510(k) · Cleared
ClearedAusam Total Albumin Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ausam Biotecthnologies, Inc. · JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Cleared on Aug 14, 2003 after a 647-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 14, 2003
- Review
- 647 days
- Class
- Class I
- Product code
- JIQ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
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.
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 | — |
What is it indicated for?
The Total Intact Albumin Assay (also known as the AusAm Microalbumin Plus Urinary Assay) is intended for in vitro diagnostic use in the quantitation of intact albumin in human urine. Measurement of intact albumin with this assay aids in the identification of patients who may warrant further testing for kidney or intestinal disease.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K013643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013643: Ausam Total Albumin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013643
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026