510(k) · Cleared
ClearedDocument (TM) Uric Acid Linearity Test Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Casco Standards · JIT Calibrator, Secondary
Cleared on Jul 20, 1989 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jul 20, 1989
- Review
- 86 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK893139 Document (TM) Uric Acid Linearity Test SetCasco Standards · 1989
- Descendant · cites it directly · 2 of its ownK013119 Validate Chem 6 Calibration Verification Test Set Model # 10006Maine Standards Co. · 2001
- Descendant · 2 generations on · 1 of its ownK133550 Validate Ferritin Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK142964 VALIDATE Anemia Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2015
- Descendant · cites it directly · 0 of its ownK012118 Validate Chem 2 Calibration Verification Test Set, Model 10002Maine Standards Co. · 2001
Most influential descendants
Showing 4 of 4 · See all- K013119Validate Chem 6 Calibration Verification Test Set Model # 10006Maine Standards Co. · 2001 · cites it directly2descendants
- K133550Validate Ferritin Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2014 · 2 generations on1descendant
- K142964VALIDATE Anemia Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2015 · 3 generations on0descendants
- K012118Validate Chem 2 Calibration Verification Test Set, Model 10002Maine Standards Co. · 2001 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K893139 | Document (TM) Uric Acid Linearity Test Set | Casco Standards | 1989 | — |
| +1 | K013119 | Validate Chem 6 Calibration Verification Test Set Model # 10006 | Maine Standards Co. | 2001 | — |
| +2 | K133550 | Validate Ferritin Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2014 | — |
| +3 | K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2015 | — |
| +1 | K012118 | Validate Chem 2 Calibration Verification Test Set, Model 10002 | Maine Standards Co. | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K013119 (Maine Standards Co., 2001) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K893139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K893139: Document (TM) Uric Acid Linearity Test Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K893139
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026