# K972024: Coda Automated Eia Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jul 30, 1997 after 58 days
- Product code: JJI (Analyzer, Enzyme, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902336 (1990). 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)
- K930898: Radias Automated Immunoassay System, Bio-Rad (1993) Summary page 4.
- K902336: Ciba Corning Acs:180 Automated Chemiluminescence, Ciba Corning Diagnostics Corp. (1990) Summary page 4.
- K931970: Abbott IMX2 Analyer, Abbott Laboratories (1993). Our OCR of the scanned summary read K831970, FDA’s number for Vivonex Tungsten Tip Tube-Monofila- (Norwich Eaton Pharmaceuticals, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Abbott IMX2 Analyzer”.

## Indications for use
CODA is an integrated immunoassay analyzer intended for the automation of microplate based assays for in vitro diagnostic use. The system is open, such that a variety of microplate-based enzyme immunoassays (EIA’s) can be programmed and run on the instrument. The sample and reagent pipettes, incubator, washer, reader and robotics are housed in the compact benchtop unit. CODA Operation and Data Management software operates in the Windows 95 environment utilizing icon-based commands for operator ease of use.

Source page: https://510kreport.com/device/K972024
Methodology: https://510kreport.com/methodology