Access Troponin I Reagents on the Access Immunoassay Analyzer

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

510(k) Number

K974075 ↗

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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See all devices from Beckman Instruments, Inc. →

• What clinical conditions is this reagent kit designed to help diagnose or monitor?

  The Access Troponin I Reagents are specifically designed for the quantitative measurement of cardiac troponin I (cTnI) in human serum or plasma. Troponin I is a biomarker used primarily in the diagnosis and monitoring of acute myocardial infarction (heart attack) and other cardiac conditions, helping clinicians assess heart damage or risk.

• Is this reagent kit single-use, or can it be reused across multiple tests?

  The Access Troponin I Reagents are supplied as a single-use reagent kit. This means each kit is intended for one use only and should not be reused, ensuring accuracy and maintaining sterility for reliable test results.

• What storage requirements does this reagent kit have beyond standard laboratory conditions?

  According to the provided data, the reagents require no special storage conditions beyond those specified in the instructions for use. This means they can be stored under typical clinical laboratory conditions, but always follow the manufacturer’s guidelines for optimal performance.

• Which clinical chemistry analyzer is required to use these reagents?

  The Access Troponin I Reagents are designed exclusively for use on the Access Immunoassay Analyzer, a dedicated clinical chemistry instrument. They are not compatible with other analyzers, so this analyzer must be available for testing.

• What regulatory pathway was followed for FDA clearance of this device?

  The Access Troponin I Reagents received FDA clearance through a 510(k) premarket notification process, specifically under the Traditional Review pathway. The device was determined to be substantially equivalent to a predicate product and falls under FDA classification 2 (862.1215), with the Clinical Chemistry (CH) Advisory Committee involved in the review.