(37 days)
Not Found
No
The summary describes a chemical reagent kit and associated calibrators and controls for a laboratory analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on standard analytical validation metrics for in vitro diagnostics.
No.
This device is for in vitro diagnostic use to measure creatine kinase levels, which aids in diagnosis and treatment monitoring, but it does not directly treat a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device's measurements "are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy." This directly indicates its role in diagnosing medical conditions.
No
The device description clearly states it consists of reagents (R1 & R2) and lyophilized calibrator and control materials, which are physical components, not software.
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 ELITech Clinical Systems CK NAC SL is intended for "quantitative in vitro determination of creatine kinase (CK) in human serum and plasma". It also mentions that the calibrator and control sera are for "in vitro diagnostic use".
- Device Description: The description details reagents, calibrators, and control materials used to perform the test on human samples (serum and plasma).
- Performance Studies: The document describes various performance studies (precision, linearity, traceability, stability, detection limit, interference, method comparison, matrix comparison) which are typical for validating an IVD device.
- Predicate Devices: The inclusion of predicate devices (K063744 Roche Diagnostics CKL; K033501 Roche Diagnostics Calibrator for Automated Systems (C.f.a.s.); K041227 Roche Diagnostics Precinorm and Precipath) further confirms its classification as an IVD, as predicate devices are used for comparison in regulatory submissions for new IVDs.
- Intended User / Care Setting: While it specifies "Prescription Use Only" and "not intended for use in Point of Care settings", this still aligns with the use of IVDs in clinical laboratory settings under the direction of healthcare professionals.
All these elements clearly indicate that the device is designed and intended for diagnostic testing performed outside of the body (in vitro) using human samples.
N/A
Intended Use / Indications for Use
ELITech Clinical Systems CK NAC SL is intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers.
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.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JHW, JIX, JJY
Device Description
CK NAC SL is available as kit only. It consists of 2 reagents R1 & reagent R2: Reagent R1 contains: Imidazole buffer (pH 6.10), D-Glucose, N-Acetyl-L-Cysteine, Magnesium acetate, NADP, EDTA, Hexokinase (microorganisms), sodium azide. Reagent R2 contains: Creatine phosphate, ADP, AMP, Diadenosine pentaphosphate, Glucose-6-phosphate Dehydrogenase (G-6-PDH) (micro-organisms), sodium azide.
ELITech Clinical Systems ELICAL2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to the antibodies to HCV and HIV according to FDA-approved methods.
ELITROL I and ELITROL II are two level quality control products consisting of a lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.
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
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Intended User / Care Setting
Prescription Use Only. It is not intended for use in Point of Care settings.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 EP5-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 EP5-A2 protocol.
Within-Run Precision:
Level 1: n=80, Mean=147 U/L, SD=1.0, CV%=0.7
Level 2: n=80, Mean=406 U/L, SD=4.6, CV%=1.1
Level 3: n=80, Mean=1154 U/L, SD=13.1, CV%=1.1
Total Precision:
Level 1: n=80, Mean=147 U/L, SD=2.4, CV%=1.7
Level 2: n=80, Mean=406 U/L, SD=9.8, CV%=2.4
Level 3: n=80, Mean=1154 U/L, SD=45.5, CV%=3.9
b. Linearity/assay reportable range
The linearity study of CK NAC SL reagent was performed according to CLSI protocol EP6-A. A measuring range from 10 to 1714 U/L has been determined. Manual dilution 1 to 10 allows an upper linearity of CK NAC SL reagent to 17140 U/L.
e. Detection limit
Determined according to CLS! protocol EP17-A.
Limit of Detection (LoD) of CK NAC SL is 1 U/L.
Limit of Quantification (LoQ) of CK NAC SL is 5 U/L.
f. Interference/analytical specificity
Interferences due to unconjugated bilirubin, conjugated bilirubin, triglycerides, acetaminophen, ascorbic acid, acetylsalicylic acid were investigated following the recommended sample levels in CLSI EP7-A2 protocol.
Concentration up to 30.0 mg/dL unconjugated bilirubin, 29.5 mg/dL unconjugated bilirubin, and 3133 mg/dL triglycerides do not show any significant interference (within ± 10% recovery).
