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

Roche Diagnostics filed the 510(k) submission for ELECSYS CK-MB STAT IMMUNOASSAY (K140404).

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

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

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

Elecsys CK-MB STAT Immunoassay (K132571).

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

K140404 · Roche Diagnostics · JHY · May 8, 2014 · Clinical Chemistry

Device Facts

Record ID	K140404
Device Name	ELECSYS CK-MB STAT IMMUNOASSAY
Applicant	Roche Diagnostics
Product Code	JHY · Clinical Chemistry
Decision Date	May 8, 2014
Decision	SESE
Submission Type	Special
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 Immunoassay is a sandwich immunoassay used for the quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. It utilizes streptavidin-coated microparticles and electrochemiluminescence (ECLIA) detection. The device is intended for use on Roche cobas e immunoassay analyzers by laboratory professionals. The assay process involves a one-step incubation where the sample, biotinylated monoclonal anti-CK-MB antibody, ruthenium-labeled monoclonal CK-MB-specific antibody, and streptavidin-coated microparticles are added simultaneously to form a sandwich complex. This complex binds to the solid phase. The analyzer measures the electrochemiluminescent signal, and results are calculated using a calibration curve generated by a 2-point calibration and a master curve provided via reagent barcode. The output provides clinicians with quantitative CK-MB levels, which serve as an aid in the diagnosis of myocardial infarction, enabling timely clinical decision-making for cardiac patients.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm that the one-step incubation modification meets acceptance criteria. Risk analysis conducted using ALARP methodology.

Technological Characteristics

Sandwich immunoassay using biotinylated and ruthenium-labeled antibodies with streptavidin-coated microparticles. Detection via electrochemiluminescence. Operates on cobas e 601 immunoassay analyzers. Reagent stability: 8 weeks on-analyzer. Calibration: 2-point calibration with master curve via barcode. Standards: CLSI EP5-A2, EP17-A, EP6-A.

Indications for Use

Indicated for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma to 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 CK-MB STAT Immunoassay (K132571)

