510(k) · Cleared
ClearedCareside Total Protein
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exigent Diagnostics, Inc. · CEK Biuret (Colorimetric), Total Protein
Cleared on Feb 4, 1998 as substantially equivalent to K912844 (Eastman Kodak Company, 1991) after a 29-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Feb 4, 1998
- Review
- 29 days
- Class
- Class II
- Product code
- CEK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K912844 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK912844 Kodak Ektachem Dtii SystemEastman Kodak Company · 1991
- This deviceK980042 Careside Total ProteinExigent Diagnostics, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912844 | Kodak Ektachem Dtii System | Eastman Kodak Company | 1991 | — |
| 0 (this device) | K980042 | Careside Total Protein | Exigent Diagnostics, Inc. | 1998 | — |
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 CEK? 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? (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 | Decided |
|---|---|---|---|
| * | K912844 | Kodak Ektachem Dtii SystemSummary page 1…tein on the Vitros DT 60 II. Name of Predicate Device: Johnson and Johnson’s Vitros Total Protein Slides (formerly Eastman Kodzk, Inc.). Predicate Device 510K nuinber: K912844/A Product Code: 7SCEK FROM : EXIGENT DIAGNOSTICS INC. PHONE NO. : 3103385783 Jan. 3@ 1998 @5:88PM P6 Exigent Di… | 1991 |
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?
- Its one ancestor has no recall.
- 28 other devices also cite its predicate K912844.
How does its category compare?
All CEK devicesCEK Biuret (Colorimetric), Total Protein: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEK
FDA has decided no CEK device since 2007.
Median 510(k) review, days · CEK
Too few CEK 510(k)s in any year since 2007 to give a median.
Recalls per year · CEK
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEK
6in 2025
MAUDE reports naming product code CEK, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 2 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 33 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use with Exigent Diagnostics CareSide™ Analyzer to measure total protein from whole blood, heparinized plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
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/K980042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980042: Careside Total Protein.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980042
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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