Clarit
by Advanced Biomedical Methods, Inc. 510(k)
Active
510(k) K945353
Overview
Clarit is a single-reagent chemistry device designed for demand analyzers, intended for clinical chemistry applications. It is classified under the product code JKA and is intended for use in laboratory settings to perform specific biochemical assays, as determined by the Clinical Chemistry advisory committee.
The device is supplied as a single-use reagent and has received FDA 510(k) clearance under the traditional pathway, with a clearance date of December 9, 1994. It is intended for use in demand analyzers and is not described as MRI-safe or reusable. No additional specifications regarding sterility, storage, or sizing are provided in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945353 | Date9 Dec 1994 | 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- Withdrawn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
- Full name
- Clarit(Tm)
- 510(k) Number
- FDA Product Code
- JKA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Advanced Biomedical Methods, Inc.
Questions
What is the Clarit™ device used for?
The Clarit™ is a single-reagent chemistry device designed specifically for demand analyzers in laboratory settings. It performs biochemical assays within the field of clinical chemistry, as determined by the Clinical Chemistry advisory committee. This makes it suitable for use in diagnostic testing where precise biochemical measurements are required.
Is the Clarit™ device single-use or reusable?
The Clarit™ device is supplied as a single-use reagent. This design ensures consistency and reduces the risk of contamination or cross-reactivity between tests, which is critical for accurate clinical chemistry results.
What type of regulatory clearance does the Clarit™ device have?
The Clarit™ device received FDA 510(k) clearance under the traditional pathway on December 9, 1994. This clearance indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to enter the market with regulatory approval.
Can the Clarit™ device be used with any demand analyzer?
The Clarit™ is explicitly designed for use in demand analyzers, which are automated systems used in clinical laboratories to perform biochemical assays. While it is not specified to be compatible with all demand analyzers, its intended use aligns with these types of systems for laboratory-based testing.
Are there any specific storage or sterility requirements for the Clarit™ device?
The provided data does not include explicit details regarding storage conditions or sterility specifications for the Clarit™ device. However, as a single-use reagent, it is typically handled under controlled laboratory conditions to maintain its integrity and accuracy for biochemical assays.