Who is the manufacturer of ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY?

Roche Diagnostics filed the 510(k) submission for ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (K132571).

What is the FDA product code for ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY?

JHY. It is classified under 21 CFR 862.1215 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY

Q: What are the predicate devices for ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY?

Elecsys 3rd Generation CK-MB STAT Assay (K022654).

K132571 · Roche Diagnostics · JHY · Oct 18, 2013 · Clinical Chemistry

Device Facts

Record ID	K132571
Device Name	ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
Applicant	Roche Diagnostics
Product Code	JHY · Clinical Chemistry
Decision Date	Oct 18, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1215
Device Class	Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

The Elecsys CK-MB STAT and CK-MB immunoassays are two-step sandwich immunoassays utilizing streptavidin-coated microparticles and electrochemiluminescence (ECLIA) detection. The device processes human serum or plasma samples (15 µL) on Roche cobas e 411 analyzers. During the first incubation, biotinylated monoclonal anti-CK-MB antibodies and ruthenium-labeled monoclonal CK-MB-specific antibodies form a sandwich complex with the analyte. In the second incubation, streptavidin-coated microparticles bind the complex to the solid phase. The analyzer measures the electrochemiluminescent signal, which is proportional to the CK-MB concentration. Results are calculated via a 2-point calibration against a master curve provided by the reagent barcode. The device is used in clinical laboratory settings by trained technicians to aid in the diagnosis of myocardial infarction. The output provides quantitative CK-MB levels, which clinicians use in conjunction with patient history and other clinical findings to assess cardiac health.

Clinical Evidence

Bench testing only. Performance validated per CLSI guidelines. Precision testing (21 days) showed total CVs ranging from 2.0% to 4.2% across the measuring range (1-300 ng/mL). Analytical sensitivity: LoB=0.1 ng/mL, LoD=0.3 ng/mL, LoQ=1 ng/mL. Method comparison (n=165) against predicate yielded a slope of 1.053 and r=0.982. Matrix equivalence studies confirmed recovery for various anticoagulants (Na-heparin, Li-heparin, K2/K3-EDTA). No interference found for common pharmaceuticals or endogenous substances (hemoglobin, bilirubin, lipids, biotin, RF, immunoglobulins) within specified limits.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence (ECLIA) detection; streptavidin-coated microparticles; biotinylated and ruthenium-labeled monoclonal antibodies. Measuring range: 1-300 ng/mL. Sample volume: 15 µL. Platform: cobas e 411 analyzer. Calibration: 2-point calibration with master curve. Traceability: Abbott IMx CK-MB assay. Standards: CLSI EP5-A2, EP17-A, EP6-A. Sterilization: Not applicable (reagent).

Indications for Use

Indicated for in vitro quantitative determination of MB isoenzyme of creatine kinase in human serum and plasma as an aid in the diagnosis of myocardial infarction. For prescription use only.

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

Elecsys 3rd Generation CK-MB STAT Assay (K022654)

