Trace Microprotein Reagent

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K925794 ↗

FDA Product Code

JGQ

Device Class

Class II

Regulation

21 CFR Part 862.1635

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K973869 Active Cleared 7 Jan 1998

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  Class II

  FDA 510(k) K980030 Active Cleared 30 Jan 1998

• Trace Hdl Cholesterol - Automated (Homogen

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  FDA 510(k) K962723 Active Cleared 13 Mar 1997

• Resubmitted Bicarbonate (CO2) Reagent Single Vial

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  FDA 510(k) K880794 Active Cleared 18 Apr 1988

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  FDA 510(k) K880795 Active Cleared 18 Apr 1988

• Porphobilinogen (Pbg)

  Class I

  FDA 510(k) K961984 Active Cleared 10 Dec 1996

See all devices from Trace America, Inc. →

• What biological samples can the Trace Microprotein Reagent measure protein levels in, and how does it work?

  The Trace Microprotein Reagent is designed to measure total protein concentrations in serum, plasma, or other biological fluids. It uses turbidimetric principles, which means it indirectly quantifies protein levels by detecting the light-scattering changes caused by protein interactions with the reagent, rather than directly measuring protein mass.

• Is the Trace Microprotein Reagent intended for single-use, and if so, what are the storage requirements?

  Yes, the Trace Microprotein Reagent is intended for single-use applications. It is supplied as a liquid and requires no special storage conditions beyond standard refrigeration to maintain its integrity until use.

• What regulatory pathway was followed for FDA clearance of this reagent, and what class does it fall under?

  The Trace Microprotein Reagent received FDA clearance through the Traditional 510(k) pathway, specifically under the decision code SESE (Substantially Equivalent) for Clinical Chemistry applications. It is classified as a Class II medical device under regulation 862.1635, indicating it has moderate risk and requires special controls beyond general controls.

• Are there multiple versions or sizes of this reagent, or is it supplied in a single formulation?

  The data provided does not specify multiple versions or sizes of the Trace Microprotein Reagent. It is described as a single liquid formulation for quantitative analysis of microprotein concentrations, with no mention of variations in concentration or packaging.