(20 days)
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No
The summary describes a quantitative immunoassay system for cardiac troponin I, which is a standard laboratory test and does not mention any AI or ML components.
No
The device is for in vitro diagnostic determination of cardiac troponin I, which aids in diagnosis rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "an aid in the diagnosis of acute myocardial infarction."
No
The provided text describes a device for the quantitative determination of cardiac troponin I using an "Automated Chemiluminescence System." This system, the Chiron Diagnostics ACS: 180®, is a piece of hardware used for laboratory analysis. The description focuses on the use of this hardware system for a specific test, not on a standalone software application.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement clearly indicates that the device is used for the "quantitative determination of cardiac troponin I in serum or heparinized plasma". This involves testing biological samples (serum or plasma) outside of the body to obtain diagnostic information. This is the core definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of cardiac troponin I in serum or heparinized plasma and as an aid in the diagnosis of acute myocardial infarction using the Chiron Diagnostics ACS: 180® Automated Chemiluminescence Systems.
Product codes
MMI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, composed of three curved lines representing the wings and body.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
William J. Pignato Director of Requlatory Affairs Chiron Diagnostics 63 North Street Medfield, Massachusetts 02052-1688
MAR - 3 1998
Re : K980528 Chiron Diagnostics ACS:180® Troponin I Assay Regulatory Class: II Product Code: MMI Dated: February 10, 1998 Received: February 11, 1998
Dear Mr. Pignato:
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 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set torth 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.
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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
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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Aitman
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
Company Confidential
Page of of ___________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
14980528
Device Name: Chiron Diagnostics ACS:180 Troponin I Assay
Indications for Use:
For the quantitative determination of cardiac troponin I in serum or heparinized plasma and as an aid in the diagnosis of acute myocardial infarction using the Chiron Diagnostics ACS: 180® Automated Chemiluminescence Systems.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division: of Clinical Laboratory Devices
510(k) Number: K980528