Cleared Traditional

K161533 - A1C EZ Glycohemoglobin Analysis System

K161533 is an FDA 510(k) clearance for A1C EZ Glycohemoglobin Analysis System, manufactured by Biohermes Co., Ltd.. The device is a Class 2 Chemistry device with product code LCP cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K161533 · Biohermes Co., Ltd. · Chemistry device
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Jun 2017
Decision
379d
Days
Class 2
Risk

K161533 is an FDA 510(k) clearance for the A1C EZ Glycohemoglobin Analysis System. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Biohermes Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on June 16, 2017 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7470 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biohermes Co., Ltd. devices

FDA 510(k) Submission Details - K161533

510(k) Number K161533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2016
Decision Date June 16, 2017
Days to Decision 379 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
291d slower than avg
Panel avg: 88d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCP Device Classification - Class 2, Special Controls

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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

Shenzhen Joyantech Consulting Co., Ltd.
Field Fu

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 - LCP Assay, Glycosylated Hemoglobin

All 208
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K161533.
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