(64 days)
ENVOY®500 CK REAGENT KIT is intended for the quantitative in vitro determination of creatine kinase (CK) in buman serum and plasma using the ENVOY 500 Chemistry System.
It is not intended for use in Point of Care settings.
Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
ENVOY CK REAGENT KIT is available as kit only. It consists of a bi-reagent R1 and R2 whose composition,
for R1: 125 mmol/L Imidazole buffer, pH 6.10; 25 mmol/L D-Glucose; 25 mmol/L N-Acetyl-L-Cysteine; 12.5 mmol/L Magnesium acetate; 2.4 mmol/L NADP; 2.0 mmol/L EDTA; > 6800 U/L Hexokinase (microorganism); < 0.1% Sodium azide
for R2: 250 mmol/L Creatine phosphate; 15.2 mmol/L ADP; 25 mmol/L AMP; 103 µmol/L Diadenosine pentaphosphate; ≥ 8800 U/L G-6-PDH (microorganism); < 0.1% Sodium azide.
This document describes the performance characteristics and acceptance criteria for the ENVOY 500 CK REAGENT KIT, an in vitro diagnostic device for the quantitative determination of creatine kinase (CK) in human serum and plasma.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within-run CV% (Level 1) | Not explicitly stated (implied to be low) | 1.5% |
| Within-run CV% (Level 2) | Not explicitly stated (implied to be low) | 1.0% |
| Within-run CV% (Level 3) | Not explicitly stated (implied to be low) | 1.4% |
| Total CV% (Level 1) | Not explicitly stated (implied to be low) | 3.6% |
| Total CV% (Level 2) | Not explicitly stated (implied to be low) | 3.5% |
| Total CV% (Level 3) | Not explicitly stated (implied to be low) | 3.6% |
| Linearity/Assay Range | Acceptable deviation from linearity of ±10% | Linear from 10-1714 U/L (with automatic dilution up to 17140 U/L) |
| Limit of Detection (LoD) | Not explicitly stated (implied to be low for clinical utility) | 2 U/L |
| Limit of Quantification (LoQ) | Precision coefficient of variation of ≤ 15% | 5 U/L (with ≤ 15% CV) |
| Interference | Accepted bias of ±10% in sample pools with low (150 U/L) or high (1200 U/L) nominal activity | No significant interference for specific interferents up to tested concentrations (e.g., Hemoglobin up to 100 mg/dL, Triglycerides up to 3000 mg/dL, Bilirubin up to 30 mg/dL, Ascorbic acid up to 20 mg/dL, Acetylsalicylic acid up to 200 mg/dL, Acetaminophen up to 30 mg/dL) |
| Method Comparison (Serum) | Not explicitly stated (implied high correlation and agreement with predicate) | y = 1.050x + 0 U/L, r = 0.998, Sy.x = 28 U/L (range: 14 to 1650 U/L) |
| Method Comparison (Lithium Heparin Plasma) | Not explicitly stated (implied high correlation and agreement with predicate) | y = 1.020x + 3 U/L, r = 0.999, Sy.x = 21 U/L (range: 10 to 1660 U/L) |
| On Board Stability | Not explicitly stated (implied to be sufficient for practical use) | 28 days |
| Real-time (Shelf) Stability | Stable until the expiry date stated on the label | Followed for 14 months on 3 different lots |
2. Sample Size Used for the Test Set and the Data Provenance
- Precision Test Set: 80 measurements for each of 3 levels of samples (Level 1, Level 2, Level 3). Each level was measured two times per run, for two runs per day, for twenty operating days, on two instruments.
- Linearity Test Set: 11 levels of patient pools (for serum).
- Detection Limit Test Set: 15 measurements of 4 samples for LoD; 15 measurements of 4 samples for LoQ.
- Interference Test Set: For each potential interferent, 2 serum sample pools (a low activity pool at 150 U/L and a high activity pool at 1200 U/L) were used. Aliquots of each pool were spiked with increasing interferent concentrations (e.g., 9 concentrations for triglycerides, 7 for unconjugated bilirubin, etc.). Each point was measured in triplicate per run.
- Method Comparison (Serum) Test Set: 100 serum patient samples.
- Method Comparison (Lithium Heparin Plasma) Test Set: 40 plasma specimens (in lithium heparin).
