510(k) Report

510(k) · Cleared

Cleared

Introl CF Panel I Control, Model: G106

K083171510(k) TraditionalCleared Dec 16, 200850-day reviewClass II21 CFR 866.5910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Maine Molecular Quality Controls, Inc. · NZB Quality Control Material, Genetics, Dna

Cleared on Dec 16, 2008 after a 50-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.

Decided
Dec 16, 2008
Review
50 days
Class
Class II
Product code
NZB
Recalls
None
Predicates
1

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared20052010201520202025
  1. This deviceK083171 Introl CF Panel I Control, Model: G106Maine Molecular Quality Controls, Inc. · 2008
  2. Descendant · cites it directly · 0 of its ownK093737 Hemosil F11 & FV Dna ControlInstrumentation Laboratory CO · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K093737Hemosil F11 & FV Dna ControlInstrumentation Laboratory CO · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083171Introl CF Panel I Control, Model: G106Maine Molecular Quality Controls, Inc.2008—
+1K093737Hemosil F11 & FV Dna ControlInstrumentation Laboratory CO2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K083171, 2008–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NZB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK060070INTROL™ 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
…Class II Product Code: NZB Panel: Immunology (82) Predicate Device: K060070 INTROLTm CF Panel I Control Device Description (same as predicate): Modified INTROLTm CF Panel I C…

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093737Hemosil F11 & FV Dna ControlInstrumentation Laboratory CO20100

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K093737 (Instrumentation Laboratory CO, 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NZB devices

NZB Quality Control Material, Genetics, Dna: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · NZB

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NZB

Too few NZB 510(k)s in any year since 2007 to give a median.

Recalls per year · NZB

No recall names NZB since 2007.

Adverse event reports per year · NZB

No MAUDE report names NZB since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20081—00
20090—00
20101—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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…

Read the full statement (142 words)

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.

Indications for use as stated in the FDA summary.

More from Maine Molecular Quality Controls, Inc.

15 FDA decisions under this applicant name. See the company

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  • K251526FilmArray GI Control Panel M238Maine Molecular Quality Controls, Inc. · 2025
  • K241289SPOTFIRE RSP Pos & Neg Controls; SPOTFIRE RSP Negative ControlMaine Molecular Quality Controls, Inc. · 2024
  • K233611SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative…Maine Molecular Quality Controls, Inc. · 2024

Recent decisions in NZB

The NZB category page

  • K093737Hemosil F11 & FV Dna ControlInstrumentation Laboratory CO · 2010
  • K063224Gentrisure Human Genomic Dna Reference ControlGentris Corporation · 2006
  • DEN060007Quality Control Material, Genetics, Dna

https://510kreport.com/device/K083171 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083171: Introl CF Panel I Control, Model: G106.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083171

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026