510(k) · Cleared
ClearedDri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JFM Enzymatic Method, Bilirubin
Cleared on Dec 16, 2005 as substantially equivalent to K843174 (Beckman Instruments, Inc., 1984) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Dec 16, 2005
- Review
- 44 days
- Class
- Class II
- Product code
- JFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791141 (1979). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK791141 Bilirubin Calibrator ControlBeckman Instruments, Inc. · 1979
- This deviceK053090 Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin…Beckman Coulter, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791141 | Bilirubin Calibrator Control | Beckman Instruments, Inc. | 1979 | — |
| 0 (this device) | K053090 | Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin Calibrator | Beckman Coulter, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 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 JFM? 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? (2)
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 |
|---|---|---|---|
| * | K843174 | Dri-Stat Enzymatic Bilirubin Test KitSummary page 1…ct) test system (21 CFR § 862.1110) Calibrator (21 CFR § 862.1150) 4.0 Predicate Device: Candidate(s) Predicate Manufacturer Docket Number Dri-STAT® Dri-STAT® Beckman K843174 Enzymatic Bilirubin Enzymatic Bilirubin | Coulter, Inc.* Reagent Reagent SYNCHRON® SYNCHRON® Beckman K791141 Systems Bilirubin Sy… | 1984 |
| * | K791141 | Bilirubin Calibrator ControlSummary page 1…icate Manufacturer Docket Number Dri-STAT® Dri-STAT® Beckman K843174 Enzymatic Bilirubin Enzymatic Bilirubin | Coulter, Inc.* Reagent Reagent SYNCHRON® SYNCHRON® Beckman K791141 Systems Bilirubin Systems Bilirubin | Coulter, Inc.* Calibrator Calibrator *Beckman Couilter, Inc., Brea, CA SSE1 File: TBE_RSP1… | 1979 |
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 2 ancestors has a recall.
How does its category compare?
All JFM devicesJFM Enzymatic Method, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFM
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JFM
Too few JFM 510(k)s in any year since 2007 to give a median.
Recalls per year · JFM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFM
1in 2025
MAUDE reports naming product code JFM, 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 | 1 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Dri-STAT® Enzymatic Bilirubin Reagent, in conjunction with the SYNCHRON® Systems Bilirubin Calibrator, is intended for use in the in vitro diagnostic determination of total bilirubin in human serum and plasma as a User Defined Reagent (UDR) application on SYNCHRON® Systems.
Measurements of total bilirubin in serum and plasma are used in the diagnosis of hemolytic disorder, biliary obstruction, hepatitis and cirrhosis
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/K053090 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053090: Dri-Stat Enzymatic Bilirubin Reagent, Synchron Systems Bilirubin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053090
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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