# K950104: ELX800 and EL800 Automated Microplate Readers

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Tek Instruments, Inc.
- Decided: Mar 21, 1995 after 69 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
No predicates in its family tree.
16 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K964506: Roche Cobas Amplicor Analyzer (1997), 15 descendants of its own
- K012966: Roche Cobas Taqman Analyzer (2002), 14 descendants of its own
- K033734: Lightcycler Instrument Version 1.2 (2003), 10 descendants of its own
- 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

## Recalls of this device
- Feb 15, 2005 · Not classified · Z-0573-05: 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.

Source page: https://510kreport.com/device/K950104
Methodology: https://510kreport.com/methodology