510(k) · Cleared
ClearedGlucose Reagent for Beckman Synchron CX & CX Delta Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Diagnostics, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Jan 30, 2004 as substantially equivalent to K942676 (Beckman-Diagnostic Systems Group, 1994) and 1 other predicate after a 123-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jan 30, 2004
- Review
- 123 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K864236 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK864236 Synchron CX3Beckman Instruments, Inc. · 1986
- This deviceK033055 Glucose Reagent for Beckman Synchron CX & CX Delta SystemsDiamond Diagnostics, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K864236 | Synchron CX3 | Beckman Instruments, Inc. | 1986 | — |
| 0 (this device) | K033055 | Glucose Reagent for Beckman Synchron CX & CX Delta Systems | Diamond Diagnostics, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 CGA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K942676 | Synchron CX3 DeltaSummary page 1…BK-443355D Glucose Reagent 443355 Glucose Reagent The predicate reagent, Beckman PN 443355, is encompassed in the 510(k)'s K942676 & K864236 cleared 11/02/1994 & 12/31/1986 respectively. 4. Device Description: Glucose concentration is de… | 1994 |
| * | K864236 | Synchron CX3Summary page 1…Glucose Reagent 443355 Glucose Reagent The predicate reagent, Beckman PN 443355, is encompassed in the 510(k)'s K942676 & K864236 cleared 11/02/1994 & 12/31/1986 respectively. 4. Device Description: Glucose concentration is determined by an oxygen r… | 1986 |
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.
- 4 other devices also cite its predicate K942676.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Mission Glucose Reagent is intended for in vitro diagnostic use for the quantitative determination of gucose in serum, plasma, cerebrospinal fluid (CSF) and urine on Beckman Synchron CX® & CX Delta Systems.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033055 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033055: Glucose Reagent for Beckman Synchron CX & CX Delta Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033055
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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