MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

K022654 · Roche Diagnostics Corp. · JHY · Aug 29, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022654
• Device Name: MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
• Applicant: Roche Diagnostics Corp.
• Product Code: JHY · Clinical Chemistry
• Decision Date: Aug 29, 2002
• 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 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.

Device Story

The Elecsys CK-MB and CK-MB STAT are in vitro diagnostic immunoassays for quantifying CK-MB isoenzyme in human serum and plasma. The device utilizes a two-step sandwich immunoassay principle with biotinylated and ruthenium-labeled antibodies and streptavidin-coated microparticles. Detection is achieved via electrochemiluminescence (ECLIA). The system is designed for use on Roche Elecsys 1010/2010 and Modular Analytics E170 analyzers. The STAT version features a 9-minute incubation time, while the standard version requires 18 minutes. Results are calculated using a 2-point calibration curve and a master curve provided via reagent barcode. The device is operated by laboratory personnel in clinical settings. Quantitative results assist clinicians in diagnosing myocardial infarction and monitoring muscle diseases, facilitating timely clinical intervention.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on analytical performance comparisons, including measuring range, analytical specificity, and standardization against AACC reference material.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles; biotinylated and ruthenium-labeled murine monoclonal antibodies. Operates on Roche Elecsys 1010/2010 and Modular Analytics E170 analyzers. Measuring range: 0.100–500.0 ng/mL. Standardization: AACC CK-MB reference material (human recombinant CK-MB).

Indications for Use

Indicated for the quantitative determination of CK-MB isoenzyme in human serum and plasma to aid in the diagnosis and treatment of myocardial infarction and muscle diseases (e.g., Duchenne-type muscular dystrophy).

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 (K974421)

Submission Summary (Full Text)

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### 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<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone]<br><br>Contact person: Sherri L. Coenen<br><br>Date prepared: August 8, 2002 | |
| Device Name | Proprietary name: ELECSYS® CK-MB STAT<br>ELECSYS® CK-MB<br>Common name: Electrochemiluminescent immunoassay for the detection of CK-MB<br><br>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.<br><br>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.<br><br>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. | |

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# 510(k) Summary - ELECSYS® CK-MB STAT and ELECSYS®

• のお気になる。

CK-MB, continued

| Characteristic | CK-MB STAT<br>(original device) | CK-MB STAT<br>(modified Device) | CK-MB<br>(modified Device) |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------------|
| Intended Use | For quantitative<br>determination of the MB<br>isoenzyme of creatine<br>kinase in human serum<br>and plasma. | Same | Same |
| Indications for<br>Use | Diagnosis of myocardial<br>ischemia, e.g. in acute<br>myocardial infarction,<br>myocarditis, etc. | Same | Same |
| Sample types | Serum, plasma (Li-, Na-<br>heparin, K2-EDTA, Na-<br>citrate) | Serum, plasma (Li-,<br>Na- heparin, K3-<br>EDTA, Na-citrate) | Same |
| Assay | Two-step sandwich assay<br>using biotinylated and<br>ruthenium labeled<br>antibodies and<br>streptavidin<br>microparticles with<br>electrochemiluminescent<br>detection | Same | Same |
| Antibodies | Murine monoclonal | Same | Same |
| Incubation<br>time | 9 minutes | 9 minutes | 18 minutes |
| Measuring<br>range | 0.100 - 500.0 ng/ml | Same | Same |
| Analytical<br>specificity | 0.100 ng/ml | Same | Same |

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## 510(k) Summary - ELECSYS® CK-MB STAT and ELECSYS® CK-MB, continued

| Characteristic | CK-MB STAT<br>(original device) | CK-MB STAT<br>(modified Device) | CK-MB<br>(modified<br>Device) |
|--------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Expected<br>values | • Median in healthy<br>individuals 1.2 ng/ml<br>• Recommended<br>threshold 5 ng/ml | • Median:<br>women 0.97 ng/ml<br>men 1.35 ng/ml<br>• 97.5th percentile:<br>women 2.88 ng/ml<br>men 4.94 ng/ml<br>• 99th percentile:<br>women 2.88 ng/ml<br>men 6.73 ng/ml | Same |
| Standardization | Calibrated against<br>commercially available<br>CK-MB test<br>(microparticle<br>immunoassay) | Calibrated against<br>AACC CK-MB<br>reference material<br>(human recombinant<br>CK-MB) | Same |

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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)

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### 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)