Cleared Traditional

K203833 - Tacrolimus Assay Kit (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203833 · Shanghai Genext Medical Technology Co., Ltd. · Chemistry device
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Jan 2023
Decision
758d
Days
Class 2
Risk

K203833 is an FDA 510(k) clearance for the Tacrolimus Assay Kit. Classified as Enzyme Immunoassay, Tracrolimus (product code MLM), Class II - Special Controls.

Submitted by Shanghai Genext Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 27, 2023 after a review of 758 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1678 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Shanghai Genext Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K203833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2020
Decision Date January 27, 2023
Days to Decision 758 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
670d slower than avg
Panel avg: 88d · This submission: 758d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MLM Enzyme Immunoassay, Tracrolimus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1678
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 Chemistry devices follow this clearance model.

Regulatory Consultant

Emergo Global Consulting, LLC
Giselle Zhang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.