# K022538: Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Chemicals, Ltd. (Usa)
- Decided: Aug 23, 2002 after 22 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For IN VITRO diagnostic use. There are several kidney disease conditions that can produce high levels of albumin in urine (1). Determining albumin in the urine at the low levels measured by this test is helpful for early detection and treatment of patients at risk for renal (kidney) disease. Low but elevated urinary albumin levels, or microalbuminuria, refers to a level of the human protein albumin in urine above about 10 mg/L. Levels above 18 mg/L are not normally found in healthy individuals. These low but significant levels are not detectable with older dipstick assays. The ImmunoDip Urinary Albumin Test classifies samples as positive or negative based on their being above or below a level of 18 mg/L. Conditions in which elevated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-8); hypertension (9; 10); and renal disease found in pregnancy (11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics develop serious kidney disease (3). Testing for elevated levels of albumin in urine helps to identify those diabetics who are prone to kidney disease. Scientific studies indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1, 9).

Source page: https://510kreport.com/device/K022538
Methodology: https://510kreport.com/methodology