Likewise, concentrations up to 30 mg/dL acetaminophen, 20.0 mg/dL ascorbic acid and 200 mg/dL acetylsalicylic acid do not show any significant interference (within ± 10% recovery).
a. Method comparison
A correlation study was performed between CK NAC SL reagent on a Selectra ProM analyzer and Roche Diagnostics CKL (Creatine kinase) reagent on a cobas c111 analyzer according to CLSI EP9-A2 protocol. This study was performed using 100 serum patient samples from 10 to 1712 U/L over a span of 5 days.
Regression analysis of the results yielded: y = 1.012 x + 2 U/L, r = 0.998, r² = 0.995, Standard error of the estimate Sy.x = 29 U/L.
b. Comparison study: Matrix comparison
40 paired serum and plasma (in lithium heparin samples, ranging from 11 to 1672 U/L, were tested on Selectra ProM analyzer according to CLSI protocol EP9-A2.
Regression analysis of the results yielded: y = 0.939 x + 9 U/L, r = 1.000, r2 = 1.000, Standard error of the estimate Sy.x = 9 U/L.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1215 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
122083
510(k) Summary
ELITech Clinical Systems CK NAC SL AUG 222 2012 July 11, 2012 1. Date: ELITech Clinical Systems SEPPIM S.A.S 2. Submitter: Zone Industrielle 61500 SEES FRANCE 3. Contact Person: Debra K. Hutson Director, QARA, North America 21720 23rd Dr SE, Suite 150 Bothell, WA 98021 Phone: 425-482-5174 425-482-5550 Fax: Email: d.hutson@elitechgroup.com ELITech Clinical Systems CK NAC SL 4. Device Description: Classification Class II JHW Clinical Chemistry 21 CFR 862.1215 ELITech Clinical Systems ELICAL 2 Device Description: Classification Class II ﺍﻟﺬ Clinical Chemistry 21 CFR 862.1150 ELITech Clinical Systems ELITROL I and ELITROL II Device Description: Class I, reserved Classification JJY Clinical Chemistry 21 CFR 862.1660 K063744 5. Predicate Device: Roche Diagnostics CKL K033501 Roche Diagnostics Calibrator for Automated Systems (C.f.a.s.) K041227 Roche Diagnostics Precinorm and Precipath 6. Intended Use ELITech Clinical Systems CK NAC SL is intended for the quantitative Reagents: in vitro determination of creatine kinase (CK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers. 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
1
| progressive. Duchenne-type muscular dystrophy. | |
|---|---|
| Calibrators: | ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator |
| for in vitro diagnostic use in the calibration of quantitative ELITech | |
| Clinical Systems methods on ELITech Clinical Systems Selectra | |
| analyzers. | |
| Controls: | ELITech Clinical Systems ELITROL I and ELITROL II are multi- |
| parametric control sera for in vitro diagnostic use in accuracy control | |
| of quantitative ELITech Clinical Systems methods on ELITech Clinical | |
| Systems Selectra analyzers. |
Special conditions for use statement(s):
Prescription Use Only. It is not intended for use in Point of Care settings.
Special instrument requirements: Performance was provided for the ELITech Clinical Systems Selectra ProM.
Device Description 7.
CK NAC SL is available as kit only. It consists of 2 reagents R1 & reagent R2: Reagent R1 contains: Imidazole buffer (pH 6.10), D-Glucose, N-Acetyl-L-Cysteine, Magnesium acetate, NADP, EDTA, Hexokinase (microorganisms), sodium azide. Reagent R2 contains: Creatine phosphate, ADP, AMP, Diadenosine pentaphosphate, Glucose-6-phosphate Dehydrogenase (G-6-PDH) (micro-organisms), sodium azide.
ELITech Clinical Systems ELICAL2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to the antibodies to HCV and HIV according to FDA-approved methods.
ELITROL I and ELITROL II are two level quality control products consisting of a lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods.
Substantial Equivalence Information -8.
