# K111999: Healgen 11 Reagent Strip for Urinalysis, Healgen 10 Reagent Strip for Urinalysis, and Healgen 4 Reagent Strip for Urinal

- Pathway: 510(k) (Traditional)
- Applicant: Healgen Scientific,, LLC
- Decided: Apr 17, 2012 after 279 days
- Product code: JIO (Blood, Occult, Colorimetric, In Urine)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K861255 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040703: Uristik H Series Reagent Strips for Urinalysis, Dirui Industrial Co., Ltd. (2004) Summary page 1.

## Recalls of this device
- Aug 22, 2024 · Class II · Z-3303-2024: The reason for this recall is Healgen Scientific Ltd. has determined that their Urinary Reagent Strip products have shown reduced sensitivity, or potential false negative results for the detection of 

## Indications for use
The Healgen Series Urine Reagent Strips and Urine Analyzers are in-vitro test systems intended for qualitative and semi-quantitative analysis of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Nitrite, Leucocytes, Glucose, Specific gravity, pH and Ascorbic Acid in urine. The test systems consist of the Healgen Series Reagent. Strips (Healgen 10 and Healgen 11) and the Healgen 500 or Healgen 800 Urine Analyzers. The Healgen 10 and 11 strips can be read visually and instrumentally with the Healgen 500 and 800 Analyzers. The Healgen 4 reagent strip can be read visually only. The Healgen Series Urine Reagent Strips and Urine Analyzers are intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The Healgen 500 and 800 Urine Analyzers use reflectance photometry to quantitate analyte values from urine samples when using the Healgen 10 and 11 reagent test strips.

Source page: https://510kreport.com/device/K111999
Methodology: https://510kreport.com/methodology