Cleared Traditional

K200904 - Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (FDA 510(k) Clearance)

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

K200904 · Tosoh Bioscience, Inc. · Chemistry device
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Aug 2021
Decision
486d
Days
Class 2
Risk

K200904 is an FDA 510(k) clearance for the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on August 5, 2021 after a review of 486 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 Tosoh Bioscience, Inc. devices

Submission Details

510(k) Number K200904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2020
Decision Date August 05, 2021
Days to Decision 486 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
398d slower than avg
Panel avg: 88d · This submission: 486d
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 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 K200904.
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