Product code QJE— Clinical Chemistry

GSP Neonatal Creatine Kinase - MM kit

Classification name: Muscular Dystrophy Newborn Screening Test
Device class: Class 2
Regulation: 21 CFR 862.1506
Advisory panel: Clinical Chemistry
Total cleared: 1
First cleared: 2019-12-12
Most recent: 2019-12-12

FDA classification definition

“A muscular dystrophy newborn screening test is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy.”
— U.S. Food and Drug Administration, device classification record for product code QJE under 21 CFR 862.1506, via openFDA

Market context for product code QJE

FDA has cleared 1 device under product code QJE, all in 2019, filed by 1 applicant company. 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.

Top applicants under product code QJE

Perkinelmer, Inc.1 clearance

Recent clearances under product code QJE

DEN180056 — GSP Neonatal Creatine Kinase - MM kitPerkinelmer, Inc.·2019-12-12

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