.39 | 0.3 | 3.74 | 2.8 |
b. Linearity/assay reportable range:
Linearity studies were performed 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. The sponsor set a range from 0 analyte concentration (or other reasonable bottom of range level ) up to a high concentration approximately 10% greater than the upper level of linearity to be claimed for the method. The results are summarized in the following table:
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K123977 510(K) Summary Randox Liquid CK-MB, Randox CK-MB Calibrator
Table 4 CKMB Linearity/ Reportable Range Summary
| CKMB | Linearity | Reportable Range |
|---|---|---|
| RX Daytona | 2000 U/L | 7 - 2000U/L |
| RX Imola | 1100 U/L | 6 - 1100U/L |
Table 5 CKMB Validated Extended Recovery
| CKMB | Extended Recovery on event of Re-run |
|---|---|
| RX Daytona | 10200 U/L ± 10% |
| RX Imola | 10200 U/L ± 10% |
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Table 6 Traceability Table Randox Liquid CK-MB Reagent and CK-MB Calibrator
| Product | Analyte | Supplier | Product No | Origin | Source |
|---|---|---|---|---|---|
| CK-MB | |||||
| Calibrator | CK-MB | Lee | |||
| Biosolutions | 190-24 | Human | Human | ||
| Heart | |||||
| Liquid | |||||
| CK-MB | CK-MB | Roche | 04688457 | Animal | Mouse |
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d. Detection limit:
Sensitivity studies have been carried out in accordance with C.L.S.I. guideline EP17-A 'Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline'. A Limit of Blank (L.o.B.), a Limit of Detection (L.o.D.) and a Limit of Quantification were performed on the RX Daytona and RX Imola systems.
CKMB on the RX Daytona
The Limit of Detection (LoD) for CKMB on the RX Daytona is 5.06 U/L based on 300 determinations, with 1 blank and 4 low level samples.
The Limit of Blank (LoB) is 2.91 U/L.
The Limit of Quantitation (LoQ) is 7.00 U/L as determined by the lowest concentration at which precision and accuracy are still met. Acceptable criteria ≤20% accuracy and ≤20% imprecision.
CKMB on the RX Imola
The Limit of Detection (LoD) for CKMB on the RX Imola is 2.41 U/L based on 300 determinations, with 1 blank and 4 low level samples.
The Limit of Blank (LoB) is 0.87 U/L.
The Limit of Quantitation (LoQ) is 6.00 U/L as determined by the lowest concentration at which precision and accuracy are still met. Acceptable criteria ≤20% accuracy and ≤20% imprecision.
e. Analytical Specificity:
The effects of potential interferents were determined by calculating the mean value of the spiked interferent with the corresponding control solution. Potential interferents and some commonly used drugs and exogenous susbstances were spiked into two serum pools with a CK-MB concentration of approximately 20U/L and 415U/L. The spiked sample results were compared to control samples prepared without the potential interferents.
Acceptance Criteria: % of Control ± 10%
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K123977 510(K) Summary Randox Liquid CK-MB, Randox CK-MB Calibrator
The results are summarized in the following table. No interference was observed at the concentrations listed in the table.
| RX daytona | RX imola | |
|---|---|---|
| Interferent | CKMB | |
| Low Pool | CKMB | |
| Low Pool | ||
| Haemoglobin | 1000 mg/dl | 1000 mg/dl |
| Bilirubin (F) | 30 mg/dl | 30 mg/dl |
| Bilirubin (C) | 60 mg/dl | 60 mg/dl |
| IntralipidⓇ | Inteferes* | Inteferes * |
| Triglycerides | 500 mg/dl | 500 mg/dl |
| Acetominophen | 1660µmol/l | 1660µmol/l |
| Caffeine | 308µmol/l | 308µmol/l |
| Phenytoin | 198µmol/i | 198µmol/l |
| Salicylic Acid | 4.34µmol/l | 4.34µmol/l |
| Digoxin | 6.15µmol/l | 6.15µmol/l |
| Nicotine | 6.2µmol/l | 6.2µmol/l |
| Theophylline | 222µmol/l | 222µmol/l |
| Acetyl Salicylic Acid | 3333µmol/l | 3333µmol/l |
| Ascorbic Acid | 227µmol/l | 227µmol/l |
| Chloramphenicol | 155µmol/l | 155µmol/l |
| Furosemide | 181 µmol/l | 181 µmol/l |
| Ibuprofen | 2425µmol/l | 2425µmol/l |
Table 7 CKMB Interference Summary
*Recommend the use of clear, non-lipemic serum and plasma
Comparison Studies:
a. 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'.
