# K982301: MICRO21 with Urine Sediment Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Triangle Biomedical Sciences, Inc.
- Decided: Aug 7, 1998 after 37 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K182062: Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device (2018), 0 descendants of its own

## Indications for use
For In Vitro Diagnostic Use Intelligent Medical Imaging, Inc.’s MICRO21® with Urine Sediment Analysis is a laboratory instrument for locating, digitally storing and displaying microscopic fields of view from urine sediments in a urine slide for examination by a qualified individual for use in reporting a urine microscopic result.

Source page: https://510kreport.com/device/K982301
Methodology: https://510kreport.com/methodology