(79 days)
Not Found
No
The summary describes a standard immunoassay with electrochemiluminescence detection and calibration curves. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
This device is an immunoassay designed for diagnostic purposes to measure the MB isoenzyme of creatine kinase, which aids in the diagnosis of myocardial infarction. It does not provide therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "used as an aid in the diagnosis of myocardial infarction."
No
The device is an immunoassay kit, which is a chemical reagent system used on specific hardware analyzers. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD. It also mentions the use of the measurements "as an aid in the diagnosis of myocardial infarction," which is a diagnostic purpose.
- Device Description: The description details a laboratory test using biological samples (serum and plasma) and reagents to measure a specific analyte (CK-MB). This is characteristic of an IVD.
- Intended User/Care Setting: The mention of "For prescription use only" suggests use in a clinical or laboratory setting under the direction of a healthcare professional, which is typical for IVDs used in diagnosis.
- Performance Studies and Key Metrics: The document provides details on performance studies (precision, method comparison) and key metrics (sensitivity, specificity, limits of detection/quantitation, interference). This type of data is required for IVDs to demonstrate their analytical and clinical performance.
- Predicate Device(s): The listing of a predicate device with a K number (K132571) indicates that this device is being compared to a previously cleared IVD by the regulatory body (likely the FDA in the US context, given the K number format).
All of these elements strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatinine 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.
Product codes (comma separated list FDA assigned to the subject device)
JHY
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.
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
Not Found
Intended User / Care Setting
For prescription use only
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Study/reference range:
Gender (N)
Female: 523 (99th percentile: 5.34 ng/mL)
Male: 568 (99th percentile: 10.36 ng/mL)
Subjects with no Self-reported risk factors:
Female: 120 (99th percentile: 4.30 ng/mL)
Male: 102 (99th percentile: 7.70 ng/mL)
Subjects represented "apparently heart healthy" population with exclusion of subjects with known poor cardiac health or known peripheral vascular disease only.
Method Comparison Elecsys CK-MB STAT on cobas e 411(two-step incubation) vs. Elecsys CK-MB STAT on cobas e 601 (one-step incubation):
n = 115
Min = 1.47 ng/ml
Max = 269 ng/ml
Passing/Bablok
Slope: 0.976
Intercept: 0.053
Tau: 0.991
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
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 |
| Assay Comparison | | |
| Feature | Predicate Device: Elecsys CK-MB
STAT (two-step incubation) Assay
(K132571) | CK-MB STAT (one-step incubation)
Assay (modified) |
| Limitations,
continued | Labeled Performance Characteristics | |
| | Testing was performed on 33 special drugs
with concentrations shown in the table
below. No interference with the assay was
found. Criterion: Recovery within ± 10%
compared to the unspiked reference
sample. | Same |
| | Special Drug | Concentration |
| | Carvedilol | 50 mg/L |
| | Propanolol | 160 mg/L |
| | Marcumar | 9 mg/L |
| | Reteplase | 20 U/L |
| | Suprarenin
(Adrenalin) | 3 mg/L |
| | Methylprednislon | 40 mg/L |
| | Verapamil | 480 mg/L |
| | Lidocain | 500 mg/L |
| | Enalapril | 40 mg/L |
| | Captopril | 150 mg/L |
| | Lisinopril | 40 mg/L |
| | Aldactone
(Spironolacton) | 400 mg/L |
| | Torasemid | 5 mg/L |
| | Insulin | 150 I.U. |
| | Tolbutamid | 10.5 mg/L |
| | Gentamycin | 420 mg/L |
| | Lovostatin | 80 mg/L |
| | Pravastatin | 8 mg/L |
| | Simvastin | 80 mg/L |
| | Bisprolol | 20 mg/L |
| | Nitrolingual
(Glyceroltrinitrat) | 1.6 mg/L |
| | Heparin | 7500 I.U. |
| | Metropolol | 200 mg/L |
| | Molsidomin | 16 mg/L |
| | Nicardipin | 160 mg/L |
| | Nifedipin | 60 mg/L |
| | Propafenon | 900 mg/L |
| | Solatol | 480 mg/L |
| | Streptokkinase | 10 000 000 I.U. |
| | Urokinase | 4200000 mg/L |
| | Digoregen (Digoxin) | 0.5 mg/L |
| | Digimerck minor
(Digitoxin) | 0.21 mg/L |
| | Clopidrogel | 300 mg/L |
| 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 rare cases, interference due to
extremely high titers of antibodies to
analyte-specific antibodies, streptavidin
or ruthenium can occur. These effects
are minimized by suitable test design.