- On Board Stability Test Set: At least 3 levels of sample (high/medium/low) were tested in duplicate at Day 0, and 4 activity levels were analyzed in duplicate for at least 30 days.
Data Provenance: The document does not explicitly state the country of origin for the patient samples or if the data was retrospective or prospective. Given the submitter is ELITech Clinical Systems SAS, France, and the testing was conducted for regulatory submission in the US, it is plausible the studies were conducted in Europe or at contract research organizations. The nature of the studies (e.g., precision, linearity, interference, method comparison) generally involves prospective collection or commercially available control/patient samples for analytical validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes the analytical performance of an in-vitro diagnostic reagent kit (ENVOY 500 CK REAGENT KIT). For such devices, "ground truth" generally refers to reference methods or measurements by highly calibrated instruments, not expert human interpretation. Therefore, the concept of "number of experts used to establish ground truth" and their qualifications is not applicable in this context. The ground truth for analytical studies is established by:
- Reference materials or calibrators traceable to international standards (e.g., IFCC method for CK).
- Predicate devices or established methods for method comparison studies.
- Precise gravimetric or volumetric preparations for linearity and spiking studies.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is typically relevant for studies involving subjective human interpretation of diagnostic images or data, where discrepancies between readers need to be resolved to establish ground truth for algorithm training or testing.
For the analytical performance studies described for the ENVOY 500 CK Reagent Kit, no such adjudication method was used or is applicable. The measurements are quantitative and objective, following established laboratory protocols and guidelines (e.g., CLSI protocols). Discrepancies would be resolved through re-testing, investigation of instrument or reagent issues, or statistical analysis (e.g., outliers).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document describes an in-vitro diagnostic reagent kit, not an AI-based diagnostic device intended for human reader assistance. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This document describes the performance of an in-vitro diagnostic reagent kit that functions on a chemistry analyzer (Envoy 500 Chemistry System). The device itself is the reagent kit, which works in conjunction with the instrument to provide quantitative results. It is not an algorithm or AI-based device. The performance described is inherently "standalone" in the sense that it measures the analytical capability of the reagent-instrument system to quantify CK levels without human intervention in the measurement process itself, beyond sample loading and system operation. No human-in-the-loop performance is relevant for the analytical measurement part of the device's function.
7. The Type of Ground Truth Used
The ground truth for the various analytical performance characteristics was established using:
- Reference Methods/Standards: For traceability, the calibration factor for the ENVOY 500 CK Reagent Kit has traceability to the IFCC method (International Federation of Clinical Chemistry and Laboratory Medicine) recommendations for CK activity determination.
- Predicate Device Comparison: For method comparison, the predicate device (ELITech Clinical Systems CK NAC SL on Selectra ProM analyzer) served as the reference for comparison using patient samples.
- Prepared Samples/Known Concentrations:
- For linearity, patient pools were prepared by spiking a serum pool and dilution to obtain 11 levels with equidistant activities (known relative concentrations).
- For detection and quantification limits, samples were prepared by diluting patient samples to obtain specific activities (e.g., approximately 3.5 U/L for LoD, 5 U/L for LoQ).
- For interference, serum sample pools were spiked with increasing concentrations of known interferents against control samples.
- Statistical Analysis: Precision studies rely on repeated measurements to quantify variability, with "ground truth" derived from the calculated mean and statistical metrics.
In summary, the ground truth is primarily based on reference methods (IFCC), comparison to a legally marketed predicate device, and precisely prepared samples with known (or highly characterized) concentrations/activities.
8. The Sample Size for the Training Set
Not applicable. This device is an in-vitro diagnostic reagent kit, not a machine learning or artificial intelligence-based device that requires a "training set" in the conventional sense. The "training" of such a system involves chemical formulation, optimization of reaction conditions, and calibration procedures using calibrators or reference materials.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this device does not utilize a "training set" in the context of machine learning. The "ground truth" for developing and optimizing the reagent kit and its associated methods would involve:
- Chemical principles and stoichiometry: The understanding of the enzyme kinetics and chemical reactions being measured (e.g., the IFCC recommended method for CK).
- Reference materials and calibrators: Used to ensure accuracy and traceability of the quantitative measurements.
- Experimental optimization: Through iterative testing and modification of reagent concentrations, pH, and reaction conditions to achieve optimal performance characteristics (sensitivity, specificity, stability, etc.).
