510(k) · Cleared
ClearedTeco Microalbumin 2-1 Combo Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teco Diagnostics · JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Cleared on Jan 26, 2007 after a 249-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 26, 2007
- Review
- 249 days
- Class
- Class I
- Product code
- JIR
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIR? 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 JIR device
- #1 K210069 Minuteful - kidney testscore 7.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 JIR devicesJIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JIR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIR
Too few JIR 510(k)s in any year since 2007 to give a median.
Recalls per year · JIR
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIR
2in 2025
MAUDE reports naming product code JIR, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Teco Diagnostics Microalbumin 2-1 combo Strip is designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine. Microalbuminuria, an abnormal elevation of the urinary albumin excretion rate, is many times one of the first signs of renal diseases and renal damage that can lead to renal failure. Creatinine measurements are used in the diagnosis and treatment of…
Read the full statement (119 words)
Teco Diagnostics Microalbumin 2-1 combo Strip is designed to give semi-quantitative results for Microalbumin and Creatinine in random urine and also determine the albumin to creatinine ratio in random urine.
Microalbuminuria, an abnormal elevation of the urinary albumin excretion rate, is many times one of the first signs of renal diseases and renal damage that can lead to renal failure.
Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
The Teco Microalbumin 2-1 Combo Strips are read by visual comparing color chart.
Teco Microalbumin 2-1 Combo Strips are recommended for use in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061419: Teco Microalbumin 2-1 Combo Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061419
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