QUANTA Flash Calprotectin and Fecal Extraction Device
FDA 510(k) K180971 · Inova Diagnostics, Inc.
510(k) numberK180971
Submission
- Device name
- QUANTA Flash Calprotectin and Fecal Extraction Device
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- April 13, 2018
- Decision date
- October 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NXO – Calprotectin, Fecal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5180
- Specialty
- Immunology
The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.
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| K220763 | ALPCO Calprotectin Immunoturbidimetric AssayNXO · Traditional | Alpco | 04/13/2023SE |
| K213858 | LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO · Traditional | DiaSorin, Inc. | 07/26/2022SE |
| K191807 | ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceNXO · Traditional | Alpco | 10/25/2019SE |
| K191718 | Buhlmann fCAL turbo and CALEX CapNXO · Traditional | Buhlmann Laboratories AG | 09/24/2019SE |
| K191592 | CalprestNG, EasyCalNXO · Special | Eurospital S.P.A. | 07/10/2019SE |
| K191589 | Calprest, EasyCalNXO · Special | Eurospital S.P.A. | 07/10/2019SE |
| K190784 | BUHLMANN fCAL turboNXO · Traditional | Buhlmann Laboratories AG | 06/25/2019SE |
| K182698 | LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…NXO · Traditional | DiaSorin, Inc. | 12/26/2018SE |
| K181012 | BUHLMANN fCAL ELISANXO · Traditional | Buhlmann Laboratories AG | 06/04/2018SE |
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| K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR · Traditional | 04/17/2019SE |
| K180975 | QUANTA Flash HMGCR ReagentsLLL · Traditional | 06/25/2018SE |
| K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…NXO · Traditional | 12/22/2017SE |
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1…NBS · Traditional | 09/06/2017SE |
Questions and answers
When was QUANTA Flash Calprotectin and Fecal Extraction Device cleared by the FDA?
QUANTA Flash Calprotectin and Fecal Extraction Device (K180971) received a 510(k) decision of Substantially Equivalent on October 16, 2018, 186 days after the submission was received.
What is the product code of K180971?
The FDA product code is NXO – Calprotectin, Fecal, a Class II (moderate risk) device regulated under 21 CFR 866.5180.