Cleared Traditional

K230944 - MeMed BV (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence.

K230944 · MeMed Diagnostics, Ltd. · Microbiology device
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Optimized for regulatory review, auditing and printing
Jun 2023
Decision
87d
Days
Class 2
Risk

K230944 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 June 30, 2023 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all MeMed Diagnostics, Ltd. devices

Submission Details

510(k) Number K230944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2023
Decision Date June 30, 2023
Days to Decision 87 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
15d faster than avg
Panel avg: 102d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT05439551 Completed Observational Industry-sponsored

Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform (Perseverance Study)

A Prospective Multi-center Sample Collection Study for Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform ("Perseverance" Study)

215
Patients (actual)
5
Sites
Condition studied Acute Infection
Eligibility All sexes · 90 Days+
Sponsor MeMed Diagnostics Ltd. (industry)
Started 2022-02-11 → Primary completion 2022-11-13 → Completed 2023-09-29
Primary outcome
Measuring the MeMed BV® score with whole blood and serum samples from patients suspected of acute bacterial or viral infection and demonstrating the equivalence between the two matrices.
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov