DeviceClearance

Product code PQW— Clinical Chemistry

NeoLSD MSMS Kit

Classification name
Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Device class
Class 2
Regulation
21 CFR 862.1488
Advisory panel
Clinical Chemistry
Total cleared
3
First cleared
Most recent

FDA classification definition

“For quantitative measurement of the activity of alpha-D-galactosidase A (GLA) from newborn dried blood spot specimens.”

— U.S. Food and Drug Administration, device classification record for product code PQW under 21 CFR 862.1488, via openFDA

Market context for product code PQW

FDA has cleared 3 devices under product code PQW between 2017 and 2019, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PQW

Recent clearances under product code PQW

Data sourced from openFDA. This site is unofficial and independent of the FDA.