# K010456: Bioscanner Creatinine Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Jun 20, 2001 after 124 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 15, 2012 · Class II · Z-1903-2012: During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not 

Source page: https://510kreport.com/device/K010456
Methodology: https://510kreport.com/methodology