# K983510: Chemstrip 101 Urine Analyzer

- Pathway: 510(k) (Special)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 27, 1998 after 20 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- 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 K943592 (1994). 1 ancestor in all.
13 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943592: Chemstrip Mini UA Urine Analyzer, Boehringer Mannheim Corp. (1994) Summary page 2.

## Most influential descendants
- K013783: Aution Max AX-4280 Urinalysis System (2002), 11 descendants of its own
- K093098: Aution Max Model AX-4030 Urinalysis System (2009), 4 descendants of its own
- K101852: Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit (2011), 3 descendants of its own
- K171083: iChemVELOCITY Automated Urine Chemistry System (2017), 2 descendants of its own
- K030600: Aution Jet AJ-4270 Urine Analyzer (2003), 2 descendants of its own

## Indications for use
The Roche Diagnostics, Boehringer Mannheim Chemstrip 101 Urine Analyzer is a reflectance photometer for in-vitro semi-quantitative determination of the following urine analytes: specific gravity, pH, leukocytes, nitrite, glucose, ketones, urobilinogen, bilirubin and blood. According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.2900, an automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device 1s used in conjunction with certain materials to measure a variety of urinary analytes.

Source page: https://510kreport.com/device/K983510
Methodology: https://510kreport.com/methodology