Cleared Traditional

MAGLUMI 2000 FT4 (K182423) - FDA 510(k) Clearance

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

K182423 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
28d
Days
Class 2
Risk

K182423 is an FDA 510(k) clearance for the MAGLUMI 2000 FT4. Classified as Radioimmunoassay, Free Thyroxine (product code CEC), Class II - Special Controls.

Submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 4, 2018 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1695 - 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: 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 Shenzhen New Industries Biomedical Engineering Co., Ltd. devices

Submission Details

510(k) Number K182423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2018
Decision Date October 04, 2018
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEC Radioimmunoassay, Free Thyroxine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1695
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

LSI International, Inc.
Joe Shia

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.

Regulatory Peers - CEC Radioimmunoassay, Free Thyroxine

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