# K972710: Quantify (901)

- Pathway: 510(k) (Traditional)
- Applicant: Hematronix, Inc.
- Decided: Aug 15, 1997 after 25 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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 K890577 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890577: Kenlor Liquid Urine Control, Kenlor Industries, Inc. (1989) Summary page 1.

## Indications for use
The Hematronix qUAntify TM Control System is a liquid, ready-to-use urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals. Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick testing. Alternative tests such as the Glucose (Clinites), Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified urine hCG tests. Two distinct levels are included to verify the recovery of normal and elevated patient values.

Source page: https://510kreport.com/device/K972710
Methodology: https://510kreport.com/methodology