Access Troponin I Reagents on the Access Immunoassay Analyzer Model Numbers: 33320, 33325 and 33329

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

510(k) Number

K963934 ↗

FDA Product Code

MMI

Models / Variants

Numbers: 33320

33325

33329

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

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• What analyzer models are these reagents compatible with, and how are they supplied?

  The Access Troponin I Reagents are designed exclusively for use with the Access Immunoassay Analyzer, specifically the model numbers 33320, 33325, and 33329. They are supplied as single-use components, meaning each set of reagents is intended for one-time use in the analyzer to ensure accurate troponin I measurement.

• Are these reagents intended for reuse, or are they meant to be used only once?

  These reagents are explicitly labeled as single-use components for the Access Immunoassay Analyzer. This design ensures consistency and reliability in troponin I quantification, as reuse could compromise accuracy and introduce contamination risks.

• What is the primary clinical purpose of these reagents, and in what setting are they used?

  The Access Troponin I Reagents are used as an immunoassay method to quantify cardiac troponin I, a biomarker critical for diagnosing and managing acute coronary syndromes. They are intended for in vitro diagnostic use in clinical laboratories, where precise detection of cardiac injury markers is essential for patient care.

• What regulatory pathway was followed for FDA clearance of these reagents?

  The Access Troponin I Reagents received FDA clearance through a 510(k) process, classified as substantially equivalent under the traditional review pathway. The device falls under the Clinical Chemistry advisory committee (CH) and is categorized as an immunoassay method for troponin subunit analysis, with a product code of MMI.