Assav
-
- Predicate Device Name Roche Diagnostics CKL
-
- Comparison with predicate
Similarities
| Parameter | CK NAC SL | Roche Diagnostics CKL |
|---|---|---|
| Intended Use | Intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers. | |
| It is not intended for use in Point of Care settings. | In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma on the cobas c111 system. |
2
| Specimen Type | Serum and Plasma free of
hemolysis 1,2 | Same |
|-----------------------|-------------------------------------------|------|
| Assay Technology | Kinetic U.V. method | Same |
| Calibration frequency | 28 days | Same |
Differences
| Parameter | CK NAC SL | Roche Diagnostics CKL |
|---|---|---|
| Assay Range | 10 - 1714 U/L | 7 — 2000 U/L |
| Instrument | Selectra ProM analyzer | cobas c111 |
| Calibrator | Recommended calibration | |
| material (not included): | ||
| ELITech Clinical Systems | ||
| ELICAL 2 | Recommended calibration | |
| material (not included): | ||
| Roche Calibrator f.a.s. | ||
| Interference | Triglycerides: No significant | |
| interference up to 3000 mg/dL. | ||
| Unconjugated bilirubin: No | ||
| significant interference up to | ||
| 30.0 mg/dL (513 µmol/L). | ||
| Conjugated bilirubin: No | ||
| significant interference up to | ||
| 29.5 mg/dL (504 µmol/L). | ||
| Ascorbic acid: No significant | ||
| interference up to 20.0 mg/dL. | ||
| Acetaminophen: No | ||
| significant interference up to | ||
| 30.0 mg/dL. | ||
| Acetylsalicylic acid: No | ||
| significant interference up to | ||
| 200.0 mg/dL. | Hemoglobin: No significant | |
| interference up to an H Index | ||
| of 100 (approximate 100 | ||
| mg/dL). | ||
| Lipemia (Intralipid): No | ||
| significant influence up to an L | ||
| index of 1000. icterus: No | ||
| significant influence up to i | ||
| Index of 15 (approximate | ||
| conjugated and unconjugated | ||
| bilirubin concentration of 15 | ||
| mg/dL (257µmol/L)). | ||
| Reference Range | Serum/plasma: 3 | Serum/plasma: |
| Men: 1 Hørder M, Elser RC, Gerhardt W, Mathieu M. Sampson EJ.International Federation of Clinical Chemistry, Committee on Enzymes. Approved recommendation on IFCC methods for the measurement of catalytic concentration for enzymes. Part 7. IFCC method for creatine kinase. Eur.J Clin Chem Clin Biochem 1991; 29:435-56. |
2 Gerhard Schumann, Roberto Bonora, Ferruccio Ceriotti, Pascale Clerc-Renaud, Carlo A. Ferrero, IFCC Primary Reference Procedures for the Measurement
of Catalytic Activity Concentrations of Enzymes at 37°C Part 2. Reference Procedure for the Measurement of Catalytic Concentration of Creatine Kinase, Clin Chem Lab Med 2002; 40(6):635-642.
3 Schumann, G., et al., Clin. Chem. Lab. Med., (2002), 40, 635-42.
3
| Similarities and Differences | ||
|---|---|---|
| Item | Candidate Device | |
| (ELITech Clinical Systems | ||
| ELITROL I and ELITROLII) | Predicate | |
| Roche Diagnostics | ||
| Precinorm U and Precipath U | ||
| (K041227) | ||
| Intended Use/Indications for | ||
| Use | ELITech Clinical Systems | |
| ELITROL I and ELITROL 11 | ||
| are multi-parametric control | ||
| sera for in vitro diagnostic | ||
| use in quality control of | ||
| quantitative ELITech | ||
| Clinical Systems methods on | ||
| ELITech Clinical Systems | ||
| Selectra Analyzers. | Precinorm U is for use in quality | |
| control by monitoring accuracy | ||
| and precision for the quantitative | ||
| methods as specified in the | ||
| value sheets. | ||
| Precipath U is for use in | ||
| quality control by monitoring | ||
| accuracy and precision for | ||
| the quantitative methods as | ||
| specified in the value sheets. | ||
| Format | Lyophilized human sera with | |
| constituents added as | ||
| required to obtain defined | ||
| component levels | Same | |
| Levels | Two Levels (Level I and | |
| Level II) | Same | |
| Stability | Lyophilized: Store at 2-8°C | |
| and protected from light until | ||
| the expiry date. After | ||
| Reconstitution: 12 hours | ||
| between 15-25°C, 5 days | ||
| between 2-8°C, 4 weeks | ||
| between -25 and -15°C | ||
| (when frozen once) | Same |
Calibrator
-
- Predicate Device Name:
- Roche Diagnostics Calibrator for Automated Systems (C.f.a.s) 2. K033501
-
- Comparison with predicate
| Similarities and Differences | ||
|---|---|---|
| Item | Candidate Device | |
| (ELITech Clinical Systems | ||
| ELICAL 2) | Predicate | |
| Roche Calibrator for | ||
| Automated Systems (C.f.a.s.) | ||
| K033501 | ||
| Intended Use/Indications for | ||
| Use | ELITech Clinical Systems | |
| ELICAL 2 is a multi- | ||
| parametric calibrator for in vitro diagnostic use in the | ||
| calibration of quantitative | ||
| ELITech Clinical Systems | ||
| methods on ELITech Clinical | ||
| Systems Selectra analyzers. | Calibrator for automated systems | |
| (C.f.a.s.) is for use in the | ||
| calibration | ||
| of quantitative Roche methods | ||
| on Roche clinical chemistry | ||
| analyzers | ||
| as specified in the value sheets. | ||
| Format | Lyophilized calibrator based | |
| on human serum with | ||
| constituents added as | Same |
4
| | requires to obtain desired
component levels | |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Level | Single Level | Same |
| Stability | Lyophilized: store at 2-8°C
and protect from light until the
expiry date.
