# K983774: UALB

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 28, 1999 after 94 days
- Product code: JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K934146 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934146: N-Assay Tia Microalbumin, Crestat Diagnostics, Inc. (1994) Summary page 1.

## Indications for use
The Microalbumin assay is used for the quantitation of low levels of albumin in human urine. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques, the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

Source page: https://510kreport.com/device/K983774
Methodology: https://510kreport.com/methodology