Reference Devices

Abbott IMx CK-MB assay

Related Devices

K140404 — ELECSYS CK-MB STAT IMMUNOASSAY · Roche Diagnostics · May 8, 2014
K022654 — MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB · Roche Diagnostics Corp. · Aug 29, 2002
K974421 — ELECSYS CK-MB STAT · Boehringer Mannheim Corp. · Dec 17, 1997
K961501 — ELECSYS CK-MB · Boehringer Mannheim Corp. · Jun 11, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ K B257/ # 510(k) Summary for Elecsys CK-MB STAT and Elecsys CK-MB Immunoassays | Date prepared: | October 17, 2013 | |-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Purpose of submission | Roche Diagnostics hereby submits this 510(k) to provide FDA with notification of intent to market a new device named Elecsys CK-MB Gen.4 reagent. All data in this submission was generated using the CK-MB STAT assay on the cobas e 411 analyzer as indicated. Method comparison data is included for the CK-MB STAT and CK-MB (18-minute) assay, as well as CK-MB STAT and Predicate device. | This candidate device is a new reagent that was developed by Roche Diagnostics. The previous generation of reagent, CK-MB STAT, was cleared in 510(k) K022654 and serves as the predicate device. The candidate and predicate devices use the same calibrator and controls. Only the reagents differ. This submission presents data to support clearance of this new reagent. | Measurand | CK-MB | |--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Type of test | Quantitative colorimetric method; Cpk or Isoenzymes | | Applicant | Kelli Turner Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 Telephone: (317) 521-4515 Fax: (317) 521-2324 Email: Kelli.Turner@Roche.com | OCT 1 8 2013 | Candidate device names | Proprietary name: (1) Elecsys CK-MB STAT Immunoassay (2) Elecsys CK-MB Immunoassay Common name: (1) CK-MB STAT Immunoassay (2) CK-MB Immunoassay | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| {1}------------------------------------------------ # 510(k) Summary for Elecsys CK-MB STAT and Elecsys CK-MB Immunoassays, Continued . Regulatory information | Product Code | Classification | Regulation | Panel | |--------------|----------------|------------------------------------------------------------------------------------------------|-----------------------| | JHY | Class II | 21 CFR 862.1215 (Creatine phosphokinase/creatine kinase or isoenzymes test system) | Clinical Chemistry | Continued on next page . {2}------------------------------------------------ ### 510(k) Summary for Elecsys CK-MB STAT and Elecsys CK-MB Immunoassays, Continued ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Intended use | CK-MB STAT Reagent and CK-MB Reagent have the same intended uses: | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction. | | | The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers. | | Indications for use | Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction. | | | The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers. | | Special conditions for use | For prescription use only | | Special instrument requirements | The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers. | | Candidate device description | The CK-MB STAT Assay and the CK-MB Assay are two-step sandwich immunoassays with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2- point calibration and a master curve (5-point-calibration) provided with the reagent bar code. | | | The CK-MB STAT application is identical to the CK-MB assay, with the only difference being the length of incubation (9 minutes vs. 18 minutes). | | | Continued on next page | : {3}------------------------------------------------ ## 510(k) Summary for Elecsys CK-MB STAT and Elecsys CK-MB Immunoassays, Continued and the control control control control control controllers and consideration of the consideration of the consideration of the consideration of the consideration of the consi Predicate Roche Diagnostics claims substantial equivalence to CK-MB, 3rd generation, device immunoassay, cleared in K022654. 。 