# K010599: Protime Microcoagulation System / Protime 3 Cuvette

- Pathway: 510(k) (Special)
- Applicant: International Technidyne Corp.
- Decided: Jul 2, 2001 after 124 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
4 of 21 devices 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.

## Most influential descendants
- K020831: PT S Test Strips and Controls for the Coaguchek S System, Models 2032422 and 3271404 (2002), 18 descendants of its own
- K060978: Coaguchek XS System (2006), 16 descendants of its own
- K071041: Coaguchek XS Plus System (2007), 6 descendants of its own
- K180780: microINR System (2019), 4 descendants of its own
- K201185: microINR System (2020), 3 descendants of its own

## Recalls of this device
- Jul 16, 2013 · Class II · Z-2198-2013: The products may have been stored at temperatures outside their required storage conditions.
- Sep 28, 2012 · Class II · Z-0837-2013: Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results.
- Nov 19, 2007 · Not classified · Z-0546-2008: An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages.

Source page: https://510kreport.com/device/K010599
Methodology: https://510kreport.com/methodology