MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI

K991299 · Princeton BioMeditech Corp. · JHT · May 28, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991299
• Device Name: MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBI
• Applicant: Princeton BioMeditech Corp.
• Product Code: JHT · Clinical Chemistry
• Decision Date: May 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.

Device Story

Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is an in vitro diagnostic device for qualitative detection of CK-MB and myoglobin in human serum, whole blood, or plasma. Used in emergency rooms, critical care, and point-of-care settings by healthcare professionals. Device provides rapid results to aid in the diagnosis of myocardial infarction. Operation involves applying patient sample to test device; results interpreted visually by clinician. Output assists in clinical decision-making regarding cardiac events. Benefits include rapid turnaround time for critical diagnostic information.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In vitro diagnostic test for qualitative determination of CK-MB and myoglobin. Form factor is a rapid one-step test device. No software or electronic components described.

Indications for Use

Indicated for the rapid qualitative detection of CK-MB and myoglobin in human serum, whole blood, or plasma to aid in the diagnosis of myocardial infarction in professional clinical settings (emergency room, critical care, point of care, or hospital).

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.

Submission Summary (Full Text)

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Received: April 06, 1999

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Food and Drug Administration Jemo Kang, Ph.D. 2098 Gaither Road MAY 2 8 1999 President Rockville MD 20850 Princeton Biomeditech Corp. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 Re : K991299 Trade Name: CardiacStAus CK-MB/Myoglobin Rapid One-Step Test . Requlatory Class: II Product Code: JHT, DDR Dated: March 31, 1999

Dear Mr. Kang:

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 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). 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 requlation (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 Reqister. 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.

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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 [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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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Princeton BioMeditech Corp Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test 510(k) Notification

## K 991399

## 510(k) Number (if Known): Not Known at this time

Device Name : Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test

Indications for Use:

The Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.

Dean Cos
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991299

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Professional Use X

Prescription Use X (Per 21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)