Cleared Traditional

K162822 - ADAMS A1c HA-8180V

K162822 is the FDA 510(k) clearance for ADAMS A1c HA-8180V by Arkray Factory, Inc.. It is a Class 2 Chemistry device (product code PDJ) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K162822 · Arkray Factory, Inc. · Chemistry device
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Jun 2017
Decision
265d
Days
Class 2
Risk

K162822 is an FDA 510(k) clearance for the ADAMS A1c HA-8180V, CALIBRATOR 80. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Arkray Factory, Inc. (Koka-Shi, JP). The FDA issued a Cleared decision on June 29, 2017 after a review of 265 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 Arkray Factory, Inc. devices

Submission Details

510(k) Number K162822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2016
Decision Date June 29, 2017
Days to Decision 265 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
177d slower than avg
Panel avg: 88d · This submission: 265d
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 21
Devices cleared under the same product code (PDJ) and FDA review panel - the closest regulatory comparables to K162822.
Afinion HbA1c Dx
K180296 · Alere Technologies AS · May 2018
CAPILLARYS Hb A1c
K171861 · Sebia · Feb 2018
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
K171771 · Siemens Healthcare Diagnostics, Inc. · Dec 2017
D-10 Hemoglobin A1c Program
K161687 · Bio-Rad Laboratories, Inc. · Oct 2016
D-100 HbA1c, D-100 HbA1c Calibrator Pack
K151321 · Bio-Rad Laboratories, Inc. · Dec 2015
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II
K142595 · Ortho-Clinical Diagnostics · Jun 2015