(64 days)
No
The summary describes a reagent kit for a chemistry analyzer, focusing on chemical composition and performance characteristics of the assay. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) reagent kit used for the quantitative determination of creatine kinase (CK) in human samples. Its purpose is diagnostic, aiding in the diagnosis and treatment of conditions, rather than providing direct therapy or treatment.
Yes
The device is intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma, and these measurements are "used in the diagnosis and treatment of myocardial infarction and muscle diseases." This directly indicates its role in diagnosis.
No
The device is a reagent kit, which is a chemical substance used in a laboratory test, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is "intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma". The term "in vitro" is a key indicator of an IVD.
- Purpose: The purpose of the test is to measure a substance (creatine kinase) in a biological sample (serum and plasma) to aid in the "diagnosis and treatment of myocardial infarction and muscle diseases". This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the chemical reagents used in the test, which are components of an in vitro assay.
- Performance Studies: The performance studies described (precision, linearity, detection limit, interference, method comparison) are typical evaluations performed on IVD devices to demonstrate their analytical performance.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JHW
Device Description
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);
§ 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.
0
:
510(k) Summary
ENVOY®500 CK REAGENT KIT
JUL 1882014
:
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. . . . . .
. . . . .
| 1. | Date: | May 12, 2014 |
|---|---|---|
| 2. | Submitter: | ELITech Clinical Systems SAS |
| Zone Industrielle • | ||
| 61500 SEES | ||
| FRANCE | ||
| 3. | Contact Person: | Debra K. Hutson |
| Manager, RA/QA, ELITechGroup, Inc. | ||
| 21720 23rd Dr SE, Suite 150 | ||
| Bothell, WA 98021 | ||
| Phone: 425-482-5174 | ||
| Fax: 425-482-5550 | ||
| Email: d.hutson@elitechgroup.com | ||
| 4. | Device Description: | |
| Classification | ENVOY® 500 CK REAGENT KIT | |
| Class II | ||
| JHW | ||
| Clinical Chemistry | ||
| 21 CFR 862.1215 | ||
| 5. | Predicate Device: | K122083 |
| ELITech Clinical Systems SAS | ||
| ELITech Clinical Systems CK NAC SL |
.
:
1
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); 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 different
concentrations 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.
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| Men | Women | ||
|---|---|---|---|
| Serum/ Plasma | Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov |
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