Olympus Chloride Reagent, Modification
by Olympus Corp. 510(k)
Active
510(k) K934136
Overview
The Olympus Chloride Reagent, Modification is a mercuric thiocyanate-based colorimetric reagent for clinical chemistry. It is designed to measure chloride ion concentrations in serum, plasma, or urine samples through a chemical reaction that produces a color change proportional to chloride levels, enabling quantitative analysis in laboratory settings.
This reagent is supplied as a liquid for in vitro diagnostic use and is intended for single-use only. It is classified under FDA product code CHJ and falls under FDA Class II regulatory requirements, with a 510(k) clearance (K934136) for substantial equivalence. Storage conditions and sterility are not specified in the regulatory data, but it is intended for use in clinical chemistry laboratories adhering to standard reagent handling protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934136 | Date5 Nov 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CHJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1170
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Olympus Corp.
Questions
What is the Olympus Chloride Reagent, Modification used for in a clinical setting?
The Olympus Chloride Reagent, Modification is a mercuric thiocyanate-based colorimetric reagent specifically designed to measure chloride ion concentrations in serum, plasma, or urine samples. It works by producing a color change proportional to chloride levels, allowing laboratories to perform quantitative analysis of chloride in clinical chemistry testing.
How is the Olympus Chloride Reagent, Modification supplied and intended for use?
This reagent is supplied as a liquid for in vitro diagnostic use and is intended exclusively for single-use applications in clinical chemistry laboratories. It relies on a chemical reaction to detect chloride levels, requiring adherence to standard reagent handling protocols for accurate results.
What regulatory pathway was followed for the Olympus Chloride Reagent, Modification?
The Olympus Chloride Reagent, Modification received FDA clearance through a 510(k) submission (K934136) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. It falls under FDA product code CHJ and is classified as a Class II device, regulated under 21 CFR 862.1170 for clinical chemistry applications.
Is the Olympus Chloride Reagent, Modification reusable, or is it designed for single-use?
The Olympus Chloride Reagent, Modification is explicitly intended for single-use only, as stated in its regulatory documentation. This ensures consistency and reliability in chloride measurements without carryover risks from repeated use.
What type of laboratories is this reagent intended for, and what storage considerations should be noted?
This reagent is intended for use in clinical chemistry laboratories that follow standard reagent handling protocols. While specific storage conditions (e.g., temperature, sterility) are not detailed in the regulatory data, it is critical to follow laboratory best practices for liquid reagents to maintain accuracy and stability during use.