Cleared Traditional

K080123 - APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 (FDA 510(k) Clearance)

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

K080123 · Wako Chemicals USA, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 2008
Decision
182d
Days
Class 2
Risk

K080123 is an FDA 510(k) clearance for the APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on July 17, 2008 after a review of 182 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K080123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2008
Decision Date July 17, 2008
Days to Decision 182 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 88d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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.