Related Devices

K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY · Roche Diagnostics · Oct 18, 2013
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}------------------------------------------------ ## Special 510(k) Summary | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Submitter Name, Address, Contact | Roche Diagnostics 9115 Hague Road, PO. Box 0416 Indianapolis, IN 46250-50416 Contact Person: Kelli Turner Phone: (317) 521-4515 FAX: (317) 521-2324 Email: kelli.turner@roche.com Date Prepared: April 28, 2014 | | | Device Name | Proprietary name: | Elecsys CK-MB STAT Immunoassay | | | Common name: | CK-MB STAT Assay | | | Classification name: | Colorimetric method; Cpk or Isoenzymes | | | Product Code: | JHY | | | Predicate Device: | CK-MB STAT Immunoassay, Roche | Continued on next page Roche Diagnostics {1}------------------------------------------------ Establishment For the CK-MB STAT Assay, the establishment registration number for Registration Roche Diagnostics GmbH in Mannheim, Germany, is 9610126 and for Penzberg, Germany, is 9610529. The establishment registration number for Roche Diagnostics United States is 1823260 Classification . The FDA has classified the CK-MB STAT as a Class II device. | Panel | Product Code | Classification Name | Regulation Citation | |--------------------|-----------------|-------------------------------------------|---------------------| | Clinical Chemistry | JHY | Colorimetric Method, Cpk Or Isoenzymes | 21 CFR 862.1215 | Performance To date, no performance standards that affect this device have been Standards finalized under Section 514 of the Act. Proposed draft labeling sufficient to describe the device, the intended use, Proposed Labeling and the directions for use on the cobas e 601 immunoassay analyzer is attached. We believe the draft version of the device labeling presented in Section V contains all of the technical information required per 21 CFR 809.10 for the CK-MB STAT (one-step incubation) Assays. {2}------------------------------------------------ | Analyzer Platform | Precision of the CK-MB STAT (one-step incubation) assay was evaluated on one cobas e 601 Immunoassay Analyzers according to CLSI EP5-A2 guidelines. A method comparison between the Elecsys CK-MB STAT (two-step incubation) and CK-MB STAT (one-step incubation) was performed and summarized in Section III, 510(k) summary, Method Comparison. | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description | The CK-MB STAT (one-step incubation) Assay is a sandwich immunoassay 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 (one-step incubation) application is identical to the CK- MB STAT (two-step incubation) assay, the only difference being for the CK- MB STAT (one-step incubation) application, the sample, reagent 1, reagent 2 and microparticles are added at one time. | | | Note: Calibrators and controls are packaged and sold separately. | Intended Use Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated and cobas e immunoassay analyzers. {3}------------------------------------------------ | 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. | | Substantial Equivalence | The CK-MB STAT Immunoassay is substantially equivalent to other devices legally marketed in the United States. CK-MB STAT (one-step incubation) Immunoassays, is equivalent to CK-MB STAT (two-step) Immunoassay, Roche Diagnostics (K132571). | | Substantial Equivalence Comparison | The following table compares the CK-MB STAT Immunoassay (one- step incubation) with the predicate device. | Continued on next page · . {4}------------------------------------------------ ### Comparison of Assays, Similarities and Differences ### Table 1 CK-MB STAT (two-step incubation) vs. CK-MB STAT (one-step incubation) | Assay Comparison | | | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | Feature | Predicate Device: Elecsys CK-MB STAT (two-step incubation) Assay (K132571) | CK-MB STAT (one-step incubation) 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. The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers. | Same | | Assay Protocol | Two step Sandwich assay using biotinylated and ruthenium labeled antibodies and streptavidin microparticles | Sandwich assay using biotinylated and ruthenium labeled antibodies and streptavidin microparticles | | Detection Protocol | Electrochemiluminescent Immunoassay | Same | | Applications | STAT (9 minute) application | Same | {5}------------------------------------------------ ### Comparison of Assays—Similarities and Differences, continued · Table 1 continued | Assay Comparison | | | | | | | | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------|------------------------|--| | Feature | Predicate Device: Elecsys CK-MB STAT (two-step incubation) Assay (K132571) | CK-MB STAT (one-step incubation) Assay (modified) | | | | | | | General Assay Features | | | | | | | | | Instrument Platform | cobas e 411 | Roche cobas e 601 | | | | | | | Sample Volume | 15 µL | Same | | | | | | | Sample Type | Human serum and plasma treated with K2-EDTA, K3-EDTA, and lithium heparin and sodium heparin plasma. | Same | | | | | | | | Specification | Na Hepar in Plasma | Li Hepar in Plasma | K2-EDTA Plasma | K3-EDTA Plasma | | | | | Sample size normally filled tubes | at least 30 | 35 | 34 | 35 | 35 | | | | Slope (BaPa) | 0.9 - 1.1 | 0.994 | 0.996 | 1.020 | 0.988 | | | | Intercept (BaPa) | ≤ +/- 0.15 | 0.0010 | 0.0045 | 0.0082 | 0.0115 | | | | Correlation on r | > 0.95 | 0.9997 | 0.9996 | 0.9999 | 0.9998 | | | | Relative