# K980120: Digene DML 2000 Microplate Luminometer

- Pathway: 510(k) (Traditional)
- Applicant: Digene Corp.
- Decided: Feb 6, 1998 after 24 days
- Product code: JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2300
- 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: 2 generations back to K915896 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962265: MLX Microtiter Plate Luminometer, Dynatech Laboratories, Inc. (1996) Summary page 1.

## Recalls of this device
- Jan 12, 2011 · Not classified · Z-1728-2011: The software component of a diagnostic medical device may be defective and could cause incorrect patient values.

## Indications for use
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.

Source page: https://510kreport.com/device/K980120
Methodology: https://510kreport.com/methodology