# K122584: Hemosil Readiplas Tin

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Mar 24, 2013 after 212 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K862301 (1986). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070005: Hemosil Recombiplastin 2G, Instrumentation Laboratory CO (2007) Summary page 2.

## Most influential descendants
- K213426: HemosIL ReadiPlasTin (2022), 0 descendants of its own

## Recalls of this device
- Apr 8, 2022 · Class II · Z-1052-2022: Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically Hemo
- Oct 13, 2021 · Class II · Z-0276-2022: The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls ar
- Aug 1, 2018 · Class II · Z-0077-2019: There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
- Aug 2, 2017 · Class II · Z-0895-2018: Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and pro

## Indications for use
Hemosli. ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP® Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

Source page: https://510kreport.com/device/K122584
Methodology: https://510kreport.com/methodology