510(k) · Cleared

Recalled · 2007

Lightcycler Instrument Version 1.2

K033734510(k) TraditionalCleared Dec 17, 200319-day reviewClass I21 CFR 862.2170Recalls 1

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

Roche Diagnostics Corp. · JJF Analyzer, Chemistry, Micro, For Clinical Use

Cleared on Dec 17, 2003 as substantially equivalent to K012966 (Roche Molecular Systems, Inc., 2002) after a 19-day review. Its family tree reaches back 3 generations to 1993. 10 later devices descend from it. It has been recalled once.

Decided: Dec 17, 2003
Review: 19 days
Class: Class I
Product code: JJF
Recalls: 1
Predicates: 1

Its longest line of descent runs back 3 generations to K922906 (1993). 5 ancestors in all. 10 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK922906 Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1993
2 generations backK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · Recalled
1 generation backK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · Recalled
This deviceK033734 Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003
Descendant · cites it directly · 4 of its ownK051713 Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005
Descendant · cites it directly · 3 of its ownK070597 Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and…Nanosphere, Inc. · 2007
Descendant · 2 generations on · 3 of its ownK071188 Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 2007
Descendant · 2 generations on · 1 of its ownK140426 Anthracis Real-Time PCR AssayCenters For Disease Control and Prevention (CDC) · 2014
Descendant · 3 generations on · 0 of its ownK192871 B. anthracis Real-time PCR AssayCenters for Disease Control and Prevention · 2019

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2005high 2 (2007) · low 0 (2006)2026

Most influential descendants

Showing 5 of 10 · See all

K051713Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005 · cites it directly4descendants
K070597Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNanosphere, Inc. · 2007 · cites it directly3descendants
K071188Modification to Jbaids Anthrax Detection SystemIdaho Technology, Inc. · 2007 · 2 generations on3descendants
K140426Anthracis Real-Time PCR AssayCenters For Disease Control and Prevention (CDC) · 2014 · 2 generations on1descendant
K192871B. anthracis Real-time PCR AssayCenters for Disease Control and Prevention · 2019 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K922906	Amplicor Chlamydia Trachomatis Test	Roche Molecular Systems, Inc.	1993	—
−2	K964506	Roche Cobas Amplicor Analyzer	Roche Molecular Systems, Inc.	1997	1
−1	K012966	Roche Cobas Taqman Analyzer	Roche Molecular Systems, Inc.	2002	3
0 (this device)	K033734	Lightcycler Instrument Version 1.2	Roche Diagnostics Corp.	2003	—
+1	K051713	Jbaids Anthrac Detection System	Idaho Technology, Inc.	2005	—
+1	K070597	Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic…	Nanosphere, Inc.	2007	—
+2	K071188	Modification to Jbaids Anthrax Detection System	Idaho Technology, Inc.	2007	—
+2	K140426	Anthracis Real-Time PCR Assay	Centers For Disease Control and Prevention (CDC)	2014	—
+3	K192871	B. anthracis Real-time PCR Assay	Centers for Disease Control and Prevention	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	2	0
2010	1	0
2011	2	0
2013	1	0
2014	2	0
2019	1	0

FIG. 1 — Lineage of K033734, 1993–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JJF? 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

Get a 510(k) Report

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K012966	Roche Cobas Taqman Analyzer Summary page 2 …ial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed COBAS TaqMan Analyzer K012966. The LightCycler Instrument is a flexible benchtop analyzer that automates the amplification a…	Roche Molecular Systems, Inc.	2002	3

Also cleared against K012966: 1 other device →

What descends from it? (10)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051713	Jbaids Anthrac Detection System	Idaho Technology, Inc.	2005	4
K070597	Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid Test	Nanosphere, Inc.	2007	3
K132978	Impact DX Factor V Leiden and Factor II Genotyping Test	Sequenom, Inc.	2014	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 30, 2007	Not classified	Z-0459-2008	Process design	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% reduction in signal

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
3 of the 5 ancestors have a recall of any class.
Of its descendants, K051713 (Idaho Technology, Inc., 2005) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K012966.

How does its category compare?

All JJF devices

JJF Analyzer, Chemistry, Micro, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJF

FDA has decided no JJF device since 2007.

Median 510(k) review, days · JJF

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

Recalls per year · JJF

2in 2018

2007high 3 (2012) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJF

2in 2025

2007high 21 (2010) · low 0 (2015)2025

MAUDE reports naming product code JJF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	10
2008	—	0	2
2009	—	0	3
2010	—	0	21
2011	—	0	19
2012	—	3	8
2013	—	0	1
2014	—	0	3
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	2	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	1
2024	—	0	0
2025	—	0	2
2026	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033734 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033734: Lightcycler Instrument Version 1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033734

Report an extraction error

Are you the manufacturer?

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