QPS · Class II · 21 CFR 866.3215

FDA Product Code QPS: Immunoassay For Host Biomarkers Of Infection

A Semi-quantitative Immunoassay That Quantifies The Relative Levels Of Host Response Proteins Isolated From Serum Or Similar Specimens.

Leading manufacturers include MeMed Diagnostics, Ltd. and DiaSorin, Inc..

4
Total
4
Cleared
186d
Avg days
2021
Since
Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Immunoassay For Host Biomarkers Of Infection Devices (Product Code QPS)

4 devices
1–4 of 4
Cleared Jun 30, 2023
MeMed BV
K230944
MeMed Diagnostics, Ltd.
Microbiology · 87d
Cleared Mar 23, 2023
MeMed BV
K222332
MeMed Diagnostics, Ltd.
Microbiology · 233d
Cleared Jul 14, 2022
LIAISON MeMed BV, LIAISON MeMed BV Control Set
K213936
DiaSorin, Inc.
Microbiology · 210d
Cleared Sep 01, 2021
MeMed BV
K210254
MeMed Diagnostics, Ltd.
Microbiology · 215d

About Product Code QPS - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code QPS since 2021, with 4 receiving FDA clearance (average review time: 186 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.