FDA product code SCJ: Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
SCJ is the FDA product code for ldt, not 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 SCJ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Laboratory developed tests (LDTs) within the scope of the phaseout policy and not subject to a targeted enforcement discretion policy described in section V.B of the preamble to the LDT Final Rule (89 FR 37286).
Classification
| Field | Value |
|---|---|
| Device name | Ldt, Not 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 SCJ devices
openFDA lists no recalls for product code SCJ.
Frequently asked questions
What is FDA product code SCJ?
SCJ is the FDA product code for ldt, not 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 SCJ?
Not classified. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SCJ
- Run a recall and safety report across every SCJ manufacturer
- Watch product code SCJ 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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