510(k) · Cleared
ClearedBeckman MA Microalbumin Reagent Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Cleared on Dec 27, 1989 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Dec 27, 1989
- Review
- 83 days
- Class
- Class I
- Product code
- JIQ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK895883 Beckman MA Microalbumin Reagent KitBeckman Instruments, Inc. · 1989
- Descendant · cites it directly · 5 of its ownK972929 N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK101203 Tina-Quant Albumin Gen 2Roche Diagnostics · 2010 · Recalled
- Descendant · cites it directly · 1 of its ownK973928 Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK153560 Optilite Low Level Albumin KitThe Binding Site Group, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK113072 Tina-Quant Albumin Gen.2Roche Diagnostics Operations · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K972929N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997 · cites it directly5descendants
- K101203Tina-Quant Albumin Gen 2Roche Diagnostics · 2010 · 2 generations on1descendant
- K973928Beckman Urine Protein Calibrator (Ucal)Beckman Instruments, Inc. · 1997 · cites it directly1descendant
- K153560Optilite Low Level Albumin KitThe Binding Site Group, Ltd. · 2016 · 2 generations on0descendants
- K113072Tina-Quant Albumin Gen.2Roche Diagnostics Operations · 2012 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895883 | Beckman MA Microalbumin Reagent Kit | Beckman Instruments, Inc. | 1989 | — |
| +1 | K972929 | N Antiserum to Human Albumin | Behring Diagnostics, Inc. | 1997 | — |
| +2 | K101203 | Tina-Quant Albumin Gen 2 | Roche Diagnostics | 2010 | 1 |
| +1 | K973928 | Beckman Urine Protein Calibrator (Ucal) | Beckman Instruments, Inc. | 1997 | — |
| +2 | K153560 | Optilite Low Level Albumin Kit | The Binding Site Group, Ltd. | 2016 | — |
| +3 | K113072 | Tina-Quant Albumin Gen.2 | Roche Diagnostics Operations | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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 JIQ? 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? (9)
3 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, K972929 (Behring Diagnostics, Inc., 1997) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JIQ devicesJIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIQ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · JIQ
Too few JIQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JIQ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIQ
9in 2025
MAUDE reports naming product code JIQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K895883 · printed Nov 4, 2026
Cite this page
510(k) Report. “K895883: Beckman MA Microalbumin Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895883
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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