After reconstitution: 8 hours
between 15-25°C, 2 days
between 2-8°C, 4 weeks
between -25 and -15°C
(when frozen once) | Same |
9. Standard/Guidance Document Reference
- Evaluation of Precision Performance of Quantitative Measurement Methods; . Approved Guideline-Second Edition. CLSI (NCCLS) document EP5-A2, Vol 24, No. 25, August 2004.
- . Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline. CLSI (NCCLS) document EP17-A, vol 24, No. 34, October 2004.
- Method Comparison and Bias estimation Using Patient Samples, Approved . Guideline-Second Edition. CLSI (NCCLS) document EP9-A2-IR, Vol 30, No. 17, July 2010.
- . 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 EP6-A, Vol 23, No. 16, April 2003.
Test Principle: 10.
UV Method.
| Creatine Phosphate + ADP | Creatine kinase
Creatine + ATP |
|---------------------------|--------------------------------------------------------------------------------------|
| ATP + D-Glucose | Hexokinase
D-Glucose-6-Phosphate + ADP |
| G-6-P + NADP + | G-6-PDH
D-Gluconate-6-Phosphate + NADPH + H+ |
Where:
G-6-P: D-Glucose-6-Phosphate and G-6-PDH: Glucose-6-Phosphate Dehydrogenase.
The increase of NADPH concentration is directly proportional to the enzymatic CK activity.
5
Performance Characteristics - Analytical Performance 11.
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 EP5-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 EP5-A2 protocol. The results are presented in the table below:
| n | Mean (U/L) | Within-run SD | Within-run CV% | |
|---|---|---|---|---|
| Level 1 | 80 | 147 | 1.0 | 0.7 |
| Level 2 | 80 | 406 | 4.6 | 1.1 |
| Level 3 | 80 | 1154 | 13.1 | 1.1 |
Within-Run Precision
Total Precision
| n | Mean (U/L) | Total SD | Total CV% | |
|---|---|---|---|---|
| Level 1 | 80 | 147 | 2.4 | 1.7 |
| Level 2 | 80 | 406 | 9.8 | 2.4 |
| Level 3 | 80 | 1154 | 45.5 | 3.9 |
b. Linearity/assay reportable range
The linearity study of CK NAC SL reagent was performed according to CLSI protocol EP6-A. From this study, a measuring range from 10 to 1714 U/L has been determined. Manual dilution 1 to 10 allows an upper linearity of CK NAC SL reagent to 17140 U/L.
c. Traceability
For calibration, a multi-parametric calibrator named ELITech Clinical Systems ELICAL 2 (manufactured by SEPPIM under product code CALI-0580) must be used. Its value is traceable to the IFCC method (Schumann, 2002), by manual measurement. The values of these control materials are traceable to the IFCC method (Schumann, 2002), by manual measurement.
d. Stability
Real-time stabilities:
On board stability for the ELITech Clinical Systems CK NAC SL was established by real time studies on the ELITech Clinical Systems Selectra ProM. The on-board stability of the reagent is 28 days. The shelf-life of CK NAC SL reagent has been followed in the real time
6
for 14 months on 3 different batches.
