# K982219: Microalbustix Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Aug 12, 1998 after 49 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. The FDA summary names its predicate without a number.
- (no number) CLINITEK® Microalbumin Reagent Strips: named in the summary without a submission number
- (no number) Micral-Test® strips: named in the summary without a submission number

## Indications for use
MICROALBUSTIX Reagent Strips are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria), creatinine in urine, and also determine the albumin-to-creatinine ratio in urine. The strips are read visually by comparing the color of the reacted strip to the color chart on the bottle label. MICROALBUSTIX Reagent Strips provide semi-quantitative results and can be used for screening urine specimens for microalbuminuria as an aid in the detection of persons at risk for developing kidney damage. MICROALBUSTIX Reagent Strips are for professional use.

Source page: https://510kreport.com/device/K982219
Methodology: https://510kreport.com/methodology