FDA product code QCL: Acid-Sphingomyelinase (Asm) Newborn Screening Test System
QCL is the FDA product code for acid-sphingomyelinase (asm) newborn screening test system. It is a Class II device, regulated under 21 CFR 862.1488 and reviewed by the Clinical Chemistry panel. Devices under QCL reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
For quantitative measurement of the activity of acid-sphingomyelinase (ASM) from newborn dried blood spot specimens as an aid in screening newborns for Niemann-Pick disease.
Classification
| Field | Value |
|---|---|
| Device name | Acid-Sphingomyelinase (Asm) Newborn Screening Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.1488 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for QCL devices
openFDA lists no recalls for product code QCL.
Frequently asked questions
What is FDA product code QCL?
QCL is the FDA product code for acid-sphingomyelinase (asm) newborn screening test system. It is a Class II device, regulated under 21 CFR 862.1488 and reviewed by the Clinical Chemistry panel.
What device class is QCL?
Class II, regulation 21 CFR 862.1488. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QCL
- Run a recall and safety report across every QCL manufacturer
- Watch product code QCL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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