Control material is purchased from a commercial vendor (previously cleared under K041227). The following is claimed for stability: Before reconstitution, the shelf-life of the ELITech Clinical Systems Elitrol 1 and Elitrol 11 is 30 months at 2-8°C. After reconstitution the stability is 12 hours when stored at 15-25°C, 5 days when stored at 2-8°C or 4 weeks (when frozen once) at -25° and -15° C.
Calibrator material is purchased from a commercial vendor (previously cleared under K033501). The following is claimed for stability. Elical 2 is stable until the expiration date printed on the label when stored at 2-8°C prior to reconstitution. After reconstitution the stability is 8 hours when stored at 15-25°C, 2 days at 2-8°C or 4 weeks (when frozen once) at -25°and -15°C. The labeling stated that the Elical 2 should be stored tightly capped and protected from light when not in use.
Value Assignment
Elitrol I and II are value assigned using multiple Vital Scientific PRO M analyzers. Each sample is tested in triplicate over several days. The target value of Level I and II are the median of the observed values range. After validation of the target value, a confidence range (high and low values) is then calculated.
Elical 2 is tested against predetermined values on multiple Vital Scientific PRO M using the CL NAC SL reagent and 2 levels of quality control material. The mean analyte value is calculated and a target value is assigned.
e. Detection limit
Determined according to CLS! protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).
Limit of Detection (LoD) of CK NAC SL obtained from 15 measurements of 4 samples with a low concentration of analyte (approximately 4 x LoB ~ 2.4 U/L) is 1 U/L.
Limit of Quantification (LoQ) of CK NAC SL obtained from 15 measurements of 4 samples at nominal concentration 5 U/L is 5 U/L.
f. Interference/analytical specificity
Interferences due to unconjugated bilirubin, conjugated bilirubin, triglycerides, acetaminophen, ascorbic acid, acetylsalicylic acid were investigated following the recommended sample levels in CLSI EP7-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition).
The results of testing interferences are the following:
-
Concentration up to 30.0 mg/dL unconjugated bilirubin, 29.5 mg/dL unconjugated ।
bilirubin, and 3133 mg/dL triglycerides do not show any significant interference for each substance. Non-significant interference is defined as within ± 10% recovery. -
Likewise, concentrations up to 30 mg/dL acetaminophen, 20.0 mg/dL ascorbic acid and เ
200 mg/dL acetyIsalicyIc acid do not show any significant interference for each
substance. Non-significant interference is defined as within ± 10% recovery.
The following statement will also be included in the labeling:
Other compounds may interfere. Users should refer to the two following literature
7
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.
Performance Characteristics - Comparison Studies 12.
a. Method comparison
A correlation study was performed between CK NAC SL reagent on a Selectra ProM analyzer and Roche Diagnostics CKL (Creatine kinase) reagent on a cobas c111 analyzer according to CLSI EP9-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline - Second edition).
This study was performed using 100 serum patient samples from 10 to 1712 U/L over a span of 5 days.
Regression analysis of the results yielded the following:
v = 1.012 x + 2 U/L r = 0.998 r² = 0.995 Standard error of the estimate Sy.x = 29 U/L.
b. Comparison study: Matrix comparison
40 paired serum and plasma (in lithium heparin samples, ranging from 11 to 1672 U/L, were tested on Selectra ProM analyzer according to CLSI protocol EP9-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition). Regression analysis of the results yielded the following: y = 0.939 x + 9 U/L
r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 9 U/L.
c. Expected values/Reference Range
As indicated in the instructions for use for CK NAC SL, each laboratory should establish and maintain its own reference values. The values given are used as guidelines only.
| Men: | Women: |
|---|---|
| Trade Name: ELITech Clinical Systems CK NAC SL ELITech Clinical Systems ELICAL2 ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II Regulation Number: 21 CFR §862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system |
Regulatory Class: Class II
Product Codes: JHW, JIX, JJY Dated: July 13, 2012 Received: July 16, 2012
Dear Ms. 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 approvisions 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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. or the ret or ary I vact is requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device and ilscing (21 or re-resily) device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and
Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours.
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
11
Indications for Use Form
510(k) Number (if known): _