Reagent, p-Nitrophenyl Phosphate
by J.T. Baker Chemical Co. 510(k)
Active
510(k) K760399
Overview
This reagent is a chemical substance used for detecting and quantifying alkaline phosphatase activity, a key enzyme in clinical chemistry. It reacts with alkaline phosphatase to produce a yellow-colored product, enabling spectrophotometric measurement of enzyme levels in biological samples.
The reagent is supplied as a laboratory reagent for in vitro diagnostic use, intended for clinical chemistry applications. It is classified as a Class II device under FDA regulation 862.1050 and has been cleared through a 510(k) submission (K760399) as substantially equivalent to a predicate device. No information on sterility, single-use, or MRI safety is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760399 | Date26 Aug 1976 | 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- Withdrawn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
- CJE
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1050
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from J.T. Baker Chemical Co.
Questions
What clinical applications is this reagent primarily used for in a laboratory setting?
This reagent is specifically designed for detecting and quantifying alkaline phosphatase activity in biological samples. It reacts with the enzyme to produce a yellow-colored product, which can then be measured spectrophotometrically. This makes it useful for clinical chemistry tests where alkaline phosphatase levels are analyzed, such as assessing liver function, bone metabolism, or diagnosing conditions like biliary obstruction or Paget’s disease.
How is this reagent supplied, and is it intended for single-use or repeated use?
The reagent is supplied as a laboratory reagent for in vitro diagnostic use, but the provided data does not specify whether it is intended for single-use or repeated use. Since it is a chemical substance, it is typically used in liquid form for multiple tests within its shelf life, though users should follow manufacturer guidelines for proper handling and storage to ensure accuracy and reliability.
What regulatory pathway was followed for this reagent’s clearance, and what does that mean for its use?
This reagent was cleared through the FDA’s 510(k) pathway (K760399) as substantially equivalent to a predicate device, meaning it was determined to have the same intended use and technological characteristics as an existing approved product. The clearance was granted under FDA regulation 862.1050, classifying it as a Class II device for clinical chemistry applications. This pathway ensures it meets FDA standards for safety and effectiveness in its designated diagnostic use.
Are there any specific storage instructions or considerations mentioned for this reagent?
The provided data does not include explicit storage instructions for this reagent. However, as a laboratory reagent, it is generally recommended to store it in a cool, dry place away from direct light and extreme temperatures to maintain its stability and accuracy. Always refer to the manufacturer’s labeling or accompanying documentation for precise storage guidelines.