510(k) · Cleared
ClearedElitech Clinical Systems Urine Total Protein Plus Standard 100 MG/DL, Elitech Clinical Systems Urine Control BI-Level
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elitechgroup · JIT Calibrator, Secondary
Cleared on Feb 15, 2013 as substantially equivalent to K092570 (Horiba Abx Sas, 2009) and 1 other predicate after a 207-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Feb 15, 2013
- Review
- 207 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971954 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971954 | Liquichek Urine Chemistry Control (Cat.NO. 397,398) | Bio-Rad | 1997 | — |
| −1 | K020817 | Liquichek Urine Chemistry Control | Bio-Rad Laboratories, Inc. | 2002 | — |
| 0 (this device) | K122177 | Elitech Clinical Systems Urine Total Protein Plus Standard 100 MG/DL, Elitech… | Elitechgroup | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 JIT? 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 |
|---|---|---|---|
| * | K092570 | Abx Pentra Tpu Cal, Model A11A01898Summary page 1…ation name CFR 862.1150 - calibrator Product code JIT - Calibrator, Secondary Predicate device HORIBA ABX PENTRA TPU Cal (K092570) Device description EtITech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is an… | 2009 |
| * | K020817 | Liquichek Urine Chemistry ControlSummary page 2…ssayed). Pmoduct code JJX - Control, Single analyte. Predicate device Biorad Liquicheck Urine Chemistry Control Level 1 and Level 2 (K020817). Device description ELITEch Clinical Systems URINE CONTROL 61-LEVEL is a liquid solution… | 2002 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
ELiTech Clinical Systems URINE TOTAL PROTEIN Standard 100 mg/dL is intended for the calibration of quantitative ELiTech Clinical Systems URINE TOTAL PROTEIN on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELiTech Clinical Systems URINE CONTROL BI-LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELiTech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122177 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122177: Elitech Clinical Systems Urine Total Protein Plus Standard 100 MG/DL, Elitech Clinical Systems Urine Control BI-Level.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122177
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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