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:
510(k) Summary
ENVOY®500 CK REAGENT KIT
JUL 1882014
:
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| 1. | Date: | May 12, 2014 |
|---|---|---|
| 2. | Submitter: | ELITech Clinical Systems SASZone Industrielle •61500 SEESFRANCE |
| 3. | Contact Person: | Debra K. HutsonManager, RA/QA, ELITechGroup, Inc.21720 23rd Dr SE, Suite 150Bothell, WA 98021Phone: 425-482-5174Fax: 425-482-5550Email: d.hutson@elitechgroup.com |
| 4. | Device Description:Classification | ENVOY® 500 CK REAGENT KITClass IIJHWClinical Chemistry21 CFR 862.1215 |
| 5. | Predicate Device: | K122083ELITech Clinical Systems SASELITech Clinical Systems CK NAC SL |
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:
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Reagents:
Envoy 500 CK Reagent is for the quantitative in vitro diagnostic determination of creatine kinase (CK) in human serum and plasma using the Envoy 500 Chemistry System. It is not intended for use in Point of Care settings.
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.
Special conditions for use statement(s):
Prescription Use Only. It is not intended for use in Point of Care settings.
Special instrument requirements: Performance is provided for the ENVOY® 500 Analyzer.
Device Descriptions
ENVOY CK REAGENT KIT is available as kit only. It consists of a bi-reagent R1 and R2 whose composition,
for R1: 125 mmol/L Imidazole buffer, pH 6.10; 25 mmol/L D-Glucose; 25 mmol/L N-Acetyl-L-Cysteine; 12.5 mmol/L Magnesium acetate; 2.4 mmol/L NADP; 2.0 mmol/L EDTA; > 6800 U/L Hexokinase (microorganism); < 0.1% Sodium azide
for R2: 250 mmol/L Creatine phosphate; 15.2 mmol/L ADP; 25 mmol/L AMP; 103 µmol/L Diadenosine pentaphosphate; ≥ 8800 U/L G-6-PDH (microorganism); < 0.1% Sodium azide.
Substantial Equivalence Information -
- Assay (reagent)
-
- Predicate Device Name
- ELITech Clinical Systems CK NAC SL
-
- Comparison with predicate
Similarities
| Parameter | ELITech Clinical Systems DeviceENVOY® 500 CK REAGENT KIT | Predicate DeviceELITech Clinical Systems CK NAC SLK122083 |
|---|---|---|
| Intended Use/ Indication forUse | Intended for the quantitative in vitrodiagnostic determination of creatinekinase (CK) in human serum andplasma using the Envoy 500 ChemistrySystem. | Intended for the quantitative in vitrodiagnostic determination of creatinekinase (CK) in human serum andplasma on ELITech Clinical SystemsSelectra analyzers. |
| It is not intended for use in Point ofCare settings. | It is not intended for use in Point of Caresettings. | |
| Measurements of creatine | Measurements of creatine | |
| Parameter | ELITech Clinical Systems DeviceENVOY® 500 CK REAGENT KIT | Predicate DeviceELITech Clinical Systems CK NAC SLK122083 |
| phosphokinase and its isoenzymes areused in the diagnosis and treatment ofmyocardial infarction and musclediseases such as progressive,Duchenne-type muscular dystrophy. | phosphokinase and its isoenzymes areused in the diagnosis and treatment ofmyocardial infarction and musclediseases such as progressive,Duchenne-type muscular dystrophy. | |
| Composition | Reagent R1:125 mmol/L Imidazole buffer, pH 6.10;25 mmol/L D-Glucose;25 mmol/L N-Acetyl-L-Cysteine;12.5 mmol/L Magnesium acetate:2.4 mmol/L NADP:2.0 mmol/L EDTA;≥ 6800 U/L Hexokinase(microorganism);< 0.1% Sodium azideReagent R2:250 mmol/L Creatine phosphate;15.2 mmol/L ADP;25 mmol/L AMP;103 µmol/L Diadenosinepentaphosphate;≥ 8800 U/L G-6-PDH (microorganism);< 0.1% Sodium azide. | Same |
| Appearanceof reagents | Liquid form, ready to use | Same |
| SpecimenType | Serum, plasma | Same |
| Reagentstorage | Store at 2-8 °C and protect from light.The reagent is stable until the expirydate stated on the label. | Same |
