i-STAT PTplus Cartridge with the i-STAT 1 System
FDA 510(k) K220282 · Abbott Laboratories
510(k) numberK220282
Submission
- Device name
- i-STAT PTplus Cartridge with the i-STAT 1 System
- Applicant
- Abbott Laboratories
Princton, NJ, US - Received
- February 1, 2022
- Decision date
- July 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GJS – Test, Time, Prothrombin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7750
- Specialty
- Hematology
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| K253188 | CoaguChek XS Plus SystemGJS · Special | Roche Diagnostics | 10/24/2025SE |
| K251564 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 07/21/2025SE |
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| K230802 | Xprecia Prime Coagulation SystemGJS · Dual Track | Universal Biosensors Pty, Ltd. | 03/15/2024SE |
| K231711 | microINR SystemGJS · Special | Iline Microsystems, S.L. | 07/11/2023SE |
| K211485 | STA- NeoPTimalGJS · Traditional | Diagnostica Stago S.A.S | 12/23/2022SE |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingGJS · Special | Coagusense, Inc. | 10/05/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | Instrumentation Laboratory CO | 08/16/2022SE |
| K201185 | microINR SystemGJS · Traditional | Iline Microsystems, S.L. | 12/18/2020SE |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring DeviceGJS · Traditional | Coagusense, Inc. | 02/21/2019SE |
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Questions and answers
When was i-STAT PTplus Cartridge with the i-STAT 1 System cleared by the FDA?
i-STAT PTplus Cartridge with the i-STAT 1 System (K220282) received a 510(k) decision of Substantially Equivalent on July 14, 2023, 528 days after the submission was received.
What is the product code of K220282?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.