510(k) · Cleared
ClearedDca 2000 + Microalbumin/Creatinine Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp. · JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Cleared on Sep 27, 1996 after a 45-day review. The FDA summary names its predicate without a number. 15 later devices descend from it.
- Decided
- Sep 27, 1996
- Review
- 45 days
- Class
- Class I
- Product code
- JIR
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 2 citing it directly.
- This deviceK963142 Dca 2000 + Microalbumin/Creatinine AssayBayer Corp. · 1996
- Descendant · cites it directly · 8 of its ownK071466 Dca Vantage, Model 5075Siemens Medical Solutions Diagnostics · 2007 · Recalled
- Descendant · cites it directly · 5 of its ownK072409 Afinion Acr and Acr ControlAxis-Shield Poc AS · 2008
- Descendant · 2 generations on · 2 of its ownK171650 Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK082275 Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor…Infopia Co, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK221813 Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K071466Dca Vantage, Model 5075Siemens Medical Solutions Diagnostics · 2007 · cites it directly8descendants
- K072409Afinion Acr and Acr ControlAxis-Shield Poc AS · 2008 · cites it directly5descendants
- K171650Alere Afinion HbA1c and ACR on Afinion 2 analyzerAbbott Rapid Diagnostics · 2017 · 2 generations on2descendants
- K082275Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023Infopia Co, Ltd. · 2010 · 2 generations on2descendants
- K221813Nova Allegro UACR Assay, Nova Allegro AnalyzerNova Biomedical Corporation · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963142 | Dca 2000 + Microalbumin/Creatinine Assay | Bayer Corp. | 1996 | — |
| +1 | K071466 | Dca Vantage, Model 5075 | Siemens Medical Solutions Diagnostics | 2007 | 1 |
| +1 | K072409 | Afinion Acr and Acr Control | Axis-Shield Poc AS | 2008 | — |
| +2 | K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | 2017 | 2 |
| +2 | K082275 | Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model… | Infopia Co, Ltd. | 2010 | — |
| +2 | K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 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? (8)
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 |
|---|---|---|---|
| * | — | Incstar® Antibody Reagent Set for Microalbumin SPQ™ Test System Named without a submission number | |
| * | — | Diagnostic Products Corporation Double Antibody Albumin RIA for microalbuminuria Named without a submission number | |
| * | — | Pharmacia Albumin RIA Named without a submission number | |
| * | — | Behring Turbitimer semiautomated method for albumin Named without a submission number | |
| * | — | Beckman Array® nephelometric method for albumin Named without a submission number | |
| * | — | Roche® Reagent for CREATININE [Roche Cobas™-Mira] Named without a submission number | |
| * | — | automated Jaffe methods for Hitachi, Olympus and Dupont Dimension analyzers Named without a submission number | |
| * | — | Sigma manual alkaline picrate method Named without a submission number |
What descends from it? (15)
See all 152 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, K071466 (Siemens Medical Solutions Diagnostics, 2007) has gone furthest, with 8 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 | — |
What is it indicated for?
The DCA 2000+ Microalbumin/Creatinine Assay is a professional use device for the measurement of microalbumin, creatinine and albumin/creatinine ratio in urine. Testing for microalbuminuria (low concentrations of albumin in the urine) is recommended in patients with insulin-dependent diabetes mellitus (IDDM) as well as patients with non-insulin dependent diabetes mellitus (NIDDM). This assay is intended for use in both screening for, and monitoring treatment of, microalbuminuria.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963142: Dca 2000 + Microalbumin/Creatinine Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963142
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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