Cleared Traditional

K220999 - Hipro Glycosylated Hemoglobin (HbA1c) Test System (FDA 510(k) Clearance)

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

K220999 · Shijiazhuang Hipro Biotechnology Co., Ltd. · Chemistry device
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Sep 2024
Decision
892d
Days
Class 2
Risk

K220999 is an FDA 510(k) clearance for the Hipro Glycosylated Hemoglobin (HbA1c) Test System. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Shijiazhuang Hipro Biotechnology Co., Ltd. (Shijiazhuang, CN). The FDA issued a Cleared decision on September 12, 2024 after a review of 892 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Shijiazhuang Hipro Biotechnology Co., Ltd. devices

Submission Details

510(k) Number K220999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2022
Decision Date September 12, 2024
Days to Decision 892 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
804d slower than avg
Panel avg: 88d · This submission: 892d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Shenzhen Joyantech Consulting Co., Ltd.
Hanson Chen

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 25
Devices cleared under the same product code (PDJ) and FDA review panel - the closest regulatory comparables to K220999.
Medconn 8K Glycated Hemoglobin Test System
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K242911 · Shanghai Medconn Medical Technology Co., Ltd. · Jun 2025
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K200904 · Tosoh Bioscience, Inc. · Aug 2021
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K200256 · Siemens Healthcare Diagnostics, Inc. · Jul 2021