510(k) · Cleared
ClearedTeco CX3 Reagent Set for Synchron CX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teco Diagnostics · CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Cleared on Mar 27, 2006 as substantially equivalent to K981106 (Teco Diagnostics, 1998) and 3 other predicates after a 69-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Mar 27, 2006
- Review
- 69 days
- Class
- Class II
- Product code
- CDQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K863926 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK863926 Glucose OxidaseTech-Co, Inc. · 1986
- This deviceK060120 Teco CX3 Reagent Set for Synchron CX SystemTeco Diagnostics · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863926 | Glucose Oxidase | Tech-Co, Inc. | 1986 | — |
| 0 (this device) | K060120 | Teco CX3 Reagent Set for Synchron CX System | Teco Diagnostics | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1998 | 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 CDQ? 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 CDQ device
- #1 K203771 Urea Nitrogen2score 3.7 · 2 generations · no Class I recall
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K981106 | Urea Nitrogen (Bun) Liquid ReagentSummary page 2…edicate device is Teco BUN Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid Reagent. The 510 (K) approval letter is provided in Appendix I. 510(K) #: K981106, K864741, K880629, K863926. Approval Date: 04-16-1998, 01-09-1987, 03-23-1988, 11-13-1986 TECO DIAGNOSTICS… | 1998 |
| * | K864741 | Cresolphthalein Complexone, CalciumSummary page 2…evice is Teco BUN Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid Reagent. The 510 (K) approval letter is provided in Appendix I. 510(K) #: K981106, K864741, K880629, K863926. Approval Date: 04-16-1998, 01-09-1987, 03-23-1988, 11-13-1986 TECO DIAGNOSTICS… | 1987 |
| * | K880629 | CreatinineSummary page 2…Teco BUN Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid Reagent. The 510 (K) approval letter is provided in Appendix I. 510(K) #: K981106, K864741, K880629, K863926. Approval Date: 04-16-1998, 01-09-1987, 03-23-1988, 11-13-1986 TECO DIAGNOSTICS… | 1988 |
| * | K863926 | Glucose OxidaseSummary page 2…Liquid, Teco Calcium Color, Teco Creatinine and Teco Glucose Liquid Reagent. The 510 (K) approval letter is provided in Appendix I. 510(K) #: K981106, K864741, K880629, K863926. Approval Date: 04-16-1998, 01-09-1987, 03-23-1988, 11-13-1986 TECO DIAGNOSTICS… | 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 4 ancestors has a recall.
How does its category compare?
All CDQ devicesCDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDQ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · CDQ
Too few CDQ 510(k)s in any year since 2007 to give a median.
Recalls per year · CDQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDQ
6in 2025
MAUDE reports naming product code CDQ, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 1 | — | 1 | 37 |
| 2012 | 0 | — | 0 | 44 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 231 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Teco CX3 Reagent Set for SYNCHRON CX System is intended for the quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System. BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal and tetany. Creatinine measurements are used in the diagnosis and…
Read the full statement (123 words)
Teco CX3 Reagent Set for SYNCHRON CX System is intended for the quantitative determination of BUN, Calcium, Creatinine and Glucose in serum on Beckman CX3 System.
BUN measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal and tetany.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and a calculation basis for measuring other urine analytes.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and pancreatic islet carcinoma.
This reagent set is intended for in vitro diagnostic 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/K060120 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060120: Teco CX3 Reagent Set for Synchron CX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060120
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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