Cleared Traditional

K151321 - D-100 HbA1c

K151321 is the FDA 510(k) clearance for D-100 HbA1c by Bio-Rad Laboratories, Inc.. It is a Class 2 Chemistry device (product code PDJ) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K151321 · Bio-Rad Laboratories, Inc. · Chemistry device
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Dec 2015
Decision
205d
Days
Class 2
Risk

K151321 is an FDA 510(k) clearance for the D-100 HbA1c, D-100 HbA1c Calibrator Pack. Classified as Hemoglobin A1c Test System (product code PDJ), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Hercules, US). The FDA issued a Cleared decision on December 9, 2015 after a review of 205 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K151321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2015
Decision Date December 09, 2015
Days to Decision 205 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
117d slower than avg
Panel avg: 88d · This submission: 205d
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 20
Devices cleared under the same product code (PDJ) and FDA review panel - the closest regulatory comparables to K151321.
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
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
Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls
K140654 · Abbott Laboratories · May 2015
VARIANT II TURBO HbA1c Kit - 2.0
K142448 · Bio-Rad Laboratories, Inc. · Mar 2015