Cleared Traditional

K140654 - Hemoglobin A1c Assay

K140654 is an FDA 510(k) clearance for Hemoglobin A1c Assay, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code PDJ cleared through the Traditional 510(k) pathway after a 434-day FDA review.

K140654 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
434d
Days
Class 2
Risk

K140654 is an FDA 510(k) clearance for the Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 22, 2015 after a review of 434 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K140654

510(k) Number K140654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2014
Decision Date May 22, 2015
Days to Decision 434 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
346d slower than avg
Panel avg: 88d · This submission: 434d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDJ Device Classification - Class 2, Special Controls

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 K140654.
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
VARIANT II TURBO HbA1c Kit - 2.0
K142448 · Bio-Rad Laboratories, Inc. · Mar 2015
HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS
K130255 · Abbott Laboratories · Feb 2014
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
DEN130002 · Roche Diagnostics · May 2013