Phospholipids Standard Solution Calibrator
by Wako Chemicals USA, Inc. 510(k)
Active
510(k) K871765
Overview
This device is a Calibrator, Secondary (21 CFR 862.1150) used to standardize and validate assays for phospholipid quantification in clinical chemistry. It provides a reference solution containing defined concentrations of phospholipids, including lecithin, lysolecithin, and sphingomyelin, to ensure accurate measurement in laboratory testing.
The Phospholipids Standard Solution Calibrator is supplied as a liquid reagent for in vitro diagnostic use, intended for single-use applications in clinical chemistry laboratories. It is regulated under the FDA 510(k) clearance (K871765) with a Traditional review pathway and classified as Class II. Storage and handling conditions are not specified in the data but must comply with standard laboratory protocols for reagent stability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871765 | Date26 May 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wako Chemicals USA, Inc.
Questions
What is the purpose of the Phospholipids Standard Solution Calibrator?
This device is a secondary calibrator used to standardize and validate assays for phospholipid quantification in clinical chemistry. It provides a reference solution with defined concentrations of phospholipids to ensure accurate measurement in laboratory testing.
How is the Phospholipids Standard Solution Calibrator supplied?
The calibrator is supplied as a liquid reagent for in vitro diagnostic use in clinical chemistry laboratories. It is intended for single-use applications to maintain measurement accuracy and reliability.
What regulatory pathway was used for this device?
The Phospholipids Standard Solution Calibrator received FDA 510(k) clearance under the Traditional review pathway and is classified as Class II. It was determined to be substantially equivalent to existing devices.
What types of phospholipids are included in this calibrator?
The calibrator contains defined concentrations of specific phospholipids including lecithin, lysolecithin, and sphingomyelin to ensure accurate quantification in clinical chemistry assays.