# K991800: Hemochek Urine Collection Kit

- Pathway: 510(k) (Traditional)
- Applicant: Osborn Group, Inc.
- Decided: Sep 24, 1999 after 121 days
- Product code: JIQ (Turbidimetric 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
Longest line of descent: 3 generations back to K970357 (1997). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984361: Oral-Eze Oral Fluid Collection System, Osborn Laboratories, Inc. (1999) Summary page 1.
- K800947: Midstream Collection Kit, Sage Products, Inc. (1980) Summary page 1.

## Indications for use
The HemoChek Urine Collection Kit is a prescription device intended to collect a urine specimen in midstream or by dipping the absorbent pad in a cup containing urine, contain the specimen, and preserve the specimen after collection and during mailing from the collection area to the laboratory for testing of creatinine and microalbumin concentrations.

Source page: https://510kreport.com/device/K991800
Methodology: https://510kreport.com/methodology