Phenylalanine Test Kit
by Isolab, Inc. 510(k)
Active
510(k) K943547
Overview
The Phenylalanine Test Kit is a clinical chemistry device designed to measure free phenylalanine, an amino acid, in serum, plasma, and urine samples. This test system is used in the diagnosis and treatment of congenital phenylketonuria, a condition that can lead to mental retardation if left untreated.
This device is identified by product code JNB and is regulated under 21 CFR 862.1555. It received FDA 510(k) clearance under K943547 on January 26, 1996. The kit is manufactured by Isolab, Inc. and is classified as a Class 2 medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK943547 | Date26 Jan 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JNB
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1555
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Isolab, Inc.
Questions
What is the primary clinical purpose of the Phenylalanine Test Kit?
This device is designed to measure levels of free phenylalanine in human serum, plasma, and urine samples. It is specifically used to assist clinicians in the diagnosis and management of congenital phenylketonuria, a metabolic condition that requires monitoring to prevent potential mental retardation.
What is the regulatory status of this test kit?
The Phenylalanine Test Kit is a Class 2 medical device that received FDA 510(k) clearance on January 26, 1996, under submission number K943547. It is regulated under 21 CFR 862.1555 and is categorized under product code JNB within the Clinical Chemistry specialty.
Who is the manufacturer of this diagnostic device?
The Phenylalanine Test Kit is manufactured by Isolab, Inc., located in Akron, Ohio. The device was submitted for regulatory review by the company to ensure it met the requirements for clinical chemistry testing systems.