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 scrum
sample containing low levels of CK-MB
and one human serum sample containing
high levels of CK-MB. | Same |
PC1=PreciControl Cardiac 1
PC2=PreciControl Cardiac 2
Continued on next page
.
9
Comparison of Assays-Similarities and Differences, continued
Table 1 continued
10
11
12
Continued on next page
.
13
Comparison of Assays-Similarities and Differences, continued
| Feature | Predicate Device: Elecsys CK-MB
STAT (two-step incubation) Assay
(K132571) | CK-MB STAT (one-step
incubation) Assay (modified) | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------|-------------------------------|-------|
| | Labeled Performance Characteristics | | | |
| Clinical
Study/
reference
range | | Gender (N) | 99th
percentile
(ng/mL) | Same |
| | All
Subjects | Female | 523 | 5.34 |
| | Subjects | Male | 568 | 10.36 |
| | Subjects
with no
Self-
reported
risk
factors | Female | 120 | 4.30 |
| | | Male | 102 | 7.70 |
| Subjects represented "apparently heart
healthy" population with exclusion of
subjects with known poor cardiac health
or known peripheral vascular disease
only. | | | | |
| Additional Performance Characteristics | | | | |
| Method
Comparison
Elecsys CK-MB
STAT on cobas
e 411(two-step
incubation) vs.
Elecsys CK-MB
STAT on cobas
e 601 (one-step
incubation) | n = 115 | | Passing/Bablok | |
| | Min = 1.47 ng/ml | | | |
| | Max = 269 ng/ml | | | |
| | Slope | | | 0.976 |
| | Intercept | | | 0.053 |
| | Tau | | | 0.991 |
Continued on next page
- 100
14
| Standard/
Guidance
Document
Reference | In addition to FDA guidance regarding 510(k) submissions, the following
standards were used for the performance studies. |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Evaluation of Precision Performance of Quantitative
Measurement Methods; Approved Guideline – Second Edition.
CLSI document EP5-A2, Volume 24, No. 25, August 2004. |
| | • Protocols for Determination of Limits of Detection and Limits of
Quantitation; Approved Guideline. CLSI document EP 17-A,
Volume 24, No. 34, October 2004. |
| | • Evaluation of the Linearity of Quantitative Measurement
Procedures: A Statistical Approach; Approved Guideline. CLSI
document EP6-A, Volume 23, No. 16, April 2003. |
| | Data for CK-MB STAT (one-step incubation) is on file at Roche
Diagnostics. |
| Conclusion | The submitted information in this premarket notification supports a
substantial equivalence decision. The differences between predicate and
candidate do not impact the indications for use or technological
characteristics. |
15
Image /page/15/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2014
ROCHE DIAGNOSTICS KELLI TURNER REGULATORY AFFAIRS PRINCIPLE 9115 HAGUE ROAD INDIANAPOLIS IN 46250
Re: K140404
:
Trade/Device Name: Elecsys CK-MB STAT Immunoassay Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinasc/creatine kinase or isoenzymes test system Regulatory Class: II Product Code: JHY Dated: April 07, 2014 Received: April 08, 2014
Dear Ms. Turner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Eederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (2) CFR Parts 801 and 809): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
16
Page 2-Ms. Turner
If you desire specific advice for your device on our labeling regulations (2) CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
Courtney H. Lias. Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
17
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Elecsys CK-MB STAT Immunoassay
Indications for Use (Describe)
Immunoassay for the in vitro quantitation of the MB iscenzyme of creatine kinasc in human secum and plasma. Measurements of the MB isoenzyme of creatine kinase are used as an aid in the diagnosis of myocardial infanction.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement on last page.
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)