Manual Phenylalanine Test
FDA 510(k)Class II (US FDA 510(k))
by Bio-Rad
Identifiers
- 510(k) Number
- K963040 FDA 510(k)
- FDA Product Code
- JNB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1555 FDA 510(k)
- Regulation Number
- 862.1555 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Manual Phenylalanine Test is a device intended to measure free phenylalanine in serum, plasma, and urine. Measurements of phenylalanine are used in the diagnosis and treatment of congenital phenylketonuria, which, if untreated, may cause mental retardation.
This test is supplied as a manual system and is classified as Class II under special controls with product code JNB. The device is regulated under FDA 510(k) clearance with K963040, issued on October 1, 1996, after a review period of 57 days.
Frequently asked questions
What is the Manual Phenylalanine Test used for?
The Manual Phenylalanine Test is used to measure free phenylalanine in serum, plasma, and urine. These measurements are essential for the diagnosis and treatment of congenital phenylketonuria, a condition that can cause mental retardation if left untreated.
How is the Manual Phenylalanine Test supplied?
The test is supplied as a manual system. It is classified as Class II under special controls with product code JNB. The device is designed for laboratory use and requires manual operation by healthcare professionals.
What is the regulatory status of the Manual Phenylalanine Test?
The device is regulated under FDA 510(k) clearance with K963040, issued on October 1, 1996, after a review period of 57 days. It was determined to be substantially equivalent to other predicate devices in the clinical chemistry field.
Is the Manual Phenylalanine Test reusable or single-use?
The device is supplied as a manual system, but the description does not specify whether it is designed for single-use or multiple uses. The classification as Class II under special controls suggests it may require specific handling and disposal protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MANUAL PHENYLALANINE TEST (K963040) — FDA 510(k) | Innolitics, MANUAL PHENYLALANINE TEST (K963040) - FDA 510 (k), MANUAL PHENYLALANINE TEST 510(k) K963040 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K963040 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bio-Rad
Sources (1)
- FDA 510(k) K963040 24 fields · synced Sep 25, 2026