FDA product code SCE: Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule
SCE is the FDA product code for ivd offered as ldt, first marketed before may 6, 2024, not modified beyond scope described in preamble to ldt final rule. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under SCE reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Currently marketed in vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that were first marketed prior to May 6, 2024, and not modified following that date or not modified beyond the scope described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).
Classification
| Field | Value |
|---|---|
| Device name | Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule |
| Device class | Not classified |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Recalls for SCE devices
openFDA lists no recalls for product code SCE.
Frequently asked questions
What is FDA product code SCE?
SCE is the FDA product code for ivd offered as ldt, first marketed before may 6, 2024, not modified beyond scope described in preamble to ldt final rule. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is SCE?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SCE
- Run a recall and safety report across every SCE manufacturer
- Watch product code SCE 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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