# K021923: Inratio Self-Test

- Pathway: 510(k) (Traditional)
- Applicant: Hemosense, Inc.
- Decided: Oct 24, 2002 after 135 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 4 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) The INRatio System: named in the summary without a submission number

## Most influential descendants
- K093243: Coagusense Self-Test Prothrombin Time/Inr Monitoring System (2010), 2 descendants of its own
- K183255: Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (2019), 1 descendant of its own
- K212779: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (2022), 0 descendants of its own
- K110212: INRATIO2 PI/NR Monitoring System; Inratio PT/Inr Test Strip (2012), 0 descendants of its own

## Recalls of this device
- Dec 5, 2014 · Class I · Z-0881-2015: In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise i
- Dec 5, 2014 · Class I · Z-0880-2015: In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise i
- Oct 11, 2011 · Not classified · Z-0188-2012: Alere has initiated a recall of the Professional Disposables International (PDI) alcohol prep products due to the potential presence of low levels of the microorganism Bacillus cereus.
- Sep 7, 2005 · Not classified · Z-0132-06: A software problem that may cause the INRatio meter to incorrectly display 'INR>7.5' test message under a particular use condition.

## Indications for use
The HemoSense INRatio is an in vitro diagnostic system that provides a quantitative prothrombin time results, expressed in seconds and as an International Normalized Ratio (INR). It uses fresh capillary whole blood and is intended for is intended for quantitative prothrombin time testing of fresh, capillary whole blood for monitoring of oral anticoagulation therapy by trained patients or their caregivers, on the prescription or other order of a treating physician.

Source page: https://510kreport.com/device/K021923
Methodology: https://510kreport.com/methodology