| Expectedvalues | Serum/plasma:Men: < 171 U/LWomen: < 145 U/L | Same |
| AssayTechnology | UV Method Kinetic based on IFCCrecommendations | Same |
| Assay Range | 10 to 1714 U/L | Same |
| Interferences | Triglycerides: No significantinterference up to 3000 mg/dL.Unconjugated bilirubin: Nosignificant interference up to 30.0mg/dL (513 µmol/L).Conjugated bilirubin: No significantinterference up to 29.5 mg/dL (504 µmol/L). | Same |
| Parameter | ELITech Clinical Systems DeviceENVOY® 500 CK REAGENT KIT | Predicate DeviceELITech Clinical Systems CK NAC SLK122083 |
| Ascorbic acid: No significantinterference up to 20.0 mg/dL.Acetaminophen: No significantinterference up to 30.0 mg/dL.Acetylsalicylic acid: No significantinterference up to 200.0 mg/dL.Hemolysis: No significant interferenceup to 100 mg/dL of hemoglobin | ||
| On Boardstability | 28 days | Same |
| Limit ofquantification(LoQ) | 5 U/L | 5 U/L |
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Differences
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| Parameter | ELITech Clinical Systems Device | Predicate Device | |
|---|---|---|---|
| ENVOY®500 CK REAGENT KIT | ELITech Clinical Systems CK NAC SL | ||
| Instrument | ENVOY®500 Analyzer | Selectra ProM Analyzer | |
| Calibrator | None. The Envoy 500 uses a | Recommended calibration material | |
| calibration factor for this assay. | (not included): | ||
| ELITech Clinical Systems ELICAL 2 | |||
| Limit of detection(LoD) | 2 U/L | 1 U/L | |
| Precision | Within run | Within run | |
| 138 UllLevelCV= 1.5% | Level 147 U/LCV= 0.7% | ||
| CV= 1.0%375 U/LLevel | Level 406 U/LCV= 1 1% | ||
| 1135 U/LCV= 1.4%Level | Level 1154 U/LCV= 1.1% | ||
| Total | Total | ||
| 138 U/LCV= 3.6%Level | Level147 U/LCV= 1.7% | ||
| 375 U/LLevelCV= 3.5% | 406 U/LLevelCV= 2.4% | ||
| 1135 U/LCV= 3.6%Level | Level 1154 U/LCV= 3.9% | ||
| Method | v= 1.050 x + 0 U/L | y= 1.012 x + 2 U/L | |
| comparison | r= 0.998 | r= 0.998 | |
| range: 14 to 1650 U/L | range: 11 to 1712 U/L | ||
| Control | Recommended: Envoy SerumControl kit (K111063) | Recommended:ELITROL I (normaland ELITROL If (abnormalcontrol)control) |
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9. Standard/Guidance Document Reference
- Evaluation of Precision Performance of Quantitative Measurement Methods; . Approved Guideline-Second Edition. CLSI (NCCLS) document EP05-A2, Vol 24, No. 25, August 2004.
- . Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use: Guidance for Industry and FDA Staff, November 2004.
- . Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition. CLSI (NCCLS) document EP07-A2, Vol 25, No. 27, November 2005.
- . Evaluation of the Linearity of the Measurement of Quantitative Procedures: a Statistical Approach; Approved Guideline. CLSI (NCCLS) document EP06-A, Vol 23, No. 16, April 2003.
- . NF EN 13640:2002 Stability Testing of in vitro Diagnostic Reagents
10. Test Principle:
Kinetic determination of creatine Kinase (CK) activity: (Kinetic_UV method, based on IFCC recommendations).
| Creatine Phosphate + ADP | Creatine + ATP |
|---|---|
| -------------------------- | ---------------- |
Creatine kinaseHexokinase ATP + D-Glucose → D-Glucose-6-Phosphate + ADP
| G-6-P + NADP+ | D-Gluconate-6-Phosphate + NADPH + H* |
|---|---|
| G-6-PDH |
G-6-P: D-Glucose-6-Phosphate
G-6-PDH: Glucose-6-Phosphate Dehydrogenase.
The rate of increase in absorbance of NADPH is measured at 340 nm and is directly proportional to the activity of CK in the sample.
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11. Performance Characteristics - Analytical Performance
a. Precision/Reproducibility
The precision of the device was determined in accordance with Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition. CLSI (NCCLS) document EP05-A2, Vol 24, No. 25, August 2004.
