Cleared Traditional

K210254 - MeMed BV

K210254 is an FDA 510(k) clearance for MeMed BV, manufactured by MeMed Diagnostics, Ltd.. The device is a Class 2 Microbiology device with product code QPS cleared through the Traditional 510(k) pathway after a 215-day FDA review.

K210254 · MeMed Diagnostics, Ltd. · Microbiology device
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Sep 2021
Decision
215d
Days
Class 2
Risk

K210254 is an FDA 510(k) clearance for the MeMed BV. Classified as Immunoassay For Host Biomarkers Of Infection (product code QPS), Class II - Special Controls.

Submitted by MeMed Diagnostics, Ltd. (Tirat Carmel, IL). The FDA issued a Cleared decision on September 1, 2021 after a review of 215 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3215 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all MeMed Diagnostics, Ltd. devices

FDA 510(k) Submission Details - K210254

510(k) Number K210254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2021
Decision Date September 01, 2021
Days to Decision 215 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 102d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QPS Device Classification - Class 2, Special Controls

Product Code QPS Immunoassay For Host Biomarkers Of Infection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3215
Definition A Semi-quantitative Immunoassay That Quantifies The Relative Levels Of Host Response Proteins Isolated From Serum Or Similar Specimens.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.