510(k) · Cleared
ClearedN-Assay Tia Microalbumin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crestat Diagnostics, Inc. · JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Cleared on Jan 11, 1994 after a 140-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Jan 11, 1994
- Review
- 140 days
- Class
- Class I
- Product code
- JIR
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934146 | N-Assay Tia Microalbumin | Crestat Diagnostics, Inc. | 1994 | — |
| +1 | K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15 | Diagnostic Chemicals, Ltd. | 2000 | — |
| +1 | K983774 | UALB | Abbott Laboratories | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
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, K994035 (Diagnostic Chemicals, Ltd., 2000) has gone furthest, with 0 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K934146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934146: N-Assay Tia Microalbumin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934146
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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