510(k) · Cleared

Recalled · 2011

Digene DML 2000 Microplate Luminometer

K980120510(k) TraditionalCleared Feb 6, 199824-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

Digene Corp. · JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

Cleared on Feb 6, 1998 as substantially equivalent to K962265 (Dynatech Laboratories, Inc., 1996) after a 24-day review. Its family tree reaches back 2 generations to 1992. It has been recalled once.

Decided: Feb 6, 1998
Review: 24 days
Class: Class I
Product code: JJQ
Recalls: 1
Predicates: 1

Its longest line of descent runs back 2 generations to K915896 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK915896 Microlite Microtiter Plate Luminometer ML2250/ModiDynatech Laboratories, Inc. · 1992
1 generation backK962265 MLX Microtiter Plate LuminometerDynatech Laboratories, Inc. · 1996
This deviceK980120 Digene DML 2000 Microplate LuminometerDigene Corp. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K915896	Microlite Microtiter Plate Luminometer ML2250/Modi	Dynatech Laboratories, Inc.	1992	—
−1	K962265	MLX Microtiter Plate Luminometer	Dynatech Laboratories, Inc.	1996	—
0 (this device)	K980120	Digene DML 2000 Microplate Luminometer	Digene Corp.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0

FIG. 1 — Lineage of K980120, 1992–1998Source: 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 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? (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
*	K962265	MLX Microtiter Plate Luminometer Summary page 1 …mmon or Usual Name: Luminometer Classification Name: Colorimeter, photometer, or spectrophotometer for clinical use Predicate Device: MLX Microtiter® Plate Luminometer (K962265) Dynatech Laboratories o0 Y = 9000 Virginia Mandr Road Beltsville, Maryland 20705 (301) 470-6500 FAX (301) 470…	Dynatech Laboratories, Inc.	1996	—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 12, 2011	Not classified	Z-1728-2011	Software design	The software component of a diagnostic medical device may be defective and could cause incorrect patient values.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
None of the 3 ancestors has a recall.

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	—

What is it indicated for?

The Digene DML 2000 Microplate Luminometer is intended to measure

light that is emitted as a result of a chemiluminescent reaction. Assay

results obtained using chemiluminescence technology in 96 well

microplates are calculated and interpreted according to assay validation

parameters.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980120 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980120: Digene DML 2000 Microplate Luminometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980120

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