Within-run and total precision results were obtained by performing two runs per day, two measures per run, for 3 levels of samples on 2 instruments during twenty operating days according to CLSI EP05-A2 protocol. The results are presented in the table below:
Precision
Serum
| Level | n | Mean (U/L) | Precision % | |
|---|---|---|---|---|
| Within-run CV% | Total CV% | |||
| Level 1 | 80 | 138 | 1.5 | 3.6 |
| Level 2 | 80 | 375 | 1.0 | 3.5 |
| Level 3 | 80 | 1135 | 1.4 | 3.6 |
b. Linearity/assay reportable range
The linearity study of ENVOY 500 CK Reagent Kit Reagent was performed according to CLSI protocol EP06-A.
Serum
Eleven (11) levels of patient pools were prepared from a high activity sample obtained by spiking a serum pool and a low activity sample obtained by dilution to obtain 11 levels with equidistant activities. The samples were measured and experimental values are compared to expected values.
This study demonstrates acceptable linearity from 10-1714 (with an acceptable deviation from linearity of ±10%).
Automatic dilution 1 to 10 allows an upper linearity of ENVOY500 CK reagent to 17140 U/L.
c. Traceability
ENVOY 500 CK Reagent Kit is calibrated automatically by the Envoy 500 through the use of a calibration factor in the instrument parameters. The calibration factor has traceability to the IFCC method. Results are automatically calculated by the factor. The original CK reagent cleared for use on Envoy 500 also makes use of a calibration factor (K112416).
Envoy Serum Control kit was cleared under K111063 (which included creatine kinase as an analyte).
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d. Stability
Real-time stability:
The shelf-life of ENVOY 500 CK Reagent Kit has been followed real time for 14 months on 3 different lots.
On board stability: This evaluates the period of time during which correct measurements are obtained after installation of a new vial on board.
At least 3 levels of sample (high/medium/low) are tested in duplicate at Day 0.
Four (4) activities levels are analyzed in duplicate, until the deviations from the results at D0 are higher than acceptance criteria or for at least 30 days. During this period, the reagents are stored on the analyzer (vial open).
This study was performed on one (1) lot on ENVOY500 analyzer. The results indicate that the reagent is stable 28 days on board.
e. Detection limit
Determined according to CLSI protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).
Limit of Detection:
The limit of Detection was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ENVOY®500 CK reagent and diluted with Albumin 6 g/dL / NaCl 0.9% to obtain an activity of approximately 3.5 U/L.
The data are not Gaussian, so LoD= LoB + DS,β (where DS,β is determined by calculating the median minus the 5th percentile of the low activity sample distribution).
Limits of Quantification:
The limit of Quantification was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ENVOY®500 CK reagent and diluted with Albumin 6 g/dL / NaCl 0.9% to obtain an activity of 5 U/L.
Acceptance criteria: The acceptable performance goal is defined as the lowest measured value with a precision coefficient of variation of ≤ 15%.
Serum
Limit of Detection (LoD) of ENVOY 500 CK Reagent Kit obtained from 15 measurements of 4 samples with a low activity of analyte (approximately 4 x LoB = 3.5 U/L) is 2 U/L.
Limit of Quantification (LoQ) of ENVOY 500 CK Reagent Kit obtained from 15 measurements of 4 samples at nominal activity is 5 U/L.
f. Interference/analytical specificity
Interferences due to hemolysis, unconjugated bilirubin, conjugated bilirubin, triglycerides. ascorbic acid, acetylsalicylic acid, acetaminophen were investigated following the recommended sample levels in CLSI EP07-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition).
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For each potential interferent tested, 2 serum sample pools at two creatine kinase levels close to those specified in Appendix B of EP7-A2 were prepared:
-135 pool: low activity at nominal 150 U/L
-200 pool: high activity at nominal 1200 U/L
Aliquots of each of the serum sample pools were spiked with increasing interferent concentration. Test ranges covered at least the interferent level specified in Appendix D of EP7-A2. Thus, there were two series of interferent spike for each potential interferent tested. A control sample was prepared from the sample pool diluted in the appropriate diluent.
| Interferent | Test range | # of differentconcentrations tested |
|---|---|---|
| Triglycerides | up to 3000 mg/dL | 9 |
| Unconjugated bilirubin | up to 30.0 mg/dL | 7 |
| Conjugated bilirubin | up to 29.5 mg/dL | 7 |
| Ascorbic acid | up to 20 mg/dL | 7 |
| Acetylsalicylic acid | up to 200 mg/dL | 7 |
| Acetaminophen | up to 30 mg/dL | 7 |
| Hemoglobin | Up to 556 mg/dL | 8 |
Two (2) levels of control (Serum control Level 1 and Serum control Level 2) were tested to check the reagents.