Page 4 of 21 {4}------------------------------------------------ ... ______________________________________________________________________________________________________________________________________________________________________________ # 510(k) Summary for Elecsys CK-MB STAT and Elecsys CK-MB Immunoassays, Continued | Substantial equivalence - | There are two tables in this summary: | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | similarities | The first table compares the CK-MB STAT generation 4 immunoassay (Master Assay) with the predicate device. | | | The second table exhibits the comparison between CK-MB STAT generation 4 immunoassay to the CK-MB 18-minute generation 4 immunoassay. | | | Continued on next page | {5}------------------------------------------------ #### Comparison of Assays, Similarities and Differences #### Table 1 CK-MB STAT 3td Generation vs. CK-MB STAT 4th Generation | Assay Comparison | | | |--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Feature | Predicate Device: Elecsys 3rd Generation CK-MB STAT Assay (K022654) | 4th Generation CK-MB STAT Assay (modified) | | General Assay Features | | | | Intended Use/ Indications for Use | Immunoassay for the in vitro quantitative determination of MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatine kinase are used as an aid in the diagnosis of myocardial infarction. | Same | | Assay Protocol | Two-step Sandwich assay using biotinylated and ruthenium labeled antibodies and streptavidin microparticles | Same | | Detection Protocol | Electrochemiluminescent Immunoassay | Same | | Applications | STAT application (noted as CK-MB STAT in the labeling) and 18-minute application (noted as CK-MB in the labeling). | STAT application (noted as CK-MB STAT in the labeling) | {6}------------------------------------------------ Comparison of Assays-Similarities and Differences, continued #### Table 1 CK-MB STAT 3rd Generation vs. CK-MB STAT 4th Generation, continued | Assay Comparison | | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Feature | Predicate Device: Elecsys 3rd Generation CK-MB STAT Assay (K022654) | 4th Generation CK-MB STAT Assay (modified) | | General Assay Features | | | | Instrument Platform | Roche Elecsys 2010 | Roche cobas e 411 | | Sample Volume | 15 µL | Same | | Sample Type | Human serum and plasma treated with K3-EDTA, lithium heparin, sodium heparin and Na-citrate plasma. | Human serum and plasma treated with K2-EDTA, K3-EDTA, lithium heparin and sodium heparin plasma. | | Reagents | Sandwich principle. Total duration of assay: 9 minutes. • 1st incubation: 15 µL of sample, a biotinylated monoclonal anti-CK-MB antibody, and a monoclonal CK-MB-specific antibody labeled with a ruthenium complex react to form a sandwich complex. • 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. | Same | | Calibrator | CK-MB STAT CalSet (CK-MB Calset for 18-minute assay) | Same | {7}------------------------------------------------ | Assay Comparison | | | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Predicate Device: Elecsys 3rd Generation CK-MB STAT Assay (K022654) | 4th Generation CK-MB STAT Assay (modified) | | | General Assay Features | | | Calibration Interval | Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the reagent kit was registered on the analyzer). Renewed calibration is recommended as follows: Elecsys 2010 analyzers: After 1 month (28 days) when using the same reagent lot. After 7 days (when using the same reagent kit on the analyzer). As required: e.g. quality control findings outside the specified limits | Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the reagent kit was registered on the analyzer). Renewed calibration is recommended as follows: cobas e 411 analyzers: After 1 month (28 days) when using the same reagent lot. After 7 days (when using the same reagent kit on the analyzer). As required: e.g. quality control findings outside the specified limits | | Controls | Elecsys PreciControl Cardiac II | Same | Comparison of Assays-Similarities and Differences, continued Table 1 CK-MB STAT 3rd Generation vs. CK-MB STAT 4" Generation, continued {8}------------------------------------------------ | Feature | Assay Comparison | | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | | Predicate Device: Elecsys 3rd Generation CK-MB STAT Assay (K022654) | 4th Generation CK-MB STAT Assay (modified) | | General assay features | | | | Traceability / Standardization | The linearity of the CK-MB STAT assay was improved by using human recombinant CK-MB from Seradyn. The test was standardized against the previous Elecsys CK-MB STAT assay in the range of 0-20.0 ng/mL; this leads to up to a 30% reduction of the test results in the range of 20-500 ng/mL. | The CK-MB STAT assay is traceable to the Abbott IMx CK-MB assay and linearized using human recombinant CK-MB from Seradyn. | | Reagent Stability | Unopened: 2-8°C - Up to the stated expiration date Opened 2-8°C - 12 weeks On Analyzers – 8 weeks | Unopened: 2-8°C - Up to the stated expiration date Opened 2-8°C - 12 weeks On Analyzers – 6 weeks | Comparison of Assays-Similarities and Differences, continued ### Table 1 CK-MB STAT 3rd Generation vs. CK-MB STAT 4th Generation, continued {9}------------------------------------------------ | Table 1 CK-MB STAT 3" Generation vs. CK-MB STAT 4" Generation, continued | | | | | | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|--|--|--|--| | Assay Comparison | | | | | | | | | | Predicate Device: Elecsys 3rd | 40 Generation CK-MB STAT | | | | | | | Feature | Generation CK-MB STAT Assay | Assay (modified) | | | | | | | | (K022654) | | | | | | | | 21 8 8 7 1 2 3 Labeled Performance Characteristics ----- | | | | | | | | | Measuring | 0.1-500 ng/mL | 1-300 ng/mL | | | | | | | Range | | | | | | | | | Precision | Elecsys 2010: | cobas e 411: | | | | | | | Within-run (will be labeled Repeatability) 5.77 ng/mL 1.5% CV @ 12.4 ng/ml. 2.1% CV (a), 39.7 ng/mlL 1.8% CV (a), 1.9% CVKI @ 5.86 ng/mL 1.9% CVPC2 @ 53.1 ng/mL Total (will be labeled Intermediate) 2.3% CV (a), 5.77 ng/mL 12.4 ng/mL 2.6% CV (1) 2.3% CV (a) 39.7 ng/mL | | Within-run (will be labeled Repeatability) 1.2% CV @ 5.46 ng/ml 29.5 ng/ml 1.3% CV @ 93.5 ng/mL 1.3% CV (a), 301 ng/mL 1.5% CV @ 0.06 SDPC1 @ 4.44 ng/ml 1.4% CVPC2 57.9 ng/mL Total (will be labeled Intermediate) 2.5% CV (1), 5.46 ng/mL 29.5 ng/mL 4.2% CV (a) 93.5 ng/mL 4.1% CV (0), | | | | | | | | 2.4% CVPCI @ 5.86 ng/ml_ 2.7% CVPC2 (a), 53.1 ng/mL | 3.3% CV (0) 301 ng/mL 0.12 SD"Cl @ 4.44 ng/ml 3.0% CVPC2 57.9 חייוון 57.9 Precision testing was completed over 21 days, according to CLSI EP5-A2, utilizing human serum samples and PreciControl Cardiac II. | | | | | | | Analytical Sensitivity | Lower Detection Limit : <0.100 ng/ml | Limit of Blank (LoB): = 0.1 ng/ml Limit of Detection (Lol): = 0.3 ווו/שוו Limit of Quantitation (LoQ): = 1 ווישים ' Established according to CLSI EP17- A | | | | | | | Assay Comparison | | | | | | | | | Feature -- | Predicate Device: Elecsvs 3rd | | 4th Generation CK-MB STAT Assay | | | | | | | Generation CK-MB STAT Assay | | (modified) | | | | | | | 2. (K022654) | | | | | | | | Labeled Performance Characteristics | | | | | | | | | Analytical | Analyte | Reactivity | Same | | | | | | Specificity | CK-MM | None | | | | | | | | CK-BB | 0.10% | | | | | | | Hook Effect | There is no high-dose hook effect at | | Same | | | | | | | CK-MB concentrations up to 5000 | | | | | | | | | ng/ml_ | | | | | | | | Limitations | The assav is unaffected by: | | The assay is unaffected by: | | | | | | | Hemoglobin <1.5 g/dL. ● | | Hemoglobin ≤1000 mg/dL. | | | | | | | Bilirubin < 34 mg/dL | | Bilirubin ≤ 34 mg/dL ● | | | | | | | Intralipid < 1.500 mg/dL | | Intralipid ≤ 1.500 mg/dL � | | | | | | | Biotin < 100 ng/mL � | | Biotin ≤ 30 ng/mL ● | | | | | | | Rheumatoid factors ≤ 1.500 IU/mL � | | Rheumatoid factors ≤ 1,500 IU/mL | | | | | | | In vitro tests were performed on 50 | | lgG < 7 g/dl ● | | | | | | | commonly used pharmaceuticals. No | | lgM < 1 g/dl | | | | | | | interference with the assay was found. | | lgA ≤ 1.6 g/dl | | | | | | | In rare cases, interference due to | | Serum Albumin ≤ 20 g/dl | | | | | | | extremely high titers of antibodies to | | In vitro tests were performed on 51 | | | | | | | analyte-specific antibodies, streptavidin | | commonly used pharmaceuticals. No | | | | | | | or ruthenium can occur. These effects | | interference with the assay was found. | | | | | | | are minimized by suitable test design. | | In rare cases, interference due to | | | | | | | For diagnostic purposes, the results | | extremely high titers of antibodies to | | | | | | | should always be assessed in | | analyte-specific antibodies, streptavidin | | | | | | | conjunction with the patient's medical | | or ruthenium can occur. These effects | | | | | | | history, clinical examination and other | | are minimized by suitable test design. | | | | | | | findings. | | For diagnostic purposes, the results should | | | | | | | | | always be assessed in conjunction with the | | | | | | | | | patient`s medical history, clinical | | | | | | | | | examination and other findings. | | | | | | | | | These limitations were established by | | | | | | | | | testing performed with one human serum | | | | | | | | | sample containing low levels of CK-MB | | | | | | | | | and one human serum sample containing | | | | | | | | | high levels of CK-MB. | | | | | Comparison of Assays-Similarities and Differences, continued