# K991315: Microalbustix Reagent Strips (Otc)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Nov 12, 1999 after 207 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) MICROALBUSTIX Reagent Strips (Professional): named in the summary without a submission number

## Indications for use
MICROALBUSTIX Reagent Strips (OTC) 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 (OTC) provide semi-quantitative results and are intended for home use by persons at risk of developing kidney disease.

Source page: https://510kreport.com/device/K991315
Methodology: https://510kreport.com/methodology