# K040359: Hemosil Special Test Controls Level 1 & 2

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Mar 19, 2004 after 35 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864271 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864271: IL Test 84673-30 Chromogenics Control Plasma, Instrumentation Laboratory CO (1986) Summary page 1.

## Indications for use
The intended use to HemosIL Special Test Controls Level 1 & 2 is being expanded with the addition of value assignments for chromogenic Factor VIII tests (Levels 1 and 2) and clotting factor assays (Level 2 only). There are no changes in product formulation or alterations in the fundamental scientific technology introduced with the new value assignments. HemosIL Special Test Controls Level 1 & 2 is labeled: For the quality control in the abnormal range of the chromogenic tests (Antithrombin, Plasminogen, Plasmin Inhibitor, Protein C and Factor VIII) and Free Protein S assay performed on the IL Coagulation Systems. For the Quality Control of von Willebrand Factor assay in the normal (Level 1) and abnormal range (Level 2) on the IL Coagulation Systems. For the Quality Control of factor assays (clotting) in the abnormal range (Level 2) on the IL Coagulation Systems.

Source page: https://510kreport.com/device/K040359
Methodology: https://510kreport.com/methodology