HemosIL Liquid Anti-Xa
FDA 510(k) K223187 · Instrumentation Laboratory CO
510(k) numberK223187
Submission
- Device name
- HemosIL Liquid Anti-Xa
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- October 12, 2022
- Decision date
- June 23, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLU – Anti-Factor Xa Activity Test System, Apixaban
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7295
- Specialty
- Hematology
A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings.
Other 510(k)s with product code QLU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…QLU · Traditional | Siemens Healthcare Diagnostics Products GmbH | 10/10/2024SE |
More from Siemens Healthcare Diagnostics Products GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | 12/13/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
| K203790 | GEM Premier 5000CHL · Special | 08/20/2021SE |
Questions and answers
When was HemosIL Liquid Anti-Xa cleared by the FDA?
HemosIL Liquid Anti-Xa (K223187) received a 510(k) decision of Substantially Equivalent on June 23, 2023, 254 days after the submission was received.
What is the product code of K223187?
The FDA product code is QLU – Anti-Factor Xa Activity Test System, Apixaban, a Class II (moderate risk) device regulated under 21 CFR 864.7295.