Cleared Traditional

K080123 - APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201

K080123 is an FDA 510(k) clearance for APOLOWAKO HBA1C, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K080123 · Wako Chemicals USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K080123

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
Combination Product No
PCCP Authorized No
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.

CFR Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CFR Hexokinase, Glucose

All 136
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K080123.
POLY-CHEM 90 GLUCOSE
K090703 · Polymedco, Inc. · Oct 2009
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · Medica Corp. · Sep 2009
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K081276 · Horiba Abx · Sep 2008
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
K072140 · Alfa Wassermann Diagnostic Technologies, Inc. · Jun 2008
BS-200 CHEMISTRY ANALYZER, MODE BS-200
K072018 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2008
POINTE 360
K062118 · Pointe Scientific, Inc., · Jul 2007