# K083430: Real-Time PCR Internal Control 2B Set

- Pathway: 510(k) (Traditional)
- Applicant: Nanogen, Inc.
- Decided: Jan 15, 2009 after 57 days
- Product code: OLD (Internal  Polymerase Chain Reaction  Control, Not Assay Specific)
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Real-Time PCR Internal Control 2B Set consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control 2B Set can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.

Source page: https://510kreport.com/device/K083430
Methodology: https://510kreport.com/methodology