PC1=PreciControl Cardiac 1 PC2=PreciControl Cardiac 2 Continued on next page ______________________________________________________________________________________________________________________________________________________________________________ {10}------------------------------------------------ Comparison of Assays-Similarities and Differences, continued ### Table I CK-MB STAT 3rd Generation vs. CK-MB STAT 4th Generation, continued {11}------------------------------------------------ ### Comparison of Assays—Similarities and Differences, continued ### Table 1 CK-MB STAT 3td Generation vs. CK-MB STAT 4" Generation, continued | Feature | Predicate Device: Elecsys 3rd Generation CK-MB STAT Assay (K022654) | | 4th Generation CK-MB STAT Assay (modified) | | | | | | |----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------|--------------------------------------------|------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------|--------------------------------------|-------------------------| | Labeled Performance Characteristics | | | | | | | | | | Method Comparison performed on Serum Samples | n = 165 Min = 1.08 ng/ml Max = 283 ng/ml | Passing/Bablok | Linear Regression | | | | | | | | Slope | 1.053 | 1.067 | | | | | | | | Intercept | -0.525 | -0.740 | | | | | | | | Tau/r | 0.982 | 0.999 | | | | | | | Clinical Study/ Reference Range Study | N Women 760 Men 628 | Median 0.97 1.35 | 97.5th percentile (ng/m L) 2.88 4.94 | 99th percentile (ng/ mL) 3.77 6.73 | All Subjects Subjects with no Self-reported risk factors | Gender Female 523 Male 568 Female 120 Male 102 | (N) 5.34 10.36 4.30 7.70 | 99th percentile (ng/mL) | | Subjects represented "apparently heart healthy" population with exclusion of subjects with known poor cardiac health | | | | | | | | | {12}------------------------------------------------ #### Comparison of Assays-Similarities and Differences, continued #### Matrix Comparison Sodium-heparin, lithium-heparin, K2-EDTA, and K3-EDTA are permissible anticoagulants for use with this reagent because they do not interfere with recovery of CK-MB. In an internal study, 35 tubes were collected per anticoagulant. Plasma results were compared to serum results and percent recovery was determined. In terms of percent recovery, all data passed the following criteria: - Slope: 0.9-1.1 ◆ - Coefficient of correlation: Pearson r > 0.95 . - Intercept: ≤± 0.15 ● - For single sample pairs: 100% ±20% based on reference . | Anticoagulant | Sample Concentration Range Tested (ng/mL) | Claimed Measuring Range (ng/mL) | |---------------|----------------------------------------------|------------------------------------| | Na-heparin | 1.46-297.83 | 1.00 – 300 ng/mL | | Li-heparin | 1.39-244.83 | | | K2-EDTA | 1.58-299.65 | | | K3-EDTA | 1.56-291.89 | | In addition, method comparisons with plasma vs. serum were calculated with the following results: | Serum vs. Na-heparin Plasma : | P/B: y = 0.994x + (-0.0100), r = 0.9997 | |-------------------------------|-----------------------------------------| | Serum vs. Li-heparin Plasma: | P/B: y = 0.9960x + (0.0045), r = 0.9996 | | Serum vs. K₂-EDTA Plasma: | P/B: y = 1.020x + (-0.0082), r = 0.9999 | | Serum vs. K₃-EDTA Plasma: | P/B: y = 0.988x + (-0.0115), r = 0.9998 | {13}------------------------------------------------ | Table 2 4th Generation STAT vs. 4th Generation 18-Minute | | | |----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | Assay Comparison | | | | Feature | 4th Generation CK-MB STAT Assay | 4th Generation CK-MB 18-Minute assay (modified) | | | General Assay Features | | | Intended Use/ Indications for Use | Immunoassay for the in vitro quantitative determination of MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatine kinase are used as an aid in the diagnosis of myocardial infarction. | Same | | Assay Protocol | Two step Sandwich assay using biotinylated and ruthenium labeled antibodies and streptavidin microparticles | Same | | Detection Protocol | Electrochemiluminescent Immunoassay | Same | | Applications | STAT application (noted as CK-MB STAT in the labeling) | 18-minute application (noted as CK- MB in the labeling). | # Table 2 4th Generation STAT vs. 4th Generation 18-Minute {14}------------------------------------------------ | Table 2 4th Generation STAT vs. 4th Generation 18-Minute, continued Assay Comparison | | | |-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | 4th Generation CK-MB STAT Assay | 4th Generation CK-MB 18-minute assay (modified)…