deviation for single sample pairs | +/- 20% | max deviation on 14.6 % | max deviation on 12.0 % | max deviation on 10.5 % | max deviation on 8.7 % | | | 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 | | Sandwich principle. Total duration of assay: 9 minutes • Antigen in the sample (15 µL), a biotinylated monoclonal anti-CK-MB antibody, a monoclonal CK-MB-specific antibody labeled with a ruthenium complex and streptavidin-coated microparticles react to form a sandwich complex, which is bound to a solid phase | | | | | {6}------------------------------------------------ ### Comparison of Assays—Similarities and Differences, continued ### Table 1 continued | Assay Comparison | | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | Feature | Predicate Device: Elecsys CK-MB STAT (two-step incubation) Assay (K132571) | CK-MB STAT (one-step incubation) Assay (modified) | | General Assay Features | | | | Calibrator | CK-MB STAT CalSet | Same | | 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: • After 12 weeks 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 | Same | | Controls | Elecsys PreciControl Cardiac II | Same | {7}------------------------------------------------ ### Comparison of Assays—Similarities and Differences, continued . Table 1 continued : | Assay Comparison | | | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Predicate Device: Elecsys CK-MB STAT (two-step incubation) Assay (K132571) | CK-MB STAT (one-step incubation) Assay (modified) | | General assay features | | | | Traceability / Standardization | The CK-MB STAT assay is traceable to the Abbott IMx CK-MB assay and linearized using human recombinant CK-MB from Seradyn | Same | | Reagent Stability | Unopened: 2-8°C - Up to the stated expiration date Opened 2-8°C - 12 weeks On Analyzers - 8 weeks | Same | | Linearity determined with serum samples. | Series 1: y=0.9421 -0.0579 Series 2: y=0.9348-0.116 Series 3: y=0.942-0.0964 | Series 1: y=0.9571 -0.1267 (range: 0.27 to 563 ng/mL) Series 2: y=0.9499-0.0957 (range: 0.13 to 548 ng/mL) Series 3: y=0.9576-0.1188 (range: 0.16 to 328 ng/mL) Note: linearity was established at ± 11.3% within the stated measuring range. | {8}------------------------------------------------ ### Comparison of Assays—Similarities and Differences, continued ### Table 1 continued | Assay Comparison | | | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Predicate Device: Elecsys CK-MB STAT (two-step incubation) Assay (K132571) | CK-MB STAT (one-step incubation) Assay (modified) | | | Labeled Performance Characteristics | | | Measuring Range | 1-300 ng/mL | Same | | Precision | cobas e 411: Within-run (will be labeled Repeatability) 1.2% CV @ 5.46 ng/mL 1.3% CV @ 29.5 ng/mL 1.3% CV @ 93.5 ng/mL 1.5% CV @ 301 ng/mL 1.3% CVPC1 @ 4.44 ng/mL 1.4% CVPC2 @ 57.9 ng/mL Total (will be labeled Intermediate) 2.5% CV @ 5.46 ng/mL 4.2% CV @ 29.5 ng/mL 4.1% CV @ 93.5 ng/mL 3.3% CV @ 301 ng/mL 2.6% CVPC1 @ 4.44 ng/mL 3.0% CVPC2 @ 57.9 ng/mL | cobas e 601: Within-run (will be labeled Repeatability) 1.1% CV @ 5.34 ng/mL 1.1% CV @ 27.3 ng/mL 1.1% CV @ 89.2 ng/mL 0.8% CV @ 283 ng/mL 1.2% CVPC1 @ 4.27 ng/mL 0.9% CVPC2 @ 54.3 ng/mL Total (will be labeled Intermediate) 1.4% CV @ 5.34 ng/mL 3.2% CV @ 27.3 ng/mL 2.5% CV @ 89.2 ng/mL 2.2% CV @ 283 ng/mL 1.4% CVPC1 @ 4.27 ng/mL 1.3% CVPC2 @ 54.3 ng/mL | | Analytical Sensitivity | Limit of Blank (LoB): = 0.1 ng/ml Limit of Detection (LoD): = 0.3 ng/ml Limit of Quantitation (LoQ): = 1 ng/ml Established according to CLSI EP17- A | Same | | Feature | Predicate Device: Elecsys CK-MB STAT (two-step incubation) Assay (K132571) | CK-MB STAT (one-step incubation) Assay (modified) | | Labeled Performance Characteristics | | | | Analytical Specificity | Analyte Reactivity | Same | | | CK-MM None | | | | CK-BB 0.10% | | | Hook Effect | There is no high-dose hook effect at CK-MB concentrations up to 5000 ng/mL | Same | | Limitations | Each interferent was evaluated at 11 numerical values. All samples were tested in duplicate. The results reported represent recovery of ± 10 % compared to the unspiked reference sample. The results of the interferences are presented below: | Same | | | Interferent tested No interference up to | | | | Intralipid® (Lipemia) 2000 mg/dL | | | | Biotin 50 ng/mL | | | | Bilirubin 40 mg/dL | | | | Hemoglobin 1000 mg/dL | | | | Rheumatoid Factor 1700 IU/mL | | | | Human Serum albumin 14 g/dL | | | | Human IgG 7 g/dL | | | | Human IgM 1 g/dL | | | | Human IgA 1.6 g/dL | | | Assay Comparison | | | | Feature | Predicate Device: Elecsys CK-MB STAT (two-step incubation) Assay (K132571) | CK-MB STAT (one-step incubation) Assay (modified) | | | Labeled Performance Characteristics | | | Limitations, continued | In vitro tests were performed on 18 commonly used pharmaceuticals. No interference with the assay was found. Criterion: Recovery within ± 10% compared to the unspiked reference sample. | Same | | These included samples with the following: | | | | | Drug | Concentration | | | Acetylcysteine | 150 mg/L | | | Ampicillin-Na | 1000 mg/L | | | Ascorbic acid | 300 mg/L | | | Ca- Dobesilate | 200 mg/L | | | Cyclosporine | 5 mg/L | | | Cefoxitin | 2500 mg/L | | | Heparin | 5000 U | | | Intralipid | 10000 mg/L | | | Levodopa | 20 mg/L | | | Methyldopa + 1.5 H2O | 20 mg/L | | | Metronidazole | 200 mg/L | | | Phenylbutazone | 400 mg/L | | | Doxycycline | 50 mg/L | | | Acetylsalicylic Acid | 1000 mg/L | | | Rifampicin | 60 mg/L | | | Acetaminophen | 200 mg/L | | | Ibuprofen | 500 mg/L | | | Theophylline | 100 mg/L…