For both sample pools for each interferent, each point was measured in triplicate per run. Acceptance criteria: an accepted bias of ±10% in sample pools with low (150U/L) or high (1200U/L) nominal activity.
The results of testing interferences are the following:
- Concentration up to 100 mg/dL of hemoglobin, 30.0 mg/dL unconjugated bilirubin, 3000 mg/dL triglycerides, 20 mg/dL ascorbic acid, 29.5 mg/dL conjugated bilirubin, 200 mg/dL acetylsalicylic acid 30 and mg/dL acetaminophen do not show any significant interference for each substance.
- In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM i type (Waldenstrom's macroglobulinemia) can cause unreliable results.
The following statement will also be included in the labeling:
Other compounds may interfere. Users should refer to the two following literature references:
-Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 200 Ed., AACC Press, (1997).
-Young, D. S., Effects of drugs on clinical laboratory tests, 40 Ed., AACC Press, (1995). -Berth, M. & Delanghe, J. Protein precipitation as a possible important pitfall in the clinical chemistry analysis of blood samples containing monoclonal immunoglobulins: 2 case reports and a review of literature, Acta Clin Belg., (2004), 59, 263.
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12. Performance Characteristics - Comparison Studies
a. Method comparison
A correlation study was performed between ENVOY 500 CK Reagent kit on ENVOY 500 analyzer and ELITech Clinical Systems CK NAC SL on Selectra ProM analyzer according to CLSI EP09-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
This study was performed using 100 serum patient samples from 14 to 1650 U/L over a span of 5 days.
Regression analysis of the results vielded the following:
y = 1.050x + 0 U/L r = 0.998 r2 = 0.996 Standard error of the estimate Sy.x = 28 U/L
b. Comparison study
To support the use of lithium heparin plasma samples, a second correlation study was performed between ENVOY®500 CK Reagent kit on ENVOY®500 analyzer and ELJ Tech Clinical Systems CK NAC SL on Selectra ProM analyzer according to CLSI EP09-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
This study was performed using 40 plasma specimens (in lithium heparin), ranging from 10 to 1660 U/L over a span of 2 days.
Regression analysis of the results yielded the following:
v = 1.020x + 3 U/L r = 0.999 r2 = 0.999 Standard error of the estimate Sy.x = 21 U/L
c. Expected values/Reference Range
As indicated in the instructions for use for ENVOY 500 CK Reagent Kit, each laboratory should establish and maintain its own reference values. The values given are used as guidelines only.
. .
| Men | Women | ||
|---|---|---|---|
| Serum/ Plasma | < 171 | THE PERSON FOR COLLECTION OF COLLEGION OF CHARGE<145 | U/L |
These reference values are from: Schumann, G., et al., Clin. Chem. Lab. Med., (2002), 40. 635-42
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d. Clinical Studies:
Not applicable
e. Clinical Cut-off:
Not applicable
13. Conclusion
The information on the principle and performance of the device that is contained in this premarket notification is complete and supports a decision that our device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three parallel lines instead of a snake.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2014
ELITECHGROUP DEBRA HUTSON MANAGER, RA/QA 21720 23RD DR SE, SUITE 150 BOTHELL WA 98021
Re: K141265
Trade/Device Name: ENVOY 500 CK Reagent Kit Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: II Product Code: JHW Dated: May 14, 2014 Received: May 15, 2014
Dear Ms. Debra Hutson:
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 11 (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 1000-1 050.
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Page 2-Ms. Hutson
If you desire specific advice for your device on our labeling regulations (2) 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/ResourcesforYou/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/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 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.
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
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
ENVOY®500 CK REAGENT KIT
Indications for Use (Describe)
ENVOY®500 CK REAGENT KIT is intended for the quantitative in vitro determination of creatine kinase (CK) in buman serum and plasma using the ENVOY 500 Chemistry System.
It is not intended for use in Point of Care settings.
Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Ruth A. Chesler -S
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§ 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.