ACS:180 Troponin I Assay (CTNI)

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Chiron Diagnostics ACS:180 Troponin I Assay (Ctni)

510(k) Number

K980528 ↗

FDA Product Code

MMI

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer

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• Chiron Diagnostics ACS:180TU P

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  Class I

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• Certain Complete Levels 1, 2, and 3; Cvm Levels 1, 2, 3, 4, and 5

  Class I

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• Chiron Diagnostics Acs: 180 Carbamazepine Assay

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  FDA 510(k) K964765 Active Cleared 14 Feb 1997

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• What is the ACS:180 Troponin I Assay (CTNI) used for?

  The ACS:180 Troponin I Assay (CTNI) is an immunoassay designed to quantify cardiac troponin I, a biomarker critical for detecting myocardial infarction and diagnosing acute coronary syndromes. By measuring troponin I levels in patient samples, clinicians can identify heart damage and assess the severity of cardiac events, supporting timely intervention.

• How is the ACS:180 Troponin I Assay (CTNI) supplied and used?

  This assay is supplied as a reagent kit specifically for use with the ACS:180 Automated Chemiluminescence System. It is intended for in vitro diagnostic use in clinical laboratories, where it analyzes troponin I levels in serum or heparinized plasma samples. The automated system ensures precise and sensitive detection, streamlining workflow in diagnostic settings.

• Is the ACS:180 Troponin I Assay (CTNI) single-use or reusable?

  The ACS:180 Troponin I Assay (CTNI) reagent kit is designed for single-use per test run on the ACS:180 system. While the system itself may be reusable, the reagents are intended for one-time use to maintain accuracy and prevent cross-contamination, adhering to standard in vitro diagnostic practices.

• What sample types can the ACS:180 Troponin I Assay (CTNI) analyze?

  The assay is approved for use with serum and heparinized plasma samples. These sample types are commonly used in clinical settings to measure cardiac troponin I levels, ensuring compatibility with standard laboratory workflows for diagnosing acute coronary syndromes.

• What regulatory pathway does the ACS:180 Troponin I Assay (CTNI) follow?

  The ACS:180 Troponin I Assay (CTNI) received FDA 510(k) clearance under the traditional pathway, classified as a Class II device under regulation number 862.1215. This classification indicates it is a moderate-risk device regulated under the Clinical Chemistry specialty, ensuring it meets stringent performance and safety standards for diagnostic use.