90 serum samples (6 spikes) were tested on the RX Daytona analyzer and 93 serum samples (4 spikes) were tested on the RX Imola across 5 working days with each sample tested in singlicate. The test method was compared to the predicate device Roche CKMB Kit (ref. 12132893) that was tested on the Hitachi 717. One RX Daytona, one RX Imola and one Hitachi 717 system were used to carry out the testing.
9
RANDOX
K123977 510(K) Summary Randox Liquid CK-MB, Randox CK-MB Calibrator
The results of the studies are shown below.
CKMB on the RX Daytona v the predicate device
This method (Y) was compared with another commercially available method (X).
90 serum patient samples were analyzed spanning the range 8.88 to 1931.75 U/L and the following linear regression equation was obtained:
Y = 0.95 + 0.59
Correlation coefficient of r = 0.999
CKMB on the RX Imola v the predicate device
This method (Y) was compared with another commercially available method (X).
93 serum patient samples were analyzed spanning the range 6.64 to 992.31 U/L and the following linear regression equation was obtained:
Y = 0.96 + 2.36
Correlation coefficient of r = 0.999
b. Matrix comparison:
Matrix method comparisons for the CKMB assay on the RX Daytona and RX Imola systems were assessed. Both serum, lithium heparin and potassium EDTA plasma were conducted to determine whether method accuracy with lithium heparin and potassium EDTA plasma specimens are equivalent to serum results and that lithium heparin and potassium EDTA plasma does not interfere with either the method or the system.
CKMB Matrix comparison on the RX Daytona (Lithium Heparin)
Patient samples were drawn in matched pairs - one sample serum (x) and the second sample lithium heparin plasma (y). A minimum of 72 matched patient sample pairs were analyzed spanning the range 9.09 to 1931.8U/L and the following linear regression equation was obtained:
Y = 1.01x + -0.19
Correlation coefficient of r = 1.000
November 12, 2013
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K123977 510(K) Summary Randox Liquid CK-MB, Randox CK-MB Calibrator
CKMB Matrix comparison on the RX Daytona (Potassium EDTA)
Patient samples were drawn in matched pairs -- one sample serum (x) and the second sample potassium EDTA plasma (y). A minimum of 71 matched patient sample pairs were analyzed spanning the range 9.09 to 1931.9 U/L and the following linear regression equation was obtained:
Y = 1.03x -1.92
RANDOX
Correlation coefficient of r = 0.999
CKMB Matrix comparison on the RX Imola (Lithium Heparin)
Patient samples were drawn in matched pairs - one sample serum (x) and the second sample lithium heparin plasma (y). A minimum of 71 matched patient sample pairs were analyzed spanning the range 6.81 to 992.31U/L and the following linear regression equation was obtained:
Y = 1.00x + 0.37
Correlation coefficient of r = 0.999
CKMB Matrix comparison on the RX Imola (Potassium EDTA)
Patient samples were drawn in matched pairs - one sample serum (x) and the second sample potassium EDTA plasma (y). A minimum of 71matched patient sample pairs were analyzed spanning the range 6.64 to 992.31 U/L and the following linear regression equation was obtained:
Y = 1.01x + 0.90
Correlation coefficient of r = 1.000
Clinical studies:
-
a. Clinical Sensitivity
Not applicable -
b. Clinical specificity:
Not applicable
November 12, 2013
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- c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
Clinical cut-off:
Not applicable
Expected values/Reference range:
The Reference range was evaluated consistent with C.L.S.I guideline C28-A2. How to Define and Determine Reference Intervals in the Clinical Laboratory. In a study, human serum from 40 normal donors (16 Male, 24 Female with age ranging from 17 to 69) were tested in singlicate on both the RX imola and RX daytona. The results obtained from both systems were ordered from lowest to highest before being examined for outliers using the Dixon test.
The following references have been cited on the package insert:
Klein G, Berger A, Bertholf R et al. Abstract: Multicenter Evaluation of Liquid Reagents for CK, CK-MB and LDH with Determination of Reference Intervals on Hitachi Systems. Clin Chem 2001; 47:Suppl. A30.
Thomas L, Müller M, Schumann G, Weidemann G et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005;29:301-308.
Upon confirmation there were no outliers in either data set, the values were compared to the quoted range of CK-MB