# K033734: Lightcycler Instrument Version 1.2

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Dec 17, 2003 after 19 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922906 (1993). 5 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012966: Roche Cobas Taqman Analyzer, Roche Molecular Systems, Inc. (2002) Summary page 2.

## Most influential descendants
- K051713: Jbaids Anthrac Detection System (2005), 4 descendants of its own
- K070597: Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test (2007), 3 descendants of its own
- K071188: Modification to Jbaids Anthrax Detection System (2007), 3 descendants of its own
- K140426: Anthracis Real-Time PCR Assay (2014), 1 descendant of its own
- K192871: B. anthracis Real-time PCR Assay (2019), 0 descendants of its own

## Recalls of this device
- Aug 30, 2007 · Not classified · Z-0459-2008: False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The affected capillaries showed up to a 40% red

## Indications for use
The LightCycler Instrument is a fully automated amplification and detection system for nucleic acids using fluorescence detection. The LightCycler is intended to be used by laboratory professionals trained in laboratory techniques and on the use of the analyzer.

Source page: https://510kreport.com/device/K033734
Methodology: https://510kreport.com/methodology