LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST

{0}------------------------------------------------ OCT 0 8 2002 ### 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92. The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ - 1. Date of Summary: Sept. 3, 2002 - 2. Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 PHONE 732-274-1000 FAX 732-274-1010 Contact Person: Jemo Kang 3. Device Name: Trade Name: LifeSign MI® Myoglobin/Troponin I Myoglobin/Troponin I Rapid Test LifeSign® Myoglobin/Troponin I BioSign™ MI Myoglobin/Troponin I BioSign™ Myoglobin/Troponin I VitalSign™ Myoglobin/Troponin I VitalSign™ MI Myoglobin/Troponin I AccuSign™ Myoglobin/Troponin I AccuSign™ MI Myoglobin/Troponin I > Common Name: Immunoassay for the detection of myoglobin and cardiac troponin I in human serum. whole blood or plasma > Classification Name: Not found (enzymatic assay and Immunology 82DEA for Myoglobin antigen) - 4. Identification of legally marketed device to which claims equivalence: K981882 Cardiac STATus™CKMB/Myoglobin/TroponinI - 5. Device Description: LifeSign MI® Myoglobin/Troponin I is simple one step immunochromatographic test for the rapid, qualitative detection of myoglobin and Troponin I. - 6. Intended Use: The LifeSign MI® Myoglobin/Troponin I Rapid Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of myoglobin and troponin I 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. - 7. Substantial Equivalence: LifeSign MI® Myoglobin/Troponin I is substantially equivalent to K981882, Cardiac STATus™ CK-MB/Myoglobin/Troponin I. LifeSign MI® Myoglobin/Troponin I I is exactly same as Cardiac STATus™ CK-MB/Myoglobin/Troponin I test except that CK/MB antibodies were removed from Cardiac STATus™ CK-MB/Myoglobin/Troponin I test. - Conclusion: The device is substantially equivalent to the legally marketed device, K981882, Cardiac STATus™ CK-MB/Myoglobin/Troponin 1. {1}------------------------------------------------ ## Substantial Equivalence The LifeSign MI® Myoglobin/Troponin I Rapid Test is substantially equivalent to Cardiac STATus™ CK-MB/Myoglobin/Troponin I, k981882, currently in commercial distribution by Princeton BioMeditech Corp. as shown below. | Features | Predicate Devices | Candidate Device | |----------------------------------|----------------------------------------------|------------------------------------------------------------------------------| | Device | solid phase immuno-<br>chromatographic assay | solid phase immuno-<br>chromatographic assay | | Antibodies | antibodies to CK-MB<br>myoglobin and TnI | antibodies to myoglobin and<br>TnI<br>same antibodies as predicate<br>device | | Membrane removal<br>of red cells | Yes | Yes | | Time to<br>result | 15 minutes | 15 minutes | | Analytes | CK-MB, myoglobin<br>Troponin I | myoglobin<br>Troponin I | | Specimens | serum, whole blood,<br>or plasma | serum, whole blood,<br>or plasma | | Sample volume | 200 μl | 200 μl | | Visual Reading | Yes | Yes | | Storage | Room temperature | Room temperature | Both the predicate device and the candidate device are developed and manufactured by the same applicant of this modification submission. The two devices are made exactly same way (protocol, reagents, chemicals) except that the candidate device does not contain antibodies for the CKMB. {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. 098 Gaither Road ockville MD 20850 # CT 0 8 2002 Jemo Kang, Ph.D. President Princeton BioMeditech Corporation P.O. Box 7139 Princeton, NJ 08543-7139 k022946 Re: > Trade/Device Name: `LifeSign MI® Myoglobin/Troponin I Rapid Test Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes system Regulatory Class: Class II Product Code: MMI Dated: September 3, 2002 Received: September 5, 2002 Dear Dr. Kang: 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. {3}------------------------------------------------ #### 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 i 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/dsma/dsmamain.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 {4}------------------------------------------------ 510(k) Number (if Known) : Device Name : LifeSign MI® Myoglobin/Troponin I Rapid Test Indications for Use: The LifeSign MI® Myoglobin/Troponin I Rapid Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of myoglobin and troponin I 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. Jean Cooper (ion Sign-Off) ion of Clinical Laboratory Devices Number K022946 (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)