CREATINE KINASE (CK)

K981218 · Abbott Laboratories · CGS · May 1, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981218
• Device Name: CREATINE KINASE (CK)
• Applicant: Abbott Laboratories
• Product Code: CGS · Clinical Chemistry
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Creatine Kinase assay is used for the quantitation of creatine kinase in human 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.

Device Story

In vitro diagnostic assay for quantitative determination of creatine kinase (CK) activity in human serum; utilizes enzymatic reaction where CK catalyzes phosphate transfer from creatine phosphate to ADP; ATP produced phosphorylates glucose via hexokinase; glucose-6-phosphate oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) reducing NAD to NADH; rate of NADH formation monitored at 340 nm proportional to CK activity; reagent includes AMP and di-(adenosine-5')-pentaphosphate to inhibit adenylate kinase interference; used in clinical laboratory settings; results interpreted by healthcare providers to assist in diagnosis and management of myocardial infarction and muscle disorders.

Clinical Evidence

Bench testing only. Method comparison study using ALCYON Analyzer vs. Roche Cobas Mira Plus showed correlation coefficient of 0.9972, slope 1.007, and Y-intercept -8.757 U/L. Precision studies (within-run, between-run, between-day) yielded total %CV of 2.6% (Level 1) and 2.3% (Level 2). Assay linearity established up to 2,100 U/L; limit of quantitation is 12 U/L.

Technological Characteristics

In vitro diagnostic enzymatic assay; photometric detection at 340 nm; utilizes hexokinase/G-6-PDH coupled reaction; includes AMP and di-(adenosine-5')-pentaphosphate as inhibitors; linear range up to 2,100 U/L; intended for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of creatine kinase in human serum to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, including progressive 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

• Roche Cobas Mira Plus Automated Chemistry System CK NAC assay (K834502)

Submission Summary (Full Text)

{0}------------------------------------------------

KG81218

#### MAY 1 1998 510(k) Summary

Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | April 02, 1998 |
|--------------------------------------------------|-----------------|
| Device Trade or Proprietary Name: | CK |
| Device Common/Usual Name or Classification Name: | Creatine Kinase |
| Classification Number/Class: | 75CGS/Class II |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

### Test Description:

Creatine Kinase (CK) is an in vitro diagnostic assay for the quantitative determination of creatine kinase activity in human serum. The Creatine Kinase assay is a clinical chemistry assay in which creatine kinase in the sample catalyzes the transfer of a high energy phosphate group from creatine phosphate to ADP. The ATP produced in this reaction is subsequently used to phosphorylate glucose to produce glucose-6-phosphate (G-6-P) in the presence of hexokinase. G-6-P is then oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the concomitant reduction of NAD to NADH. The rate of formation of NADH is monitored at 340 nm and is proportional to the activity of CK in the sample. This reagent also contains AMP and di-(adenosine-5')-pentaphoshate to prevent interference from adenylate kinase.

Creatine Kinase 510(k) April 2, 1998 CkfE2.lwp

Section II Page 1

Image /page/0/Picture/11 description: The image shows a sequence of numbers. The sequence is composed of zeros and ones. Specifically, the sequence is "0000011".

{1}------------------------------------------------

## Substantial Equivalence:

The Creatine Kinase assay is substantially equivalent to the Roche® Cobas Mira® Plus Automated Chemistry System CK NAC assay (K834502).

Both assays yield similar Performance Characteristics.

Similarities:

- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of creatine kinase . activity.
- . Both assays yield similar clinical results.

Differences:

- There is a minor difference between the assay range. .
#### Intended Use:

The Creatine Kinase assay is used for the quantitation of creatine kinase in human serum.

#### Performance Characteristics:

Comparative performance studies were conducted using the ALCYON™ Analyzer. The Creatine Kinase assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay. The correlation coefficient = 0.9972. slope = 1.007, and Y-intercept = - 8.757 U/L. Precision studies were conducted using the Creatine Kinase assay. Within-run, between-run, and between-day studies were performed using two levels of control material. The total %CV for Level 1/Panel 111 is 2.6% and 2.3% for Level 2/ Panel 112. The Creatine Kinase assay is linear up to 2,100 U/L. The limit of quantitation (sensitivity) for the Creatine Kinase assay is 12 U/L. These data demonstrate that the performance of the Creatine Kinase assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay.

Creatine Kinase 510(k) April 2, 1998 CkfE2.lwp

Section II Page 2

Image /page/1/Picture/15 description: The image shows the number 0000012. The number is written in a bold, sans-serif font. The numbers are all the same size and are evenly spaced. The number is black and the background is white.

{2}------------------------------------------------

# Conclusion:

The Creatine Kinase assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System CK NAC assay as demonstrated by results obtained in the studies.

Creatine Kinase 510(k) April 2, 1998
CkfE2.lwp

Section II Page 3

Image /page/2/Picture/4 description: The image shows a sequence of numbers, specifically "0000013". The number is written in a bold, sans-serif font. The numbers are all the same size and are evenly spaced.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

1 1998 MAY

Mark Littlefield . Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

K981218 Re: Creatine Kinase Regulatory Class: II ପ୍ରତିଶତ Product Code: Dated: April 2, 1998 Received: April 3, 1998

Dear Mr. Littlefield:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set --forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact. the Centers for Disease Control and Prevention (CDC) at [phone].

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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}------------------------------------------------

K991218 510(k) Number (if known): __

Creatine Kinase Device Name:

Indications For Use:

The Creatine Kinase assay is used for the quantitation of creatine kinase in human 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.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number.
KC984218

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use ------------------------------------Prescription Use OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)

00000000