FDA product code SCG: Modified Version Of Another Manufacturer’S Fda-Authorized Test Within Scope Described In Preamble To Ldt Final Rule

SCG is the FDA product code for modified version of another manufacturer’s fda-authorized test within scope described in preamble to ldt final rule. It is a Not classified device, reviewed by the Clinical Chemistry panel. Devices under SCG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

Definition

When a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meeting CLIA’s regulatory requirements to perform high complexity testing modifies another manufacturer’s 510(k) cleared or De Novo authorized test, and in compliance as described in section V.C.3 of the preamble to the LDT Final Rule, in a manner that could not significantly affect the safety or effectiveness of the test and does not constitute a major change or modification in intended use, and where the modified test is performed only in the laboratory making the modification as described in sections V.C.4 and V.C.5 of the preamble to the LDT Final Rule (89 FR 37286).

Classification

Recalls for SCG devices

openFDA lists no recalls for product code SCG.

Frequently asked questions

What is FDA product code SCG?

SCG is the FDA product code for modified version of another manufacturer’s fda-authorized test within scope described in preamble to ldt final rule. It is a Not classified device, reviewed by the Clinical Chemistry panel.

What device class is SCG?

Not classified. Typical premarket route: 510(k) exempt.

Next steps

• Run an FDA pathway report with predicate devices for product code SCG
• Run a recall and safety report across every SCG manufacturer
• Watch product code SCG 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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