N-Assay L AST/GOT
by Crestat Diagnostics, Inc. 510(k)
Active
510(k) K980902
Overview
The N-Assay L AST/GOT is an in vitro diagnostic reagent designed for the enzymatic kinetic measurement of aspartate aminotransferase (AST) activity in human serum. It employs an optimized method where L-aspartic acid and α-ketoglutaric acid are converted by AST into oxalacetic acid and glutamic acid, with malic dehydrogenase reducing oxalacetic acid and oxidizing NADH to NAD. This device falls under the category of enzymatic assays for clinical chemistry applications, specifically for evaluating liver function or tissue damage.
Supplied as a ready-to-use liquid reagent, the N-Assay L AST/GOT is intended for single-use in clinical laboratory settings. It requires no additional preparation beyond standard in vitro diagnostic procedures and is classified as a Class II device under FDA regulations. The product is authorized via a 510(k) clearance (K980902) and adheres to regulatory standards outlined in 21 CFR 803 and 21 CFR 809. Storage conditions and shelf life are not specified in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980902 | Date26 Mar 1998 | 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- Withdrawn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
- CIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1100
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Crestat Diagnostics, Inc.
Questions
What is the N-Assay L AST/GOT used for in clinical settings?
The N-Assay L AST/GOT is designed for the enzymatic kinetic measurement of aspartate aminotransferase (AST) activity in human serum. AST levels are critical for evaluating liver function or detecting tissue damage, making this reagent useful in clinical chemistry for diagnosing and monitoring liver-related conditions.
How is the N-Assay L AST/GOT supplied and prepared for use?
The N-Assay L AST/GOT is supplied as a ready-to-use liquid reagent, eliminating the need for additional preparation beyond standard in vitro diagnostic procedures. This simplifies workflow in clinical laboratories, ensuring ease of use while maintaining accuracy for AST measurement.
Is the N-Assay L AST/GOT intended for single-use or repeated use?
The N-Assay L AST/GOT is explicitly designed for single-use in clinical laboratory settings. This ensures sterility and consistency in results, as reuse could compromise accuracy or introduce contamination risks.
What regulatory pathway does the N-Assay L AST/GOT follow?
The N-Assay L AST/GOT is classified as a Class II medical device under FDA regulations and has obtained 510(k) clearance (K980902). This clearance confirms its substantial equivalence to a predicate device, adhering to regulatory standards outlined in 21 CFR 803 and 21 CFR 809.
Are there specific storage conditions or shelf life details provided for the N-Assay L AST/GOT?
The available data does not specify storage conditions or shelf life for the N-Assay L AST/GOT. Laboratories should follow standard practices for in vitro diagnostic reagents to ensure optimal performance and safety until further guidance is provided by the manufacturer.