510(k) · Cleared
ClearedHichem Total Protein Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elan Holdings, Inc. · CEK Biuret (Colorimetric), Total Protein
Cleared on Oct 18, 1999 after a 55-day review. The FDA summary names its predicate without a number.
- Decided
- Oct 18, 1999
- Review
- 55 days
- Class
- Class II
- Product code
- CEK
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | SYNCHRON® CX® Systems Total Protein Reagent Kit, product no. 450224 Named without a submission number |
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.
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?
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems.
Total protein results are used 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.
This reagent is intended for professional use only.
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/K992846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992846: Hichem Total Protein Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992846
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026