FDA product code SCI: Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
SCI is the FDA product code for ivd offered as ldt, not an ldt or under a targeted enforcement discretion policy described in preamble to ldt final rule. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under SCI reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
In vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that are not designed, manufactured, and used within a single laboratory, are within the scope of the phaseout policy and are not subject to a targeted enforcement discretion policy described in the preamble to the LDT Final Rule (89 FR 37286).
Classification
| Field | Value |
|---|---|
| Device name | Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy 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 SCI devices
openFDA lists no recalls for product code SCI.
Frequently asked questions
What is FDA product code SCI?
SCI is the FDA product code for ivd offered as ldt, not an ldt or under a targeted enforcement discretion policy described in preamble to ldt final rule. It is a Not classified device, reviewed by the Clinical Chemistry panel.
What device class is SCI?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SCI
- Run a recall and safety report across every SCI manufacturer
- Watch product code SCI 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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