(20 days)
Not Found
No
The description details a standard immunoassay with electrochemiluminescence detection and calibration curves, with no mention of AI or ML technologies.
No
The device is an immunoassay for in vitro diagnostic (IVD) use, intended to measure creatine kinase MB, which aids in the diagnosis and treatment of conditions like myocardial infarction, but it does not directly treat a disease.
Yes.
The device measures creatine kinase MB isoenzymes, which are used in the diagnosis and treatment of myocardial infarction and muscle diseases.
No
The device description clearly states it is an immunoassay using streptavidin microparticles and electrochemiluminescence detection, which are hardware components and chemical reagents, 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 it is an "Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Purpose: The intended use also describes that the measurements are "used in the diagnosis and treatment of myocardial infarction and muscle diseases." This indicates the device is used to analyze samples taken from the human body to provide information for medical purposes, which is the definition of an IVD.
- Device Description: The description details a laboratory-based immunoassay process using human serum and plasma samples, further confirming its use outside of the living body.
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.
For quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma.
Diagnosis of myocardial ischemia, e.g. in acute myocardial infarction, myocarditis, etc.
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. 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.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JHY
Device Description
The ELECSYS® CK-MB STAT and Elecsys® CK-MB Assays are a two step 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 provided with the reagent bar code.
The Elecsys® CK-MB application is identical to the Elecsys® CK-MB STAT assay, the only difference being the length of incubation (18 minutes vs. 9 minutes).
Two-step sandwich assay using biotinylated and ruthenium labeled antibodies and streptavidin microparticles with electrochemiluminescent detection.
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
Not Found
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)
Not Found
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
510(k) Summary - ELECSYS® CK-MB STAT and ELECSYS® CK-MB Assays K022654
| 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 Corporation | |
| 9115 Hague Rd | ||
| Indianapolis IN 46250 | ||
| (317) 521-3831 |
Contact person: Sherri L. Coenen
Date prepared: August 8, 2002 | |
| Device Name | Proprietary name: ELECSYS® CK-MB STAT
ELECSYS® CK-MB
Common name: Electrochemiluminescent immunoassay for the detection of CK-MB
Classification name: Creatine Kinase Test | |
| Device description | The ELECSYS® CK-MB STAT and Elecsys® CK-MB Assays are a two step 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 provided with the reagent bar code.
The Elecsys® CK-MB application is identical to the Elecsys® CK-MB STAT assay, the only difference being the length of incubation (18 minutes vs. 9 minutes). | |
| Intended use | Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. | |
| Predicate | We claim substantial equivalence to the currently marketed Elecsys® CK-MB | |
| Device | STAT Assay. (K974421). | |
| Reagent | The following table describes the similarities and differences between the | |
| Summary | original Elecsys® CK-MB STAT and restandardized assays. | |
1
510(k) Summary - ELECSYS® CK-MB STAT and ELECSYS®
• のお気になる。
CK-MB, continued
| Characteristic | CK-MB STAT
(original device) | CK-MB STAT
(modified Device) | CK-MB
(modified Device) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------------|
| Intended Use | For quantitative
determination of the MB
isoenzyme of creatine
kinase in human serum
and plasma. | Same | Same |
| Indications for
Use | Diagnosis of myocardial
ischemia, e.g. in acute
myocardial infarction,
myocarditis, etc. | Same | Same |
| Sample types | Serum, plasma (Li-, Na-
heparin, K2-EDTA, Na-
citrate) | Serum, plasma (Li-,
Na- heparin, K3-
EDTA, Na-citrate) | Same |
| Assay | Two-step sandwich assay
using biotinylated and
ruthenium labeled
antibodies and
streptavidin
microparticles with
electrochemiluminescent
detection | Same | Same |
| Antibodies | Murine monoclonal | Same | Same |
| Incubation
time | 9 minutes | 9 minutes | 18 minutes |
| Measuring
range | 0.100 - 500.0 ng/ml | Same | Same |
| Analytical
specificity | 0.100 ng/ml | Same | Same |
2
510(k) Summary - ELECSYS® CK-MB STAT and ELECSYS® CK-MB, continued
| Characteristic | CK-MB STAT
(original device) | CK-MB STAT
(modified Device) | CK-MB
(modified
Device) |
|--------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Expected
values | • Median in healthy
individuals 1.2 ng/ml
• Recommended
threshold 5 ng/ml | • Median:
women 0.97 ng/ml
men 1.35 ng/ml
• 97.5th percentile:
women 2.88 ng/ml
men 4.94 ng/ml
• 99th percentile:
women 2.88 ng/ml
men 6.73 ng/ml | Same |
| Standardization | Calibrated against
commercially available
CK-MB test
(microparticle
immunoassay) | Calibrated against
AACC CK-MB
reference material
(human recombinant
CK-MB) | Same |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 9 2002
Ms. Sherri L. Coenen Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K022654
Trade/Device Name: Elecsys® CK-MB STAT and Elecsys® CK-MB Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHY Dated: August 8, 2002 Received: August 9, 2002
Dear Ms. Coenen:
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.
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 the Code of Federal 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 (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 2
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): N/A
Device Name: ELECSYS® CK-MB
Indications For Use:
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. 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.
022654
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys® 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
Alain Cooger
(Division Sign-Off) (Division of Clinical Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V Over-The-Counter Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
6
INDICATIONS FOR USE STATEMENT
Page 2 of 2
510(k) Number (if known): N/A K 022265 4
Device Name: ELECSYS® CK-MB STAT
Indications For Use:
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. 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.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010 / 2010 and Modular Analytics E170 (Elecsys module) Immunoassay Analyzers.
Tom Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 1022405 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrenee of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)