510(k) · Cleared
ClearedCoda Automated Eia Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJI Analyzer, Enzyme, For Clinical Use
Cleared on Jul 30, 1997 as substantially equivalent to K930898 (Bio-Rad, 1993) and 2 other predicates after a 58-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jul 30, 1997
- Review
- 58 days
- Class
- Class I
- Product code
- JJI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K902336 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK902336 Ciba Corning Acs:180 Automated ChemiluminescenceCiba Corning Diagnostics Corp. · 1990
- This deviceK972024 Coda Automated Eia AnalyzerBio-Rad · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902336 | Ciba Corning Acs:180 Automated Chemiluminescence | Ciba Corning Diagnostics Corp. | 1990 | — |
| 0 (this device) | K972024 | Coda Automated Eia Analyzer | Bio-Rad | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
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 JJI? 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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K930898 | Radias Automated Immunoassay SystemSummary page 4…ted EIA Analyzer Common Name: Coda Classification Name: Enzyme Analyzer, for Clinical Use, 75JJI Predicate Devices 1. Radius™ Immunoassay System, Bio-Rad Laboratories, K930898. 2. ACS 180 Automated Chemiluminescence System, Ciba Corning, K902336. 3. Abbott IMX2 Analyzer, Abbott Laboratories, K831970.… | 1993 |
| * | K902336 | Ciba Corning Acs:180 Automated ChemiluminescenceSummary page 4…r, for Clinical Use, 75JJI Predicate Devices 1. Radius™ Immunoassay System, Bio-Rad Laboratories, K930898. 2. ACS 180 Automated Chemiluminescence System, Ciba Corning, K902336. 3. Abbott IMX2 Analyzer, Abbott Laboratories, K831970. To establish substantial equivalence to an existing device, and thus es… | 1990 |
| * | K931970 | Abbott IMX2 Analyer 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”. | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All JJI devicesJJI Analyzer, Enzyme, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJI
FDA has decided no JJI device since 2007.
Median 510(k) review, days · JJI
Too few JJI 510(k)s in any year since 2007 to give a median.
Recalls per year · JJI
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJI
1in 2017
MAUDE reports naming product code JJI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
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/K972024 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972024: Coda Automated Eia Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972024
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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