# K083171: Introl CF Panel I Control, Model: G106

- Pathway: 510(k) (Traditional)
- Applicant: Maine Molecular Quality Controls, Inc.
- Decided: Dec 16, 2008 after 50 days
- Product code: NZB (Quality Control Material, Genetics, Dna)
- Device class: 2
- Regulation: 21 CFR 866.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K060070: INTROL™ CF Panel I Control. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K093737: Hemosil F11 & FV Dna Control (2010), 0 descendants of its own

## Indications for use
The intended use for the cleared and modified INTROL™ CF Panel I Controls is the same. The INTROL™ CF Panel I Control is intended for in vitro diagnostic use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of diagnostic assays used in the detection of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations and variants. This product is intended to be extracted and analyzed routinely with each CFTR assay run. The INTROL™ CF Panel I Control is designed to monitor the detection of 38 CFTR mutations associated with cystic fibrosis, including the 23 mutations recommended for testing by American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG). The INTROL CF Panel I Control also monitors 3 polymorphisms (I506V, I507V, F508C) and the 5/7/9T variants. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K083171
Methodology: https://510kreport.com/methodology