K Number
K973999
Device Name
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30
Date Cleared
1998-03-11

(141 days)

Product Code
Regulation Number
862.1215
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitative determination of creatine kinase in serum. For IN VITRO diagnostic use.
Device Description
Creatine Kinase-SL Assay, Catalogue Number 326-10, 326-30
More Information

Not Found

Not Found

No
The summary describes a standard in vitro diagnostic assay for creatine kinase, with no mention of AI, ML, image processing, or any other indicators of AI/ML technology.

No
The device is described as being for "IN VITRO diagnostic use," meaning it is used for testing samples outside the body to diagnose conditions, not to treat them.

Yes
The "Intended Use / Indications for Use" section explicitly states "For IN VITRO diagnostic use," which indicates it is a diagnostic device used for the quantitative determination of creatine kinase in serum.

No

The device description clearly states it is an "Assay" with "Catalogue Number 326-10, 326-30", indicating a physical kit or reagent for in vitro diagnostic use, not a software-only device.

Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).

The key phrase that confirms this is:

"For IN VITRO diagnostic use."

This statement explicitly indicates that the device is intended for diagnostic purposes performed outside of the living body, which is the definition of an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

For the quantitative determination of creatine kinase in serum. For IN VITRO diagnostic use.

Product codes

CGS

Device Description

Not Found

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of four abstract shapes that resemble a stylized human figure with outstretched arms.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 1 1998

Karen Callbeck, R.T.B.Sc. Regulatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0

Re : K973999 Creatine Kinase-SL Assay, Catalogue Number 326-10, 326-30 Regulatory Class: II Product Code: CGS Dated: January 9, 1998 Received: January 20, 1998

Dear Ms. Callbeck:

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 of the Act. The general controls provisions of the Act include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with "-" the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 action. In addition, FDA may publish further announcements 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 requlations.

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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 (770) 488-7655.

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 Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Sitman

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

2

510(k) Number (if known): _

Device Name: Creatine Kinase-SL Assay

Indications For Use:

For the quantitative determination of creatine kinase in serum. For IN VITRO diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K97-399

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)