Cleared Traditional

K260468 - H100Plus Hemoglobin Testing System

K260468 is an FDA 510(k) clearance for H100Plus Hemoglobin Testing System, manufactured by Shenzhen Lifotronic Technology Co., Ltd.. The device is a Class 2 Chemistry device with product code PDJ cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K260468 · Shenzhen Lifotronic Technology Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
232d
Days
Class 2
Risk

K260468 is an FDA 510(k) clearance for the H100Plus Hemoglobin Testing System. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Shenzhen Lifotronic Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 2, 2026 after a review of 232 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1373 - 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. Standard predicate reliance. 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 Shenzhen Lifotronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K260468

510(k) Number K260468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2026
Decision Date October 02, 2026
Days to Decision 232 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
144d slower than avg
Panel avg: 88d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDJ Device Classification - Class 2, Special Controls

Product Code PDJ Hemoglobin A1c Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1373
Definition Quantitative Determination Of Hemoglobin A1c To Aid In The Diagnosis Of Diabetes.
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

Guangdong Grzan Group Co., Ltd.
Lorna Li

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 - PDJ Hemoglobin A1c Test System

All 26
Devices cleared under the same product code (PDJ) and FDA review panel - the closest regulatory comparables to K260468.
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