510(k) · Cleared

Recalled · 2005

ELX800 and EL800 Automated Microplate Readers

K950104510(k) TraditionalCleared Mar 21, 199569-day reviewClass I21 CFR 862.2300Recalls 1

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

Bio-Tek Instruments, Inc. · JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

Cleared on Mar 21, 1995 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it. It has been recalled once.

Decided: Mar 21, 1995
Review: 69 days
Class: Class I
Product code: JJQ
Recalls: 1
Predicates: 0

16 later devices descend from it, 1 citing it directly.

This deviceK950104 ELX800 and EL800 Automated Microplate ReadersBio-Tek Instruments, Inc. · 1995
Descendant · cites it directly · 15 of its ownK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · Recalled
Descendant · 2 generations on · 14 of its ownK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · Recalled
Descendant · 3 generations on · 10 of its ownK033734 Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · Recalled
Descendant · 4 generations on · 4 of its ownK051713 Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005
Descendant · 4 generations on · 3 of its ownK070597 Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and…Nanosphere, Inc. · 2007

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1997high 2 (2007) · low 0 (1998)2026

Most influential descendants

Showing 5 of 16 · See all

K964506Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · cites it directly15descendants
K012966Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · 2 generations on14descendants
K033734Lightcycler Instrument Version 1.2Roche Diagnostics Corp. · 2003 · 3 generations on10descendants
K051713Jbaids Anthrac Detection SystemIdaho Technology, Inc. · 2005 · 4 generations on4descendants
K070597Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic Acid TestNanosphere, Inc. · 2007 · 4 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K950104	ELX800 and EL800 Automated Microplate Readers	Bio-Tek Instruments, Inc.	1995	—
+1	K964506	Roche Cobas Amplicor Analyzer	Roche Molecular Systems, Inc.	1997	1
+2	K012966	Roche Cobas Taqman Analyzer	Roche Molecular Systems, Inc.	2002	3
+3	K033734	Lightcycler Instrument Version 1.2	Roche Diagnostics Corp.	2003	1
+4	K051713	Jbaids Anthrac Detection System	Idaho Technology, Inc.	2005	—
+4	K070597	Verigene System, F2 Nucleic Acid Test, F5 Nucleic Acid Test, and Mthfr Nucleic…	Nanosphere, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	1	0
2003	1	0
2005	1	0
2007	2	0
2010	2	0
2011	2	0
2012	1	0
2013	2	0
2014	2	0
2019	1	0

FIG. 1 — Lineage of K950104, 1995–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in JJQ? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K964506	Roche Cobas Amplicor Analyzer	Roche Molecular Systems, Inc.	1997	15

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 15, 2005	Not classified	Z-0573-05	Other	The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K964506 (Roche Molecular Systems, Inc., 1997) has gone furthest, with 15 descendants of its own.

How does its category compare?

All JJQ devices

JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJQ

FDA has decided no JJQ device since 2007.

Median 510(k) review, days · JJQ

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

Recalls per year · JJQ

1in 2025

2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · JJQ

20in 2025

2007high 69 (2014) · low 0 (2020)2025

MAUDE reports naming product code JJQ, 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	—	0	1
2008	—	2	4
2009	—	1	10
2010	—	0	46
2011	—	1	6
2012	—	0	3
2013	—	0	63
2014	—	0	69
2015	—	0	13
2016	—	0	9
2017	—	0	10
2018	—	0	2
2019	—	0	1
2020	—	0	0
2021	—	0	3
2022	—	1	22
2023	—	0	14
2024	—	0	7
2025	—	1	20
2026	—	0	—

https://510kreport.com/device/K950104 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950104: ELX800 and EL800 Automated Microplate Readers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950104

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026