RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

K123977 · Randox Laboratories, Ltd. · CGS · Nov 21, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123977
• Device Name: RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
• Applicant: Randox Laboratories, Ltd.
• Product Code: CGS · Clinical Chemistry
• Decision Date: Nov 21, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Randox Liquid 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 the RX Imola. The Randox CK-MB calibrator is an in vitro diagnostic product intended for use in the calibration of Randox CK-MB methods. The Randox Liquid CK-MB test system for the RX Imola and RX Daytona is a prescription use device intended to be used in clinical laboratories only.

Device Story

Randox Liquid CK-MB is an immunoinhibition assay kit used on RX Daytona and RX Imola clinical chemistry analyzers. Input: patient serum or plasma samples. Principle: mouse monoclonal anti-human CK-M antibody inhibits CK-M subunit activity; remaining CK-B activity is measured via kinetic rate immunoassay (CK NAC method) at 340/700nm; result multiplied by factor of two to determine CK-MB activity. Output: quantitative CK-MB concentration (U/L). Used in clinical laboratories by trained personnel to assist in myocardial infarction diagnosis and treatment. Benefits: provides rapid, automated assessment of cardiac biomarker levels to support clinical decision-making.

Clinical Evidence

Bench testing only. Precision studies (CLSI EP5) conducted on RX Daytona and RX Imola systems over 20 days showed total CVs ranging from 2.5% to 12.5%. Linearity established up to 2000 U/L (Daytona) and 1100 U/L (Imola). Method comparison (CLSI EP9-A2) against the predicate on 90-93 patient samples yielded correlation coefficients (r) of 0.999. Interference testing showed no significant interference from common substances at tested concentrations. Limit of Quantitation (LoQ) determined to be 7.00 U/L (Daytona) and 6.00 U/L (Imola).

Technological Characteristics

Immunoinhibition kinetic rate immunoassay. Reagents: mouse anti-human CK-M monoclonal antibody, buffer, substrate. Analyzers: RX Daytona, RX Imola. Measuring range: 6-2000 U/L. Calibration: human serum-based lyophilized calibrator. Standards: EP5-A2 (precision), EP6-A (linearity), EP7-A2 (interference), EP9-A2-IR (method comparison), EP17-A (LoD/LoQ), C28-A3c (reference intervals).

Indications for Use

Indicated for quantitative in vitro determination of CK-MB concentration in serum and plasma for the diagnosis and treatment of myocardial infarction (MI). For use in clinical laboratories by professional users.

Regulatory Classification

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.

Predicate Devices

• Roche Diagnostics CK-MB reagent, Roche Diagnostics CK-MB calibrator for automated systems (k003158)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

Contact: Dr Pauline Armstrong E-mail: [e-mail]

#### 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<br>SYSTEMS Inc. CK-MB<br>REAGENT K003158 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | The CK-MB test system is a<br>device intended for the<br>quantitative in vitro determination<br>of CK-MB concentration in serum<br>and plasma. Measurements of<br>CK-MB are used in the diagnosis<br>and treatment of myocardial<br>infarction (MI). This product is<br>suitable for use on the RX series<br>instruments including the RX<br>Daytona and RX Imola.. | The Roche Diagnostic Systems Inc.<br>CK-MB reagent is an immunoinhibition<br>assay for the quantitative in vitro<br>determination of the MB isoenzyme of<br>creatine kinase in human serum and<br>plasma on Roche automated clinical<br>chemistry analysers. |
| ASSAY PROTOCOL | Immunoinhibition Assay | UV assay with immunological inhibition<br>of CK-M |
| FORMAT | Liquid which are ready to use | Liquids which are ready to use |
| KEY MATERIAL | Mouse anti-human CK-M<br>monoclonal antibody | Mouse anti-human CK-M monoclonal<br>antibody |
| STORAGE<br>(unopened) | Reagents are stable up to the<br>expiry date when stored<br>unopened at +2 to +8°C | Reagents are stable up to the<br>expiry date when stored unopened<br>at +2 to +8°C |
| Sample Type | Plasma and serum | Plasma and serum |
| Sample Tubes | Heparin, EDTA | Heparin, EDTA |
| Control<br>(Frequency) | -Randox CK-MB Control<br>-Randox Tri-level Cardiac<br>Controls levels 2 and 3<br>-Two levels of control should be | -Precinorm CK-MB Control<br>-Precipath CK-MB<br>-PreciControl ClinChem Multi 1<br>-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<br>CALIBRATOR | ROCHE DIAGNOSTIC<br>SYSTEMS Inc. CK-MB<br>CALIBRATOR<br>K003158 |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE | The Randox CK-MB calibrator is<br>an in vitro diagnostic product<br>intended for use in the calibration<br>of Randox CK-MB methods. | C.f.a.s (Calibrator for automated<br>systems) CK-MB is for use in the<br>calibration of Roche methods for the<br>quantitative determination of CK-MB on<br>Roche clinical chemistry analysers as<br>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<br>reconstituted calibrator:<br>At +25°C 8 hours<br>At +4°C 5 days<br>At -20°C 4 weeks when frozen<br>once | Stability of components in the<br>reconstituted calibrator:<br>At 15-25°C 24 hours<br>At 2-8°C 2 days<br>At (-15)-(-25)°C 4 weeks when frozen<br>once |
| (Unopened) | Stable to the expiration date at 2-<br>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<br>Calibrator | CK-MB | Lee<br>Biosolutions | 190-24 | Human | Human<br>Heart |
| Liquid<br>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<br>Low Pool | CKMB<br>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.

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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 <25U/L. Results of the study indicate that all values reported in the range for Healthy Individuals.

#### 10. CONCLUSION

Testing results indicate that the proposed device is safe and effective for the stated intended use and is substantially equivalent to the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2013

RANDOX LABORATORIES, LTD. DR. PAULINE ARMSTRONG 55 DIAMOND RD. CRUMLIN, COUNTY ANTRIM BT29 4QY UK

Re: K123977

Trade/Device Name: Randox Liquid CK-MB, Randox CK-MB Calibrator Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: II Product Code: CGS, JIT Dated: November 13, 2013 Received: November 18, 2013

Dear Dr. 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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol Ei 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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K123977

#### Device Name

Randox Liquid CK-MB, Randox CK-MB Calibrator

Indications for Use (Describe)

#### 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Pan 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FOR MENT FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR oncurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)